Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry.

ABSTRACT: OBJECTIVE:The aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry. METHODS:Patients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years' follow-up. RESULTS:Data from 199 RA patients (CT-P13: n?=?147; reference infliximab: n?=?52) were analyzed. Median treatment duration was 1.22 years for CT-P13 and 1.40 years for reference infliximab (p?=?0.67). Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 versus reference infliximab was comparable for the overall population (p?=?0.84) and for first-line (p?=?0.66) and subsequent treatment lines (p?=?0.96). Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 and 69.6% with reference infliximab. The most common reason for treatment changes or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were reported for CT-P13 and eight for reference infliximab. CONCLUSION:Long-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile. CLINICALTRIALS. GOV IDENTIFIER:NCT01965132.

SUBMITTER: Kim HA 

PROVIDER: S-EPMC6985057 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature