Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial

Abstract

Objective To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. Methods Patients received 48 weeks’ treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48–72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. Results At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. Conclusion Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. Trail registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.

Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies

“…No meaningful differences were observed in safety, immunogenicity or efficacy for patients who switched from the RP in the DB study to FKB327 in the OLE or vice versa. Similar results of treatment safety, efficacy and immunogenicity were reported in the phase 3 EGALITY study of an etanercept biosimilar in patients with chronic plaque psoriasis 14 ; a phase 3 study of a rituximab biosimilar in patients with RA 15 ; and a phase 3 study of an infliximab biosimilar in patients with active Crohn’s disease. 16 Both the EGALITY study and the current study assessed multiple switching between biosimilars and RP treatment; however, the EGALITY study had shorter treatment intervals and follow-up.…”

“…14 Studies investigating the rituximab and infliximab biosimilars included a single-switch treatment with follow-up to 72 or 54 weeks, respectively, which was shorter than in the current study. 15 16 Although these studies reported similar outcomes, the current data, based on 6-month switching intervals and 2-year follow-up, provide more robust clinical information on the safety and efficacy of treatment switching in patients with RA.…”

Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis

“…Other studies have supported the use of anti‐TNF biosimilars. A phase 3 trial investigating a rituximab biosimilar in patients with RA demonstrated that long‐term use of the biosimilar to 72 weeks was well tolerated and effective 21 . In this study, patients who underwent a single switch from the RP to the biosimilar exhibited similar results in terms of efficacy, pharmacodynamics, immunogenicity, and safety.…”

“…A phase 3 trial investigating a rituximab biosimilar in patients with RA demonstrated that long-term use of the biosimilar to 72 weeks was well tolerated and effective. 21 In this study, patients who underwent a single switch from the RP to the biosimilar exhibited similar results in terms of efficacy, pharmacodynamics, immunogenicity, and safety. A phase 3 study of an infliximab biosimilar in patients with moderate-to-severe RA demonstrated similar safety, efficacy, and immunogenicity of the biosimilar compared with the RP to 54 weeks.…”

Comparison of Rituximab Originator With CT-P10 Biosimilar in Patients With Primary Sjögren's Syndrome: A Retrospective Analysis in a Real-Life Setting

“…Several clinical trials assessing CT-P10 in follicular lymphoma and rheumatoid arthritis (26)(27)(28)(29)(30)(31)(32)(33) and a few data concerning the real-world experience (34,35) have been published so far. However, data concerning this compound in pSS are not available.…”