P536 Comparison of outcomes of infliximab biosimilar CT-P13 with infliximab originator in patients with inflammatory bowel disease

Abstract

Abstract Background Studies on the efficacy and safety of Infliximab (IFX) biosimilar CT-P13 and IFX originator are needed in Crohn’s disease (CD) and ulcerative colitis (UC). Methods The aim of this study was to evaluate the short and long-term clinical efficacy and safety of IFX biosimilar CT-P13 compared to IFX originator in adult patients with inflammatory bowel disease (IBD). Data were retrospectively collected. Therapeutic failure was defined as discontinuation of biological therapy because of primary lack of response (p-LOR), secondary loss of response (s-LOR, including steroid needed, IBD-related hospitalization, IBD-related surgery, and switch to other biotherapy) and serious adverse events (SAE). Results 252 patients who received IFX were identified between January 2007 and November 2021 (66 IFX biosimilar CT-P13 and 186 IFX originator). Data were analyzed for 188 CD (62.2% males; 34.6% biologics experienced; 27.7% IFX biosimilar CT-P13 / 72.3% IFX originator and 64 UC (59.4% males; 20.3% biologics experienced; 21.9% IFX biosimilar CT-P13 / 78.1% IFX originator). There were no significant differences between the two groups with respect to all demographic features at the beginning of the treatment (p>0.05). Median follow-up time was 1.58 years and 1.74 years after starting IFX in biosimilar CT-P13 and originator, respectively. There were no significant differences in the rates of p-LOR (4.5% vs. 5.4%, p>0.999) and SAE (6.1% vs. 15.6%, p=0.078) between IFX biosimilar CT-P13 and IFX originator, while the rate of s-LOR was significantly higher in IFX originator group (13.6% vs. %31.2, p=0.009). Considering all types of s-LOR, we did not detect significant differences between IFX biosimilar CT-P13 and IFX originator in the rates of IBD-related hospitalization (10.6% vs. 15.6%, p=0.430) and IBD-related surgery (7.6% vs. 12.4%, p=0.403). Nevertheless, the rates of steroid needed (0.0% vs. 6.5%, p=0.040), and switch to another biotherapy (4.5% vs. 19.4%, p=0.008) were significantly higher in IFX originator. There were also no significant differences in terms of these outcomes between concomitant immunomodulator therapy and monotherapy within IFX biosimilar CT-P13 and IFX originator (p>0.05). Conclusion In this study, outcomes did not reveal significant differences between IFX biosimilar CT-P13 and IFX originator in terms of the p-LOR and SAE. There was no difference between the two groups in the IBD-related hospitalization and IBD-related surgery, however the rates of steroid needed and switch to another biotherapy were significantly higher in the IFX originator within the s-LORs group. No difference was observed in terms of all outcomes between the two groups treated with monotherapy or concomitant immunomodulator therapy.