Safety and efficacy of switching from infliximab biosimilar CT-P13 to infliximab biosimilar SB2 in patients with inflammatory bowel disease

Abstract

Introduction For patients with inflammatory bowel diseases, switching from infliximab originator to biosimilars is effective and safe. Few data on single switch have been published, and data on multiple switches of different infliximab are unavailable. Methods A retrospective analysis of patients who switched from CT-P13 to SB2, and of those with multiple switches among different infliximab compounds was conducted. Clinical activity, C reactive protein (CRP), adverse events (AE) and loss of response (LOR) were recorded. Results Thirty-six patients (26 males, 14 Crohn’s disease and 22 ulcerative colitis) were enrolled and followed up for >6 months. All patients switched from CT-P13 to SB2; 12 of them (33.3%) had already switched from reference Infliximab to CT-P13, and for the remaining patients CT-P13 was the first infliximab. The clinical remission rate six months before and three months after SB2-switch was the same (58.3%) and the rate of mild activity varied from 27.8 to 33.3% (P = 0.68); the percentage of patients with normal CRP values passed from 94.4 to 91.7% (P = 1). Two patients (5.5%) had AE and 11 (30.5%) a LOR. At univariate analysis, patients with a single switch had a non-significant risk of LOR during SB2 [odds ratio (OR) = 7.86; 95% confidence interval (CI) 0.87–71, P = 0.06]. SB2-LOR was associated with previous AE under CT-P13 (OR = 9.1, 95% CI 0.82–100, P = 0.07). None of such factors was significant at multivariate analysis. Conclusion Switching from CT-P13 to SB2 seems to be safe and effective either in patients with a single than in those with multiple switches.

Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea

“…Furthermore, patients in interventional clinical studies are in general more closely monitored than in real-world practice, which may result in higher rates of reported AEs. Compared to available RWE data of SB2 in different populations and different switching schemes reporting up to 27.8% with AEs and up to 20.7% with SAEs, the proportions in this study are well within and below the range reported in RWE [11][12][13][14][15].…”

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies

“…Findings from the study suggested that patients with IBD can be successfully transitioned from reference or biosimilar infliximab to SB2 with no loss of disease control or safety concerns, and over 92% of patients who transitioned from reference infliximab or another biosimilar infliximab continued SB2 treatment at 12 months post-initiation [ 33 ]. A study with a follow-up period of < 1 year (6 months) showed similar clinical remission rates (58.3%) and normal C-reactive protein (CRP) values (94.4% and 91.7% of patients) prior to 6 months and after 3 months of treatment in 36 patients who switched from CT-P13 to SB2 (12 of them switched from reference infliximab to CT-P13 to SB2) [ 34 ]. Furthermore, in another study with a follow-up period of < 1 year (8 months, safety events in single-switch ( n = 43; CT-P13 to SB2) and double-switch ( n = 24, infliximab reference biologic to CT-P13 to SB2) groups did not differ from those of the reference-to-biologic switch group [ 35 ].…”

Switching Among Biosimilars: A Review of Clinical Evidence

“…These preliminary data that did not suggest switching had an impact on drug persistence. Ten controlled cohort studies compared switching between two biosimilars vs. switching from originator to a biosimilar or vs. multiple switches, for example, from an originator to biosimilar A to biosimilar B ( Lauret et al, 2020 ; Gall et al, 2021 ; Hanzel et al, 2021 ; Khan et al, 2021 ; Lovero et al, 2021 ; Luber et al, 2021 ; Macaluso et al, 2021 ; Trystram et al, 2021 ; Lontai et al, 2022 ; Mazza et al, 2022 ). Eight were single-arm cohort studies, where participants switched from one biosimilar to another and outcome were compared before and after the switch ( Bouhnik et al, 2020 ; Gisondi et al, 2020 ; Kiltz et al, 2020 ; Mott et al, 2021 ; Peters et al, 2021 ; Piaserico et al, 2021 ; Ribaldone et al, 2021 ; Siakavellas et al, 2021 ).…”