Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab

Abstract

Background: Long-term data on inflammatory bowel disease (IBD) patients switched from originator to biosimilar infliximab SB2 are lacking. The aim of the conducted study was to investigate the effectiveness, immunogenicity and safety of a large prospectively followed-up IBD patient cohort that was entirely switched from originator infliximab to biosimilar SB2 treatment. Methods: This was a prospective, single-center, longitudinal, observational study describing clinical outcomes in IBD patients, over an 80-week period following switch from originator infliximab to SB2. Primary outcome measures were change of disease activity [Harvey-Bradshaw Index for Crohn’s disease (CD), partial Mayo Score for ulcerative colitis (UC)], C-reactive protein (CRP), infliximab trough levels (TLs), anti-drug antibodies (ADAs) and adverse events. Results: One hundred and forty-four IBD patients (94 CD, 50 UC), with median duration of 30.5 months’ (range 2–110) treatment with originator infliximab were evaluated. Mean change of disease activity compared with baseline was −0.9 (SD 2.6), –0.4 (2.2) and –0.4 (2.0) in CD; 0.1 (1.1), 0.1 (1.1) and 0.1 (1.3) in UC patients at weeks 24, 48 and 72. Median infliximab TLs were 6.2 µg/ml (interquartile range 2.3–12.2), 5.0 µg/ml (2.7–10.0), 6.6 µg/ml (3.5–12.4) and 5.1 µg/ml (2.7–10.9) at baseline and weeks 24, 48 and 72. Median CRP levels were within normal ranges throughout the study. After the switch, 9.8% of the patients developed new ADAs. Persistence on SB2 was 90% (95% confidence interval 0.85–0.95), 79% (0.72–0.86), 72% (0.64–0.80) at weeks 26, 52 and 78. Serious adverse events occurred in 11 patients. Conclusion: Over the individual patient follow-up of 80 weeks, switch to biosimilar SB2 from originator infliximab does not result in increased disease activity or changed immunogenicity patterns. The switch to SB2 was well tolerated.

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].…”

“…Mean change of pMS score in UC were 0.1 (SD 1.1), 0.1 (SD 1.1) and 0.1 (SD 1.3) in UC patients at weeks 24, 48 and 72 respectively. Further, median change of CRP level were 0.5 mg/l (IQR -1.5-2.1 mg/l) at week 72 in CD patients and 0.0 mg/l (-0.4-1.2 mg/l) at week 72 in UC patients compared to baseline [8]. In a retrospective study of US veteran affairs health service (VAHS) data, the treatment persistence rate was 87% after 1 year of follow-up in the 101 IBD patients switching from RP [7].…”

“…Additional data published either as an abstract or manuscript after August 14, 2020, were separately included in the results as hand-selected. Specifically, this includes, one full manuscript [7] based on an abstract by Pernes T et al from the 2020 American College of Gastroenterology Annual Scientific Meeting and one full manuscript [8] based on an abstract by Fisher S et al from the 2020 European Crohn's and Colitis Organisation Congress. Following removal of duplicates, a first screening was performed based on titles and abstracts, followed by full-text screening and appraisal.…”

“…Seven RWE studies investigated switches from the RP to SB2, five in IBD [7,8,18,19,23] and two in rheumatic diseases [26,27] (Table 3).…”

“…Furthermore, pre-and post-switch therapeutic drug monitoring (TDM) was shown to support high rates of sustained clinical responses in patients with IBD after a switch from RP to SB2, with 73% (n=54/74) remaining on treatment with a sustained clinical response [19]. In a prospective, single-center, longitudinal, observational cohort study including 144 patients with IBD (94 with CD and 50 with UC) with a follow-up of 80 weeks, switching from the RP to SB2 was not associated with an increase in disease activity, as measured by median Harvey Bradshaw Index (HBI) in CD and median partial Mayo Score (pMS) in UC, as well as Creactive protein (CRP) levels [8]. Mean change of HBI score in CD at week 24, 48 and 72 were -0.9 (SD 2.6), -0.4 (SD 2.2) and -0.4 (SD 2.0) respectively.…”