The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune‐Mediated Inflammatory Disease

Funding

Open Access funding enabled and organized by Projekt DEAL. This study was funded by Biogen International GmbH.

Conflicts of Interest

Ulf Müller-Ladner has served as a speaker/advisor for Biogen, AbbVie, and Medac. Axel Dignass has received fees for participation in clinical trials and for review activities, such as data monitoring boards, statistical analysis, and endpoint committees from Abivax, AbbVie, Arena, Celgene/Bristol Myers Squibb, Falk, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene/Bristol Myers Squibb, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, Janssen, Eli Lilly, MSD, Pfizer, Pharmacosmos, Roche/Genentech, Sandoz/Hexal, Takeda, Tillotts, and Vifor; and payment for lectures including service on speaker bureaus from AbbVie, Amgen, Biogen, Celltrion, Falk Foundation, Ferring, Gilead/Galapagos, Janssen, Eli Lilly, MSD, Pharmacosmos, Pfizer, Takeda, Tillotts, and Vifor. Karl Gaffney has received research grants from NASS, AbbVie, UCB, Novartis, Eli Lilly, Celgene, Celltrion, Janssen, Gilead, and Biogen; consultancy fees/honoraria from AbbVie, Eli Lilly, and Novartis; and speaker/bureau fees from AbbVie, UCB, Novartis, and Eli Lilly. Deepak Jadon has received research grants, education grants, and/or consulting fees or honoraria from AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Fresenius Kabi, Galapagos/Gilead, GSK, Healthcare Celltrion, Janssen, Merck, Novartis, Pfizer, Roche, and Sandoz. Marco Matucci-Cerinic has received research grants from MSD and speaker fees from Sandoz, Boehringer Ingelheim, and Biogen. Triana Lobaton has received financial research support from AbbVie, Viatris, MSD, Mundipharma, Biogen, Janssen, Pfizer, and Takeda; speaker fees from Ferring, MSD, AbbVie, Janssen, Amgen, Fresenius Kabi, Galapagos, Viatris, and Takeda; and consultancy fees from Janssen, Galapagos, Amgen, Bristol Myers Squibb, Fresenius Kabi, and Takeda. Philippe Carron has received consulting/speaker’s fees from AbbVie, Biogen, Eli Lilly, Fresenius Kabi, Galapagos, MSD, Pfizer, and UCB. Javier P. Gisbert has served as a speaker, consultant, and advisory member for, or has received research funding from, MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers Squibb, Gilead/Galapagos, Eli Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine, and Vifor Pharma. Ira Pande has received research funding, consulting, speaker fees, and sponsorship from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, MSD, Pfizer, Proctor & Gamble, and Roche. Maximilian Utzinger and Janet Addison are employees of Biogen and may hold company stock.

Availability of Data and Material

The data pertaining to this research will not be shared.

Ethics Approval

The protocol, its amendment, and the patient-informed consent form were approved by the Ethics Committees of the participating sites. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and all applicable local regulations.

Consent to Participate

Prior to enrolling a patient into the study or entering any patient data into the electronic Case Report Form, the Investigator was responsible for obtaining written informed consent from the patient through an Ethics-Committee-approved Informed Consent Form (ICF) in accordance with local practice and regulations. The patient was asked to sign the ICF only after receiving an explanation of the backgrounds, methods, procedures, and benefits and potential risks of the study, and being informed that their participation was voluntary.

Patient Consent to Publish

Not applicable.

Code Availability

Not applicable.

Author Contributions

JA developed the concept for this publication, developed the methodology, and acquired funding. Formal analysis and investigation were conducted by JA and MU who, along with UM-L, prepared the original draft of the manuscript. All authors were involved in the review and editing of the draft manuscript. KG, DJ, MM-C, TL, PC, and IP were principal investigators at their respective study sites. Supervision for this study was provided by JA, MU, UM-L, AD, DJ, TL, PC, JG, and MM-C. All authors read and approved the final version of this manuscript.

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