Aggarwal, Rohit
Schessl, Joachim
Charles-Schoeman, Christina
Bata-Csörgő, Zsuzsanna
Dimachkie, Mazen M.
Griger, Zoltan
Moiseev, Sergey
Oddis, Chester V.
Schiopu, Elena
Vencovský, Jiri
Beckmann, Irene
Clodi, Elisabeth
Levine, Todd
,
Funding for this research was provided by:
Octapharma Pharmazeutika Produktionsges.m.b.H
Article History
Received: 8 June 2023
Accepted: 6 December 2023
First Online: 17 January 2024
Declarations
:
: The study was conducted in accordance with the Declaration of Helsinki, in compliance with good clinical practice guidelines. Informed consent was obtained from each patient before any study-related procedures were conducted.The study was approved by the following ethics committees: Ethik-Kommission des Landes, Berlin, Germany; Bioethics Committee at the National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw, Poland; Medical Research Council, Ethics Committee for Clinical Pharmacology (ECCP), Budapest, Hungary; Ethics Committee for Multi-Centric Clinical Trials, The University Hospital Kralovske Vinohrady, Prague, Czech Republic; Ministry of Health of the Russian Federation (MOH) Council of Ethics, Moscow, Russia; Amsterdam UMC, Medical Review Committee AMC, Amsterdam, Netherlands; National Bioethics Committee for Medicines and Medical Devices, Bucharest, Romania; Ethics Committee at Sumy Regional Clinical Hospital, Public Institution of Sumy Regional Council 18, Ukraine; Ethics Committee Ternopil University Hospital, Ternopil, Ukraine; Ethics Committee at the Ivano-Frankivsk City, Clinical Hospital No. 1, Ivano-Frankivsk, Ukraine; Jewish General Hospital - Research Ethics Committee, Quebec, Canada; Western Institutional Review Board, Puyallup, WA, USA; IntegReview, Austin, TX, USA; UCLA IRB, Institutional Review Board, University of California LA, USA; The University of Kansas Medical Center Institutional Review Board, KS, USA; University of Michigan Medical School Institutional Review Board; Mayo Clinic Institutional Review Board, Rochester, MN, USA; Oregon Health & Science University Independent Review Board, Portland, OR, USA; and UMiami Human Subject Research Office (M809), Miami, FL, USA.
: Specific consent for publication was not provided as all data in this international study (from 36 European and North American centres) is fully anonymised.
: RA has received grants or contracts from Mallinckrodt, Pfizer, Bristol Myers-Squibb, Boehringer Ingelheim, Q32, EMD Serono and Janssen; and consulting fees from Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, Alexion, Boehringer Ingelheim, Janssen, Roivant, Galapagos, Abbvie, Horizontal Therapeutics, Biogen, ANI Pharmaceutical, Capella, Ililli, Medicxi, EMD Serono, Kezar, Pfizer, Astra Zeneca, Argenx, Corbus, Kyverna, Merck, Actigraph, Scipher, Teva, Beigene, Nuvig, Cabaletta Bio and Sanofi. JS has received support for the current manuscript and funding and consultancy fees from Octapharma; and honoraria for presentations, from Pfizer. CC-S has received grants or contracts from Pfizer, Bristol Myers Squibb, Abbvie, CSL Behring, Alexion and Priovant; consulting fees from Pfizer, Bristol Myers Squibb, Abbvie, Octapharma, Priovant, Galapagos, Recludix and Boehringer Ingelheim Pharmaceuticals; and participated on a Data Safety Monitoring Board or Advisory Board for Bristol Myers Squibb. ZB-C has received payment or honoraria for lectures from Sanofi, Berlin-Chemie and Abbvie; support for attending meetings from Sanofi and Biotest AG; and unpaid board membership in the Hungarian Dermatology and Immunology and Allergy Societies. MMD has received grants or contracts from Alexion, Alnylam Pharmaceuticals, Amicus, Biomarin, Bristol-Myers Squibb, Catalyst, Corbus, CSL-Behring, FDA/OOPD, GlaxoSmithKline, Genentech, Grifols, Kezar, Mitsubishi Tanabe Pharma, MDA, NIH, Novartis, Octapharma, Orphazyme, Ra Pharma/UCB, Sanofi Genzyme, Sarepta Therapeutics, Shire Takeda, Spark Therapeutics, The Myositis Association, UCB Biopharma/RaPharma, Viromed/Healixmith and TMA; consultancy fees, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, and participated on a Data Safety Monitoring Board or Advisory Board for Abcuro, Amazentis, ArgenX, Astellas, Catalyst, Cello, Covance/Labcorp, CSL-Behring, EcoR1, Janssen, Kezar, MDA, Medlink, Momenta, NuFactor, Octapharma, Priovant, RaPharma/UCB, Roivant Sciences Inc, Sanofi Genzyme, Shire Takeda, Scholar Rock, Spark Therapeutics, Abata/Third Rock and UCB Biopharma; and received royalty fees or licenses, consultancy fees, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from UpToDate. ZG has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Lilly, Novartis, Roche; received support for attending meetings and/or travel from Biotest, CSL Behring, Novartis, Abbvie and Lilly; and participated on a Data Safety Monitoring Board or Advisory Board for Octapharma. CVO has received research support from Genentech and consulting fees from Pfizer. JV has received support for the current manuscript from the Czech Ministry of Health; grants or contracts from Abbvie; consulting fees from Argenx; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Werfen and Octapharma; and Participated on a Data Safety Monitoring Board or Advisory Board for Horizon, Kezar, Boehringer and Octapharma. IB was an employee of Octapharma Pharmazeutika Produktionsges.m.b.H until June 2022; and has subsequently received Consulting fees from Octapharma. EC is an employee of Octapharma Pharmazeutika Produktionsges.m.b.H. TL is a consultant for FFF Enterprises. SM and ES have no conflicts of interest to declare.