Kristensen, Lars-Erik
Okada, Masato
Tillett, William
Leage, Soyi Liu
El Baou, Celine
Sapin, Christophe
Bradley, Andrew J.
Meszaros, Gabriella
Dutz, Jan P.
de Vlam, Kurt
Funding for this research was provided by:
Eli Lilly and Company (The study was funded by Eli Lilly and Company)
Article History
Received: 6 July 2021
Accepted: 12 October 2021
First Online: 28 October 2021
Declarations
:
: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA.
: The authors would like to acknowledge Dr. Elinor Wylde and Dr. Sue Chambers (Rx Communications, Mold, UK) for medical writing assistance with the preparation of this manuscript, funded by Eli Lilly and Company.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
: Lars-Erik Kristensen made substantial contributions to the acquisition and interpretation of data, and critical revision of the manuscript. Masato Okada made substantial contributions to the interpretation of data and critical revision of the manuscript. William Tillett made substantial contributions to the interpretation of data and critical revision of the manuscript. Soyi Liu Leage made substantial contributions to conception and design of the work, the analysis and interpretation of data, and drafting and critical revision of the manuscript. Celine El Baou made substantial contributions to the design of the work, the analysis and interpretation of data, and critical revision of the manuscript. Christophe Sapin made substantial contributions to the design of the work, the analysis and interpretation of data, and critical revision of the manuscript. Andrew Bradley made substantial contributions to the analysis and interpretation of data, and critical revision of the manuscript. Gabriella Meszaros made substantial contributions to conception and design of the work, the analysis and interpretation of data, and drafting and critical revision of the manuscript. Jan Dutz made substantial contributions to the interpretation of data and critical revision of the manuscript. Kurt de Vlam made substantial contributions to the acquisition and interpretation of data, and critical revision of the manuscript.
: The authors would like to acknowledge the investigators and participants in the SPIRIT-H2H study. The SPIRIT-H2H investigators were: Leonardo Naftal, Rodolfo Ariel Pardo Hidalgo, Eduardo Mario Kerzberg, Veronica Gabriela Savio, Alicia Lazaro, Benito Jorge Velasco, Norma Beatriz Verzero, Cecilia Adma Asnal, Eduardo Fabian Mysler, Alberto Berman, Federico Javier Ariel, Maureen Rischmueller, Jane Margaret Zochling, Paul A Bird, Stephen Hall, Andrew Ostor, Evange Romas, Georg Stummvoll, Klaus Machold, Peter Spellitz, Ursula Hanusch, Marc Vanden Berghe, Marc Leon, Johan Louis Magda Vanhoof, Filip Eduard Jeanne Van den Bosch, Kurt Leo Francois De Vlam, Frederic Morin, Louis Bessette, Derek A Haaland, Annette Margrethe Schlemmer, Lars Erik Kristensen, Pentti Jarvinen, Ritva Liisa Peltomaa, Laura Pirila, Jorma Vuotila, Eric Lespessailles, Philippe Goupille, Bernard Combe, Arnaud Constantin, Gregoire Cormier, Celine Cozic, Cyrille B Confavreux, Hendrik Schulze-Koops, Andrea Everding, Micheala Kohm, Siegfried Wassenberg, Magdolna Nagy, Noemi Bakos, Eva Melegh, Edit Drescher, Lalit Duggal, Piyush Narayanbhai Joshi, Srabani Ghosh Zoha, A Ramakrishnam Naidu, Puja Pushkarkumar Srivastava, Vishnu Devkinandan Sharma, Ajit Bapurao Nalawadae, Jyotsna Laxmikant Oak, Sarath Chandra Mouli Veeravalli, Jugal Kishore Kadel, Manisha Ashwin Daware, Yogesh S Marfatia, Sumeet Agarwal, Yolanda Braun Moscovici, Ori Elkayam, Yair Molad, Tatiana Reitblat, Moshe Tishler, Yair Levy, Merav Lidar, Devy Zisman, Antonio Costanzo, Paolo Amerio, Riccardo Meliconi, Rosario Foti, Roberto Perricone, Maurizio Rossini, Elisa Gremese, Beatriz Elena Zazueta Montiel, Juan Manuel Miranda Limon, Marco Antonio Maradiaga Cecena, Sandra Araceli Sicsik Ayala, Miguel Angel Alvarez Guerrero, Jorge Rojas Serrano, Efren Antonio Canul Novelo, Francisco Fidencio Cons-Molina, Ed N Griep, Andrzej Kaszuba, Jolanta Bogna Węgłowska, Barbara Bazela, Maria Rell-Bakalarska, Malgorzata Miakisz, Catherine Elizabeth Spargo, Elsa Margaretha Van Duuren, Asokan Naidoo, Nomawethu Cleopatra Matsiliza, Johannes Breedt, Gareth Scott Tarr, Jenny Potts, Savithree Nayiager, Mahmood Moosa Tar Mahomed Ally, Francisco Javier Blanco Garcia, Antonio Mera Varela, Jose Rosas, Juan Miguel Sanchez Burson, Javier Garcia Miguel, Jon Lampa, Milad Rizk, Giovanni Cagnotto, Per Larsson, Guozhong Fei, Ruediger Mueller-Mar, Andrea Rubbert-Roth, Michael John Nissen, Oleh Iaremenko, Svitlana Anatoliivna Trypilka, Dmytro Rekalov, Mykola Stanislavchuk, Viktoriia Viktorivna Vasylets, Olena Garmish, Svitlana Smiyan, David Walker, Deepak Jadon, Stuart Ralston, Stephen Boyle, Pippa Anne Watson, James E Dale, Sara Carty, Karen Douglas, Christopher J Edwards, David Hutchinson, and Nick Barkham.
: This manuscript is based on work that has been previously published [CitationRef removed, CitationRef removed] and on an abstract presented on 8 November at ACR Convergence 2020 (virtual meeting): Kristensen L, et al. Efficacy of ixekizumab versus adalimumab in psoriatic arthritis (PsA) patients with and without moderate-to-severe psoriasis: 52-week results from a multicentre, randomised open-label study [abstract]. Arthritis Rheumatol. 2020;72(Suppl 10). ExternalRef removed.
: LEK has received consultancy fees and speaker’s bureau fees from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen Pharmaceuticals, Merck, Sharp & Dohme (MSD), Novartis, Pfizer, Roche, Sanofi, and UCB Pharma (unrelated to the present work). MO and KdV have nothing to disclose. SLL, CS, AB and GM are employees and stockholders of Eli Lilly and Company. CEB is an independent consultant contracted by Eli Lilly and Company. WT has received research grants, consulting fees or speaker fees from AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer and UCB. JD has performed clinical trials for Corbus, Eli Lilly and Company and Janssen; has received honoraria from AbbVie, Amgen, Bausch, Celgene, Leo, Janssen, Novartis and Sanofi; and has worked on the speaker bureau for Celgene and Eli Lilly and Company.
: SPIRIT-H2H was conducted in accordance with the ethical principles of the Helsinki Declaration of 1964 and its later amendments. All patients involved provided written informed consent, and the study protocol was approved by the ethical review board of each investigative site (Supplementary Table S3) and the National Research Ethics Service Committee London (17/LO/0794) prior to the start of study-related procedures. SPIRIT-H2H is registered at ClinicalTrials.gov (NCT03151551).
: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.