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

Abstract

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.

A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence

“…Thirteen (13) references reported on RWE studies with SB2, performed in patients with IBD including CD and UC [7,8,[18][19][20][21][22][23][24][25] and other inflammatory diseases such as RA, PsA and spondyloarthritis (SpA) [26], and PsO [25][26][27][28] (Table 3). The RWE studies included different subgroups of patients receiving SB2, including treatmentnaïve patients (TNFα or IFX-naïve) [18,23,27], patients switched from RP to SB2 [7,8,18,19,23,26,27], patients switched from another IFX biosimilar (i.e. CT-P13) to SB2 [7,18,20,21,23,25,27], and patients undergoing multiple switches [7,[22][23][24][25]28].…”

“…The RWE studies included different subgroups of patients receiving SB2, including treatmentnaïve patients (TNFα or IFX-naïve) [18,23,27], patients switched from RP to SB2 [7,8,18,19,23,26,27], patients switched from another IFX biosimilar (i.e. CT-P13) to SB2 [7,18,20,21,23,25,27], and patients undergoing multiple switches [7,[22][23][24][25]28]. The reported outcomes covered treatment persistence with SB2, effectiveness pertaining to the relevant indications, safety and immunogenicity.…”

Enhancing treatment success in inflammatory bowel disease: Optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice

“…Data also recently became available from a French cohort study known as PERFUSE [48] , conducted in patients initiating biosimilar infliximab (SB2) for any indication. An interim analysis was conducted, including 578 patients with CD and 174 with UC; mean duration of disease was relatively long in both groups (CD, 13.1 years; UC, 9.4 years).…”

“…No clinically relevant changes in disease scores were observed at 1 year amongst patients switching to SB2. Thus, it appears that patients with IBD can be successfully transitioned to SB2 from either the originator or biosimilar infliximab [48] .…”

“…Persistence with SB2 biosimilar infliximab in the PERFUSE study according to prior infliximab therapy[48] CD, Crohn's disease; M, month; UC, ulcerative colitis.…”