Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease

Abstract

Background and Aims To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®. Methods Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The ‘switch cohort’ [SC] comprised patients who made the switch from Remicade® to CT-P13, and the ‘non-switch’ cohort [NC] patients remained under Remicade®. Results A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2–6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05]. Conclusions Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.

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.…”

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 Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

“…Most importantly, these effects may be amplified in the context of multiple switches. Of note, it is important to clarify that, when a patient’s disease is controlled, there is generally no expectation for improvement when switching from an originator to a biosimilar; however, based upon the current evidence, switching for non-medical reasons may carry risks such as treatment failure/discontinuation of therapy [ 1 , 39 , 40 , 42 ]. Overall, considering the large variation in discontinuation rates across the current single-switch studies, and because none of the studies meet the minimum requirements for a robust switching study, the evidence on the occurrence of treatment failures following single or multiple non-medical switches remains inconclusive [ 1 ].…”

“…As stated above, numerous studies have investigated the safety and efficacy of a single non-medical switch from an originator to a biosimilar [ 1 , 39 , 40 ]. Although many of these studies showed that such a switch is generally feasible and well-tolerated, 0–87% of patients discontinued therapy after the switch.…”