Efficacy of Infliximab Biosimilar for Induction and Maintenance Therapy in Inflammatory Bowel Disease After Switch From Drug Originator: A Meta-Analysis

Abstract

Introduction: Few studies investigated the efficacy of infliximab (IFX) biosimilar (CT-P13) in inflammatory bowel disease (IBD), after switch from the originator drug. We aim to assess the efficacy of CT-P13 for induction or maintenance therapy in Crohn's disease (CD) and ulcerative colitis (UC) after switch from IFX. Methods: Searching the literature through May of 2017, we identified the studies which reported the results of the switch strategy. To assess the efficacy of CT-P13, we used a per-protocol analysis. Only, patients who were considered as treatment failure (loss or lack of response to CT-P13, or adverse events after switch), counted toward the efficacy analysis. Overall efficacy was defined as the percentage of patients who continued CT-P13 (improve or no change in the disease activity) at the end of the study follow-up. Maintenance efficacy was defined as maintaining remission at the end of the study follow-up, among patients in remission at the time of switch. A meta-analysis was performed to calculate the pooled estimate of overall and maintenance efficacy, using a random effect model with assessment of heterogeneity by I2 statistic. Results: 8 studies (7 prospective, 1 retrospective), comprising 594 IBD patients, were included in the final analysis. Studies' follow-up period ranged from 8 to 24 weeks. Meta-analysis of all studies showed that the pooled estimate of overall efficacy was 83.5% (confidence interval [CI]: 75-92%; P:0.30, I2:16.64) (Fig. 1A). Pooled estimate of maintenance efficacy (calculated in 5 studies) was 82.6% (CI: 73-93%; P:0.94, I2:0.00) (Fig. 1B). Pooled estimate of overall and maintenance efficacy of CT-P13 in patients with CD and UC are shown in Table 1. Overall efficacy of CT-P13 for CD and UC was reported in 5 studies. Pooled estimate of overall efficacy in CD vs UC was not different (odds ratio [OR]: 0.85; CI: 0.39-1.85; P:0.19, I2: 34.97) (Fig. 2A). Pooled estimate of maintenance efficacy in CD vs UC (3 studies) was not different (OR: 1.04; CI: 0.53-2.07; P:0.83, I2: 0.00) (Fig. 2B). Conclusion: Switch from IFX to CT-P13 is an efficacious strategy in IBD patients. This strategy is equally effective in CD and UC patients. Considering the cost-effectiveness, switch strategy is a viable option in management of IBD.Figure: Pooled estimate of overall (A) and maintenance (B) efficacy of CT-P13 in IBD patients.Figure: Pooled estimate of overall (A) and maintenance (B) efficacy of CT-P13 in CD vs. UC.Table: Table. Pooled estimate of overall and maintenance efficacy of CT-P13 in patients with CD and UC