Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Abstract

Background:As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13.Methods:In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events.Results:A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events.Conclusions:This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

Switching Australian patients with moderate to severe inflammatory bowel disease from originator to biosimilar infliximab: a multicentre, parallel cohort study

“…Our findings are consistent with overseas reports that switching from originator to biosimilar infliximab is safe and not accompanied by increased numbers of adverse drug events or infusion reactions 17,18,19,20. Severe adverse events requiring discontinuation of infliximab therapy were rare in both groups in our study, and could not be linked with switching from originator to biosimilar infliximab.…”

Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

“…Switching from originator to biosimilar is generally advised in patients under stable remission with an IFX originator. Current literature data found switching from Remicade’ to Remsima’ safe and feasible in both pediatric and adult IBD patients [13,28,40-43], though a recent systematic review recommends caution in switching from originator to biosimilar [44]. In our study group there were only few patients switched from IFX originator to biosimilar IFX CT-P13, and we did not find any significant difference between patients naïve to IFX and patients switching from IFX originator to IFX biosimilar with respect to achievement of remission.…”

Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective

“…The key words were: (infliximab and biosimilar) and (inflammatory bowel disease). A total of 29 studies (Table 1) assessing switching from IFX originator to biosimilar CT-P13 22–50 and 14 assessing induction therapy with IFX-B CT-P13 were found. 32,39,43,46,51–60…”