Supplementary appendix 1

This appendix formed part of the original submission and has been peer reviewed.
We post it as supplied by the authors.

This online publication has been corrected. The corrected version irst appeared
at [Link] on February 15, 2023

Supplement to: Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-
severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52
results of two identical, multicentre, randomised, placebo-controlled, double-blind
phase 3 trials. Lancet 2023; published online Feb 3. [Link]
6736(23)00022-3.
1 Supplementary Appendix
2 This appendix has been provided by the authors to give readers additional information about their

3 work.

4 Title
5 Secukinumab in Moderate to Severe Hidradenitis Suppurativa: Week 16 and 52 results from
6 SUNSHINE and SUNRISE, two identical, double-blind, placebo-controlled, Phase 3 randomised trials

7 Authors
8 Alexa B. Kimball, Gregor B.E. Jemec, Afsaneh Alavi, Ziad Reguiai, Alice B. Gottlieb, Falk G. Bechara,
9 Carle Paul, Evangelos J. Giamarellos Bourboulis, Axel Villani, Andreas Schwinn, Franziska Ruëff,
10 Larisha Pillay Ramaya, Adam Reich, Ines Lobo, Rodney Sinclair, Thierry Passeron, Antonio Martorell,
11 Pedro Mendes-Bastos, Georgios Kokolakis, Pierre-Andre Becherel, Magdalena B. Wozniak, Angela
12 Llobet Martinez, Xiaoling Wei, Lorenz Uhlmann, Anna Passera, Deborah Keefe, Ruvie Martin, Clarice
13 Field, Li Chen, Marc Vandemeulebroecke, Shoba Ravichandran, Elisa Muscianisi

14 Table of Contents
15 The SUNSHINE study group: List of Investigators, Sub-investigators, and Study Sites Involved
16 in SUNSHINE. ........................................................................................................................................ 3
17 The SUNRISE study group: List of Investigators, Sub-investigators, and Study Sites Involved
18 in SUNRISE. ......................................................................................................................................... 15
19 Supplementary Methods .................................................................................................................... 27
20 Full list of inclusion criteria................................................................................................................. 27
21 Full list of exclusion criteria................................................................................................................ 27
22 Sample size calculations ................................................................................................................... 29
23 Analysis of two different database locks ........................................................................................... 30
24 Statistical testing procedure .............................................................................................................. 31
25 Sensitivity analysis for week 52 efficacy data ................................................................................... 32
26 Pooled study analysis ........................................................................................................................ 33
27 Supplementary Results ...................................................................................................................... 34
28 Sensitivity analysis for week 52 efficacy data ................................................................................... 34
29 Pooled study analysis ........................................................................................................................ 34
30 Supportive analysis: AN50 response ................................................................................................ 34
31 Safety................................................................................................................................................. 35
32 Treatment emergent adverse events ............................................................................................. 35
33 Candida infections ......................................................................................................................... 35
34 Supplementary Tables ........................................................................................................................ 37
35 Table S1. Odds ratio and least squares means of primary and secondary endpoints ..................... 37

1
36 Table S2. Frequent* treatment-emergent AEs by PT to week 16 in the SUNSHINE and SUNRISE
37 trials ................................................................................................................................................... 38
38 Table S3. Deaths, other serious or clinically significant AEs or related discontinuations to week 52
39 in the SUNSHINE and SUNRISE trials ............................................................................................. 40
40 Table S4. Treatment-emergent SAEs by PT to week 16 in the SUNSHINE and SUNRISE trials .... 42
41 Table S5. Treatment-emergent SAEs by PT to week 52 in the SUNSHINE and SUNRISE trials .... 43
42 Table S6. Treatment-emergent AEs by primary SOC to week 16 in the SUNSHINE and SUNRISE
43 trials ................................................................................................................................................... 46
44 Table S7. Frequent* treatment-emergent AEs by PT to week 52 in the SUNSHINE and SUNRISE
45 trials ................................................................................................................................................... 47
46 Table S8. Treatment-emergent AEs by primary SOC to week 52 in the SUNSHINE and SUNRISE
47 trials ................................................................................................................................................... 50
48 Table S9. Candida infections by PT to week 16 in the SUNSHINE and SUNRISE trials ................. 52
49 Table S10. Candida infections by PT to week 52 in the SUNSHINE and SUNRISE trials ............... 53
50 Supplementary Figures ...................................................................................................................... 54
51 Figure S1. Study design of the SUNSHINE and SUNRISE trials ...................................................... 54
52 Figure S2. The effects of secukinumab and placebo on components of the HiSCR to week 52 ...... 55
53 Figure S3. The effects of secukinumab and placebo on DLQI responders and EQ-5D VAS score to
54 week 52 ............................................................................................................................................. 57
55 Figure S4. Hierarchical testing strategy employed in the SUNSHINE and SUNRISE trials ............. 58
56 Figure S5. Sensitivity analysis of week 52 efficacy data ................................................................... 59
57 Figure S6. The effects of secukinumab on HiSCR, AN count and flares to week 52: pooled study
58 data .................................................................................................................................................... 62
59 Figure S7. The effects of secukinumab on DLQI responders to week 52: pooled trial data ............. 63
60 Figure S8. The effects of secukinumab on AN50 response rates to week 52 .................................. 64
61 Figure S9. The effects of secukinumab on AN50 response rates to week 52: pooled trial data ...... 65
62 Supplementary References ................................................................................................................ 66
63

64

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65 The SUNSHINE study group: List of Investigators, Sub-investigators, and
66 Study Sites Involved in SUNSHINE.

Investigator/Sub- Position/Role Study site

investigator
Dr. Gabriel Alejandro Principal Investigator Psoriahue Buenos Aires, Buenos Aires,
Magariños Argentina, C1425DKG
Dr. Carla Castro Sub-investigator
Carlos Adrian Antonelli Sub-investigator
Carolina Meaggia Sub-investigator
Esteban Covian Sub-investigator
Federico Strambach Sub-investigator
Florencia Benigni Sub-investigator
Dr. Giselle Vazquez Sub-investigator
Dr. Javier Ubogui Sub-investigator
María Laura García Sub-investigator
Pazos
Dr. Juan Pedro Russo Principal Investigator Framingham Centro Medico La Plata, Buenos
Dr. Jesus Abel Cuadrado Sub-investigator Aires, Argentina, B1902COS
Dr. Juan Francisco Sub-investigator
Palazzolo
Dr. Paula Carolina Luna Principal Investigator Consultorio Particular Dra. Larralde Ciudad
Larralde Margarita Sub-investigator Autonoma de Bs As, Buenos Aires, Argentina,
Luciana Tirelli Sub-investigator C1425BEA
Panizzardi A. Anabel Sub-investigator
Ramiro Cano Sub-investigator
Carla Luna Study Coordinator
Prof. Rodney Sinclair Principal Investigator Sinclair Dermatology, East Melbourne, VIC,
Ameshin Moodley Sub-investigator Australia, 3002
Anneliese Margaret Sub-investigator
Willems
Anthony Moussa Sub-investigator
Karolina Kerkemeyer Sub-investigator
Ferial Ismail Sub-investigator
Georgina Hollmann Sub-investigator
Jared John Sub-investigator
Lara Trindade de Sub-investigator
Carvalho
Louise Photiou Sub-investigator
Rebekka Jerjen Sub-investigator
Dr. Michael Freeman Principal Investigator The Skin Centre, Benowa, QLD, Australia,
Andrew Freeman Sub-investigator 4217
Dr. Diana M Rubel Principal Investigator Woden Dermatology, Phillip, ACT, Australia,
Dr. Estella Janz- Sub-investigator 2606
Robinson
Dr. Subashini Sub-investigator
Gnanendran
[Link]. [Link]. Dr. Principal Investigator Univ Klinik Dermatologie AKH Wien, Wien,
Constanze Jonak Austria, A 1090
Dr. Antonia M Wesinger Sub-investigator
Dr. Julia B Tittes Sub-investigator
Assoc. Prof. Dr. Patrick M Sub-investigator
Brunner
Prof. Dr. med. univ. Principal Investigator Ordensklinikum Linz GmbH Elisabethinen,
Norbert Sepp u (Since Aug 2019) Linz, Austria, 4020

3
OA Dr. Barbara Ernst Principal Investigator
(Until Aug 2019)
Dr. Astrid Badesc Sub-investigator
Dr. Elisabeth Fabian Sub-investigator
Prof. Dr. Veronique Del Principal Investigator Hospital Erasme, Bruxelles, Belgium, 1070
Marmol
Carmen Orte Cano Sub-investigator
Daoud Mathieu Sub-investigator
Dr. Farida Benhadou Sub-investigator
Dr. Julio Tannous Sub-investigator
Dr. Mariano Suppa Sub-investigator
Dr. Mathilde Daxhelet Sub-investigator
Dr. Nancy Hajjar Sub-investigator
Prof. Dr. Evgeniya Principal UMHAT Prof. Dr. Stoian Kirkovich, Stara
Hristakieva Investigator Zagora, Bulgaria, 6000
Dr. Desislava Sub-investigator
Gancheva
Dr. Rositsa Lavcheva Sub-investigator
Dr. Tanya Gancheva Sub-investigator
Dr. Zhenya Troeva Sub-investigator
Hristova
Prof. Dr. Nikolay Tsankov Principal Investigator EuroDerm Clinic, Sofia, Bulgaria, 1606
Dr. Ivan Bogdanov Sub-investigator
Dr. Margarita Kacheva Sub-investigator
Assoc. Prof. Zana Sub-investigator
Kazandjieva
Dr. Wei Jing Loo Principal Investigator Derm Effects, London, ON, Canada, N6H 5L5
Dr. Keng Tay Sub-investigator
Fatma Alqahwaji Study Coordinator
Jayla Franks Study Coordinator
Nina Nissan Study Coordinator
Christina Graig Lead Study
Coordinator
Tammy Turbide Nurse Injector
Dr Melinda J Gooderham Principal Investigator Skin Centre for Dermatology, Peterborough,
Ashley O'Toole Sub-investigator ON, Canada, K9J 5K2
William Swales Sub-investigator
Novin Nezamoloma Study Coordinator
Daryl Baquillos Study Coordinator
Marie Fisher Study Coordinator
Dr. Kim Alexander Papp Principal Investigator Dr. K Papp Clinical Research, Waterloo,
Dr. Ajith Cy Sub-investigator Ontario, Canada, N2J 1C4
Dr. Jensen Yeung Sub-investigator
Beverly Vanderstelt Study Coordinator
Carolyn Nadeau Study Coordinator
Melissa Nuhn Study Coordinator
Simone Paynter Study Coordinator
Yuriy Voznyak Study Coordinator
Prof. MUDr. Petr Principal Investigator Sanatorium Profesora Arenbergera Prague,
Arenberger Prague 1, Czech Republic, 11000
MUDr. Emanuel Marques Sub-investigator
Milena Tanczosova Sub-investigator
Doc. MUDr. Monika Sub-investigator
Arenbergerova
Doc. MUDr. Spyridon Sub-investigator
Gkalpakiotis
MUDr. Athanasios Sub-investigator
Stefanis

4
Petra Cetkovska Principal Investigator Fakultni nemocnice Plzen Plzen, Bory, Czech
Dr. Adela Ruzickova Sub-investigator Republic, 305 99
Bohumil Rosocha Sub-investigator
Dr. Iva Lomicova Sub-investigator
Dr. Veronika Svobodova Sub-investigator
Prof. Dr. Marie Polina Principal Investigator Hopital De Larrey, Toulouse Cedex 9, France,
Konstantinou (Since Jan 2020) 31059
Prof. Dr. Carle Paul Principal Investigator
(Until Jan 2020)
Amel Bouznad Sub-investigator
Dr. Cristina Livideanu Sub-investigator
Dr. Salama Hegazy Sub-investigator
Marie Tauber Sub-investigator
Prof. Dr. Herve Bachelez Principal Investigator Hopital Saint Louis, Paris cedex 10, France,
Dr. Charles Cassius Investigator 75475
Laure Frumholtz Investigator
Pierre Schneider Investigator
Dr Laurent Misery Principal Investigator Hopital Augustin Morvan, Brest, France,
Dr. Emilie Brenaut Sub-investigator 29609
Dr. Flavien Huet Sub-investigator
Dr. Olivier Dereure Principal Investigator CHRU de Montpellier Hopital Saint Eloi,
Dr. Anouck Lamoureux Sub-investigator Montpellier cedex 5, France, 34295
Dr. Celine Girard Sub-investigator
Dr. Brigitte Dreno Principal Investigator CHU de Nantes Hotel Dieu, Nantes Cedex 1,
Dr. Barbara Bregeon Sub-investigator France, 44093
Dr. Cecile Frenard Sub-investigator
Dr. Charlotte Paugam Sub-investigator
Dr. Sarah Le Naour Sub-investigator
Dr. Olivier Cogrel Principal Investigator Hospital Saint Andre, Bordeaux Cedex,
Dr. Severine Amico Sub-investigator France, 33075
Dr. Brigitte Milpied Sub-investigator
Dr. Diane Heron-Mermin Sub-investigator
Dr. Laure Dequidt Sub-investigator
Dr. Marie Levy Sub-investigator
Dr. Marie Beylot-Barry Sub-investigator
Dr. Ocean Ducharme Sub-investigator
Prof. Dr. Denis Jullien Principal Investigator Hopital Edouard Herriot, Lyon, France, 69437
Dr. Axel Villani Co-investigator
Pascaline Bouscton Co-investigator
Kinda Fattouh Co-investigator
Dr. Philippe Guillem Co-investigator
Andrea Calugreanu Sub-investigator
Dr. Cecile Lesort Sub-investigator
Laurie Gouillon Sub-investigator
Dr. Claire Hotz Principal Investigator Hopital Henri Mondor, Creteil, France, 94010
Dr. med. Beate Schwarz Principal Investigator Praxis Langenau, Germany, 89129
Dr. med. Simone Sub-investigator
Fuenkele
Dr. med. Abdou Zarzour Principal Investigator Praxis Halle, Germany, 06108
Prof. Dr. med. Klaus- Sub-investigator
Michael Taube
Prof. Dr. med. Falk Principal Investigator Universitaetsklinikum Bochum, Bochum,
Georges Bechara Germany, 44791
Caroline Seifert Co-investigator
Celine Richards Co-investigator
Dr. med. Christina Scheel Co-investigator
Christine Kronenberg Co-investigator
Laura Selke Co-investigator

5
Lisa Scholl Co-investigator
Marc Hanno Segert Co-investigator
Maria Bakirtzi Co-investigator
Philipp Cramer Co-investigator
Vanessa Witte Co-investigator
Lutz Schmitz Sub-investigator
Prof. Dr. med. Eggert Sub-investigator
Stockfleth
Dr. med. Thomas Volz Principal Investigator Klinik und Poliklinik fur Dermatologie und
Christian Oesterlin Co-investigator Allergologie am Biederstein der TU München,
Danielle Franziska Co-investigator München, Germany, 80802
Boehmer
Dr. med. Peter Seiringer Co-investigator
Rosi Wang Co-investigator
Viktoria Lang Co-investigator
Dr. med. Alexander Zink Sub-investigator
Dr. med. Andreas Principal Investigator Beldio Research GmbH Dr Schwinn,
Schwinn Memmingen, Germany, 87700
Corinna Rendl Co-investigator
Dr. med. Gertraud Sub-investigator
Kraehn Senftleben
Dr. med. Nicolai Treiber Sub-investigator
Prof. Dr. med. Khusru Principal Investigator Hauraztpraxis Prof. Dr. med. Khusru
Asadullah Asadullah, Potsdam, Germany, 14467
Franziska Flessner Co-investigator
Dr. med. Katja Sub-investigator
Fuhrmeister
Prof. Dr. med. Isaak Principal Investigator Klinikum Bielefeld Hautklinik gGmbH,
Effendy Bielefeld, Germany, 33647
Benjamin Bury Co-investigator
Carolin Halfar Co-investigator
Helene Tonner Co-investigator
Dr. med. Lea Kristin Co-investigator
Oberfeld
Dr. med. Katharina Sub-investigator
Kreutzer
Dr. med. Andreas Pinter Principal Investigator Klinikum der Johann-Wolfgang Goethe
Dr. med. Amelie Co-investigator Universitaet Zentrum fuer Dermatologie und
Buchinger Venerologie Theodor-Stern-Kai 7, Frankfurt,
Clara Geppert Co-investigator Germany, 60590
Deniz Ozistanbullu Co-investigator
Kim Nikola Zeiner Co-investigator
Samuel Thomas Co-investigator
Dr. med. Sebastian Co-investigator
Osowski
Thomas Mayer Co-investigator
Bartosz Malisiewicz Sub-investigator
Prof. Evangelos Principal Investigator University General Hospital ATTIKON, Athens,
Giamarellos-Bourboulis Greece
Dr. Asimina Safarika Sub-investigator
Dr. Dimitra Stergianou Sub-investigator
Dr. Katrini Konstantina Technician
Dr. Nikolaos Antonakos Sub-investigator
Dr. Panagiotis Technician
Koufargyris
Sofia Rellou Sub-investigator
Styliani Micha Sub-investigator
Dr. Vassiliki Tzanetakou Sub-investigator

6
Angeliki Konstantopoulou Study Coordinator
Georgia Damoraki Technician
Theodora Kanni Sub-investigator
Gkavogianni Theologia Technician
Prof. Dimitrios Ioannidis Principal Investigator Hospital of Skin and Venereal Diseases of
Dr. Aikaterini Bakirtzi Sub-investigator Thessaloniki, Thessaloniki, Greece, 546 43
Dr. Efstratios Vakirlis Sub-investigator
[Link]. Eleni Sotiriou Sub-investigator
Michael Arabatzis Sub-investigator
Prof. Dr Rolland P. Gyulai Principal Investigator PTE Klinikai Kozpont Pecs, Baranya,
Dr. Agnes Kinyo Sub-investigator Hungary, 7632
Dr. Dorottya Kovesdi Sub-investigator
Dr. Miklos Sardy Principal Investigator Semmelweis Egyetem, Budapest, Hungary,
Kende Lorincz Sub-investigator 1085
Dr. Lili Robert Sub-investigator
Dr. Rohit Batra Principal Investigator Sir Ganga Ram Hospital, New Delhi, Delhi,
Dr. Subhash Chandra Sub-investigator India, 110 060
Bharija
Dr. Suneel Vartak Principal Investigator Sujata Birla Hospital and Medical Research
Trupti Desale Co-investigator Center, Nashik, Maharashtra, India, 422 101
Dr. Ramesh Bhat M Principal Investigator Father Muller Medical College, Mangalore,
Dr. Jyothi Jayaraman Sub-investigator Karnataka, India, 575002
Dr. Nanjundaswamy B L Principal Investigator KR Hospital, Mysore, Karnataka, India,
Dr. Bangaru H Sub-investigator 570001
Dr. Raghavendra K R Sub-investigator
Prof. Abraham Principal Investigator Hadassah Medical Organization Ein Karem,
Zlotogorski Jerusalem, Israel, 91120
Dr. Gil Armoni Sub-investigator
Dr. Ruba Ibrahim Sub-investigator
Prof. Yuval Ramot Sub-investigator
Dr. Yossef Haim Taieb Principal Investigator Rabin Medical Center Belinson, Petach Tikva,
(Since Aug 2020) Israel, 49100
Dr. Shany Sherman Principal Investigator
Bergman (Until Aug 2020)
Dr. Adi Nosrati Sub-investigator
Dr. Einav Bercovichi Sub-investigator
Dr. Jonathan Noyman Sub-investigator
Dr. Meital Oren-Shabtai Sub-investigator
Dr. Omri Zidan Sub-investigator
Roie Holzman Sub-investigator
Prof. Angelo Valerio Principal Investigator [Link] Ca' Granda [Link]
Marzano Policlinico [Link], Milano, MI, Italy, 20122
Dario Antonio Marletta Sub-investigator
Dr. Gianluca Nazzaro Sub-investigator
Dr. Simona Muratori Sub-investigator
Prof. Dr. Francesca Principal Investigator Azienda USL Toscana Centro, Firenze, FI,
Prignano Italy, 50122
Dr. Elia Rosi Sub-investigator
Dr. Federica Ricceri Sub-investigator
Ilaria Scandagli Sub-investigator
Dr. Leonardo Pescitelli Sub-investigator
Maria Thais Fastame Sub-investigator
Prof. Marco Romanelli Principal Investigator AOU Pisana Presidio Ospedaliero S Chiara,
Dr. Bianca Benedetta Sub-investigator PISA, PI, Italy, 56124
Benincasa
Cristian Fidanzi Sub-investigator
Giulia Tonini Sub-investigator
Dr. Michela Iannone Sub-investigator

7
Dr. Valentina Dini Sub-investigator
Laura Bigi Principal Investigator A O Univ Policl di Modena Univ Studi Modena
(Since Jan 2021) e R Emilia, Modena, MO, Italy, 41124
Giuseppe Pellacani Principal Investigator
(Until Jan 2021)
Marco Maneredwi Sub-investigator
Matteo Giovani Sub-investigator
Nicola Lippons Sub-investigator
Camilla Reggiani Sub-investigator
Gioia Pedroni Sub-investigator
Dr. Koremasa Hayama Principal Investigator Nihon University Itabashi Hospital Itabashi-ku,
Asami Takatori Sub-investigator Tokyo, Japan, 173-8610
Ayano Kurumatani Sub-investigator
Chihiro Fujinuma Sub-investigator
Daisuke Fujisawa Sub-investigator
Hideki Fujita Sub-investigator
Hironori Kawana Sub-investigator
Keisuke Shimizu Sub-investigator
Kyoko Yoshida Sub-investigator
Madoka Ishii Sub-investigator
Maho Tagui Sub-investigator
Mana Ito Sub-investigator
Masafumi Ozaki Sub-investigator
Dr. Nobuyuki Nishimori Sub-investigator
Satoshi Izaki Sub-investigator
Tadashi Terui Sub-investigator
Takahiro Endo Sub-investigator
Tomomi Tagui Sub-investigator
Yuki Tsutsui Sub-investigator
Yusuke Niwa Sub-investigator
Dr. Akimichi Morita Principal Investigator Nagoya City University Hospital Nagoya-city,
Aya Nakada Sub-investigator Aichi, Japan, 467-8602
Emi Nishida Sub-investigator
Haruna Nishihara Sub-investigator
Kato Hiroshi Sub-investigator
Dr. Kentaro Hayashi Principal Investigator University of the Ryukyus Hospital Nakagami,
Dr. Osao Arakaki Sub-investigator Okinawa, Japan, 903 0215
Ririko Iwamoto Sub-investigator
Dr. Ryo Yasumura Sub-investigator
Dr. Sayaka Yamaguchi Sub-investigator
Dr. Takuya Miyagi Sub-investigator
Takuya Omine Sub-investigator
Dr. Yuichi Yamamoto Sub-investigator
Dr. Kazuhiro Inafuku Principal Investigator Kimitsu Chuou Hospital Kisarazu, Chiba,
Ryosuke Tagashira Sub-investigator Japan, 292-8535
Yu Kawahara Sub-investigator
Dr. Kazumoto Katagiri Principal Investigator Dokkyo Medical University Saitama Medical
Marina Yamazaki Sub-investigator Center Koshigaya-city, Saitama, Japan, 343-
Megumi Yokoyama Sub-investigator 8555
Dr. Nao Ichimasu Sub-investigator
Rana Kawai Sub-investigator
Sakiko Shimura Sub-investigator
Sou Suzuki Sub-investigator
Tokihiro Nishimura Sub-investigator
Yasunori Matsuki Sub-investigator
Dr. Chiharu Tateishi Principal Investigator Osaka City University Hospital Osaka, Osaka,
(Since Oct 2020) Japan, 545-8586

8
Dr. Koji Sugawara Principal Investigator
(Until Oct 2020)
Aiko Yamauchi Sub-investigator
Kozo Nakai Sub-investigator
Dr. Mika Takaichi Sub-investigator
Miyu Shiratori Sub-investigator
Rie Teranishi Sub-investigator
Dr. Tatsuhiko Ikenaga Sub-investigator
Toshiyuki Ozawa Sub-investigator
Yuka Ayano Sub-investigator
Prof. Dr. Dae Hun Suh Principal Investigator Seoul National University Hospital, Seoul,
Dong Hyo Kim Sub-investigator Republic of Korea, 03080
Ji Won Kim Sub-investigator
Dr. Jihoon Yang Sub-investigator
Dr. Soo Ick Cho Sub-investigator
Sungjum Choi Sub-investigator
Prof. Dr. Hye One Kim Principal Investigator Hallym University Kangnam Sacred Heart
Dr. Bo Young Chung Sub-investigator Hospital, Seoul, Republic of Korea, 07441
Dr. Chun Wook Park Sub-investigator
Minje Jung Sub-investigator
Seok Young Kang Sub-investigator
Dr. Hyo Hyun Ahn Principal Investigator Korea University Anam Hospital, Seoul,
Dae Yeon Kim Sub-investigator Republic of Korea, 02841
Dr. Min Seok Ham Sub-investigator
Dr. Sung Jin Park Sub-investigator
OkSun On Study Coordinator
Dr. Delfina Guadalupe Principal Investigator Delfina Villanueva Quintero, Guadalajara,
Villanueva Quintero Jalisco, Mexico, 44657
Dr. Cipactli Ariel Navarro Sub-investigator
Hernandez
Dr. Jorge De Jesus Principal Investigator Hosp Univ Dr Jose E Gonzalez, Monterrey,
Ocampo Candiani Nuevo Leon, Mexico, 64460
Adrian Bernardo Cuellar Sub-investigator
Barboza
Dr. Maira Elizabeth Herz Sub-investigator
Ruelas
Dr. Sonia Chavez Alvarez Sub-investigator
Gabriela Zapata Study Coordinator
Gonzalez
Dr. Victoria Patino Principal Investigator Southern Philippines Medical Center, Davao
Guillano City, Davao del Sur, Philippines, 8000
Dr. Bryan Edgar Guevara Sub-investigator
Dr. Jenifer R. Otadoy Principal Investigator University of Perpetual Help DALTA Medical
Agustin Center, Las Pinas, Philippines, 1740
Dr. Celine Antoinette Sub-investigator
Yapjuangco
Dr. Johanna Dizon Sub-investigator
Dr. Lily Lyralin L Tumalad Principal Investigator East Avenue Medical Centre, Quezon City,
Dr. Gemmy P David Sub-investigator Philippines, 1100
Dr. Maria Franchesca S Sub-investigator
Quinio
Dr. Jacek Szepietowski Principal Investigator City Clinic, Wroclaw, Poland, 50 566
Iwona Chlebicka Sub-investigator
Julia Seniuta Sub-investigator
Łukasz Matusiak Sub-investigator
Dr. Beata Bergler- Czop Principal Investigator NZOZ Labderm s c, Ossy, Poland, 42 624
Hubert Arasiewicz Sub-investigator
Natalia Salwowska Sub-investigator

9
Dr. Ewa Ring Principal Investigator Prywatna Praktyka Lekarska Ewa Ring ul.
Magdalena Jasińska Sub-investigator Solipska 27 lok. LU- 3, Warszawa, Poland, 02-
482
Dr. Joana Cabete Principal Investigator Ctro Hosp Lisboa Central E P E Hosp St
Dr. Andre Lencastre Sub-investigator Antonio dos Capuchos, Lisboa, Portugal, 1150
Jose Neves Sub-investigator 314
Neila Cuhna Sub-investigator
Dr. Pedro Andrade Principal Investigator Unidade Local de Saude de Matosinho
Joana Rocha Sub-investigator Hospital Pedro Hispano, Matosinhos,
Portugal, 4454 513
Dr. Ines Lobo Principal Investigator Centro Hospitalar do Porto Hospital de Santo
Joel Reis Sub-investigator Antonio, Porto, Portugal, 4099-001
Dr. Pedro Bastos Principal Investigator Hospital CUF Descobertas, Lisboa, Portugal,
Ana Isabel Gouveia Co-investigator 1998-018
Dr. Alkes Khotko Principal Investigator Clinical Dermatovenerological Dispensary,
Dr. Afina Aslanova Sub-investigator Krasnodar, Russia, 350020
Dr. Diana Sub-investigator
Vyacheslavovna
Mikhaylova
Mohamed Chahin Surgeon
Oksana Pshidatok Sub-investigator
Prof. Vladimir Principal Investigator Clinical Emergency Hospital n a N V Soloviev,
Valentinovich Yakusevich Yaroslavl, Russia, 150003
Alexander Turovnik Sub-investigator
Dr. Alexey Esenin Sub-investigator
Dr. Andrey Kabanov Sub-investigator
Dr. Ella Vvedenskaya Sub-investigator
Natalia Lebedeva Study Nurse
Dr. Iskander Kagapovich Principal Investigator Republican Clinical dermatovenerologic
Minullin Dispensary, Kazan, Russia, 420012
Dr. Evgenia Bildyuk Sub-investigator
Ildar Nurmeev Sub-investigator
Dr. Svetlana Amurovna Sub-investigator
Zalyaleeva
Tatiana Naymushina Unblinded ESR
Processor
Dr. Evgeny Sokolovskiy Principal Investigator First Saint Petersburg State Medical University
Dr. Andrey Demin Sub-investigator n a I P Pa, St. Petersburg, Russia, 197022
Dr. Anna Maximova Sub-investigator
Dr. Denis Shustov Sub-investigator
Dr. Elizaveta Manasheva Sub-investigator
Olga Prudnikova Study Nurse
Ekaterina Barysheva Study Coordinator
Dr. Juraj Pec Principal Investigator Univerzitna nemocnica Martin, Martin,
Dr. Karolina Vorcakova Sub-investigator Slovakia, (Slovak Republic), 03 659
Robert Vysehradsky Pneumologist
Kamil Zelenak Radiologist
Martin Vorcak Radiologist
MUDr. Tomas Kampe Principal Investigator UN L Pasteura, Kosice, Slovakia, (Slovak
MUDr. Janette Baloghova Co-investigator Republic), 04 001
MUDr. Andraj Somos Pneumologist
MUDr. Lubomir Demsky Radiologist
Dr. Concepcion Postigo Principal Investigator Hospital Universitario 12 De Octubre, Madrid,
Raquzl Rivera Sub-investigator Spain, 28041
Veronica Monsecicz Sub-investigator
Dr. Maria Angeles Florez Principal Investigator Centro de Especialidades de Mollabao,
Menendez Pontevedra, Spain, 36003
Dra. Aqurina Ramirez Sub-investigator

10
Beatriz Gonzalez Sixto Sub-investigator
Laura Mesa Sub-investigator
Dra. Laura Salgado Sub-investigator
Boquete
M-Teresa Abalde Pintos Sub-investigator
Dr. Marcos Oro Ayude Sub-investigator
Queila Rcdrguez Jato Sub-investigator
Dr. Jose Carlos Pascual Principal Investigator Hospital General Universitario de Alicante,
Maria Jose Sanchez Sub-investigator Alicante, Comunidad Valenciana, Spain,
PuJol 03010
Dr. Iris Gonzalez Sub-investigator
Villanueva
Dr. Eva Rull Vilarrasa Principal Investigator Hospital Sant Pau Barcelona, Barcelona,
Euginia Agut Busquet Sub-investigator Spain, 08041
Flavia Bittencourt Moraes Sub-investigator
Dr. Alberto Romero Principal Investigator Hospital de Fuenlabrada, Fuenlabrada,
Begona Echevevvia Sub-investigator Madrid, Spain, 28942
Cristina M Moran Sub-investigator
Tamara Kueder Sub-investigator
Dr. David Jimenez Gallo Principal Investigator Hospital Puerta del Mar, Cadiz, Andalucía,
Cristina Collantes Sub-investigator Spain, 11009
Gonzalo Gallo Pineda Sub-investigator
Irene Navarro Navarro Sub-investigator
Mario Linares Barrios Sub-investigator
Sandra Valenzuel Ubina Sub-investigator
Dr. Ansam Al-Bayatti Principal Investigator Akademiska sjukhuset, Uppsala, Sweden, 751
Dr. Lotta Sandelin Co-investigator 85
Francke
Marie Virtanen Sub-investigator
Dr. Emmanuel Laffitte Principal Investigator Hopitaux Universitaire Geneve, Geneve,
Dr. Alexia Maillard Sub-investigator Switzerland, 1205
Dr. Audrey Loretan Sub-investigator
Dr. Marem Abosaleh Sub-investigator
Fabio Cassano Study Coordinator
Sylvie Von Der Weid Study Coordinator
Prof. Dr. med. Robert E. Principal Investigator Inselspital Bern, Bern, Switzerland, 3010
Hunger
Lorenzo Pelloni Sub-investigator
Matthias Lehmann Sub-investigator
Morteza Jafari Sub-investigator
Petra Margith Schorno Sub-investigator
Dr. Chung-Yee Roasaline Principal Investigator Chang Gung Memorial Hospital LinKou,
Hui Taoyuan, Taiwan, 33305
Dr. Chin Yi Yang Sub-investigator
Dr. Chung-Wei Lu Sub-investigator
Dr. Jennifer Wu Sub-investigator
Dr. Wen-Hung Chung Sub-investigator
Yu-Huei Huang Sub-investigator
Dr. Yi-Hua Liao Principal Investigator National Taiwan University Hospital, Taipei,
Dr. Tsen-Fang Tsai Sub-investigator Taiwan, 10002
Prof. Dr. Serhat Inaloz Principal Investigator Gaziantep University Medical Faculty,
Dr. Idris Demir Sub-investigator Gaziantep, Turkey, 27310
Prof. Dr. Erkan Alpsoy Principal Investigator Akdeniz University Medical Faculty, Antalya,
Kifayat Mammadli Sub-investigator Turkey, 07070
Soner Uzun Sub-investigator
Meltem Uslu Principal Investigator Adnan Menderes University Medical Faculty,
(Since Sep 2020) Aydin, Turkey, 09100

11
Prof. Dr. Neslihan Sendur Principal Investigator
(Until Sep 2020)
Dr. Fatma Nalbant Sub-investigator
Dr. Kave Shams Principal Investigator Chapel Allerton Hospital, Leeds, Yorkshire,
Dr. Jairabanu M. Kassim Sub-investigator United Kingdom, LS7 4SA
Dr. Nazaveen Hassan Sub-investigator
Philip Laws Sub-investigator
Eileen Ogrady Research Nurse
Julie Bush Research Nurse
Karen Hughes Research Nurse
Dr. Deborah Shipley Principal Investigator University Hospitals Bristol NHS Foundation
Dr. Giles Dunnill Sub-investigator Trust, Bristol, United Kingdom, BS2 8HW
Edel Robbins Research Nurse
Jebin Tomy Research Nurse
Jo Roberts Research Nurse
Moira Tait Research Nurse
Natasha Beck Research Nurse
Dr. Kay Baxter Principal Investigator Barnsley Hospital NHS Foundation Trust,
Ambar Shaukat Sub-investigator Barnsley, South Yorkshire, United Kingdom,
S75 2EP
Dr. Emma McMullen Principal Investigator Salford Royal NHS Foundation Trust, Salford,
Anelle RA Sub-investigator Manchester, United Kingdom, M6 8HD
Dr. David Fitzgerald Sub-investigator
Durga Vishweshwaratna Sub-investigator
Dr. Zoe Littlewood Sub-investigator
Jacqueline Howe Research Nurse
Rebecca Jane Batchelor Principal Investigator Royal Devon and Exeter NHS Foundation
Yusur Aenuaimi Consultant Trust, Exeter, Devon, United Kingdom, EX1
Fangyi Xie Registrar 2ED
Jane Hall Research Nurse
Rob James Research nurse
Alistair Brown Sub Principal
Investigator
Helen Frow Sub Principal
Investigator
Dr. Syed Shah Principal Investigator Norfolk and Norwich University Hospital,
Adam Hafez Co-investigator Norwich, United Kingdom, NR4 7UY
Dr. Anila Kapadia Co-investigator
Harsharan Kaur Bansal Co-investigator
Hina Jalil Co-investigator
Atheer Al Haddafi Sub-investigator
Jawad Khan Clinical Fellow
Cathy Haughton Research Nurse
Emily Tropman Research Nurse
Gill Pout Research Nurse
Karen Convery Research Nurse
Dr. Paul Getz Principal Investigator Dundee Dermatology West, Dundee, IL,
United States, 60118
Dr. Stephanie Lee Mehlis Principal Investigator NorthShore University Health System, Skokie,
Erendida Sanchez Sub-investigator IL, United States, 60077
Jason Sachman Sub-investigator
Joel Joyce Sub-investigator
Maria Mihailescu Sub-investigator
Rene Chen Sub-investigator
Samantha Gongora Sub-investigator
Cherlyn Cagadas Coordinator
Cristina Fernandez Coordinator
Barbara Gold Nurse Coordinator

12
Judy Spolarich-Kroll Regulatory and
Coordinator
Brianna David Coordinator
Dr. Steven E. Kempers Principal Investigator Minnesota Clinical Studies Center, New
Barabara Schwandt Sub-investigator Brighton, MN, United States, 55432
Dawn Snow Sub-investigator
Dr. Jane Lindholm Sub-investigator
Jenjira Skrei Unblinded ESR
processing
Dr. Aida Lugo- Somolinos Principal Investigator University of North Carolina, Chapel Hill, NC,
Dr. Christopher Sayed Co-investigator United States, 27516
Dr. Walter K Nahm Principal Investigator University Clinical Trials, San Diego, CA,
Darin Martel Sub-investigator United States, 92123
Dr. Melanie Appell Principal Investigator Total Skin and Beauty Dermatology Center
Dr. James Krell Sub-investigator PC, Birmingham, AL, United States, 35205
Brittany Powell Study Coordinator
Candi Nelson Study Coordinator
Angela Powell Lab-Study
Coordinator
Dr. Todd Schlesinger Principal Investigator Clinical Research Center of the Carolinas,
Gina O'Callaghan Sub-investigator Charleston, SC, United States, 29407

Dr. Cheryl Hull Principal Investigator Northwest Arkansas Clinical Trials Center,
Kendall L. Key Sub-investigator PLLC, Rogers, AR, United States, 72758
Thomas D. Davis Sub-investigator
Dr. Alexa B Kimball Principal Investigator Beth Israel Deaconess Medical Center
Jean Mcgee Sub-investigator Harvard Medical School, Boston, MA, United
Kelsey Flood Sub-investigator States, 02215
Martina Poster Sub-investigator
Monica Santilan Sub-investigator
Natalle Eng Sub-investigator
Rand Nashi Sub-investigator
Dr. Ruby Gibson Sub-investigator
Dr. Cheryl L Effron Principal Investigator Cheryl Effron MD Inc, Anaheim, CA, United
Laura A King Sub-investigator States, 92807
Alan Menter Principal Investigator Menter Dermatology Research Institiute at
(Since Aug 2020) Baylor University, Dallas, TX, United States,
Dr. So Yeon Paek Principal Investigator 75246
(Until Aug 2020)
Dr. Dario Kivelevitch Sub-investigator
Quinette Haynes Sub-investigator
Tiffany Small Study Coordinator
Xochitl Flores Study Coordinator
Dr. Annika Silfvast- Sub Principal
Kaiser Investigator
Dr. Marcus Zaayman Sub Principal
Investigator
Dr. Keith H. Loven Principal Investigator Rivergate Dermatology and Skin Care Center,
Narey Cooper Coordinator Goodlettsville, TN, United States, 37072-
Peggy Washer Coordinator 2301
Tammy Mahaffey Coordinator
Sally Lewis Unblinded
Coordinator
Dr. Stephen Miller Principal Investigator Dr. Stephen Miller, MDPA, San Antonio, TX,
Dr. Catherine Tisdall Sub-investigator United States, 78229
Rita Garcia Sub-investigator
William Cragun Sub-investigator
Dr. Anna Nichols Principal Investigator

13
 Anita Arthur Sub-investigator
Dr. Eran Gwillim Sub-investigator
Flor MacQuhae Sub-investigator
Dr. Hadar Lev-Tor Sub-investigator
Olumide Morufu Ojoola Sub-investigator
Dr. Robert Kirsner Sub-investigator University of Miami Health System
Valerina De Bedovt Sub-investigator Dermatology, Miami, FL, United States, 33125
Dr. Jeffrey Bryant Travers Principal Investigator Wright State University, FAIRBORN, OH,
Clayton Conner Sub-investigator United States, 45324
Craig Rohan Sub-investigator
Jaclyn Scholtz Sub-investigator
Patrick Veerkamp Sub-investigator
Elizabeth Usedom Study Coordinator
Hannah Hayes Study Coordinator
Elizabeth Cates Back up Coordinator
Amy Williams Research Assistant
Dr. Melody Lynn Stone Principal Investigator MediSearch Clinical Trials, St Joseph, MO,
Amy L. Horner Sub-investigator United States, 64506
Austin Shandley Sub-investigator
Dr. Laura Ferris Principal Investigator University of Pittsburgh Medical Center Health
Emily R Clark Sub-investigator System, Pittsburgh, PA, United States, 15213-
Hannah Glass Sub-investigator 3403
Dr. Timothy J Patton Sub-investigator
Charity Ruhl Study Coordinator
Megan Sullivan Study Coordinator
Dr. James Grichnik Principal Investigator University of South Florida, Tampa, FL, United
(Since Jun 2021) States, 33612
Dr. Lucia Seminario Vidal Principal Investigator
(Until Jun 2021)
Adam E Bennett Sub-investigator
Dr. Amanda Krenitsky Sub-investigator
Dr. Kerry Hennessy Sub-investigator
Nora Vera Sub-investigator
Dr. Wei-Shen Chen Sub-investigator
67

14
68 The SUNRISE study group: List of Investigators, Sub-investigators, and Study
69 Sites Involved in SUNRISE.

Investigator/Sub- Position/Role Study site

investigator
Dr. Ramon A Fernandez Principal Investigator Instituto de Especialidades de la Salud
Bussy Rosario, Rosario, Santa Fe, Argentina,
Dr. Dario Daniel Ardusso Sub-investigator S2000DBS
Dr. Ledit Ramon Sub-investigator
Francisco Ardusso
Maria Soledad Crisci Sub-investigator
Yanina Pistelli Sub-investigator
Dr. Ricardo Luis Principal Investigator CINME, CABA, Buenos Aires, Argentina,
Galimberti C1056ABJ
Daniel Ricardo Sub-investigator
Galimberti
Maria Alejandra Sub-investigator
Rodriguez
Maria Laura Galimberti Sub-investigator
Marisa Beatriz Zocca Sub-investigator
Dr. Mariano Gabriel Principal Investigator STAT Research Capital Federal, Argentina,
Marini C1023AAB
Tania Zarowsky Sub-investigator
Prof. Dr. Arjen Fokko Principal Investigator CHU Sart Tilman, Liege, Belgium, 4000
Nikkels
Dr. Eve Lebas Sub-investigator
Dr. Florence Libon Sub-investigator
Gabrielle Giet Sub-investigator
Dr. Gaelle Jouret Sub-investigator
Dr. Gilles Absil Sub-investigator
Dr. Louise Sub-investigator
Vanhakendover
Sophie Bailleux Sub-investigator
Dr. Thomas Damsin Sub-investigator
Yseult Senterre Sub-investigator
Prof. Dr. Lambert Jo Principal Investigator Universitair Ziekenhuis Gent, Gent,
Lydie Wilfried Belgium, 9000
Dr. Katia Ongenae Sub-investigator
Prof. Dr. Dimitar Principal Investigator UMHAT Dr Georgi Stranski, Pleven,
Gospodinov Bulgaria, 5800
Dr. Ivelina Yordanova Sub-investigator
Veronika Gincheva Sub-investigator
Dr. Ivan Nikolov Botev Principal Investigator UMHAT Alexandrovska EAD Sofia, Sofia,
Prof. Lybka Stoyanova- Sub-investigator Bulgaria, 1431
Miteva
Dr. Viktoriya Koleva Sub-investigator
Dr. Isabelle Delorme Principal Investigator Dr Isabelle Delorme Inc, Drummondville,
Dr. Nancy Brouillette Sub-principal QC, Canada, J2B 5L4
Investigator
Dr. Maryam Shayesteh Principal Investigator SimcoMed Health Ltd, Barrie, ON, Canada,
Alam L4M 7G1
Mahnaz Mahmoodi Sub-investigator
Dr. Afsaneh Alavi Principal Investigator York Dermatology Center, Richmond Hill,
ON, Canada, L4C 9M7

15
Dr. Angelique Gagne- Principal Investigator Dre Angelique Gagne-Henley M.D. Inc,
Henley Saint Jerome, QC, Canada, J7Z 7E2

Dra. Esperanza Maria Principal Investigator Circaribe Barranquilla, Atlantico, Colombia

Melendez
Elics Fozero Sub-investigator
Dr. Carolina Ivette Principal Investigator Riesgo de Fractura SA, Bogota,
Cortes Correa Cundinamarca, Colombia, 110221
Andrse Alfanso Sub-investigator
Gonzalez Romeo
Elkin Omar Contreras Sub-investigator
Penaranda
Katherine Gonzalez Physician
Sergio Andres Diaz Physician
Dr. Ines Sjerobabski Principal Investigator Clinical Hospital Centre Sestre Milosrdnice
Masnec Zagreb, HRV, Croatia, 10000
Dr. Marija Delas Azdajic Sub-investigator
MUDr. Olga Filipovska Principal Investigator Krajska zdravotni a s Masarykova
MUDr. Eduard Hirncir Sub-investigator nemocnice Sociální péče 3316
Lucie Zgazarova Sub-investigator /12A, Usti nad Labem, Czech Republic,
MUDr. Marcela Hlavata Sub-investigator 401 13
MUDr. Marie Policarova Principal Investigator Kozni oddleni Nemocnice Jihlava, Jihlava,
MUDr. Martina Blazkova Sub-investigator Czech Republic, 586 33
Prof. Dr. Simon Francis Principal Investigator Bispebjerg Hospital, Copenhagen NV,
Thomsen Denmark, 2400
PD Dr. Astrid- Helene Sub-investigator
Ravn Joergensen
Caecilie B Johansen Sub-investigator
Jennifer Astrup Sub-investigator
Soerensen
Dr. Jesper Groenlund Sub-investigator
Holm
Misbah Noshela Sub-investigator
Ghazanfar
Yiqiu Yao Sub-investigator
Dr. Mads Kircheiner Principal Investigator Aarhus Universitetshospital, Aarhus N,
Rasmussen Denmark, 8200
Simon Wehner Fage Sub-investigator
Trine Hoegsberg Sub-investigator
Dr. Ziad Reguiai Principal Investigator Polyclinique de Courlancy, Reims, France,
Fabienne Leonard Sub-investigator 51100
Dr. Thierry Passeron Principal Investigator Hopital l Archet 2, Nice, France, 06202
Dr. Abdallah Khemis Sub-investigator
Dr. Jean-Philippe Lacour Sub-investigator
Dr. Jean Luc Perrot Principal Investigator Hopital Nord, Saint-Etienne, France, 42055
Anne-Catherine Biron- Sub-investigator
Schneider
Caroline Couzan Sub-investigator
Chloe David Sub-investigator
Emmanuelle Couty Sub-investigator
Laurne Huppert Sub-investigator
Dr. Anne-Claire Principal Investigator HIA Begin, Saint Mande, France, 94160
Fougerousse
Roussel Aude Co-investigator

16
Dr. Pierre Andre Principal Investigator Hopital Prive d Antony, Antony, France,
Becherel 92160
Dr. Marina Thomas Sub-investigator
Dr. Mireille Ruer- Mulard Principal Investigator Le Bâteau Blanc - Cabinet Médical,
Jacques Martignoni Sub-investigator Martigues, France, 13500
Dr. Anne Benedicte Principal Investigator CHU de Rouen, Rouen Cedex, France,
Duval Modeste 76031
Dr. Camille Pinard Sub-investigator
Vivien Hebert Sub-investigator
Dr. Thierry Boye Principal Investigator Hopital d Instruction des Armees Sainte
Dr. Jean-Jacque Morand Co-investigator Anne, Toulon Cedex 9, France, 83800
Mathilde Barre Co-investigator
Dr. Safia Abed Co-investigator
Aude Valois Sub-investigator
Aurelia Palladini Co-investigator
Prof. Christophe Bedane Principal Investigator CHU Dupuytren, Limoges cedex, Haute
Safae Assikar Sub-investigator Vienne, France, 87000
Dr. Ioana Matei Sub-investigator
Dr. Laurence Sub-investigator
Nespoulous
Dr. med. Dagmar Principal Investigator Universitaetsklinikum Wuerzburg,
Presser Wuerzburg, Germany, 97080
Alaa Badran Co-investigator
Dr. Caroline Glatzel Co-investigator
Franziska Graen Co-investigator
Joanna Kuhl Co-investigator
Joanna Olk Co-investigator
Lucia Kern Co-investigator
Dr. med. Patrick Co-investigator
Schummer
Dr. med. Philipp Co-investigator
Schruefer
Prof. Dr. med. Matthias Deputy-SI
Goebeler
Prof. Dr. med. Michael Principal Investigator Universitaetsklinikum Erlangen Nuernberg,
Sticherling Erlangen, Germany, 91054
Christine Meder Co-investigator
Florina Kersting Co-investigator
Dr. med. Franz Heppt Co-investigator
Judith Popp Co-investigator
Lucas Sollfrank Co-investigator
Martin Zescihcz Co-investigator
PD Dr. med. Regina Sub-investigator
Sofia Renner
Dr. med. Margrit Simon Principal Investigator Isa GmbH interdisciplinary study
Alexandra Zambrano Co-investigator association, Berlin, Germany, 10789
Dr. med. Georg Reiner Sub-investigator
Nitzsche
Dr. med. Erika Sub-investigator/Deputy
Hernekamp
Prof. Dr. med. Knut Principal Investigator Universitaetsklinikum Heidelberg,
Schaekel Heidelberg, Germany, 69120
Dr. med Alexandra Co-investigator
Christine Dorschel
Dr. Med Christina Alt Co-investigator
Silvia Mihalceanu Co-investigator
Dr. Therezia Bokor Co-investigator
Billmann

17
Timo Schonk Co-investigator
Dr. Jochen Hoffmann Sub-investigator
Olivia Bochnig Sub-investigator
Prof. Dr. med. Christos C Principal Investigator Staedtisches Klinikum Dessau-Rosslau,
Zouboulis Dessau-Rosslau, Germany, 06847
Dr. med. Aristeidis Co-investigator
Vaiopoulos
Katja Wolter Co-investigator
Dr. med. Richard Co-investigator
Angkasa
Dr. med. Georgios Sub-investigator
Nikolakis
Dr. med. Georgios Principal Investigator Universitaetsmedizin Charite, Venerologie
Kokolakis und Allergologie, Berlin, Germany, 10117
Dr. med. Ivanna Co-investigator
Fatschild
Marie Luise Irmer Co-investigator
Dr. med. Torben Krause Co-investigator
Prof. Dr. med. Kamran Principal Investigator
Ghoreschi Deputy
Dr. med. Evelin Roloff Principal Investigator Klinische Forschung Schwerin GmbH,
Charlotte von Engelhardt Co-investigator Schwerin, Germany, 19055
Dr. med. Christine Co-investigator
Paschen
Dr. med. Stefanie Teske Co-investigator
Dr. med. Andreas Klare Sub-investigator/Deputy
Prof. Dr. med. Franziska Principal Investigator Universitaetsklinikum Muenchen LMU,
Rueff (Since Jul 2021) Muenchen, Germany, 81377
Prof. Dr. med. Kathrin Principal Investigator
Giehl (Until Jul 2021)
Benjamin Kendziora Co-investigator
Knop Macarena Co-investigator
Laurie Eicher Co-investigator
[Link]. Michaela Co-investigator
Kubieniec
Nora Aszodi Co-investigator
Pia-Charlotte Stadler Co-investigator
Sonja Senner Co-investigator
Sophia Czell Co-investigator
Surina Frey Co-investigator
Dr. med. Till Kammerer Co-investigator
Ugne Olendraite Co-investigator
Dr. med. Nina Magnolo Principal Investigator Universitaetsklinikum Muenster, Muenster,
Elsa Elena Dikeoulia Sub-investigator Germany, 48149
Dr. med. Henriette Sub-investigator
Kuithan
Dr. med. Max Goerg Sub-investigator
Dr. med. Hanna Post Co-investigator
Dr. med. Claudia Riepe Sub-investigator
Dr. med. Claudia Zeidler Sub-investigator
Kira Suessmuth Co-investigator
Dr. med. Natalia Kirsten Principal Investigator Universitaetsklinikum Hamburg Eppendorf,
Dr. med. Brigiitte Co-investigator Hamburg, Germany, 20246
Stephan
Caroline Hilbring Co-investigator
Christine Lee Seifert Co-investigator
Dr. med. Franziska Co-investigator
Gensel

18
Girbig Gefion Co-investigator
Nesrine Ben Anaya Co-investigator
Rabea Reinert Co-investigator
Prof. Dr. med. Matthias Sub-investigator
Augustin
Prof. Dimitrios- Principal Investigator Hospital of Cutaneous & Venereal
Rigopoulos Diseases of Athens ANDREAS
Dr. Aikaterini Liakou Sub-investigator SYGGROS, Athens, Greece, 161 21
Eleni Chatzidmitriou Sub-investigator
Areti Charakopidou Study Nurse
Dimou Eleftheria Study Nurse
Eleni Tsefou Study Nurse
Pesli Maria Study Nurse
Polyxeni Lagiokapa Study Nurse
Georgia Kokla Study Coordinator
Dr. Elisabeth Lazaridou Principal Investigator General Hospital of Thessaloniki
Dr. Aikaterini Patsatsi Co-investigator Papageorgiou, Thessaloniki, Greece, 564
Dr. Anastasia Trigoni Sub-investigator 29
Dr. Despoina Sub-investigator
Papathemeli
Dr. Elissavet Mingiani Sub-investigator
Dr. Evangelia Kalloniati Sub-investigator
Parthena Meltzanidou Sub-investigator
Dr. Valentina Oflidou Sub-investigator
Dra. Maria del Pilar Principal Investigator Clinica Dra. Pilar Manrique, Guatemala
Manrique City, Guatemala, 01010
Dra. Karla Isabel Sub-investigator
Martinez Rodas
Dr. Enrique Rivas Principal Investigator Clinica Dr. Rivas, Guatemala City,
Dr. Edder Higueros Sub-investigator Guatemala, 01015
Prof. Dr. Lajos Kemeny Principal Investigator Szegedi Tudomanyegyetem, Szeged,
Dr. Katalin Glasenhardt Sub-investigator Hungary, 6720
Dr. Reka Kovacs Sub-investigator
Prof. Dr. Eva Remenyik Principal Investigator Debreceni Egyetem Klinikai Kozpont,
Dr. Agnes Tosaki Sub-investigator Debrecen, Hungary, 4032
Dr. Andrea Szegedi Sub-investigator
Dr. Krisztian Gaspar Sub-investigator
Dr. Lilla Pogacsas Sub-investigator
Dr. Zita Battyani Principal Investigator Somogy Megyei Kaposi Mor Oktato
Dr. Aliz Kovacs Sub-investigator Korhaz, Kaposvar, Hungary, 7400
Dr. Jayesh Mukhi Principal Investigator Government Medical College and Hospital
Dr. Rajesh Kumar Soni Sub-investigator Nagpur, Maharashtra, India, 440009
Dr. Sujit Gavali Sub-investigator
Dr. Kiran Godse Principal Investigator Dr D Y Patil Hospital and Research Centre
Dr. Aswathy Sub-investigator Navi Mumbai, Maharasthra, India, 400706
Radhakrishnan
Dr. Ratnakar Shukla Sub-investigator
Dr. Ariela Hafner Principal Investigator Tel Aviv Sourasky Medical Center Ichilov,
Dr. Eyal Taleb Sub-investigator Tel Aviv, Israel, 64239
Dr. Tamir Horovitz Sub-investigator
Dr. Yenoratan Kaplan Sub-investigator
Dr. Yuval Hilerowicz Sub-investigator
Prof. Aviv Barzilai Principal Investigator The Chaim Sheba Medical Center, Ramat
Dr. Adam Dalal Sub-investigator Gan, Israel, 5265601
Dr. Eran Galily Sub-investigator
Dr. Felix Pavlotsky Sub-investigator
Dr. Keren Or Zahavi Sub-investigator
Dr. Oz Segal Sub-investigator

19
Dr. Sharon Baum Sub-investigator
Dr. Yaron Ben Sub-investigator
Mordechai
Prof. Dr. Gabriella Principal Investigator A O Universitaria Policlinico Federico II
Fabbrocini Univ Studi Fed II, Napoli, Italy, 80131
Fabrizio Martora Sub-investigator
Dr. Claudio Marasca Sub-investigator
Dr. Maria Ferrillo Sub-investigator
Dr. Maria Carmela Sub-investigator
Annunziata
Dr. Marianna Sub-investigator
Donnarumma
Dr. Vincenzo Marino Sub-investigator
Dr. Vincenzo Bettoli Principal Investigator Az. Osp-Univ. Ferrara - Arcispedale
Bencivelli Dario Sub-investigator [Link] Univ. degli Studi Cona, Ferrara,
Elisa Marzola Sub-investigator Italy, 44100
Giulia Odorici Sub-investigator
Lucrezia Pacetti Sub-investigator
Dr. Pierantonia Zedde Sub-investigator
Dr. Valeria Scuderi Sub-investigator
Prof. Luca Bianchi Principal Investigator [Link] Vergata-Univ. degli
Chiara Tartaglia Sub-investigator Studi Tor Vergata, Roma, Italy, 00133
Dr. Raffaele Dante Sub-investigator
Caposiena Caro
Prof. Anna Maria Offidani Principal Investigator AOU Osp Riuniti Umberto I GM Lancisi G
Dr. Anna Campanati Sub-investigator Salesi Univ Studi, Ancona, Italy, 60126
Claudia Sapigini Sub-investigator
Dr. Elisa Molinelli Sub-investigator
Glovanni Marco Sub-investigator
D'Agostino
Valerio Brisigotti Sub-investigator
Dr. Hadi Hamam Principal Investigator Hammoud Hospital University Medical
Center, Saida, Lebanon, 652
Assoc. prof. Skaidra Principal Investigator HoLUoHS Kaunas Clinics, Kaunas,
Valiukeviciene Lithuania, LT 50161
MD Vesta Kucinskiene Sub-investigator
PD Dr. Jurate Grigaitiene Principal Investigator Vilnius University Hospital Santaros clinics
MD. Milda Krivickaite Sub-investigator Vilnius, Vilniaus, Lithuania, LT-08411
Raimonda Mcglone Sub-investigator
Tadas Raudonis Sub-investigator
Dr. Wooi Chiang Tan Principal Investigator Hospital Pulau Pinang, Georgetown, Pulau
Dr. Janet Hoong May Sub-investigator Pinang, Malaysia, 10450
Lee
Dr. Loo Chai Har Sub-investigator
Dr. Norazlima Mohd Ali Sub-investigator
Dr. Shin Yi Ooi Sub-investigator
Dr. Yek Huan Khor Sub-investigator
Dr. Yeon Chiat Teh Sub-investigator
Dr. Suganthi Thevarajah Principal Investigator Hospital Kuala Lumpur, Kuala Lumpur,
Dr. Mashor Mazliha Sub-investigator Wilayah Persekutuan, Malaysia, 50586
Dr. Moonyza Akmal Bt Sub-investigator
Ahmad Kamil
Dr. Tang Min Moon Sub-investigator
Dr. Siew Eng Choon Principal Investigator Hospital Sultanah Aminah, Johor Bahru,
Dr. Kwee Eng Tey Sub-investigator Johor, Malaysia, 80100
Dr. Wong Kit Wan Sub-investigator
Dr. Yoong Wei Lee Sub-investigator

20
L.M.T. Vander Spek- Principal Investigator Bravis Ziekenhuis Bergen op Zoom,
Keyser (Since May 2020) Boerhaaveplein, Netherlands, 4624 VT
Dr. Milan Tjioe Principal Investigator
(Until May 2020)
Kevin Kwee Sub-investigator
Mireille Van Baar Sub-investigator
Qiqi Yin Sub-investigator
Jennie Janssens Research Nurse
Dr. Vermen Verallo Principal Investigator VMV Skin Research Centre and Clinics,
Rowell Makati City, Philippines, 1220
Janice Almeda Sub-investigator
Veronica Uy Sub-investigator
Prof. Dr. Joanna Narbutt Principal Investigator Dermoklinika Centrum Medyczne sc, Łódż,
Justyna Ceryn Sub-investigator Poland, 90-436
Dr. Irmina Olejniczak- Sub-investigator
Staruch
Anna Zuchowska Sub-investigator
Paula Mazan Sub-investigator
Dr. Adam Reich Principal Investigator Wojewodzki Szpital Specjalistyczny w
Dominik Samotij Sub-investigator Rzeszowie, Rzeszow, Poland, 35 055
Edyta Sawińska Sub-investigator
Justyna Szczęch Sub-investigator
Prof. Witold Owczarek Principal Investigator Wojskowy Instutyt Medyczny CSK MON,
Anna Kozera Sub-investigator Warszawa, Poland, 04141
Elwira Paluchowska Sub-investigator
Joanna Zolcinska Sub-investigator
Nina Wiśniewska Sub-investigator
Dr. Alla Semenovna Principal Investigator Uromed LLC, Smolensk, Russia, 214031
Andreeva
Anna Zhukova Sub-investigator
Dr. Dmitrii Kornev Sub-investigator
Dr. Ivan Andreevich Sub-investigator
Grinev
Sergi Aleksandra Study Coordinator
Aleksandra Grineva Unblinded ESR specialist
Prof. Oleg Raisovich Principal Investigator Chelyabinsk Regional Clinical
Ziganshin Dermatovenerology dispensary,
Prof Dr. Alexey Sub-investigator Chelyabinsk, Russia, 454092
Valerievich Privalov
Dr. Anastasiya Olegovna Sub-investigator
Laknitskaya
Dr. Anna Andreevna Sub-investigator
Kopaneva
Olga Bobrova Sub-investigator
Dr. Inna Victorovna Sub-investigator
Semenova
Evgenia Shitova Study Nurse
Dr. Sergey Skrek Principal Investigator Clinic of skin diseases n a Pierre
Dr. Anastasia Sub-investigator Wolkenstein LLC, Saint Petersburg,
Aleksandrovna Russia, 191123
Yunovidova
Konstantin Medvedev Sub-investigator
Dana Mashuka Nurse
Oksana Zaslavskaia Nurse
Dr. Yeo Yi Wei Kristen Principal Investigator Singapore General Hospital, Singapore,
Dr. Lee Haur Yeuh Co-investigator 169608
Dr. Hazel Oon Hwee Principal Investigator National Skin Centre, Singapore, 308205
Dr. Kong Yan Ling Co-investigator

21
Dr. Etienne Wang Co-investigator
Dr. Sean Leong Sub-investigator
Dr. Nisha Su Yien Principal Investigator National University Hospital, Singapore,
Subash Chandran 119074
Kalyani Rajesh Co-investigator
Patwardhan
Sam Shiyao Yang Co-investigator
Dr. Ellie Ci En Choi Sub-investigator
Tomas Uhrin Principal Investigator FNsP J A Reimana, Presov,
(Since Nov 2019) Slovakia (Slovak Republic), 081 81
Dr. Katarina Melnikova Principal Investigator
(Until Nov 2019)
Dr. Martin Sofranko Pneumologist
MUDr. PhD. Principal Investigator Nemocnica s poliklinikou F D Roosevelta,
Slavomir Urbancek Banska Bystrica, Slovakia (Slovak
Dr. Maria Breznicka Sub-investigator Republic), 97401
Monika Kubishova Pneumologist
Dr. Larisha Pillay Principal Investigator Global Clinical Trials, Pretoria, Gauteng,
Ramaya (Since Feb 2020) South Africa, 0001
Dr Nazir Ahmed Hoosen Principal Investigator
(Until Feb 2020)
Dr. Nazira Carrim- Principal Investigator
Ganey (Until Dec 2019)
Dr. Lushen Pillay Sub-investigator
Dr. Aysha Ebrahim Principal Investigator Chris Hani Baragwaneth Clinical, Soweto,
Badat Gauteng, South Africa, 2013
Nkehli Lindinkululeko Sub-investigator
Brenda Zwazo Study Coordinator
Nkeko Mashike Study Coordinator
Thembekile Molefe Study Coordinator
Dr. Antonio Martorell Principal Investigator Hospital de Manises, Dermatologóa (Planta
Calatayud 1), Manises, Valencia, Spain, 46940
Alberto Alfaro Sub-investigator
Luis Hueso Sub-investigator
Luisa Melgares Garcia Sub-investigator
Dr. Alejandro Molina Principal Investigator Hospital Universitario Virgen de las Nieves,
Leyva Granada, Spain, 18012
Andrea Rodriguez Tejero Sub-investigator
Luis Salvador Rodriguez Sub-investigator
Salvador Arias Santiago Sub-investigator
Dr. Yolanda Delgado Principal Investigator Hospital Universitario La Princesa, Madrid,
Jimenez Spain, 28006
Alejandra Reolid Perez Sub-investigator
Ester Munoz Aceituno Sub-investigator
Dr. Gregorio Carretero Principal Investigator Hospital Universitario Doctor Negrin, Las
Hernandez Palmas de Gran Canaria, Spain, 35012
Dr. Alicia Gonzalez Sub-investigator
Quesada
Elena Catro Sub-investigator
Hector Morales Sub-investigator
Dra. Ofelia Baniandres Principal Investigator Hospital Gregorio Maranon, Madrid, Spain,
Rodriguez 28007
Angel Rosell Sub-investigator
Garcia Paloma Sub-investigator
Dr. Marta Ferran Ferres Principal Investigator Hospital del Mar, Dermatología (Letra K
Alvaro March Sub-investigator despacho 69), Barcelona, Catalunya,
Gemma Martin Sub-investigator Spain, 08003
Ramon Pujol Vallverdu Sub-investigator

22
Dr. Christa Maria Maniu Principal Investigator CHUV, Hopital Beaumont, Lausanne,
(Since Sep 2021) Switzerland, 1011
Dr. Teofila Caplanusi Principal Investigator
(Until Sep 2021)
Dr. Julie Di Lucca Principal Investigator
(Until Jun 2020)
Dr. Elena Chiticariu Sub-investigator
Dr. med. Florian Principal Investigator University Hospital Zurich, Zurich,
Anzengruber Switzerland, CH- 8091
Lara Grossmann Sub-investigator
Carole Guillet Sub-investigator
Nina Rosset Sub-investigator
Prof. Dr. Safiye Atlas Principal Investigator Marmara University Medical Faculty,
Tülin Ergün Istanbul, Turkey, 34662
Elif Comert Sub-investigator
Gonca Sarac Sub-investigator
Prof. Dr. Burhan Engin Principal Investigator Istanbul University Cerrahpasa Faculty of
Dr. Ayse Mine Gok Sub-investigator Medicine, Istanbul, Turkey, 34098
Ozge Askin Sub-investigator
Prof. Dr. Murat Borlu Principal Investigator Erciyes University Medical Faculty, Talas /
Demet Kartal Sub-investigator Kayseri, Turkey, 38039
Eda Oksum Solak Sub-investigator
Salih Levent Cinar Sub-investigator
Prof. Dr. Ilgen Ertam Principal Investigator Ege University Medical Faculty, Bornova,
Ayda Acar Sub-investigator Izmir, Turkey, 35040

Dr. Evmorfia Ladoyanni Principal Investigator Russells Hall Hospital, Dudley, West
Dr. Kayalvizhi Sub-investigator Midlands, United Kingdom, DY1 2HQ
MohanKumar
Wedad Abdelrahman Principal Investigator Guys Hospital, London, United Kingdom,
(Since Jul 2021) SE1 9RT
Dr. Ellie Rashidghamat Principal Investigator
(Until Jul 2021)
Adarsh Shah Sub-investigator
Carmen Hew Sub-investigator
Dr. Felicity Ferguson Sub-investigator
Libin Mathew Sub-investigator
Stephan Mounsey Sub-investigator
Sita Zulu Clinical Research Nurse
Andrea Pentelow Research Nurse
Eiko Tomokiyo Research Nurse
Dr. Agustin Martin- Principal Investigator Queen Elizabeth Hospital, Birmingham,
Clavijo West Midlands, United Kingdom, B15 2TH
Emily Tetteh Sub-investigator
Hellen Lewis Sub-investigator
Richard Jerrom Sub-investigator
Sara Mirhadi Sub-investigator
Simon Unter Sub-investigator
Simon De Leon Study Nurse
Donna Breakspear Research Nurse
Jessica Bayliss Research Nurse
Dr. Anthony Paul Bewley Principal Investigator Royal London Hospital, London, United
Albert Sunghwan Hong Sub-investigator Kingdom, E1 1BB
Maria Angeliki Gkini Sub-investigator
Pia Tookey Sub-investigator
Chipo Chitsenga Study Coordinator
Geetha Boyapati Back up Blinded Study
Nurse

23
Siqapheliso Millin Back up Blinded Study
Nurse
Dr. Alison Margaret Principal Investigator Harrogate and District Foundation Trust,
Layton Harrogate, North Yorkshire, United
Nadira Singh Research Nurse Kingdom, HG2 7SX
Ruth Goodfellow Research Nurse
David Wright Sub-principal
Investigator
Dr. Eva Lau Sub-principal
Investigator
Prof. Dr. Andrew Leslie Principal Investigator St Lukes Hospital, Bradford, West
Wright Yorkshire, United Kingdom, BD5 0NA
Dr. Miriam Wittmann Sub-investigator
Suzanne Hatfield Sub-investigator
Carol Denniss Research Nurse
Dr. [Link] Hurley Principal Investigator Saint Louis University Clinical Research
Daniel Tinker Sub-investigator Unit, St Louis, MO, United States, 63104
Kavita Darji Sub-investigator
Laura Russell Sub-investigator
Dr. David M Pariser Principal Investigator Virginia Clinical Research, Norfolk, VA,
Dr. Robert J Pariser Sub-investigator United States, 23502
Tina M Watkins Sub-investigator
Deanna Rixon Back-up Coordinator
Celina Devis Primary Study
Coordinator
Dr. Michelle Pelle Principal Investigator MedDerm Associates, San Diego, CA,
Michael Lee Sub-investigator United States, 92103
Patrick Blake Sub-investigator
Dr. Kenneth W Dawes Principal Investigator Dawes Fretzin Clinical Research Group,
Amber Nunes Sub-investigator Indianapolis, IN, United States, 46256
Ann Marie Hyatt Sub-investigator
Christina L Race Sub-investigator
Christy L Nebesio Sub-investigator
Elizabeth A Golden Sub-investigator
Jennifer M Conners Sub-investigator
Mary M Spolyar Sub-investigator
Priya K Young Sub-investigator
Dr. Scott Fretzin Sub-investigator
Ashley N Wallace Study Coordinator
Heather Able Study Coordinator
Kara K Jones Study Coordinator
Laura R Murphy Study Coordinator
Sarah L Ragan Study Coordinator
Vickie L Mcdonel Study Coordinator
Dr. Milan J Anadkat Principal Investigator Washington University School of Medicine,
Amy Musiek Sub-investigator St Louis, MO, United States, 63110
Heather Jones Sub-investigator
Dr. Francisco Armando Principal Investigator Florida Academic Dermatology Center,
Kerdel Coral Gables, FL, United States, 33134
Dr. Frank A. Don Sub-investigator
Neda Ghiam Sub-investigator
Martha Gutierrez CCRC
Marcela Gutierrez CRC
Fabio Azevedo Project Manager
Dr. Craig F. Teller Principal Investigator Bellaire Dermatology Associates, Bellaire,
Angela Tatavak Husted Sub-investigator TX, United States, 77401
Garland James Sub-investigator

24
Arjana Amataj BSN Blinded Study
Coordinator
Hormony Saqr Blinded Study
Coordinator
Maribel Rodriquez Unblinded Study
Coordinator
Dr. David Rosmarin Principal Investigator Tufts Medical Center, Boston, MA, United
Courtney Kachuk Study Coordinator States, 2108
Nicole Dumont Study Coordinator
Caroline Roberta Principal Investigator Icahn School of Medicine at Mount Sinai,
Campbell (Since Mar 2021) New York, NY, United States, 10003
Dr. George Zonggi Han Principal Investigator
(Until Mar 2021)
Dr. Alice Bendix Gottlieb Principal Investigator
(Until Jan 2020)
Dr. Avi Bitterman Sub-investigator
Stephanie Tadayon Sub-investigator
Dr. Edward Lewis Lain Principal Investigator Austin Inst for Clinical Research,
Dr. Aron Jeffrey Sub-investigator Pflugerville, TX, United States, 78660
Gewirtzman
Jennifer Jean Jordan Sub-investigator
Dr. Tanya Y. Evans Principal Investigator Southern California Skin and Laser,
Whittier, CA, United States, 92677
Dr. Jamie Weisman Principal Investigator Advanced Medical Research Inc, Sandy
Dr. Aimen Ismail Sub-investigator Springs, GA, United States, 30328
Laura Quinn Sub-investigator
Dr. Joel Schlessinger Principal Investigator Skin Specialists PC, Omaha, NE, United
Jacqueline G Hall Sub-investigator States, 68144
Shea Perillo Sub-investigator
Kelley W. Yokum Principal Investigator Olympian Clinical Research, Tampa, FL,
(Since May 2020) United States, 33614
Dr. Gisela Torres-Bonilla Principal Investigator
(Until May 2020)
Jennifer Moye Sub-investigator
Patricia Delgado Sub-investigator
Wilhelmina Hernandez Sub-investigator
Cheryl O' Neill Study Coordinator
Karina Perez Study Coordinator
Katelyn Castor Study Coordinator
Lora Pea Study Coordinator
Martha Colon-Diaz Study Coordinator
Michele Stilwell Study Coordinator
Moroni Berrios Study Coordinator
Tiffany Robison Study Coordinator
Dr. Alex Ortega Loayza Principal Investigator Oregon Health and Science University,
Eric Simpson Sub-investigator Portland, OR, United States, 97239
Jesse Keller Sub-investigator
Susan Tofte Sub-investigator
Teri Greiling Sub-investigator
Dr. Le Huu Doanh Principal Investigator National Hospital of Dermatology and
Le Thanh Hien Sub-investigator Venereology, Hanoi, Vietnam, 100000
Nguyen Hong Son Sub-investigator
Nguyen Manh Tan Sub-investigator
Nguyen Quang Minh Sub-investigator
Vu Huy Luong Sub-investigator
Dr. Hao Trong Nguyen Principal Investigator HCMC Dermato-Venereology Hospital, Ho
Dr. Hien Thao Le Sub-investigator Chi Minh city, Vietnam, 70000
Dr. Hoang Vu Nguyen Sub-investigator

25
 Dr. Khoa Duy Dang Ngo Sub-investigator
Dr. Nhi Thi Uyen Pham Sub-investigator
Dr. Phuong Thi Doan Vo Sub-investigator
Dr. Thao Thi Phuong Vu Sub-investigator
Dr. Tu Nguyen Anh Tran Sub-investigator
Dr. Tuong Dang Trong Sub-investigator
Pham
70

71

26
72 Supplementary Methods

73 Full list of inclusion criteria

74 Patients eligible for inclusion in either study were required to meet all of the following criteria:

75 1. Patients from whom written informed consent was obtained before any assessment was

76 performed

77 2. Male and female patients ≥18 years of age

78 3. Patients with a diagnosis of hidradenitis suppurativa (HS) ≥1 year prior to baseline

79 4. Patients with moderate to severe HS defined as:

80 a. A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules

81 and

82 b. Inflammatory lesions should affect at least 2 distinct anatomical areas

83 5. Patients who agreed to daily use of topical over-the-counter antiseptics on the areas affected

84 by HS lesions while on study treatment

85 Full list of exclusion criteria

86 Patients meeting any of the following criteria were not eligible for inclusion in either trial:

87 1. Total fistulae count ≥20 at baseline

88 2. Any other active skin disease or condition that may interfere with assessment of HS

89 3. Active ongoing inflammatory diseases other than HS that require treatment with prohibited

90 medications (see Study Protocol for more information on prohibited medications)

91 4. Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic,

92 pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal conditions such as

93 inflammatory bowel disease [IBD]), which in the opinion of the investigator would significantly

94 immunocompromise the patient and/or place the patient at unacceptable risk for receiving an

95 immunomodulatory therapy

96 5. Current severe progressive or uncontrolled diseases that render the patient unsuitable for the

97 trial or put the patient at increased risk, including any medical or psychiatric condition which,

98 in the investigator’s opinion, would preclude the participant from adhering to the protocol or

99 completing the study per protocol

27
100 6. Use or planned use of prohibited treatments (see Study Protocol for prohibited treatments

101 and required washout periods)

102 7. For patients enrolling in the non-antibiotic strata, use of systemic antibiotics for the treatment

103 of HS within 28 days before baseline. For patients enrolling in the antibiotic strata: patients

104 could enter the study under concomitant treatment with systemic antibiotics (as per protocol)

105 on a stable dose (defined as a dose or dose regimen that had not changed in the 28 days

106 before baseline and was considered unlikely to change at least for the first 16 weeks during

107 the study)

108 8. History of hypersensitivity to any of the study drug constituents

109 9. Previous exposure to secukinumab or any other biologic drug directly targeting interleukin

110 (IL)-17A/F or the IL-17 receptor

111 10. History of chronic or recurrent systemic infections or active systemic infections during the 2

112 weeks (exception: common cold) prior to randomization

113 11. Evidence of tuberculosis (TB) infection, as defined by a positive QuantiFERON® TB-Gold test

114 (QFT) at screening. Patients with a positive or indeterminate QFT test may have participated

115 in the study if a full TB work-up (according to local practice/guidelines) was completed within

116 12 weeks prior to randomisation, establishing conclusively that the patient had no evidence of

117 active TB. Patients positive for latent TB per work-up could be randomised to the trial if

118 sufficient treatment has been initiated according to local routine clinical practice and was

119 completed at least 4 weeks before randomisation

120 12. Medical history record of infection with human immunodeficiency virus (HIV) or hepatitis B or

121 C prior to randomisation, except for hepatitis C successfully treated and cured

122 13. History of lymphoproliferative disease or any known malignancy or history of malignancy of

123 any organ system treated or untreated within the past 5 years, regardless of whether there

124 was evidence of local recurrence or metastases (except for skin Bowen’s disease, basal cell

125 carcinoma, or actinic keratoses that had been treated with no evidence of recurrence in the

126 past 12 weeks; carcinoma in situ of the cervix; or non-invasive malignant colon polyps that

127 had been removed)

128 14. History or evidence of ongoing alcohol or drug abuse that, in the opinion of the investigator,

129 would prevent the patient from adhering to the protocol and completing the study

28
130 15. Pregnant or lactating women

131 16. Women of childbearing potential, defined as all women physiologically capable of becoming

132 pregnant, unless they are using methods of contraception during the entire study, or longer, if

133 required by locally approved prescribing information (e.g., in European Union [EU] 20 weeks).

134 See the Study Protocol for information on contraceptive methods allowed

135 No additional exclusions could be applied by the investigator to ensure that the study population was

136 representative of all eligible patients with moderate to severe HS.

137 Sample size calculations

138 Sample size requirements for this study were primarily driven by the primary endpoint. A 5% two-

139 sided alpha level was used to control for the type I error. As two secukinumab doses were tested

140 versus placebo with respect to the primary endpoint (Hidradenitis Suppurativa Clinical Response

141 [HiSCR] at week 16), the alpha level was unequally split to 4% and 1% for secukinumab 300 mg

142 every 2 weeks (SECQ2W) versus placebo and secukinumab 300 mg every 4 weeks (SECQ4W)

143 versus placebo, respectively. A total of 471 patients was originally planned to be randomised to each

144 of the trials in a 1:1:1 ratio. Both trials were independently powered to test the primary endpoint

145 (HiSCR) and the secondary endpoints (percentage change from baseline in abscess and

146 inflammatory nodule [AN] count at week 16 and flares over 16 weeks). The secondary endpoint,

147 NRS30 (defined as a ≥30% reduction and ≥2-point reduction from baseline in Patient's Global

148 Assessment of Skin Pain on a continuous numeric rating scale [NRS]; assessed in patients with a

149 baseline NRS ≥3), was analysed in the pooled populations of both trials, provided the primary null

150 hypothesis (H1 and H’1, or H2 and H’2; see Section “Statistical testing procedure” below) could be

151 rejected in both trials. All sample size calculations were done in nQuery Advisor 7.0. To account for

152 the disruptive impact of the COVID-19 pandemic, the number of randomised patients was increased

153 to approximately 541 in both trials. This was done to ensure the originally planned power in the

154 statistical test procedure was maintained.

155 • HiSCR: Based on previous phase 3 trials in moderate to severe HS (1), a placebo response

156 rate of 30% was assumed. The original total sample size of 471 patients for both trials was

157 sufficient to achieve 93% power for the demonstration of a 20% points difference of SECQ2W

158 over placebo based on the primary endpoint, when assuming a secukinumab response rate of

29
159 50%. In the comparison of SECQ4W with placebo, the original total sample size was sufficient

160 to achieve 83% power for demonstration of superiority.

161 • AN count: Based on previous phase 3 trials in moderate to severe HS (1), an at least 18%

162 points difference between secukinumab and placebo was assumed in favour of secukinumab

163 when considering the mean percentage change from baseline in AN count at week 16.

164 Although an analysis of covariance (ANCOVA) model was planned to be used for the

165 analysis, an approximate sample size was based on a simple t-test. The total sample size of

166 471 patients was sufficient to achieve 92% power in SECQ2W versus placebo and 81%

167 power in SECQ4W versus placebo when assuming a standard deviation of 46%.

168 • Flares: Based on previous phase 3 trials in moderate to severe HS (1), a placebo flares rate

169 of 35% was assumed. The total sample size of 471 patients was sufficient to achieve 98%

170 power for the demonstration of a 20% points difference of SECQ2W over placebo based on

171 the secondary endpoint when assuming a SECQ2W flares rate to be 15%. Assuming the

172 same rate for SECQ4W, the sample size was considered sufficient to achieve 92% power in a

173 comparison of SECQ4W versus placebo.

174 • NRS30 (skin pain): Based on previous phase 3 trials in moderate to severe HS (1), a

175 placebo NRS30 response rate of 23% was assumed. Assuming that 80% of patients would

176 qualify for NRS30 analysis (i.e., baseline NRS ≥3), a total sample size of 942 patients across

177 the two trials was sufficient to achieve 85% power for the demonstration of a 13% points

178 difference of SECQ2W over placebo based on the secondary endpoint when assuming the

179 rate to be 36%. The sample size was also sufficient to achieve 70% power to demonstrate

180 superiority of SECQ4W over placebo based on the same assumptions regarding the rates of

181 secukinumab and placebo as above.

182 Analysis of two different database locks

183 The analyses presented in the manuscript were based on two database locks (DBLs). The week 16

184 (primary endpoint analysis) DBL was used for all analyses up to week 16 (placebo-controlled

185 Treatment Period 1) and the final DBL was used for all analyses up to week 52 (entire treatment

186 period).

30
187 Statistical testing procedure

188 The statistical hypotheses (H) for the primary and secondary endpoints were that there was no

189 difference in the endpoints at week 16 in the secukinumab arms (SECQ2W and SECQ4W) versus the

190 placebo arms (hypotheses without an apostrophe refer to SUNSHINE [e.g., H1], hypotheses with an

191 apostrophe refer to SUNRISE [e.g., H’1]; H7 and H8 were tested based on pooled data):

192 Primary endpoint:

193 • H1 (H’1): SECQ2W is not different to placebo with respect to HiSCR at week 16

194 • H2 (H’2): SECQ4W is not different to placebo with respect to HiSCR at week 16

195 Secondary endpoints

196 • H3 (H'3): SECQ2W is not different to placebo with respect to percentage change from

197 baseline in AN count at week 16

198 • H4 (H'4): SECQ4W is not different to placebo with respect to percentage change from

199 baseline in AN count at week 16

200 • H5 (H'5): SECQ2W is not different to placebo with respect to flares at week 16

201 • H6 (H'6): SECQ4W is not different to placebo with respect to flares at week 16

202 • H7: SECQ2W is not different to placebo with respect to NRS30 at week 16

203 • H8: SECQ4W is not different to placebo with respect to NRS30 at week 16

204 Hypotheses could only be tested in the order as indicated by the arrows in Figure S4. To improve

205 readability, the hypotheses for SUNSHINE are focused on in this paragraph, with the same rules also

206 applying for SUNRISE. Hypothesis H1 for the primary endpoint (HiSCR at week 16) for SECQ2W

207 versus placebo was tested at 4α/5, whereas the hypothesis H2 of the primary objective (HiSCR at

208 week 16) for SECQ4W versus placebo was tested at α/5 simultaneously (α=0.025). If H1 and/or H2

209 was rejected, then H3 and/or H4 (percentage change from baseline in AN count at week 16) was

210 tested, respectively. If H3 and/or H4 was rejected, then the corresponding alpha was passed to H5

211 and/or H6 (flares over 16 weeks), respectively.

212 Once HiSCR, percentage change from baseline in AN count, and flares hypotheses for a

213 secukinumab arm were rejected, the respective 4α/5 for SECQ2W and α/5 for SECQ4W were passed

214 on to the other arm’s hypotheses if they were not already rejected at the initial significance level (i.e.,

215 α/5 for SECQ4W and 4α/5 for SECQ2W). If both trials independently rejected the primary null

31
216 hypothesis on the same secukinumab arm (H1 and H’1, or H2 and H’2), then the corresponding

217 secukinumab arm’s hypothesis for NRS30 (H7 or H8) was tested.

218 In addition, the significance level for the NRS30 hypothesis was passed from one arm to the other

219 arm if the hypothesis for one arm was rejected and the primary null hypotheses on the two

220 secukinumab arms were all rejected. The initial significance level for NRS30 hypothesis (H7 and/or

221 H8) was set to α‒α2. The subtraction of α2 was to account for the maximum possible type I error rate

222 to claim a success for HiSCR, percentage change from baseline in AN count and flares in both trials.

223 Missing values for the components of the primary and secondary endpoints were imputed separately

224 based on a fully conditional specification approach. The imputations were performed including the

225 corresponding baseline value, geographical region, Hurley stage (stage I and II combined vs. stage

226 III), use of antibiotics, and body weight (categorised as stratified [<90 kg and ≥90 kg]) as covariates.

227 Missing values for covariates were also imputed. The components are measured at several visits. In

228 the imputation model of a single component at a specific visit, all previous visits were considered as

229 covariates. To impute data, linear regression models were applied (with predictive mean matching) for

230 continuous variables and logistic regression models for categorical variables (including binary

231 variables). The number of imputations was set to 100 and the SAS procedure MI was used to

232 generate the multiple imputed data sets. Additional details on the multiple imputation process are

233 detailed in the Study Protocol and Statistical Analysis Plan.

234 Sensitivity analysis for week 52 efficacy data

235 A mixed effects logistic regression model (MELRM; used for HiSCR, flares, NRS30 and AN50) and a

236 mixed model for repeated measures (MMRM; used for percentage change from baseline in AN count)

237 were utilised as a sensitivity analysis to assess long-term data at all time points from week 2 to week

238 52. The covariates included as fixed effects for analysis of HiSCR, AN count, proportion of patients

239 with at least a 50% reduction in the abscess and inflammatory nodule count compared with baseline

240 (AN50), and flares were treatment arm, visit, baseline AN count, and the interaction between visit and

241 treatment arm. The covariates included as fixed effects for analysis of NRS30 were treatment arm,

242 visit, baseline NRS score, and the interaction between visit and treatment arm. An unstructured

243 covariance structure was applied, in case of non-converge, simpler covariance structures were

32
244 implemented. Only data from the SECQ2W and SECQ4W arms were considered in the MELRMs and

245 the MMRM.

246 Pooled study analysis

247 An additional analysis was conducted based on pooled data from SUNSHINE and SUNRISE for the

248 following outcomes: HiSCR, percentage change from baseline in AN count, flares, DLQI response

249 and AN50. The analysis approach followed that of the single trials. Relative rates by visit and

250 treatment arm for HiSCR, AN50, and DLQI response, as well as flares over a period of time are

251 presented. For percentage change from baseline in AN count, mean values by visit and treatment arm

252 are presented. Data up to week 16 are based on the primary or secondary estimand and multiple

253 imputation. Beyond week 16, data is reported as observed. Pooled data for DLQI response is

254 reported as observed (from week 2 up to week 52). Furthermore, mixed models were fitted based on

255 pooled data (MELRM used for HiSCR, flares, NRS30 and AN50; MMRM used for percentage change

256 from baseline in AN count).

257

33
258 Supplementary Results

259 Sensitivity analysis for week 52 efficacy data

260 The MELRM results at week 52 were similar to the week 52 observed data for HiSCR in SUNSHINE

261 (SECQ2W [54.8%, n# (MELRM adjusted n)/N: 64.1/117]; SECQ4W [55.3%, n#/N: 70.8/128]) and

262 SUNRISE (SECQ2W [63.4%, n#/N: 86.9/137]; SECQ4W [58.6%, n#/N: 74.4/127]; Figure S5A-B).

263 Similar results were observed for percentage change from baseline in AN count at week 52 (using

264 MMRM; Figure S5C–D), the proportion of patients experiencing flares over 52 weeks (MELRM;

265 Figure S5E–F) and NRS30 at week 52 (MELRM; Figure S5G), supporting the observed data.

266 Pooled study analysis

267 Pooled SUNSHINE and SUNRISE HiSCR, percentage change from baseline in AN count, and flares

268 data are shown in Figure S6. Analyses based on the primary/secondary estimand and multiple

269 imputation demonstrated similar results to the respective MELRM or MMRM at week 16 and were

270 aligned with single study level results. Further, observed data at week 52 was also aligned with the

271 results based on the respective MELRM/MMRM data (Figure S6, A–C vs D–F). Pooled SUNSHINE

272 and SUNRISE DLQI results were in line with those reported at the single study level (Figure S7).

273 Supportive analysis: AN50 response

274 AN50 response rates achieved in SUNSHINE and SUNRISE are shown in Figure S8. In the

275 SUNSHINE and SUNRISE trials, AN50 responses following either dose regimen of secukinumab

276 were higher compared with placebo at week 16. In SUNSHINE, the proportion of patients achieving

277 AN50 was 54.7% (n* [rounded average number of patients with response in 100 imputations]/N:

278 99.1/181), 53.9% (n*/N: 96.9/180) and 40.6% (n*/N: 73.0/180) in the SECQ2W, SECQ4W and

279 placebo arms, respectively (Figure S8A). In SUNRISE, the proportion of patients achieving AN50

280 was 51.9% (n*/N: 93.5/180), 58.5% (n*/N: 105.3/180) and 38.8% (n*/N: 71.0/183) in the SECQ2W,

281 SECQ4W and placebo arms, respectively (Figure S8B). In both trials, the AN50 responses at week

282 16 continued to improve up to week 52 (SUNSHINE: SECQ2W [70.1%, n/N: 82/117]; SECQ4W

283 [71.1%, n/N: 91/128]; SUNRISE: SECQ2W [70.8%, n/N: 97/137]; SECQ4W [70.1%, n/N: 89/127];

284 Figure S8A–B). Sensitivity analyses using MELRM methods showed similar results in both

34
285 SUNSHINE (Figure S8C) and SUNRISE (Figure S8D). AN50 responses based on pooled data

286 (SUNSHINE and SUNRISE) are also shown in Figure S9; results are aligned with single study data.

287 Safety

288 Treatment emergent adverse events

289 Treatment-emergent adverse events (TEAEs) by system organ class (SOC) and preferred term (PT)

290 up to week 16 and for the entire study period (up to week 52) are detailed in Table S2 and Tables

291 S6–8. The most reported TEAE by SOC in both the SUNSHINE and SUNRISE trials was infections

292 and infestations, which was generally similar between treatment regimens and trials (Table S6 [up to

293 week 16]; Table S8 [up to week 52]). In the SUNSHINE and SUNRISE trials, other commonly

294 reported TEAEs by primary SOC included skin and subcutaneous tissue disorders, gastrointestinal

295 disorders, nervous system disorders, and general disorders and administration site conditions (Table

296 S6, Table S8). In both trials, headache, nasopharyngitis, (worsening of) hidradenitis, diarrhoea,

297 pyrexia, and upper respiratory tract infection were commonly reported TEAEs by PT (Table S2 [up to

298 week 16]; Table S7 [up to week 52]).

299 The majority of TEAEs during the entire study period were mild or moderate. The most commonly

300 reported serious adverse events (SAEs) by SOC up to week 16 and up to week 52 are reported in

301 Table S4 and Table S5, respectively. In the placebo-controlled period, SAEs were infrequent and

302 comparable across treatment arms (Table S4). The only SAE PTs with >1 events in any treatment

303 arm was (worsening of) hidradenitis (reported in the placebo arm of SUNSHINE, 2 [1.1%]) (Table S4).

304 In the entire treatment period, SAE PTs with ≥2 events in any treatment arm included (worsening of)

305 hidradenitis, sweat gland infection, pneumonia, pyrexia, acute kidney injury and intervertebral disc

306 protrusion (Table S5).

307 Candida infections

308 The rate of candida infections (high-level term [HLT], including preferred terms [PTs] of oral

309 candidiasis, skin candida, vulvovaginal candidiasis, candida infection and balanitis candida) was low

310 and generally balanced across treatment arms in the placebo-controlled period (up to week 16) in

311 both SUNSHINE (SECQ2W, 1.1% [n/N: 2/181]; SECQ4W, 0.6% [n/N: 1/180]; placebo, 2.2% [n/N:

312 4/180]) and SUNRISE (SECQ2W, 2.8% [n/N: 5/180]; SECQ4W, 2.8% [n/N: 5/180]; placebo, 1.1%

313 [n/N: 2/183]) (Table 2).

35
314 Over the entire treatment period the rate of candida infections (HLT) remained low in both SUNSHINE

315 (SECQ2W, 6.1% [n/N: 11/181]; SECQ4W, 4.4%[n/N: 8/180]; any SECQ2W, 5.6% [n/N: 15/266]; any

316 SECQ4W, 4.5% [n/N: 12/267]) and SUNRISE (SECQ2W, 6.7% [n/N: 12/180]; SECQ4W, 4.4% [n/N:

317 8/180]; any SECQ2W, 5.4% [n/N: 14/261]; any SECQ4W, 3.8% [n/N: 10/266]) (Table S3), with a

318 trend for higher rates in the SECQ2W/any SECQ2W treatment arms, which is consistent with what

319 has previously been shown with IL-17 inhibitors. (2)

320 The rates of candida infection by PT in SUNSHINE and SUNRISE up to week 16 and up to week 52

321 are shown in Tables S9 and S10, respectively.

322 The most common candida infections were oral candidiasis and skin candida; systemic candida

323 infections were infrequent. Candida infections were mostly of mild or moderate severity, the majority

324 did not lead to study discontinuation, and typically resolved with treatment.

36
325 Supplementary Tables

326 Table S1. Odds ratio and least squares means of primary and secondary endpoints

SUNSHINE (N=541) SUNRISE (N=543)

SECQ2W (N=181) SECQ4W (N=180) SECQ2W (N=180) SECQ4W (N=180)
HiSCR
OR 1.75 1.48 1.64 1.90
95% CI 1.12, 2.73 0.95, 2.32 1.05, 2.55 1.22, 2.96
S/NS S NS S S
AN count
LSM difference −23.05 −18.46 −16.33 −22.94
95% CI −33.90, −12.21 −29.32, −7.60 −28.79, −3.88 −35.24, −10.63
S/NS S NS S S
Flares
OR 0.42 0.71 0.68 0.49
95% CI 0.25, 0.73 0.43, 1.17 0.41, 1.14 0.29, 0.84
S/NS S NS NS S
NRS30*
OR 2.08 1.77
95% CI 1.37, 3.16 1.15, 2.70
S/NS S NS
*NRS30 included data pooled from both SUNSHINE and SUNRISE.

AN, abscess and inflammatory nodule; CI, confidence interval; HiSCR, hidradenitis suppurativa clinical response; LSM, least squares mean; N, number of patients in group;
NRS, numeric rating scale; OR, odds ratio; Q2W, every 2 weeks; Q4W, every 4 weeks; S/NS, significant or non-significant based on the pre-defined testing hierarchy; SEC,
secukinumab 300 mg.
327

37
328 Table S2. Frequent* treatment-emergent AEs by PT to week 16 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

PT, n (%) SECQ2W SECQ4W Placebo SECQ2W SECQ4W Placebo
(N=181) (N=180) (N=180) (N=180) (N=180) (N=183)
Any PT 122 (67.4) 118 (65.6) 120 (66.7) 113 (62.8) 114 (63.3) 116 (63.4)
Nasopharyngitis 20 (11.0) 16 (8.9) 13 (7.2) 13 (7.2) 9 (5.0) 16 (8.7)
Headache 17 (9.4) 20 (11.1) 14 (7.8) 21 (11.7) 17 (9.4) 15 (8.2)
Hidradenitis 11 (6.1) 5 (2.8) 24 (13.3) 10 (5.6) 11 (6.1) 14 (7.7)
Arthralgia 7 (3.9) 2 (1.1) 8 (4.4) 5 (2.8) 1 (0.6) 5 (2.7)
Abdominal pain 6 (3.3) 3 (1.7) 1 (0.6) 0 (0.0) 4 (2.2) 2 (1.1)
Diarrhoea 5 (2.8) 13 (7.2) 9 (5.0) 8 (4.4) 7 (3.9) 13 (7.1)
Upper respiratory tract infection 5 (2.8) 6 (3.3) 4 (2.2) 9 (5.0) 3 (1.7) 7 (3.8)
Oropharyngeal pain 5 (2.8) 3 (1.7) 3 (1.7) 4 (2.2) 3 (1.7) 1 (0.5)
Pyrexia 5 (2.8) 4 (2.2) 2 (1.1) 4 (2.2) 3 (1.7) 4 (2.2)
Gastroenteritis 5 (2.8) 2 (1.1) 1 (0.6) N/A N/A N/A
Pharyngitis 5 (2.8) 0 (0.0) 1 (0.6) 2 (1.1) 4 (2.2) 3 (1.6)
Dizziness 5 (2.8) 2 (1.1) 3 (1.7) 1 (0.6) 4 (2.2) 3 (1.6)
Urinary tract infection 4 (2.2) 3 (1.7) 3 (1.7) 4 (2.2) 7 (3.9) 5 (2.7)
Fatigue 4 (2.2) 8 (4.4) 8 (4.4) 4 (2.2) 6 (3.3) 2 (1.1)
Nausea 4 (2.2) 6 (3.3) 7 (3.9) 5 (2.8) 4 (2.2) 4 (2.2)
Pruritus 4 (2.2) 3 (1.7) 2 (1.1) 5 (2.8) 2 (1.1) 5 (2.7)
Eczema 4 (2.2) 2 (1.1) 1 (0.6) N/A N/A N/A
Toothache 4 (2.2) 2 (1.1) 4 (2.2) N/A N/A N/A
Rhinorrhoea 4 (2.2) 1 (0.6) 2 (1.1) N/A N/A N/A
Vulvovaginal mycotic infection 4 (2.2) 0 (0.0) 1 (0.6) N/A N/A N/A
Asthenia 3 (1.7) 2 (1.1) 4 (2.2) N/A N/A N/A
Back pain 3 (1.7) 3 (1.7) 8 (4.4) 0 (0.0) 7 (3.9) 4 (2.2)
Abdominal pain upper 2 (1.1) 4 (2.2) 1 (0.6) N/A N/A N/A
Cough 1 (0.6) 5 (2.8) 1 (0.6) N/A N/A N/A
Dysmenorrhoea 1 (0.6) 1 (0.6) 4 (2.2) N/A N/A N/A
Cellulitis 0 (0.0) 3 (1.7) 4 (2.2) N/A N/A N/A
Pain in extremity 0 (0.0) 2 (1.1) 5 (2.8) N/A N/A N/A
White blood cell count increased 0 (0.0) 1 (0.6) 4 (2.2) N/A N/A N/A
Influenza 0 (0.0) 0 (0.0) 4 (2.2) N/A N/A N/A
Depression N/A N/A N/A 2 (1.1) 1 (0.6) 4 (2.2)
Hypertension N/A N/A N/A 4 (2.2) 4 (2.2) 2 (1.1)
*Frequent is defined as a treatment emergent adverse event occurring in ≥2% of any treatment arm. A patient with multiple AEs with the same PT is counted only once for
that PT.

38
 AE, adverse event; N, number of patients in group; n, number of patients with outcome; N/A, not applicable as incidence is <2%; PT, preferred term; Q2W, every 2 weeks;
Q4W, every 4 weeks; SEC, secukinumab 300 mg.
329

39
330 Table S3. Deaths, other serious or clinically significant AEs or related discontinuations to week 52 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

SECQ2W SECQ4W Any Any SECQ2W SECQ4W Any Any
(N=181) (N=180) SECQ2W SECQ4W (N=180) (N=180) SECQ2W SECQ4W
(N=266) (N=267) (N=261) (N=266)
Patients with any AEs, n 154 (85.1) 154 (85.6) 220 (82.7) 227 (85.0) 147 (81.7) 153 (85.0) 209 (80.1) 217 (81.6)
(%)
Patients with serious or other significant events, n (%)
Death# 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 2 (0.8)
Non-fatal SAEs 13 (7.2) 9 (5.0) 18 (6.8) 19 (7.1) 19 (10.6) 14 (7.8) 22 (8.4) 21 (7.9)
Discontinued study 10 (5.5) 5 (2.8) 11 (4.1) 7 (2.6) 7 (3.9) 9 (5.0) 9 (3.4) 10 (3.8)
treatment due to any
AEs
AEs of special interest, n (%)
Infections and
106 (58.6) 94 (52.2) 139 (52.3) 126 (47.2) 91 (50.6) 95 (52.8) 134 (51.3) 137 (51.5)
infestations (SOC)
URTI (HLT) 53 (29.3) 45 (25.0) 67 (25.2) 58 (21.7) 44 (24.4) 40 (22.2) 60 (23.0) 55 (20.7)
Fungal infectious 28 (15.5) 15 (8.3) 35 (13.2) 24 (9.0) 22 (12.2) 18 (10.0) 28 (10.7) 20 (7.5)
disorders (HLGT)†
Candida infections 11 (6.1) 8 (4.4) 15 (5.6) 12 (4.5) 12 (6.7) 8 (4.4) 14 (5.4) 10 (3.8)
(HLT)‡
Hypersensitivity (SMQ, 29 (16.0) 24 (13.3) 35 (13.2) 32 (12.0) 23 (12.8) 19 (10.6) 28 (10.7) 23 (8.6)
narrow)
Malignant or unspecified 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 1 (0.6) 2 (1.1) 1 (0.4) 2 (0.8)
tumours (SMQ)
MACE (NMQ) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 2 (0.8)
IBD* 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 1 (0.6) 2 (0.8) 1 (0.4)
#In total, 2 deaths occurred in SUNRISE (one in the SECQ4W arm and the other in the placebo-SECQ4W arm). The death in the SECQ4W arm occurred in a patient who
had pre-existing aortic valve stenosis and experienced a fatal myocardial infarction on day 219. The death in the placebo-SECQ4W arm occurred in a patient who entered
the study with a history of stable Crohn's disease who suffered from a severe upper gastrointestinal haemorrhage due to duodenal ulcers on day 219 (49 days after last
dose of secukinumab) during concomitant treatment with ibuprofen; patient died on day 249 (79 days after last dose of secukinumab) due to this event.
*One case of IBD, one case of ulcerative colitis, and one case of Crohn’s disease.
†Fungal infectious disorders include the following preferred terms: vulvovaginal mycotic infection, oral candidiasis, fungal skin infection, fungal infection, tinea infection, tinea

pedis, body tinea, dermatophytosis, genital candidiasis, oral fungal infection, vulvovaginal candidiasis, candida infection, ear infection fungal, tinea versicolour, skin candida,
tinea cruris, and oesophageal candidiasis.
‡Candida infections includes the following preferred terms: vulvovaginal candidiasis, candida infection, mucocutaneous candidiasis, urinary tract candidiasis, skin candida,

oral candidiasis, genital candidiasis, and oesophageal candidiasis.

40
 AE, adverse event; HLGT, high-level group terms; HLT, high-level term; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular events; MedDRA, medical
dictionary for regulatory activities; N, number of patients in arm; n, number of patients with outcome; NMQ, Novartis MedDRA query; Q2W, every 2 weeks; Q4W, every 4
weeks; SAE, serious adverse event; SEC, secukinumab 300 mg; SMQ, standardised MedDRA queries; SOC, system organ class; URTI, upper respiratory tract infection.
331

41
332 Table S4. Treatment-emergent SAEs by PT to week 16 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

PT, n (%) SECQ2W SECQ4W Placebo SECQ2W SECQ4W Placebo
(N=181) (N=180) (N=180) (N=180) (N=180) (N=183)
Any PT 3 (1.7) 3 (1.7) 6 (3.3) 6 (3.3) 6 (3.3) 5 (2.7)
Hidradenitis 1 (0.6) 0 (0.0) 2 (1.1) 1 (0.6) 0 (0.0) 0 (0.0)
Amyloidosis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
Appendicitis 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Arrhythmia 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0)
Asthma 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.5)
Basal cell carcinoma 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
Cellulitis 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Cholecystitis 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0)
Colitis ulcerative 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0)
Confusional state 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
COVID-19 pneumonia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.5)
Glomerular vascular disorder 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.5)
Inflammatory bowel disease 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
Inguinal hernia 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Intentional overdose 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
Osteoarthritis 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0)
Otitis externa 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
Pelvi-ureteric obstruction 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0)
Pyrexia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.5)
Suicide attempt 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Sweat gland infection 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Urinary tract infection 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.5)
Clostridium difficile colitis 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
Diarrhoea haemorrhagic 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
Foot fracture 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
Lung cancer metastatic 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
Ureterolithiasis 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
A patient with multiple SAEs with the same PT is counted only once for that PT.

COVID-19, coronavirus disease 2019; N, number of patients in arm; n, number of patients with outcome; PT, preferred term; Q2W, every 2 weeks; Q4W, every 4 weeks;
SAE, serious adverse event; SEC, secukinumab 300 mg.
333

42
334 Table S5. Treatment-emergent SAEs by PT to week 52 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

PT, n (%) Any Any Any Any
SECQ2W SECQ4W SECQ2W SECQ4W
SECQ2W SECQ4W SECQ2W SECQ4W
(N=181) (N=180) (N=180) (N=180)
(N=266) (N=267) (N=261) (N=266)
Any PT 13 (7.2) 9 (5.0) 18 (6.8) 19 (7.1) 19 (10.6) 15 (8.3) 22 (8.4) 23 (8.6)
Hidradenitis 3 (1.7) 3 (1.7) 4 (1.5) 4 (1.5) 4 (2.2) 0 (0.0) 5 (1.9) 0 (0.0)
Sweat gland infection 1 (0.6) 3 (1.7) 1 (0.4) 3 (1.1) 1 (0.6) 0 (0.0) 1 (0.4) 1 (0.4)
Pneumonia 0 (0.0) 0 (0.0) 0 (0.0) 2 (0.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Pyrexia 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 2 (1.1) 0 (0.0) 2 (0.8) 0 (0.0)
Acute kidney injury 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (1.1) 0 (0.0) 2 (0.8) 0 (0.0)
Intervertebral disc
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (0.8)
protrusion
Appendicitis 0 (0.0) 1 (0.6) 1 (0.4) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
COVID-19 1 (0.6) 0 (0.0) 1 (0.4) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Cellulitis 1 (0.6) 1 (0.6) 1 (0.4) 1 (0.4) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Abdominal pain 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Breast cellulitis 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
C3 glomerulopathy 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Constipation 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Dizziness 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Fatigue 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Foot deformity 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Headache 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Hypertensive emergency 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Infection 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Influenza 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Inguinal hernia 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Large intestine infection 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Meniscus injury 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Non-small cell lung
1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
cancer metastatic
Pericarditis 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Peritonsillar abscess 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Post procedural infection 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Pulmonary embolism 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Sciatica 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Sepsis 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

43
Skin candida 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Sleep apnoea syndrome 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Suicidal ideation 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Suicide attempt 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Tachycardia 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Thrombosis 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Urinary tract infection 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Vomiting 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Lower limb fracture 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 1 (0.6) 1 (0.4) 1 (0.4)
Nephrolithiasis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 1 (0.6) 1 (0.4) 1 (0.4)
Abscess 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0)
Abscess limb 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
Amyloidosis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Ankle fracture 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Arrhythmia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Basal cell carcinoma 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Breast cancer 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Cholecystitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Cholecystitis acute 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Cholelithiasis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Clostridium difficile colitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
Colitis ulcerative 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Colonic abscess 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Confusional state 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Depression 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Dermatitis infected 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Enterocolitis infectious 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Fibula fracture 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Gastrointestinal
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
haemorrhage
Hypotension 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Inflammatory bowel
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
disease
Injection site abscess 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0)
Intentional overdose 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Joint dislocation 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Localised infection 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Muscle spasms 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Myocardial infarction 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)

44
 Obsessive-compulsive
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
disorder
Osteoarthritis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Otitis externa 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Pelvi-ureteric obstruction 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Pyelonephritis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Scrotal infection 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Scrotal inflammation 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
Skull fracture 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Soft tissue infection 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
Systematic inflammatory
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
response syndrome
Unevaluable event 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Viral upper respiratory
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
tract infection
A patient with multiple SAEs with the same PT is counted only once for that PT.

COVID-19, coronavirus disease 2019; N, number of patients in arm; n, number of patients with outcome; PT, preferred term; Q2W, every 2 weeks; Q4W, every 4 weeks;
SAE, serious adverse event; SEC, secukinumab 300 mg.
335

45
336 Table S6. Treatment-emergent AEs by primary SOC to week 16 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

Primary SOC, n (%) SECQ2W SECQ4W Placebo SECQ2W SECQ4W Placebo
(N=181) (N=180) (N=180) (N=180) (N=180) (N=183)
Any primary SOC 122 (67.4) 118 (65.6) 120 (66.7) 113 (62.8) 114 (63.3) 116 (63.4)
Infections and infestations 59 (32.6) 51 (28.3) 53 (29.4) 52 (28.9) 59 (32.8) 62 (33.9)
Skin and subcutaneous tissue disorders 33 (18.2) 22 (12.2) 39 (21.7) 28 (15.6) 22 (12.2) 31 (16.9)
Gastrointestinal disorders 28 (15.5) 29 (16.1) 25 (13.9) 24 (13.3) 26 (14.4) 27 (14.8)
Nervous system disorders 23 (12.7) 26 (14.4) 22 (12.2) 24 (13.3) 24 (13.3) 20 (10.9)
General disorders and administration site 23 (12.7) 22 (12.2) 23 (12.8) 16 (8.9) 14 (7.8) 14 (7.7)
conditions
Musculoskeletal and connective tissue disorders 18 (9.9) 14 (7.8) 27 (15.0) 13 (7.2) 14 (7.8) 17 (9.3)
Respiratory, thoracic, and mediastinal disorders 14 (7.7) 12 (6.7) 10 (5.6) 12 (6.7) 10 (5.6) 10 (5.5)
Investigations 10 (5.5) 14 (7.8) 17 (9.4) 15 (8.3) 14 (7.8) 14 (7.7)
Metabolism and nutrition disorders 9 (5.0) 9 (5.0) 6 (3.3) 7 (3.9) 5 (2.8) 8 (4.4)
Injury, poisoning, and procedural complications 8 (4.4) 7 (3.9) 10 (5.6) 7 (3.9) 7 (3.9) 6 (3.3)
Psychiatric disorders 6 (3.3) 5 (2.8) 5 (2.8) 4 (2.2) 8 (4.4) 10 (5.5)
Blood and lymphatic system disorders 5 (2.8) 2 (1.1) 4 (2.2) 7 (3.9) 6 (3.3) 4 (2.2)
Eye disorders 5 (2.8) 4 (2.2) 3 (1.7) 3 (1.7) 2 (1.1) 4 (2.2)
Reproductive system and breast disorders 4 (2.2) 5 (2.8) 6 (3.3) 1 (0.6) 8 (4.4) 3 (1.6)
Renal and urinary disorders 2 (1.1) 3 (1.7) 2 (1.1) 5 (2.8) 0 (0.0) 4 (2.2)
Vascular disorders 2 (1.1) 4 (2.2) 2 (1.1) 5 (2.8) 4 (2.2) 3 (1.6)
Hepatobiliary disorders 2 (1.1) 2 (1.1) 4 (2.2) 1 (0.6) 0 (0.0) 1 (0.5)
Immune system disorders 1 (0.6) 2 (1.1) 0 (0.0) 1 (0.6) 1 (0.6) 0 (0.0)
Cardiac disorders 1 (0.6) 1 (0.6) 0 (0.0) 3 (1.7) 1 (0.6) 0 (0.0)
Ear and labyrinth disorders 0 (0.0) 5 (2.8) 2 (1.1) 1 (0.6) 3 (1.7) 1 (0.5)
Neoplasms benign, malignant, and unspecified 0 (0.0) 1 (0.6) 1 (0.6) 2 (1.1) 3 (1.7) 4 (2.2)
(including cysts and polyps)
Product issues 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0)
Endocrine disorders 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.5)
Pregnancy, puerperium, and perinatal conditions 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
A patient with multiple AEs within a primary SOC is counted only once in the SOC.

AE, adverse event; N, number of patients in arm; n, number of patients with outcome; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg; SOC, system
organ class.
337

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338 Table S7. Frequent* treatment-emergent AEs by PT to week 52 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

PT, n (%) SECQ2W SECQ4W Any SECQ2W Any SECQ4W SECQ2W SECQ4W Any SECQ2W Any SECQ4W
(N=181) (N=180) (N=266) (N=267) (N=180) (N=180) (N=261) (N=266)
Any PT 154 (85.1) 154 (85.6) 220 (82.7) 227 (85.0) 147 (81.7) 153 (85.0) 209 (80.1) 217 (81.6)
Headache 33 (18.2) 32 (17.8) 39 (14.7) 47 (17.6) 31 (17.2) 27 (15.0) 39 (14.9) 36 (13.5)
Nasopharyngitis 32 (17.7) 24 (13.3) 40 (15.0) 29 (10.9) 21 (11.7) 18 (10.0) 28 (10.7) 25 (9.4)
Hidradenitis 19 (10.5) 20 (11.1) 31 (11.7) 30 (11.2) 22 (12.2) 23 (12.8) 28 (10.7) 31 (11.7)
Pyrexia 13 (7.2) 8 (4.4) 16 (6.0) 13 (4.9) 9 (5.0) 8 (4.4) 11 (4.2) 12 (4.5)
Diarrhoea 11 (6.1) 16 (8.9) 12 (4.5) 24 (9.0) 13 (7.2) 14 (7.8) 19 (7.3) 19 (7.1)
Arthralgia 11 (6.1) 6 (3.3) 14 (5.3) 9 (3.4) 7 (3.9) 4 (2.2) 11 (4.2) 9 (3.4)
Pruritus 11 (6.1) 6 (3.3) 15 (5.6) 8 (3.0) 8 (4.4) 3 (1.7) 11 (4.2) 5 (1.9)
Intertrigo 10 (5.5) 7 (3.9) 11 (4.1) 8 (3.0) 4 (2.2) 5 (2.8) 6 (2.3) 8 (3.0)
Back pain 7 (3.9) 8 (4.4) 7 (2.6) 12 (4.5) 4 (2.2) 12 (6.7) 7 (2.7) 14 (5.3)
Upper respiratory tract
9 (5.0) 13 (7.2) 12 (4.5) 17 (6.4) 13 (7.2) 8 (4.4) 16 (6.1) 11 (4.1)
infection
Urinary tract infection 9 (5.0) 8 (4.4) 10 (3.8) 10 (3.7) 7 (3.9) 7 (3.9) 8 (3.1) 12 (4.5)
Nausea 4 (2.2) 8 (4.4) 6 (2.3) 13 (4.9) 6 (3.3) 5 (2.8) 12 (4.6) 7 (2.6)
Oropharyngeal pain 9 (5.0) 5 (2.8) 11 (4.1) 7 (2.6) 8 (4.4) 8 (4.4) 8 (3.1) 9 (3.4)
Eczema 8 (4.4) 6 (3.3) 9 (3.4) 9 (3.4) 10 (5.6) 6 (3.3) 11 (4.2) 7 (2.6)
Lipase increased 8 (4.4) 7 (3.9) 8 (3.0) 9 (3.4) 3 (1.7) 7 (3.9) 5 (1.9) 7 (2.6)
Rhinorrhoea 8 (4.4) 2 (1.1) 9 (3.4) 4 (1.5) N/A N/A N/A N/A
Gastroenteritis 8 (4.4) 4 (2.2) 8 (3.0) 4 (1.5) N/A N/A N/A N/A
Abdominal pain 7 (3.9) 6 (3.3) 8 (3.0) 11 (4.1) 4 (2.2) 7 (3.9) 5 (1.9) 10 (3.8)
Toothache 7 (3.9) 6 (3.3) 9 (3.4) 7 (2.6) 6 (3.3) 5 (2.8) 7 (2.7) 5 (1.9)
Pharyngitis 7 (3.9) 5 (2.8) 8 (3.0) 7 (2.6) 3 (1.7) 6 (3.3) 4 (1.5) 9 (3.4)
Fatigue 6 (3.3) 11 (6.1) 8 (3.0) 14 (5.2) 4 (2.2) 6 (3.3) 7 (2.7) 7 (2.6)
COVID-19 6 (3.3) 3 (1.7) 7 (2.6) 8 (3.0) 10 (5.6) 7 (3.9) 13 (5.0) 14 (5.3)
SARS-CoV-2 test
6 (3.3) 5 (2.8) 8 (3.0) 7 (2.6) N/A N/A N/A N/A
negative
Dizziness 6 (3.3) 3 (1.7) 7 (2.6) 6 (2.2) 4 (2.2) 7 (3.9) 6 (2.3) 7 (2.6)
Hypertension 6 (3.3) 4 (2.2) 8 (3.0) 5 (1.9) 11 (6.1) 6 (3.3) 14 (5.4) 7 (2.6)
Ligament sprain 6 (3.3) 4 (2.2) 8 (3.0) 4 (1.5) 1 (0.6) 4 (2.2) 1 (0.4) 5 (1.9)
Psoriasis 6 (3.3) 5 (2.8) 6 (2.3) 5 (1.9) 6 (3.3) 4 (2.2) 6 (2.3) 6 (2.3)
Tonsillitis 6 (3.3) 2 (1.1) 7 (2.6) 4 (1.5) 2 (1.1) 4 (2.2) 4 (1.5) 5 (1.9)
Vulvovaginal mycotic
6 (3.3) 2 (1.1) 7 (2.6) 4 (1.5) N/A N/A N/A N/A
infection
Vomiting 5 (2.8) 7 (3.9) 6 (2.3) 10 (3.7) 2 (1.1) 1 (0.6) 6 (2.3) 1 (0.4)

47
Bronchitis 5 (2.8) 6 (3.3) 5 (1.9) 8 (3.0) 5 (2.8) 5 (2.8) 5 (1.9) 7 (2.6)
Suspected COVID-19 5 (2.8) 3 (1.7) 6 (2.3) 7 (2.6) N/A N/A N/A N/A
Conjunctivitis 5 (2.8) 4 (2.2) 5 (1.9) 6 (2.2) 4 (2.2) 6 (3.3) 4 (1.5) 7 (2.6)
Migraine 5 (2.8) 1 (0.6) 5 (1.9) 3 (1.1) N/A N/A N/A N/A
Cellulitis 5 (2.8) 4 (2.2) 7 (2.6) 7 (2.6) N/A N/A N/A N/A
Cough 4 (2.2) 8 (4.4) 7 (2.6) 10 (3.7) 5 (2.8) 7 (3.9) 6 (2.3) 9 (3.4)
Abdominal pain upper 4 (2.2) 5 (2.8) 4 (1.5) 9 (3.4) 3 (1.7) 9 (5.0) 4 (1.5) 10 (3.8)
Seborrhoeic dermatitis 4 (2.2) 5 (2.8) 6 (2.3) 6 (2.2) N/A N/A N/A N/A
Acne 4 (2.2) 5 (2.8) 5 (1.9) 6 (2.2) N/A N/A N/A N/A
Rash 4 (2.2) 4 (2.2) 6 (2.3) 5 (1.9) N/A N/A N/A N/A
Folliculitis 4 (2.2) 4 (2.2) 6 (2.3) 4 (1.5) 9 (5.0) 2 (1.1) 9 (3.4) 4 (1.5)
Sinusitis 4 (2.2) 2 (1.1) 7 (2.6) 2 (0.7) 3 (1.7) 3 (1.7) 7 (2.7) 3 (1.1)
Hepatic steatosis 4 (2.2) 2 (1.1) 4 (1.5) 3 (1.1) N/A N/A N/A N/A
Hyperuricaemia 4 (2.2) 3 (1.7) 4 (1.5) 3 (1.1) N/A N/A N/A N/A
Vulvovaginal candidiasis 4 (2.2) 2 (1.1) 4 (1.5) 3 (1.1) N/A N/A N/A N/A
Fungal skin infection 4 (2.2) 0 (0.0) 4 (1.5) 0 (0.0) N/A N/A N/A N/A
Depression 4 (2.2) 2 (1.1) 6 (2.3) 3 (1.1) 6 (3.3) 5 (2.8) 6 (2.3) 5 (1.9)
Pain in extremity 3 (1.7) 4 (2.2) 5 (1.9) 5 (1.9) N/A N/A N/A N/A
Asthenia 3 (1.7) 4 (2.2) 5 (1.9) 4 (1.5) N/A N/A N/A N/A
Dermatitis 3 (1.7) 4 (2.2) 4 (1.5) 5 (1.9) 3 (1.7) 4 (2.2) 4 (1.5) 4 (1.5)
Dermatitis contact 3 (1.7) 6 (3.3) 3 (1.1) 6 (2.2) N/A N/A N/A N/A
Amylase increased 3 (1.7) 4 (2.2) 3 (1.1) 5 (1.9) N/A N/A N/A N/A
Ear infection 3 (1.7) 4 (2.2) 3 (1.1) 4 (1.5) 4 (2.2) 1 (0.6) 5 (1.9) 1 (0.4)
SARS-CoV-2 test
2 (1.1) 4 (2.2) 4 (1.5) 5 (1.9) 3 (1.7) 4 (2.2) 5 (1.9) 4 (1.5)
positive
Weight increased 2 (1.1) 5 (2.8) 3 (1.1) 5 (1.9) N/A N/A N/A N/A
Influenza 1 (0.6) 6 (3.3) 1 (0.4) 7 (2.6) 5 (2.8) 1 (0.6) 7 (2.7) 1 (0.4)
Constipation 1 (0.6) 5 (2.8) 1 (0.4) 6 (2.2) 4 (2.2) 1 (0.6) 4 (1.5) 1 (0.4)
Sweat gland infection 1 (0.6) 5 (2.8) 1 (0.4) 5 (1.9) 3 (1.7) 2 (1.1) 9 (3.4) 3 (1.1)
Chest pain 0 (0.0) 5 (2.8) 0 (0.0) 5 (1.9) N/A N/A N/A N/A
Gastroesophageal reflux
N/A N/A N/A N/A 4 (2.2) 4 (2.2) 7 (2.7) 6 (2.3)
disease
Rhinitis N/A N/A N/A N/A 4 (2.2) 4 (2.2) 6 (2.3) 7 (2.6)
Dental caries N/A N/A N/A N/A 4 (2.2) 1 (0.6) 4 (1.5) 1 (0.4)
Skin candida N/A N/A N/A N/A 6 (3.3) 4 (2.2) 8 (3.1) 4 (1.5)
Oral candidiasis N/A N/A N/A N/A 5 (2.8) 1 (0.6) 5 (1.9) 3 (1.1)
Gamma-glutamyl
N/A N/A N/A N/A 5 (2.8) 1 (0.6) 5 (1.9) 1 (0.4)
transferase increased
Dysmenorrhoea N/A N/A N/A N/A 2 (1.1) 5 (2.8) 3 (1.1) 5 (1.9)

48
 Haemorrhoids N/A N/A N/A N/A 1 (0.6) 5 (2.8) 1 (0.4) 5 (1.9)
Influenza like illness N/A N/A N/A N/A 1 (0.6) 5 (2.8) 1 (0.4) 5 (1.9)
Weight decreased N/A N/A N/A N/A 0 (0.0) 4 (2.2) 0 (0.0) 4 (1.5)
Myalgia N/A N/A N/A N/A 3 (1.7) 4 (2.2) 4 (1.5) 6 (2.3)
*Frequent is defined as a treatment emergent adverse event occurring in ≥2% of any treatment arm. A patient with multiple AEs with the same PT is counted only once for
that PT.

AE, adverse event; COVID-19, coronavirus disease 2019; N, number of patients in arm; n, number of patients with outcome; N/A, not applicable as incidence is <2%; PT,
preferred term; Q2W, every 2 weeks; Q4W, every 4 weeks; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SEC, secukinumab 300 mg.
339

49
340 Table S8. Treatment-emergent AEs by primary SOC to week 52 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

Primary SOC, n (%) Any Any Any Any
SECQ2W SECQ4W SECQ2W SECQ4W
SECQ2W SECQ4W SECQ2W SECQ4W
(N=181) (N=180) (N=180) (N=180)
(N=266) (N=267) (N=261) (N=266)
Any primary SOC 154 (85.1) 154 (85.6) 220 (82.7) 227 (85.0) 147 (81.7) 153 (85.0) 209 (80.1) 217 (81.6)
Infections and infestations 106 (58.6) 94 (52.2) 139 (52.3) 126 (47.2) 91 (50.6) 95 (52.8) 134 (51.3) 137 (51.5)
Skin and subcutaneous tissue
74 (40.9) 65 (36.1) 98 (36.8) 92 (34.5) 58 (32.2) 47 (26.1) 74 (28.4) 67 (25.2)
disorders
Gastrointestinal disorders 48 (26.5) 49 (27.2) 60 (22.6) 67 (25.1) 40 (22.2) 50 (27.8) 58 (22.2) 65 (24.4)
Nervous system disorders 41 (22.7) 39 (21.7) 49 (18.4) 59 (22.1) 39 (21.7) 40 (22.2) 50 (19.2) 52 (19.5)
General disorders and
36 (19.9) 36 (20.0) 42 (15.8) 52 (19.5) 27 (15.0) 32 (17.8) 38 (14.6) 40.0 (15.0)
administration site conditions
Musculoskeletal and connective
33 (18.2) 27 (15.0) 40 (15.0) 42 (15.7) 24 (13.3) 31 (17.2) 35 (13.4) 47 (17.7)
tissue disorders
Respiratory, thoracic, and
29 (16.0) 19 (10.6) 36 (13.5) 30 (11.2) 19 (10.6) 21 (11.7) 23 (8.8) 24 (9.0)
mediastinal disorders
Investigations 27 (14.9) 37 (20.6) 37 (13.9) 49 (18.4) 26 (14.4) 31 (17.2) 31 (11.9) 36 (13.5)
Injury, poisoning, and procedural
19 (10.5) 17 (9.4) 28 (10.5) 26 (9.7) 21 (11.7) 21 (11.7) 25 (9.6) 28 (10.5)
complications
Metabolism and nutrition
19 (10.5) 16 (8.9) 21 (7.9) 20 (7.5) 13 (7.2) 10 (5.6) 15 (5.7) 16 (6.0)
disorders
Reproductive system and breast
13 (7.2) 9 (5.0) 18 (6.8) 14 (5.2) 9 (5.0) 15 (8.3) 11 (4.2) 19 (7.1)
disorders
Eye disorders 10 (5.5) 7 (3.9) 14 (5.3) 12 (4.5) 6 (3.3) 3 (1.7) 6 (2.3) 5 (1.9)
Psychiatric disorders 9 (5.0) 10 (5.6) 15 (5.6) 12 (4.5) 14 (7.8) 15 (8.3) 17 (6.5) 16 (6.0)
Vascular disorders 9 (5.0) 8 (4.4) 11 (4.1) 13 (4.9) 14 (7.8) 7 (3.9) 18 (6.9) 10 (3.8)
Hepatobiliary disorders 7 (3.9) 5 (2.8) 9 (3.4) 8 (3.0) 4 (2.2) 5 (2.8) 5 (1.9) 5 (1.9)
Blood and lymphatic system
6 (3.3) 7 (3.9) 6 (2.3) 10 (3.7) 11 (6.1) 7 (3.9) 13 (5.0) 9 (3.4)
disorders
Renal and urinary disorders 6 (3.3) 4 (2.2) 7 (2.6) 5 (1.9) 9 (5.0) 4 (2.2) 10 (3.8) 5 (1.9)
Ear and labyrinth disorders 3 (1.7) 8 (4.4) 5 (1.9) 8 (3.0) 5 (2.8) 3 (1.7) 5 (1.9) 4 (1.5)
Cardiac disorders 2 (1.1) 5 (2.8) 2 (0.8) 7 (2.6) 4 (2.2) 3 (1.7) 4 (1.5) 4 (1.5)
Neoplasms benign, malignant,
and unspecified (including cysts 2 (1.1) 4 (2.2) 2 (0.8) 6 (2.2) 7 (3.9) 3 (1.7) 7 (2.7) 3 (1.1)
and polyps)
Immune system disorders 2 (1.1) 5 (2.8) 2 (0.8) 5 (1.9) 2 (1.1) 4 (2.2) 2 (0.8) 5 (1.9)

50
 Congenital, familial, and genetic
1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
disorders
Endocrine disorders 0 (0.0) 1 (0.6) 0 (0.0) 2 (0.7) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
Product issues 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Social circumstances 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
A patient with multiple AEs within a primary SOC is counted only once in the SOC.

AE, adverse event; N, number of patients in arm; n, number of patients with outcome; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg; SOC, system
organ class.
341

51
342 Table S9. Candida infections by PT to week 16 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

PT, n (%) SECQ2W (N=181) SECQ4W (N=180) Placebo SECQ2W (N=180) SECQ4W (N=180) Placebo
(N=180) (N=183)
Vulvovaginal 1 (0.6) 1 (0.6) 0 (0.0) 1 (0.6) 1 (0.6) 0 (0.0)
candidiasis
Candida infection 1 (0.6) 0 (0.0) 1 (0.6) 0 (0.0) 0 (0.0) 0 (0.0)
Skin candida 0 (0.0) 0 (0.0) 3 (1.7) 1 (0.6) 3 (1.7) 1 (0.5)
Oral candidiasis 0 (0.0) 0 (0.0) 0 (0.0) 3 (1.7) 1 (0.6) 0 (0.0)
Balanitis candida 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.5)
N, number of patients in arm; n, number of patients with outcome; PT, preferred term; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.
343

52
344 Table S10. Candida infections by PT to week 52 in the SUNSHINE and SUNRISE trials

SUNSHINE (N=541) SUNRISE (N=543)

PT, n (%) SECQ2W SECQ4W Any SECQ2W Any SECQ4W SECQ2W SECQ4W Any SECQ2W Any SECQ4W
(N=181) (N=180) (N=266) (N=267) (N=180) (N=180) (N=261) (N=266)
Oral candidiasis 3 (1.7) 3 (1.7) 4 (1.5) 3 (1.1) 5 (2.8) 1 (0.6) 5 (1.9) 3 (1.1)
Vulvovaginal 4 (2.2) 2 (1.1) 4 (1.5) 3 (1.1) 2 (1.1) 2 (1.1) 2 (0.8) 2 (0.8)
candidiasis
Skin candida 2 (1.1) 1 (0.6) 3 (1.1) 3 (1.1) 6 (3.3) 4 (2.2) 8 (3.1) 4 (1.5)
Candida infection 2 (1.1) 1 (0.6) 3 (1.1) 1 (0.4) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4)
Genital candidiasis 0 (0.0) 1 (0.6) 1 (0.4) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Oesophageal 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
candidiasis
Mucocutaneous 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
candidiasis
Urinary tract 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 0 (0.0) 1 (0.4) 0 (0.0)
candidiasis
N, number of patients in arm; n, number of patients with outcome; PT, preferred term; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.
345

53
346 Supplementary Figures

347
348 Figure S1. Study design of the SUNSHINE and SUNRISE trials

349 For Treatment Period 1 (baseline to week 16), patients were randomised 1:1:1 to SECQ2W, SECQ4W, or placebo.

350 Randomised treatment allocation of placebo arm patients to secukinumab arms at week 16 was performed in a 1:1

351 ratio at baseline and did not account for potential discontinuations during Treatment Period 1. Patients who

352 prematurely discontinued treatment during Treatment Period 1 or 2 (week 16 to week 52), or patients who did not

353 enrol in the extension study, entered the follow-up period.

354 BSL, baseline; EOT1/2, end of Treatment Period 1/2; F8, 8-week follow-up visit (8 weeks after the last dose of

355 secukinumab); Q2W, every 2 weeks; Q4W, every 4 weeks; s.c, subcutaneous; SEC, secukinumab 300 mg.

356

54
357

358 Figure S2. The effects of secukinumab and placebo on components of the HiSCR to week 52

359 Line graphs showing the effects of SECQ2W, SECQ4W, and placebo from baseline to week 52 on inflammatory

360 nodules in the (A) SUNSHINE and (B) SUNRISE trials, on abscesses in the (C) SUNSHINE and (D) SUNRISE trials,

361 and on draining fistulae in the (E) SUNSHINE and (F) SUNRISE trials. Data for baseline to week 16 are based on
55
362 observed data from the week 16 database lock. Data for week 18 to 52 are based on observed data from the week 52

363 database lock. Dashed lines represent patients switching from placebo at week 16.

364 IN, inflammatory nodule; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

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365

366 Figure S3. The effects of secukinumab and placebo on DLQI responders and EQ-5D VAS score to week 52

367 Line graphs showing the effects of SECQ2W, SECQ4W, and placebo from baseline to week 52 on DLQI responders

368 in the (A) SUNSHINE and (B) SUNRISE trials and on the EQ-5D VAS score in the (C) SUNSHINE and (D) SUNRISE

369 trials. Data for baseline to week 16 are based on observed data from the week 16 database lock. Data for week 18 to

370 52 are based on observed data from the week 52 database lock. Dashed lines represent patients switching from

371 placebo at week 16.

372 DLQI, dermatology life quality index; EQ-5D, European quality of life 5-dimension; Q2W, every 2 weeks; Q4W, every 4

373 weeks; SEC, secukinumab 300 mg; VAS, visual analogue scale.

374

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375

376 Figure S4. Hierarchical testing strategy employed in the SUNSHINE and SUNRISE trials

377 The hypothesis testing strategy employed in this study was previously reported. (3) Type-I error rate (one-sided) at the

378 study-level was set at <0.025. Hypotheses can only be tested in the order of the arrows. Rejection of H1/H’1 allows for

379 the testing of subsequent hypotheses. H1/H’1, HiSCR SECQ2W; H2/H’2, HiSCR SECQ4W; H3/H’3, AN count

380 SECQ2W; H4/H’4, AN count SECQ4W; H5/ H’5, flare SECQ2W; H6/H’6, flare SECQ4W; H7, NRS30 pooled

381 SECQ2W; H8, NRS30 pooled SECQ4W.

382 α, type-I error rate; AN, abscess and inflammatory nodule; H, hypothesis; HiSCR, hidradenitis suppurativa clinical

383 response; NRS, numeric rating scale; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

384

58
385

386 Figure S5. Sensitivity analysis of week 52 efficacy data

387 Line graphs showing the effects of SECQ2W and SECQ4W from baseline to week 52 on HiSCR in the (A) SUNSHINE

388 and (B) SUNRISE trials, on AN count in the (C) SUNSHINE and (D) SUNRISE trials, on the proportion of patients

389 experiencing flares in the (E) SUNSHINE and (F) SUNRISE trials and on (G) NRS30 in SUNSHINE and SUNRISE

390 (pooled data). Data for baseline to week 52 are based on a mixed effects logistic regression model (HiSCR, flares,

391 and NRS30) or a mixed model for repeated measures (AN count) from the week 52 database lock.
59
392 AN, abscess and inflammatory nodule; CFB, change from baseline; HiSCR, hidradenitis suppurativa clinical response;

393 NRS, numeric rating scale; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

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 61
394
395 Figure S6. The effects of secukinumab on HiSCR, AN count and flares to week 52: pooled study data

396 Line graphs showing the effects of SECQ2W, SECQ4W and placebo based on pooled data from the SUNSHINE and SUNRISE trials from baseline to week 52 on (A, D)

397 HiSCR, (B, E) AN count and (C, F) flares. In (A–C), data for baseline to week 16 are based on the primary or secondary estimand and multiple imputation from the week 16

398 database lock and data for week 18 to 52 are based on observed data from the week 52 database lock. Dashed lines represent patients switching from placebo at week 16.

399 Grey box represents observed data. In (D–F), data for baseline to week 52 are based on a mixed effects logistic regression model (HiSCR and flares) or a mixed model for

400 repeated measures (AN count) analysed from the week 52 database lock.

401 AN, abscess and inflammatory nodule; CFB, change from baseline; HiSCR, hidradenitis suppurativa clinical response; MELRM, mixed effects logistic regression model;

402 MMRM, mixed model for repeated measures; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

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403

404
405 Figure S7. The effects of secukinumab on DLQI responders to week 52: pooled trial data

406 Line graph showing the effects of SECQ2W, SECQ4W and placebo on DLQI responders based on pooled data from

407 the SUNSHINE and SUNRISE trials from baseline to week 52. Data for baseline to week 16 are based on observed

408 data from the week 16 database lock. Data for week 18 to 52 are based on observed data from the week 52 database

409 lock. Dashed lines represent patients switching from placebo at week 16.

410 DLQI, dermatology life quality index; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

411

63
412

413 Figure S8. The effects of secukinumab on AN50 response rates to week 52

414 Line graphs showing the effects of SECQ2W, SECQ4W and placebo on AN50 response from baseline to week 52 in

415 the (A, C) SUNSHINE and (B, D) SUNRISE trials. In (A) and (B), data for baseline to week 16 are based on the

416 secondary estimand and multiple imputation from the week 16 database lock and data for week 18 to 52 are based on

417 observed data from the week 52 database lock. Dashed lines represent patients switching from placebo at week 16.

418 Grey box represents observed data. In (C) and (D), data for baseline to week 52 are based on a mixed effects logistic

419 regression model analysed from the week 52 database lock.

420 AN50, at least a 50% reduction in abscess and inflammatory nodule count relative to baseline; MELRM, mixed effects

421 logistic regression model; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

422

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423

424 Figure S9. The effects of secukinumab on AN50 response rates to week 52: pooled trial data

425 Line graphs showing the effects of SECQ2W, SECQ4W and placebo on AN50 response based on pooled data from

426 the SUNSHINE and SUNRISE trials from baseline to week 52. In (A), data for baseline to week 16 are based on the

427 secondary estimand and multiple imputation from the week 16 database lock and data for week 18 to 52 are based on

428 observed data from the week 52 database lock. Dashed lines represent patients switching from placebo at week 16.

429 Grey box represents observed data. In (B), data for baseline to week 52 are based on a mixed effects logistic

430 regression model analysed from the week 52 database lock.

431 AN50, at least a 50% reduction in abscess and inflammatory nodule count relative to baseline; MELRM, mixed effects

432 logistic regression model; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.

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433 Supplementary References

434 1. Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, et al. Two Phase 3
435 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016;375(5):422-34.
436 2. Yamanaka-Takaichi M, Ghanian S, Katzka DA, Torgerson RR, Alavi A. Candida Infection
437 Associated with Anti-IL-17 Medication: A Systematic Analysis and Review of the Literature. Am J Clin
438 Dermatol. 2022;23(4):469-80.
439 3. Bretz F, Maurer W, Xi D. Replicability, Reproducibility, and Multiplicity in Drug Development.
440 CHANCE. 2019;32(4):4-11.
441

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