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

• Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy Vol. 34; no. 1; pp. 89 - 98
• Main Authors: Kim, Hyoun-Ah, Lee, Eunyoung, Lee, Sun-Kyung, Park, Yong-Beom, Lee, Young Nam, Kang, Hee Jung, Shin, Kichul
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.02.2020; Springer Nature B.V
• Subjects: Antibodies; Antibodies, Monoclonal - therapeutic use; Antirheumatic Agents; Arthritis, Rheumatoid - drug therapy; Biological products; Biomedical and Life Sciences; Biomedicine; Biosimilar Pharmaceuticals - therapeutic use; Blood Sedimentation - drug effects; C-reactive protein; Cancer Research; Clinical medicine; Data collection; Drug Substitution - methods; Erythrocyte sedimentation rate; Female; Humans; Infliximab; Infliximab - therapeutic use; Joint diseases; Male; Middle Aged; Molecular Medicine; Monoclonal antibodies; Original; Original Research Article; Patients; Pharmacotherapy; Registries; Republic of Korea; Retention; Rheumatoid arthritis; Rheumatology; Rheumatology - methods; Safety; Severity of Illness Index; Studies; Treatment Outcome; Tumor necrosis factor-TNF; Tumor necrosis factor-α; Republic of Korea
• ISSN: 1173-8804; 1179-190X
• DOI: 10.1007/s40259-019-00393-y

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.