The authors would like to acknowledge Clare Proudfoot, PhD, and Matthew Reaney, MSc, of Sanofi for their contribution to the analyses and revisions of the manuscript.
Competing interests
VS has received consulting fees from AbbVie, Afferent, Amgen, Biogen, Bioventus, BMS, Carbylan, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo Bioscience, Eli Lilly, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc, Sanofi Genzyme, SKK, Takeda, UCB, and Vertex. MK has received consulting fees from Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. CC and NMHG are employees of Regeneron Pharmaceuticals, Inc, and may hold stock and/or stock options in the company. GJ was an employee of Sanofi Genzyme when the study was conducted and may hold stock in Amgen and Pfizer. RR-B has received consulting fees from Regeneron Pharmaceuticals, Inc. HvH and CF are employees of Sanofi Genzyme and may hold stock and/or stock options in the company. MB is an employee of Optum, which provides services to Sanofi Genzyme. TWJH has received lecture or consulting fees from Merck, UCB, Bristol-Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi Genzyme, Abbott, Crescendo Bioscience, Nycomed, Boehringer, Takeda, Zydus, and Eli Lilly. MCG has received research grants and/or consulting fees from Bristol-Myers Squibb, GlaxoSmithKline, R-Pharma, Roche, RuiYi, and Sanofi Genzyme. No author has a nonfinancial competing interest.
Ethics approval and consent to participate
The protocol received approval from the Institutional Review Board and Independent Ethics Committee of the investigational centers and was performed in accordance with the Declaration of Helsinki. The specific ethical bodies that approved study EFC11072-Part B are as follows: CIE Para Ensayos en Farmacologia Clin Prof Dr Luis M. Zieher Jose E. Uriburu, Buenos Aires; CIEIS - Italiano De Cordoba Roma, Córdoba; Comité de Etica Instituto Strusberg, Córdoba; CIEM-NOA Las Piedras, Tucumán; CIEFA Uruguay, Buenos Aires; Instituto De Investigaciones Clínicas Zarate F. Andrade, Buenos Aires Province; Dim Clínica Privada Belgrano, Buenos Aires Province; CECIC - Comité de Ética de CER Investigaciones Clínicas Vicente Lopez, Buenos Aires Province; Instituto De Investigaciones Clínicas Avda, Buenos Aires Province; Redcliffe-Caboolture Health Service District Ethics Committee, Queensland; Sydney Local Health Network (SLHN) Ethics Review Committee, New South Wales; Austin Health Human Research Ethics Committee Austin Hospital, Victoria; Human Research Ethics Committee (TQEH/LMH/MH) The Queen Elizabeth Hospital, South Australia; Royal Brisbane Hospital EC Royal Brisbane Hospital & Women’s Hospital Health, Queensland; ACT Health Human Research Ethics Committee Canberra Hospital, Australian Capital Territory; Bellberry Human Research Ethics Committees, South Australia; Ethikkommission der Medizinischen Universität Graz, Graz; EK der Stadt Wien gemäß KAG, AMG und MPG Town, Wien; CHU de Liège Domaine Universitaire du Sart-Tilman, Liège; EC of Hospital das Clínicas da Univ. Federal do Parana Rua General Carneiro, Parana; Comissão Nacional de Ética em Pesquisa - CONEP Edifício Ex-INAN - Unidade II, Brasilia; EC of Instituto de Assistancia Medica Servidor Publico Estadual, Sao Paulo; Ethics Committee of Hospital Heliopolis Rua Conego Xavier, Sao Paulo; EC of Pontifícia Universidade Católica do Rio Grande do Sul, Rio Grande do Sul; EC of Hospital Universitario Pedro Ernesto, Rio de Janeiro; Ethics Committee of Hospital Geral de Goiania, Goias; EC of Pontifícia Univ. Católica de Campinas, Sao Paulo; EC of Hospital Universitario da Univ Federal de Juiz de Fora, Minas Gerais; Ethics Committee Prof. Dr. Celso Figueiroa SCMBA Praca Conselheiro Almeida Couto, Bahia; EC of Faculdade de Ciencias Medicas UNICAMP, Sao Paulo; EC of Centro Integrado de Atencao a Saude - UNIMED Vitoria, Espirito Santo; Local Ethics Committee of the City Clinical Hospital Number 9, Minsk; LEC of the Clinical Hospital 6, Minsk; Institutional Review Board Services, Aurora; University Health Network Research Ethics Board, Toronto; Comité de Ética de la Investigacion S.S.M Centra, Santiago; Comité de Ética Científico S.S. M Oriente, Santiago; Comité Etico de Investigacion Servicio de Salud Valdivia, Valdivia; Comité de Ética de la Investigacion S.S. Viña Quillota, Vina Del Mar; Comité de Ética de la Investigacion S.S.M Sur Oriente, Santiago; Comité de Ética de la Investigacion S.S.M. Sur; Santiago; Comité de Ética Cientifica del Servicio de Salud del Maule, Talca; National Taiwan University Hospital 7, Taipei; Chang Gung Memorial Hospital (Institutional Review Board) Chang Gung Memorial Hospital Number 5, Taoyuan; CIE en Investigacion del H. Militar Central, Bogotá; Comité de Investigaciones y Etica en Investigaciones, Medellin; Comité de Etica en Investigacion de la Universidad del Norte, Barranquilla; Comité de Ética de la Investigacion Riesgo de Fractura, Bogotá; Comité de Ética en Investigaciones del Oriente, Bucaramanga; Fundacion Instituto de Reumatologia Fernando Chalem, Bogotá; Comité de Etica en Investigacion de Servimed EU, Bucaramanga; Tallinn Medical Research Ethics Committee, Tallinn; HUS Medisiininen Eettinen Toimikunta Biomedicum Helsinki 2 C, Helsinki; Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster, Münster; Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main; Ethik-Kommission der Medizinischen Fakultät Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen; Ethik-Kommission der Ärztekammer Hamburg, Hamburg; Ärztekammer Niedersachsen Ethikkommission zur Beurteilung Medizinischer Forschung am Menschen, Hannover; Ethik-Kommission des Landes Berlin Landesamt für Gesundheit und Soziales Berlin, Berlin; Ethik-Kommission I der Medizinischen Fakultät Heidelberg, Heidelberg; Ethik-Kommission des Landes Sachsen-Anhalt, Dessau-Rosslau; National Ethics Committee 284, Messoghion, Athens; Medical Research Council, Ethics Committee for Clin. Pharm., Budapest; Center for Rheumatic Diseases (CRD) Ethics Committee CRD, 11, Hermes Elegance, Pune; Medanta Independent Ethics Committee Medanta - The Medicity, Gurgoan; CMMH National Ethics Committee National Ethics Committee, Chennai; IEC of Sri Deepti Rheumatology Center Sri Deepti Rheumatology Center, Hyderabad; Institution Ethics Committee #149, Bangalore; Penta Med Ethics Committee Medipoint Hospitals PVT LTD, Pune; KIMS Institutional Ethics Committee, Secunderabad; Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow; Gachon University Gil Hospital IRB, Incheon; CMC Central IRB, Seoul; Institutional Review Board of the Catholic University of Korea, Seoul; Institutional Review Board of Kyungpook Nat’l Univ. Hospital, Daegu; IRB of Eulji University Hospital, Daejeon; Pusan National University Hospital, Busan; Institutional Review Board of National University Hospital, Seoul; Ajou University Hospital, Gyeonggi-do; Institutional Review Board of Inha University Hospital, Incheon; Institutional Review Board of Chonnam National University Hospital, Gwangju; Institution Review Board of Chonbuk National University Hosp, Jeollabuk-do; The Hospital for Rheumatic Disease Hanyang University, Seoul; Institutional Review Board of Hallym Sacred Heart Hospital, Gyeonggi-do; Medical Research & Ethics Committee C/o Institute for Health Management, Kuala Lumpur; Comité Bioetico para la Investigacion Clínica S.C., México, D.F.; CEI Centro de Estudios de Investigación Básica y Clínica SC, Jalisco; CEI Centro de Especialidades Médicas del Sureste, S.A.de C.V., Yucatan; Comité de Ética Faculdad de Medicina de la UANL y HU, Nuevo Leon; Comité de Ética de la F. de Med. de la UAEM Paseo Tollocan S/N Col., Estado de México; Comision de Investigacion Etica y Bioseguridad Cen. Esp. en Diab., Ob. y Prev. de Enf. Cardiovasc., SC, México, D.F.; CEI Unidad de Atención Médica e Invest. en Salud (UNAMIS), Yucatan; Multi-region Ethics Committee NZ Multi-region EC, Wellington; Regional Komité for Medisinsk og Helsefaglig Forskningsetikk, Oslo; Institutional Review Board-University of Sto. Tomas Hospital University of Sto. Tomas Hospital, Manila; UP PGH-RIDO Philippine General Hospital, Manila; Cebu Doctors University Institutional Ethics Review Committee, Cebu; Komisja Bioetyczna przy Kujawsko-Pomorskiej Okr. Izbie Lekar, Kujawsko-pomorskie; CEIC - Comissão de Ética para a Investigação Clínica, Lisboa; National Ethics Committee for Clinical Trial of the Medicine, Bucharest; LEC of the Scientific Research Institute of Rheumatology, Moscow; National Ethics Committee of the Russian Federation, Moscow; Russian State Medical University, Moscow; LEC of Aviation Clinical Hospital #7, Moscow; LEC of the Kemerovo State Medical Academy, Kemerovo; LEC of the Hospital #25, Saint-Petersburg; LEC of t Dzhanelidze Research Institute, Saint-Petersburg; LEC of Immunology Research Institute, Novosibirsk; LEC of Samara Region Hospital named after M.I. Kalinin, Samara; LEC of the Saratov State Medical University, Saratov; LEC of the Central Clinical Hospital with Outpatient Department, Moscow; LEC of Republican Clinical Hospital named by G.G. Kuvatov, Ufa; LEC of the City Clinical Hospital #26, Saint-Petersburg; Ryazan Regional Clinical Cardiological Dispensary, Ryazan; LEC of the Kemerovo Regional Clinical Hospital, Kemerovo; LEC of ‘Applied Medicine,’ Moscow; Wits Human Research EC, Gauteng; Pharma Ethics (Pty) Ltd, Pretoria; University of Kwazulu-Natal, Biomedical Research Ethics Committee, Durban; The Research Ethics Committee, University of Pretoria Faculty of Health Sciences, University of Pretoria, Pretoria Gauteng; CEIC Hospital Virgen Macarena, Sevilla; The Ethical Clearance Committee on Human Rights Related to Research Involving Human Subjects Ramathibodi Hospital, Bangkok; The Ethical Committee on Research Involving Human Subject Siriraj Hospital, Bangkok; LEC of Central City Clinical Hospital #1, Donetsk; LEC of Railway Clinical Hospital, Dnipropetrovsk; LEC of “M.D. Strazhesko Institute of Cardiology of AMS of Ukraine,” Kyiv; LEC of City Clinical Hospital #4, Lviv; LEC of “University Clinic,” Simferopol; LEC of Oleksandrivska Clinical Hospital, Kyiv; LEC of Municipal Institution “Zaporizhzhya Regional Clinical Hospital,” Zaporizhzhya; LEC of Kharkov Regional Clinical Hospital, Khark; Compass IRB, Mesa, AZ; Emory University IRB, Atlanta, GA; Schulman Associates Institutional Review Board, Cincinnati, OH; IRB - University of Florida Health Center Institutional Review Board, Gainesville, FL; New York University School of Medicine IRB, New York, NY; Ethics Committee of Centro de Ciencias da Saude UFPE, Pernambuco; Ethik-Kommission der Landesärztekammer in Hessen, Frankfurt; Ethics Committee for Research on Human Subject Seth GS Medical College and KEM Hospital, Mumbai; Ethics Committee on Clinical Trials Indraprastha Apollo Hospitals, Delhi; Institutional Ethics Committee CSSMU Office of the Research Cell of C.S.M. Medical University, Lucknow; Ethics Committee of Care Institute of Medical Sciences CIMS Hospitals, Ahmedabad; Daegu Catholic University Medical Center, Daegu-si; Ministry of Health Ethics Committee, Ankara; Research Ethics Committee Faculty of Medicine Cairo University, Cairo; WIRB, Olympia, WA; University of California, San Diego IRB, La Jolla, CA; University of Texas Southwestern Medical Center IRB, Dallas, TX. All patients provided written, informed consent prior to study participation.