Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Abstract

Objective: To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn’s disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn’s Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Results: Altogether, 85 patients with CD ( n = 38) or UC ( n = 47) received biosimilar infliximab for up to 30 weeks. Most patients ( n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8–78.9) of CD patients and 55.3% (95% CI = 41.2–68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5–62.7) and 48.9% (95% CI = 35.3–62.8), respectively, were in remission. Statistically significant ( p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved ( p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Conclusion: Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.

Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

“…Recently, more studies have been published regarding the experience of patients with IBD who switched to infliximab-dyyb from RP infliximab [22][23][24][25][26][27][28][29][30][31][32][33][34]. These included one meta-analysis [22], many single group observational studies [23][24][25][26][27][28][29][30][31][32], and two studies with comparison groups [33,34]. The length of follow-up ranged from 4 months [23] to 5 years [24].…”

“…The length of follow-up ranged from 4 months [23] to 5 years [24]. Patients with IBD were recruited from Europe [25][26][27][28][29][30][31][32][33][34] and Asia [23,24]. All except one study [34] have demonstrated no differences or noninferiority in effectiveness and safety between RP infliximab and infliximab-dyyb.…”

“…Due to the lack of US-based data and a lack of independent comparison groups in most of the published studies [23][24][25][26][27][28][29][30][31][32], the aim of the current study was to compare the real-world effectiveness of switching from RP infliximab to infliximab-dyyb versus remaining on RP infliximab in patients with IBD within a US integrated healthcare system using a non-inferiority propensity score-matched cohort design.…”

Quality of life in patients with moderate to severe ulcerative colitis and the impact of treatment: A narrative review

“…After 8 weeks of treatment with infliximab, significant improvements compared to placebo were seen in the physical (PCS) and mental component summaries (MCS) of the Medical Outcomes Study 36-Item Short Form Health Survey, and continued benefit was seen through week 54 [for infliximab 5 and 10 mg: PCS 6.8 and 5.9, respectively, MCS 5.9 and 6.4, respectively, placebo PCS 3.7, MCS 3.0; P < 0.01 for all comparisons). In 2019, Gheorghe published the results of a small real-life study on biosimilar infliximab in 85 patients with IBD [50] . After 30 weeks of therapy, of the 47 patients with ulcerative colitis, 55.3% showed a clinical response and 48.9% were in remission.…”

Clinical Benefits of Switching from Original Infliximab to its Biosimilar (CT-P13) as a Potential TNF-α Inhibitor

“…Other studies have shown more effectiveness and tolerability in patients with UC. 63 The Peruvian Social Security (known as Es-Salud) reported biosimilarity between infliximab and CT-P13, and according to financial analysis determined it is a cost-effective decision. 64 In 2013, Park and colleagues 65 reported a Phase 1, doubleblind, parallel-group study of 22 and 30 weeks on 250 patients administered with either CT-P13 (n = 125) or infliximab (n = 125) (in two groups).…”