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

Abstract

Background Long-term, real-world data are required to support the use of CT-P13 in chronic conditions such as ankylosing spondylitis. However, real-world evidence may be influenced by selection bias, which can confound outcomes. The aim of the current analysis was to confirm the long-term comparability of CT-P13 and reference infliximab treatment in patients with ankylosing spondylitis, using propensity score matching to adjust for baseline differences between groups. Methods A propensity score-matching analysis was conducted on data from patients with ankylosing spondylitis in the Korean College of Rheumatology Biologics registry who received CT-P13 or reference infliximab. Drug retention, reasons for biologic therapy changes or discontinuation, and efficacy parameters were analyzed overall and by treatment line with up to 4 years of follow-up. Adverse events were recorded for each treatment group. Results Propensity score matching was effective in matching 124 CT-P13-treated and 124 reference infliximab-treated patients. Median treatment duration and drug retention were similar between CT-P13 and reference infliximab. Three-year retention rates (95% confidence interval [CI]) were 64.2% (53.5-73.0) for CT-P13 and 55.6% (42.9-66.6) for reference infliximab. Overall, 17.1% (CT-P13) and 29.3% (reference infliximab) of patients discontinued biologic therapy, and 20.0% (CT-P13) and 15.2% (reference infliximab) changed biologic therapy. Efficacy assessments were generally similar between groups; both treatments were well tolerated. Conclusions Propensity score-matching analysis confirmed that CT-P13 treatment was not associated with significant differences in drug retention, treatment duration, most efficacy parameters, or safety versus reference infliximab in Korean patients with ankylosing spondylitis, building evidence for the long-term comparability of these treatments. Trial registration ClinicalTrials.gov identifier: NCT01965132.

Impact of Infliximab Biosimilar CT-P13 Dose and Infusion Interval on Real-World Drug Survival and Effectiveness in Patients with Ankylosing Spondylitis

“…The comparability of drug survival regardless of baseline dose or treatment pattern changes complements the previous report from the RAAS study demonstrating no significant difference in CT-P13 drug survival between naïve and switched patients with AS [ 20 ]. Overall 5-year drug survival in this study exceeded 60%, broadly in keeping with previous reports for reference infliximab [ 28 , 29 , 30 , 31 , 32 , 33 ], and reflecting the comparability of drug retention demonstrated between CT-P13 and reference infliximab after up to four years in the Korean College of Rheumatology Biologics Registry [ 34 ]. Drug survival in this study was somewhat higher than the 50% reported after four years of low-dose (3 mg/kg) reference infliximab treatment in a Canadian prospective observational analysis [ 14 ].…”

KOBIO, the First Web-based Korean Biologics Registry Operated With a Unified Platform Among Distinct Disease Entities

“…Interstitial lung disease was the most common comorbidity associated with adverse events. In addition, several studies regarding efficacy, safety profiles, and drug retention of newly introduced biologics, tsDMARDs, and biosimilars in patients with RA and AS have been reported [ 34 - 36 ].…”

Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System

“…Several observational studies assessed the effectiveness of biosimilar products in these remaining indications and showed that there was no difference between originator and biosimilar products. However, they were often small, 4 5 non-comparative [6][7][8] or pathology-specific, [9][10][11][12] as we already did for inflammatory bowel diseases using the same database from 2015 to 2017. 13 14 In Europe, four IFX, four ETA and 12 ADA biosimilars have been approved from 2015, 2016 and 2018, respectively, 15 based on bioequivalence data demonstrated in 1-3 indications.…”