Effectiveness and Safety of Switching from Innovator Infliximab to Biosimilar CT-P13 in Inflammatory Rheumatic Diseases: A Real-World Case Study

Vergara-Dangond, C; Belló, Marina Sáez; Climente‐Martí, Mónica; Salvia, P Llopis; Sancho, Juan José Alegre

doi:10.1007/s40268-017-0194-8

Cited by 12 publications

(4 citation statements)

References 14 publications

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“…In a small, controlled, single‐centre retrospective, observational study of patients with RA, PsA, and AS, safety and efficacy were compared in those that switched from reference infliximab to CT‐P13 (n = 7) to those that maintained treatment with reference infliximab (n = 6) . Switching did not appear to be related to changes in safety or efficacy in these patients.…”

Section: Resultsmentioning

confidence: 99%

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%

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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“…Six (54.5%) of the 11 patients in this cohort who discontinued biosimilar infliximab did so for subjective reasons without evidence of increased disease activity. Smaller ‘real-world’ observational studies also have confirmed comparable efficacy and safety of transitioning from bio-originator infliximab to biosimilar infliximab CT-P13 to that of continuing treatment with bio-originator infliximab 15…”

mentioning

confidence: 89%

Clinical trial and ‘real-world’ data support switching from a bio-originator to its biosimilar

et al. 2019

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“…Authors found that patients with previous IFX treatment with a duration of >5 years had longer CT-P13 retention. Smaller 'real-world' observational studies also confirmed comparable efficacy and safety of transitioning from originator to biosimilar IFX CT-P13 to that of continuing treatment with biooriginator IFX [71,72].…”

Section: Infliximabmentioning

confidence: 76%

Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life

Ditto¹,

Parisi²,

Talotta³

et al. 2022

Biosimilars

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Biosimilars are broadly available for the treatment of several diseases including inflammatory arthritis. Thanks to biosimilars it has been possible to treat a greater number of rheumatic patients who previously were undertreated due to the high cost of originators, in several countries. There are a lot of data from double blind, randomized, controlled clinical trials, especially on TNF inhibitors (TNFi), concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe mainly for economic reasons. However, despite the considerable saving, such shifts to biosimilar drugs are still being debated, principally over their ethical implications. Since the drugs are similar but not identical, the main issues are related to the possibility to compare the adverse events and/or the lack of efficacy and, to date, the variability in effectiveness for a single patient remains an unpredictable datum before effecting the switch. Despite encouraging data about the maintenance of efficacy and safety after the switch, there are many reports of discontinuation due both lack of efficacy or and adverse events. In this chapter we aim at showing the disease activity trend and the safety after the transition to TNF-i biosimilars in patients with rheumatic diseases in real life..

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Effectiveness and Safety of Switching from Innovator Infliximab to Biosimilar CT-P13 in Inflammatory Rheumatic Diseases: A Real-World Case Study

Cited by 12 publications

References 14 publications

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

Clinical trial and ‘real-world’ data support switching from a bio-originator to its biosimilar

Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life

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