Last week, at the European Crohn's and Colitis Organisation's 13th annual congress in Vienna, Austria, researchers presented data from the NOR-SWITCH EXTENSION trial—a 26-week open label extension of the NOR-SWITCH trial—concerning the inflammatory bowel disease (IBD) subgroup.
The NOR-SWITCH trial—a 52-week, double-blind, noninferiority trial that has become the basis on which the case for switching patients to biosimilars has been made—demonstrated that switching from reference infliximab to biosimilar infliximab (CT-P13) was noninferior to continued treatment with the reference product in terms of efficacy, safety, and immunogenicity.
However, the study was not powered to demonstrate noninferiority of the biosimilar in the individual disease states, including Crohn disease (CD), ulcerative colitis (UC), rheumatoid arthritis, psoriatic arthritis, and psoriasis. In recent months, those who are skeptical about switching patients to biosimilars have highlighted this fact, and some clinicians have asked whether the extrapolation of indications is reasonable.
Last week, at the European Crohn’s and Colitis Organisation’s 13th annual congress in Vienna, Austria, researchers presented data from the NOR-SWITCH EXTENSION trial—a 26-week open label extension trial—concerning the inflammatory bowel disease (IBD) subgroup.
The extension assessed the safety of uninterrupted treatment with biosimilar inflixmab through week 78 compared with switching from the reference product to the biosimilar at week 52. The primary endpoint of the extension was overall disease worsening during follow-up.
In total, 380 of 438 patients who completed the main trial entered the extension, and overall disease worsening occurred in 16.8% in the CT-P13 maintenance group and 11.6% in the switch group. The 95% confidence interval (CI) of the adjusted difference was within the pre-specified 15% noninferiority margin. The incidence of adverse events, presence of anti-drug antibodies, and patient-reported outcome measures were also comparable between the 2 groups.
Disease worsening occurred in 20.6% and 12.1% of the maintenance group and the switch group, respectively, among patients with CD, and 15.4% and 2.9% in the maintenance group and the switch group, respectively, among patients with UC. The researchers report that these findings were also within the pre-specified noninferiority margin.
Changes from baseline to the study’s end in both CD and UC showed similarity between the maintenance and switch arms with respect to the Harvey Bradshaw Index, Partial Mayo score, C-reactive protein, and fecal calprotectin.
The authors concluded that the open-label extension did not show any difference between patients who remained on CT-P13 versus those who switched from the reference product to the biosimilar, and that the exploratory subgroup analyses of patients with CD and UC showed similarity between the groups in terms of efficacy, safety, and immunogenicity.
Reference
Jørgensen KK, Goll GL, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: explorative subgroup analyses in IBD from the NOR-SWITCH EXTENSION trial. Presented at the 13th Congress of the European Crohn’s and Colitis Organisation, February 14 to 17, 2018; Vienna, Austria. Abstract P483. https://www.ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018/item/p483-long-term-efficacy-and-safety-of-biosimilar-infliximab-ct-p13-after-switching-from-originator-infliximab-explorative-subgroup-analyses-in-ibd-from-the-nor-switch-extension-trial.html
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar and Biologic Use Increasing in Greek Patients With IBD
April 19th 2025A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
Early Success of Adalimumab Biosimilars Featured at AMCP 2025
April 5th 2025High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).