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

Shim, Seung Cheol; Božić-Majstorović, Ljubinka; Kasay, Alfredo Berrocal; El-Khouri, Elias Chalouhi; Irazoque-Palazuelos, Fedra; Molina, Francisco Fidencio Cons; Medina-Rodriguez, Francisco G.; Miranda, Pedro; Shesternya, P. А.; Chavez-Corrales, Jose; Wiland, Piotr; Jeka, Sławomir; Garmish, Olena; Hrycaj, Paweł; Фомина, Н. В.; Park, Won; Suh, Chang‐Hee; Lee, Sang Joon; Lee, Sung Young; Bae, Young‐Hoon; Yoo, Dae Hyun

doi:10.1093/rheumatology/kez152

Cited by 37 publications

(26 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…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.…”

Section: Discussionsupporting

confidence: 73%

“…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.…”

Section: Discussionmentioning

confidence: 69%

See 1 more Smart Citation

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

et al. 2020

View full text Add to dashboard Cite

Background/ObjectiveFKB327 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.MethodsPatients 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.ResultsOf 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.ConclusionEfficacy, 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.

show abstract

Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 69%

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

et al. 2020

View full text Add to dashboard Cite

show abstract

“…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.…”

Section: Discussionmentioning

confidence: 58%

“…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.…”

Section: Discussionmentioning

confidence: 60%

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

et al. 2020

View full text Add to dashboard Cite

Tumor necrosis factor (TNF)-alpha inhibitors are the most common type of biologics used for treating patients with rheumatoid arthritis (RA) who do not respond to methotrexate (MTX) or other disease-modifying antirheumatic drugs (DMARDs). TNF-alpha inhibitors include infliximab, certolizumab pegol, etanercept, golimumab, and adalimumab. 1 Adalimumab is approved globally for treating RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. 2

show abstract

“…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.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

View full text Add to dashboard Cite

Introduction: Over the last two decades, rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren's syndrome (pSS). Several studies reported that B lymphocyte depletion with RTX is effective to treat some aspects within the disease spectrum, by reducing disease activity and affecting the inflammation and lymphoid organization that occur in target tissues. Notwithstanding, randomized controlled trials failed to confirm such evidence. With the recent release of several RTX biosimilars on the market, their efficacy and safety compared to the originator must be ascertained across different indications. This study aimed at comparing efficacy and safety of RTX originator and CT-P10 RTX biosimilar in pSS patients in a real-life setting. Methods: Clinical and laboratory records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least two courses of either RTX originator or CT-P10 with complete data at baseline and after 12, 24, 36, and 48 weeks of treatment were enrolled. Disease activity was assessed with the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and its clinical version without the biological domain (clinESSDAI). Patient-reported symptoms were assessed with the EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI). Adverse events (AEs) occurring during the study period were also recorded. Results: Nine patients who received RTX originator and eight patients who received CT-P10 were enrolled. Baseline clinical and serological features, including ESSDAI and ESSPRI, were similar in the two treatment groups. An efficient depletion of circulating CD19 + B lymphocytes was achieved in both treatment arms. Both RTX originator and CT-P10 significantly reduced ESSDAI and clinESSDAI by week 24, and no difference between the groups was observed at any timepoint. Conversely, changes of ESSPRI overtime did not differ between the two treatment arms and were not statistically significant compared to corresponding baseline values. With regard to safety, at 48 weeks of follow-up, only four mild AEs (two in the RTX originator and two in the CT-P10 group) were observed. Pavlych et al. Rituximab in Primary Sjögren's Syndrome Conclusion: Our study provides the first evidence that, at 48 weeks of follow-up, RTX originator and CT-P10 display similar efficacy and safety profiles in pSS.

show abstract

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

Cited by 37 publications

References 29 publications

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

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

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

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

Contact Info

Product

Resources

About