SAT0286 Retention rate and safety data of biosimilar ct-p13 in ankylosing spondylitis patients: data from the korean college of rheumatology biologics registry

Abstract

BackgroundCT-P13 is a biosimilar prescribed in a number of countries for indications approved for the reference infliximab (RINF), including ankylosing spondylitis (AS), rheumatoid arthritis, and inflammatory bowel diseases. Clinical data of CT-P13 have been analysed in previous clinical trials, demonstrating equivalence of efficacy and pharmacokinetic profile to RINF. However, there are few studies showing long-term data of its drug survival or safety.ObjectivesTo investigate the drug retention rate and safety data of biosimilar CT-P13 in Korean AS patients.MethodsSubjects were AS patients enrolled in the Korean College of Rheumatology biologics registry (KOBIO). Data from patients who received RINF and CT-P13 were included in the analysisDec 2012 ~ .Dec 2017 Discontinuation was defined as switching or stopping the biologic agent. Kaplan-Meier curve and Cox proportional hazard model were used for further analysis. Reason for RINF or CT-P13 discontinuation was also assessed.ResultsData from 399 AS patients (CT-P13; 256, RINF; 143) were analysed. The mean age of patients was 39.0 in the CT-P13 group, and 73% were males. The mean disease duration was 4.1 years. Eighty percent of patients were first-time biologic users. Discontinuation of CT-P13 occurred in 30.9% (switching in 17.6%) of patients during follow-up. The drug retention rate of first-line users of CT-P13 was marginally higher compared with second or more (≥2)-line users of CT-P13, first-line users of RINF, and ≥2 line users of CT-P13 in Korean AS patients (p=0.0518). The reason of discontinuation was inefficacy (42.7%), adverse events (20.2%), clinical improvement (7.9%), and others (18.0%) in the CT-P13 group. The incidence of adverse events of CT-P13, including infusion reaction (n=10), mycobacterial infection (n=2), and skin eruption (n=1) was comparable to that of RINF.ConclusionsOur study demonstrates that the drug retention rate of CT-P13, especially in first-line users was relatively higher than that of RINF,[H1] and CT-P13 showed a reasonable long-term safety profile in Korean AS patients.Disclosure of InterestNone declared

Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score–Matched Analysis from the Korean College of Rheumatology Biologics Registry

“…In our analysis, the 3-year retention rate (95% CI) was 64.2% (53.5-73.0) for CT-P13 and 55.6% (42.9-66.6) for reference infliximab in the overall patient population. Therefore, the CT-P13 retention rate based on the 124 patients included in this analysis was similar to the 4-year retention rate of 66% reported in a previous analysis of 244 patients with AS enrolled in the KOBIO registry [22]. In addition, CT-P13 retention did not differ significantly between patients receiving first-line or subsequent-line therapy, in keeping with previous findings from this registry [22].…”

“…In this analysis, 20.0% and 17.1% of patients receiving CT-P13 changed to another biologic and permanently discontinued biologic treatments, respectively. This is fairly similar to the rates reported in a previous analysis of 244 patients with AS in the KOBIO registry (15.6% and 13.1%, correspondingly) [22]. While proportions of patients changing to another biologic were similar between groups, a greater proportion of patients receiving reference infliximab discontinued biologic therapy (29.3% vs 17.1% in the CT-P13 group), in contrast to what might be expected with biosimilar-related nocebo effects [31].…”

“…Therefore, the CT-P13 retention rate based on the 124 patients included in this analysis was similar to the 4-year retention rate of 66% reported in a previous analysis of 244 patients with AS enrolled in the KOBIO registry [22]. In addition, CT-P13 retention did not differ significantly between patients receiving first-line or subsequent-line therapy, in keeping with previous findings from this registry [22]. The 77% and 79% 1-year retention rates for CT-P13 and reference infliximab, respectively, in our analysis were slightly lower than those reported for the DANBIO registry of patients with rheumatic diseases, where overall crude retention rates (95% CI) were 84.1% (81.3-86.5) and 86.2% (84.0-88.0) for CT-P13 and reference infliximab, respectively [15].…”

“…In the current analysis, major improvement in ASDAS criteria was achieved by 34.3% and 43.1% of CT-P13-treated patients after 1 and 2 years of treatment, respectively. This is somewhat lower than the corresponding 56.5% and 56.9% of patients reported in a previous analysis of patients with AS included in the KOBIO registry [22], which may be a result of the differences in baseline characteristics between the studies. Nonetheless, efficacy was similar between CT-P13 and reference infliximab in both analyses.…”

“…Of the 3424 patients included in the KOBIO registry between December 2012 and December 2017, 1658 had been diagnosed with AS [22]. Among AS patients included in the registry, 256 received treatment with CT-P13 and 143 received treatment with reference infliximab.…”