FRI0182 Disease worsening and safety in patients switching from originator infliximab to biosimilar infliximab (CT-P13) in the nor-switch study: explorative analysis of RA patients

Goll, G. L.; Olsen, I.C.; Bolstad, Nils; Jørgensen, K. K.; Lorentzen, M; Mørk, Cato; Jahnsen, Jørgen; Haavardsholm, E.A.; Kvien, TK

doi:10.1136/annrheumdis-2017-eular.2319

Cited by 2 publications

(3 citation statements)

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“…Among the other patient subgroups, disease worsening, immunogenicity, and safety profiles were similar across the reference infliximab and CT‐P13 groups . However, these sub‐studies were not powered to evaluate non‐inferiority …”

Section: Resultsmentioning

confidence: 99%

“…Further exploratory analyses of safety, efficacy, and immunogenicity, in spondyloarthritis, RA, CD, and UC patient subgroups in NOR‐SWITCH were also conducted . In the largest of these cohorts (CD; N = 129), disease worsening occurred in more frequently in the switch arm (36.5%) than the maintenance arm (21.2%; 95% CI of adjusted difference, −29.3% to 0.7%) .…”

Section: Resultsmentioning

confidence: 99%

“…In the largest of these cohorts (CD; N = 129), disease worsening occurred in more frequently in the switch arm (36.5%) than the maintenance arm (21.2%; 95% CI of adjusted difference, −29.3% to 0.7%) . Among the other patient subgroups, disease worsening, immunogenicity, and safety profiles were similar across the reference infliximab and CT‐P13 groups . However, these sub‐studies were not powered to evaluate non‐inferiority …”

Section: Resultsmentioning

confidence: 99%

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Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab

Feagan

Lam

et al. 2018

Aliment Pharmacol Ther

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Summary Background Biosimilar versions of widely prescribed drugs, including the tumour‐necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non‐inferior to a reference product after multiple switches between products. Aims To investigate the evidence evaluating the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Methods Published studies presenting data on switching between reference and biosimilar infliximab were identified by searching the MEDLINE database. Congress abstracts were identified by searching the EMBASE database and manually searching abstracts from relevant congresses. Results A total of 113 journal articles and 149 abstracts were found. Of these, 70 were considered relevant and included in this analysis. Most of the publications were uncontrolled, observational studies. Data from six randomised, controlled trials were identified. In general, the evidence revealed no clinically important efficacy or safety signals associated with switching. Conclusions While available data have not identified significant risks associated with a single switch between reference and biosimilar infliximab, the studies available currently report on only single switches and were mostly observational studies lacking control arms. Additional data are needed to explore potential switching risks in various populations and scenarios.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab

Feagan

Lam

et al. 2018

Aliment Pharmacol Ther

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Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54

Alten

Batko²,

Hala³

et al. 2019

RMD Open

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ObjectiveTo investigate the efficacy, safety and immunogenicity of PF-06438179/GP1111 (PF-SZ-IFX) compared with European reference infliximab (Remicade®; ref-IFX) in patients with moderate-to-severe, active rheumatoid arthritis after continued long-term use of PF-SZ-IFX, and in patients who were switched from ref-IFX to PF-SZ-IFX.MethodsREFLECTIONS B537-02 was a double-blind, active-controlled, multinational study in which patients (N=650) were initially randomised to PF-SZ-IFX or ref-IFX for 30 weeks (treatment period [TP] 1). During weeks 30–54 (TP2), the PF-SZ-IFX group (n=280) continued treatment with PF-SZ-IFX (PF-SZ-IFX/PF-SZ-IFX) and patients in the ref-IFX group (n=286) were rerandomised (1:1) to continue ref-IFX (ref-IFX/ref-IFX) (n=143) or switch to PF-SZ-IFX (ref-IFX/PF-SZ-IFX) (n=143) for a further 24 weeks. Efficacy, safety, immunogenicity and pharmacokinetics were evaluated.ResultsDuring TP2, patients in all three treatment groups continued to maintain comparable treatment response. At week 54, the American College of Rheumatology (ACR20) response rates were 71.1% (PF-SZ-IFX/PF-SZ-IFX), 64.3% (ref-IFX/ref-IFX) and 70.6% (ref-IFX/PF-SZ-IFX). Observations for other endpoints, including ACR50/70, Disease Activity Score in 28 Joints Based on High-Sensitivity C Reactive Protein(DAS28-CRP) remission, and mean change in DAS28-CRP and Health Assessment Questionnaire-Disability Index, were also comparable. Treatment-emergent adverse events were reported in 36.8% (PF-SZ-IFX/PF-SZ-IFX), 33.6% (ref-IFX/ref-IFX) and 37.8% (ref-IFX/PF-SZ-IFX) of patients; there were no clinically meaningful differences in the safety profiles between groups. The percentage of patients who were antidrug antibody-positive was generally stable through the treatment period and comparable overall between the PF-SZ-IFX/PF-SZ-IFX (52.1%; neutralising: 80.8%), ref-IFX/ref-IFX (60.1%; neutralising: 84.9%) and ref-IFX/PF-SZ-IFX (58.0%; neutralising 78.3%) groups.ConclusionsThe similar efficacy, safety and immunogenicity of PF-SZ-IFX compared with ref-IFX were maintained for up to 54 weeks and were not affected by blinded treatment switch from ref-IFX to PF-SZ-IFX at week 30.Trial registration numberNCT02222493.

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FRI0182 Disease worsening and safety in patients switching from originator infliximab to biosimilar infliximab (CT-P13) in the nor-switch study: explorative analysis of RA patients

Cited by 2 publications

References 1 publication

Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab

Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab

Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54

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