Bouhnik, Y., Brigui, A., Freudensprung, U., Addison, J., (October 2020). PERFUSE: A French Prospective/Retrospective Non-interventional Cohort Study of Infliximab-naive and Transitioned Patients Receiving Infliximab Biosimilar SB2; Interim Analysis. UEGW 2020 P0549.
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. This study immunogenicity of SB2, in patients initiated on SB2 as their first IFX (IFX-naïve) and in those transitioning from reference IFX or another IFX biosimilar.
Methods : 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 inflammatory bowel disease (IBD) patient cohort, based on data captured up to 14 August 2020. For the IBD cohort, 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 reported here for up to 12 months (M12) following initiation and were captured prospectively and/or retrospectively from patient records obtained during routine clinic visits, 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), disease scores from 3 months prior to baseline through to M12, i.e., Harvey-Bradshaw Index (HBI) and Simple Clinical Colitis Activity Index (SCCAI), and anti-IFX antibody (ADA) status.
Conclusions : This interim analysis indicates that patients with IBD can be successfully transitioned from originator or biosimilar IFX to SB2, without loss of disease control, and with no immunogenicity concerns, over a 12-month period. Over 90% of patients with CD or UC previously treated with IFX continued on SB2 treatment at M12 post-initiation, with no difference whether transitioned from reference or from biosimilar IFX. Over 80% of naïve patients with CD or UC continued on SB2 treatment at M12 post-initiation.
(publication) Bouhnik, Y., Brigui, A., Freudensprung, U., Addison, J., (October 2020). PERFUSE: A French Prospective/Retrospective Non-interventional Cohort Study of Infliximab-naive and Transitioned Patients Receiving Infliximab Biosimilar SB2; Interim Analysis. UEGW 2020 P0549.