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PERFUSE: A French Prospective/Retrospective Non interventional Cohort Study [...]

Bouhnik, Y., Fautrel, B., Desjeux, G., Brigui, A., Freudensprung, U., Addison, J. (February 2020)

Background : SB2 (Flixabi) is a biosimilar infliximab (IFX). It was approved in the EU based on a demonstration of similarity to reference IFX in terms of physicochemical and biological characteristics, pharmacokinetics and clinical efficacy, safety and immunogenicity. There is limited real-world evidence published on persistence or safety of SB2, either in IFX-naïve patients or in those transitioning from reference IFX or another biosimilar IFX.

Methods : PERFUSE is an ongoing non-interventional study of 1,374 patients receiving SB2 as routine therapy, with the objective of describing clinical characteristics, effectiveness, treatment persistence and safety in patients initiating SB2 in routine clinical practice and followed for 24 months at specialist sites (12 gastroenterology and 9 rheumatology) across France. Eligible adult patients have a diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) and initiated SB2 in routine clinical practice after September 2017, either as their first IFX or after transitioning directly from treatment with reference IFX or another biosimilar IFX. Data are captured prospectively and/ or retrospectively from patient records obtained during routine clinic visits for up to 12 months (M12) following initiation, being entered by clinic staff into a study-specific database. There are no protocol-specified assessments. Outcome measures include persistence on SB2, clinical characteristics at baseline (time of initiation of SB2), and disease scores from 3 months prior to baseline through to M12. i.e. HarveyBradshaw Index (HBI) and Simple Clinical Colitis Activity Index (SCCAI).

Conclusions : This interim analysis indicates that patients with IBD can be successfully transitioned from reference or biosimilar IFX to SB2, with no loss of disease control and without safety concerns. Over 92% of patients who transitioned from reference or another biosimilar IFX continued SB2 treatment at 12 months post-initiation. Subsequent to these 12-month data, the study will provide ongoing, pertinent information about long-term outcomes in IBD patients treated with SB2, helping to inform evidence-based treatment decisions.


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