Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)

ABSTRACT

Objective: To evaluate long-term safety, efficacy, and immunogenicity of BI 695501 in patients with moderately-to-severely active rheumatoid arthritis (RA) who have completed VOLTAIRE-RA.

Methods: Eligible patients for this phase 3b open-label extension study (VOLTAIRE-RAext), who had completed 48 weeks’ treatment with BI 695501 (Group A), 24 weeks each of adalimumab RP then BI 695501 (Group B), or 48 weeks of adalimumab RP (Group C) in VOLTAIRE-RA, were enrolled.

Results: Altogether, 430 patients received BI 695501 fortnightly for 48 weeks: Group A, n = 225; Group B, n = 103; Group C, n = 102. The proportion of patients with drug-related adverse events (AEs; overall 20.2%) was similar across Groups A, B, and C: 21.3%, 20.4%, and 17.6%, respectively. The majority of treatment-emergent AEs were non-serious and of mild/moderate intensity. Consistent with adalimumab RP’s safety profile, most drug-related AEs were in the system organ class infections and infestations. BI 695501 and adalimumab RP responses at the end of VOLTAIRE-RA were sustained during VOLTAIRE-RAext and all efficacy and immunogenicity endpoints were similar across groups.

Conclusion: Over 2 years, BI 695501 showed similar safety, efficacy, and immunogenicity to adalimumab RP, independent of initial treatment in VOLTAIRE-RA. No previously unknown adalimumab side effects were identified.

Clinical trial registration: NCT02640612.

KEYWORDS:

• Adalimumab
• BI 695501
• biosimilar
• rheumatoid arthritis
• tumor necrosis factor alpha inhibitor

Acknowledgments

The authors thank Tamara Bailey PhD of GeoMed, an Ashfield company, part of UDG Healthcare plc, for medical writing support, which was funded by Boehringer Ingelheim.

Author Contributions

All authors conceived the study, collected the data, analyzed the data, prepared the manuscript and agree to be accountable for all aspects of the work.

Declaration of interest

S Cohen has received research grants from Amgen, Boehringer Ingelheim, Coherus, Pfizer, and consulting fees from Amgen, Boehringer Ingelheim, Celltrion, Merck, Pfizer, Sandoz. N Czeloth and G Jayadeva are employees of Boehringer Ingelheim. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One of the reviewers of this paper has served as a consultant to AbbVie, Amgen, Biogen, and Fresenius. One of the reviewers on this paper has received research Support (paid to university from Pfizer Inc.; and UCB, Inc, and has acted as a consultant to AbbVie Inc.; Boehringer Ingelheim GmbH; Celltrion Healthcare Co. Ltd. Merck Sharp & Dohme Corp.; Pfizer Inc.; Roche Laboratories, Inc.; Samsung Bioepis; Sandoz Inc.; and UCB, Inc.)

Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Boehringer Ingelheim provided the funding and was responsible for the design and conduct of this study.