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.

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

“…These real-world, long-term findings provide robust evidence of the comparability of CT-P13 and reference infliximab, supporting the routine clinical use of CT-P13 in patients with ankylosing spondylitis. comparable for CT-P13 and reference infliximab in patients with rheumatoid arthritis [23].…”

“…Previous analyses of patients from the KOBIO registry have reported encouraging drug retention rates, efficacy, and safety for CT-P13 treatment in patients with AS, after 4 years of follow-up [ 22 ]. In addition, each of these outcomes was shown to be comparable for CT-P13 and reference infliximab in patients with rheumatoid arthritis [ 23 ].…”

Increased Expression of PPAR-γ Modulates Monocytes Into a M2-Like Phenotype in SLE Patients: An Implicative Protective Mechanism and Potential Therapeutic Strategy of Systemic Lupus Erythematosus

“…Sodium valproate (VPA), as a histone deacetylase inhibitor, could successfully promote the anti-inflammatory reaction by supporting the polarization of MDMs from SLE patients toward the M2-like phenotype (33). Another study also reported that Pam3CSK4, a TLR2 agonist, could stimulate SLE patientderived monocytes to differentiate into M2-like macrophages, leading to an improved outcome of murine lupus (34).…”

Clinical Benefits of Switching from Original Infliximab to its Biosimilar (CT-P13) as a Potential TNF-α Inhibitor

“…Retention rates were also comparable between inflectra and remicade; this study confirmed that CT-P13 is a safe and efficacious option. 89 Rheumatoid arthritis study with various parameter calculations was given by Kim et al 90 in 2020, where DAS28-erythrocyte sedimentation rate, DAS28-CRP and ACR responses were analyzed for 199 rheumatoid arthritis patients with CT-P13 (n = 147) and reference infliximab (n = 52). However, some changes in treatment were made, where CT-P13 demonstrated improvements over reference infliximab, as seen from the data.…”