The SPOSIB SB2 Sicilian Cohort: Safety and Effectiveness of Infliximab Biosimilar SB2 in Inflammatory Bowel Diseases, Including Multiple Switches

Abstract

Background No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. Methods The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. Results Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). Conclusions The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.

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

“…While various studies have investigated a switch from originator infliximab to the biosimilar CT-P13, so far there have been published data from only one cohort study of IBD patients in Italy (SPOSIB SB2) regarding treatment with SB2. 5 – 8 , 10 , 16 , 17 The analyses included 8 and 17 IBD patients switched from originator infliximab treatment to SB2, with a follow-up time of 6 and 18-months respectively; the majority of patients analyzed in the studied cohort were naïve to infliximab. 16 , 17 Based on the study results, overall safety and effectiveness of SB2 were estimated by the authors to be similar to those reported for originator infliximab and CT-P13.…”

“…The other study publication with a follow-up time of 18 months also included only a small fraction of patients that were switched from originator infliximab to SB2 (17 of 276), as nearly 70% of the analyzed patients were naïve to infliximab. 17 Assessment of safety was the primary endpoint of the study, with a total follow-up time of 182.7 person-years. Here, an SAE incidence rate of 36.7 per 100 person-years was recorded.…”

“…At week 8, 57.3% of infliximab naïve IBD patients had steroid-free remission and 13.5% achieved partial response, while of the 74 IBD patients with a 52 weeks follow-up, 24.3% had steroid-free remission and 39.2% achieved a partial response at that time point. 17 Data regarding immunogenicity of the SB2 treated patients were missing. We here present the first long-term data over an 18-month follow-up period that aimed to assess 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.…”

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

“…Overall, the safety and efficacy of the infliximab biosimilar SB2 were similar to those reported for the infliximab originator and CT-P13, which switching patients who were in stable status showed relatively favourable clinical outcomes than those of naïve to infliximab patients. The study results also showed that biosilmilar to biosimlar switch or multiple switch groups were not significantly different in terms of treatment persistency compared to infliximab naïve or single switch groups [49] .…”

“…Another one of the most recently published data came from The SPOSIB SB2 Sicilian Cohort [49] . It is a multicentre, observational, prospective study performed amongst the cohort of the Sicilian Network for IBD which included 276 patients (CD: 49.3%, UC: 50.7%).…”