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Poster presentations: Clinical: Therapy and Observation 2020

P637 PERFUSE: A french non-interventional cohort study of infliximab-naive and transitioned patients receiving infliximab biosimilar SB2; An interim analysis

Y. Bouhnik1, B. Fautrel2, G. Desjeux3, U. Freudensprung4, A. Brigui5, J. Addison6

1Beaujon Hospital, Department of Gastroenterology- AP-HP- Paris Diderot University, Clichy, France, 2Pitié-Salpêtrière Hospital, Department of Rheumatology- AP-HP- Sorbonne University- UPMC university, Paris, France, 3E-health Services Sanoïa, Digital CRO, Gémenos, France, 4Biogen International GmbH, n/a, Zug, Switzerland, 5Biogen France SAS, n/a, Paris, France, 6Biogen UK, n/a, Maidenhead, UK

Background

SB2 is approved in the EU as infliximab (IFX) biosimilar, having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the reference. Little evidence is published on real-world use of SB2 in patients who are either IFX-naïve, or transitioned from originator or another IFX biosimilar. PERFUSE is an ongoing non-interventional study of 1,374 patients receiving SB2 as routine therapy at 12 gastroenterology sites across France, with objectives to describe clinical characteristics, immunogenicity and SB2 persistence over 12 months.

Methods

Eligible adult patients are diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) and initiated SB2 in routine clinical practice after September 2017 as their first IFX or transitioning from treatment with reference IFX or another IFX biosimilar. Data are captured from routine patient records for up to 12 months (M12) following initiation. Outcome measures include persistence on SB2, clinical characteristics at baseline (time of initiation of SB2) and disease scores (Harvey–Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI)) and SB2 dose over time.

Results

This interim analysis (IA) includes 755 patients (580 with CD; 59 IFX-naïve, 521 transitioned from prior IFX: 175 with UC; 33 IFX-naïve, 142 transitioned from prior IFX). In the 663 patients with prior IFX, no clinically relevant difference in disease score from baseline to M12 was observed; mean individual change was −0.3 (95% CI −0.8, 0.1) and -0.2 (95% CI −0.6, 0.3) in the CD cohort transitioned from reference IFX (n = 157) and biosimilar IFX (n = 83), respectively; −0.3 (−1.1, 0.4) and 0.0 (-0.9, 0.9) in the UC cohort transitioned from reference IFX (n = 41) and biosimilar IFX (n = 26), respectively. Mean (95% CI) SB2 dose (mg/kg), was similarly unchanged from baseline to M12: 7.2 (5.0, 10.0) and 7.6 (5.0, 10.0) in patients with CD transitioned from reference IFX or from biosimilar IFX; 7.0 (5.0, 10.0) and 7.3 (5.0, 10.0), 7.5 (5.0, 10.0) and 7.7 (5.0, 10.0) in patients with UC transitioned from reference IFX or biosimilar IFX, respectively. By data extraction date (23 October 2019), 374 patients with CD and 105 with UC had reached M12; persistence on SB2 was 92.2% (95% CI 89.1, 94.7) and 90.5% (95% CI 83.2, 95.3) in CD and UC, respectively. Reasons for discontinuation (n) were: adverse event (9), primary loss of response (7), secondary loss of response (12) and unspecified (16).

Conclusion

This IA indicates that patients with IBD can be successfully and safely transitioned from reference or biosimilar IFX to SB2, with no loss of disease control and without need for dose escalation. Over 90% of transitioned patients continued SB2 treatment at M12 post-initiation.