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

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

Background : SB2 (Flixabi) is a biosimilar infliximab (IFX). It was approved by the European Medicines Agency 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 effectiveness of SB2, either in patients initiated on SB2 as their first IFX (IFX-naïve) or in those transitioning from reference IFX or another IFX biosimilar. PERFUSE is an ongoing non- interventional study of 1374 patients (500 with rheumatology diagnoses, 874 with gastroenterology diagnoses) receiving SB2 as routine therapy, with objectives to describe clinical characteristics, effectiveness, treatment persistence and safety in patients initiating SB2 and followed for 24 months at 21 specialist sites (12 gastroenterology, 9 rheumatology) across France. This poster describes results obtained from an interim analysis of the rheumatology patient cohort, based on a data extract of 1st May 2020.

Methods : Eligible adult patients have a diagnosis of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) and initiated SB2 in routine clinical practice after September 2017, either as their first IFX or transitioned from treatment with reference IFX or another IFX biosimilar. Data are captured prospectively and/or retrospectively from patient records obtained during routine clinic visits, being entered by clinic staff into a study-specific database. Outcome measures include persistence on SB2, clinical characteristics at transition- (time of initiation of SB2), disease scores (from transition through to M12) i.e. Disease Activity Score 28 (DAS28), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), disease status (high/low disease activity, remission), SB2 utilisation and Serious Adverse Events (SAEs).

Conclusions : This interim analysis indicates that patients with RA, AS or PsA can be successfully transitioned from originator or biosimilar IFX to SB2, without loss of disease control, with no dose penalty, and with no safety concerns. The majority of transitioned patients continued SB2 treatment at M12 post-initiation. The PERFUSE study continues to provide ongoing, pertinent information about long-term outcomes in these populations, helping to inform evidence-based treatment decisions.


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