Article Text
Abstract
Background/Objective FKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients with active rheumatoid arthritis (RA) inadequately controlled with methotrexate (MTX). A subsequent randomised open-label extension (OLE) study with treatment switching assessed long-term safety, efficacy, pharmacokinetics and immunogenicity of FKB327 compared with the RP.
Methods Patients with moderate-to-severe, active RA on a stable dose of MTX were randomised 1:1 to receive FKB327 or the RP (40 mg subcutaneously every other week) for 24 weeks. Patients who completed the DB study were enrolled in the OLE and rerandomised 2:1 to receive FKB327 or the RP; two-thirds continued on the same treatment and one-third switched for 30 weeks. All patients received FKB327 through Week 76. Long-term efficacy, safety and immunogenicity were assessed.
Results Of 728 patients in the DB study, 645 were enrolled in the FKB327-OLE study. The American College of Rheumatology (ACR)20 response rates for all treatment groups at Week 30 in the OLE ranged from 83.2% to 85.9%. ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76. The safety profile and incidence of antidrug antibodies were comparable across sequences.
Conclusion Efficacy, safety and immunogenicity were similar among patients with RA treated with FKB327 or the RP for up to 2 years, and were not affected by single- or double-switching treatment.
- rheumatoid arthritis
- treatment
- anti-TNF
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Footnotes
Contributors MG, RA and YA initiated the study design and helped with implementation. MG and RA are grant holders. MG, RA, YA and RM contributed to the refinement and development of the manuscript and approved the final manuscript.
Competing interests MG has received consultant fees from Fujifilm Kyowa Kirin Biologics Co., including for the design of this trial. HK has no conflicts of interest to report. YA is an employee of Fujifilm Kyowa Kirin Biologics Co. and has received personal fees from the company, both during the conduct of the study and outside the submitted work. RM is an employee and shareholder of Mylan Inc. RA has received consultant fees from Mylan Inc and has been a paid speaker for Mylan Inc.
Patient consent for publication Consent obtained directly from patient(s).
Disclaimer The authors were fully responsible for all content and editorial decisions and received no financial support or other form of compensation related to the development of this manuscript.
Data sharing statement Data are available in a public, open-access repository.
Provenance and peer review Not commissioned; externally peer reviewed.