A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis

Rheumatology and Therapy

Juan Sánchez-Bursón¹  Hisashi Yamanaka²  Manfred Rettenbacher³  Dhananjay Bakhle⁴  Chirag Shah⁴  Snehal Gadve⁴  Girish Bhatia⁵  Naoyuki Kamatani⁶  Yoshiya Tanaka⁷  Edit Drescher⁸  Toshihiko Hibino⁹ 

[1] Hospital Infanta Luisa;Institute of Rheumatology, Tokyo Women’s Medical University;Lupin Atlantis Holdings SA;Lupin Research Park, Lupin Limited;Medipoint Hospital Pvt. Ltd;StaGen;University of Occupational and Environmental Health;Vitál Medical Center;YL Biologics Ltd;

关键词: Anti-TNF;    Etanercept;    Rheumatoid arthritis;    Treatment;   

DOI  :  10.1007/s40744-019-00186-3

来源: DOAJ

【 摘 要 】

Abstract Introduction YLB113 is a biosimilar of the reference product (RP), etanercept, under development for treatment of patients with moderate-to-severe rheumatoid arthritis (RA) and other approved indications. A phase 3 study was conducted in Europe, Japan, and India to compare the efficacy, safety, and immunogenicity of YLB113 with the RP over a treatment period of 52 weeks. Methods Overall, 528 patients with moderate-to-severe RA receiving concomitant methotrexate were randomized to receive a once-weekly, subcutaneous dose of 50 mg YLB113 or the RP. The primary endpoint was ACR20 response rate at week 24, with similarity confirmed if the 95% confidence interval (CI) for YLB113 and the RP was within the range of − 15 to 15%. Safety and immunogenicity endpoints were assessed to week 52. Results Based on the European analysis, in the full analysis set, ACR20 response at week 24 was 83.3% and 88.5% for YLB113 and the RP, respectively. Responses were within the predefined clinical equivalence margin. The sensitivity analysis in the per protocol set revealed a similar proportion of subjects exhibiting ACR20 response at week 24 between groups, with a difference of − 5.1% (95% CI − 11.07 to 0.81). The incidence of treatment-emergent adverse events was comparable between groups, and the incidence of antidrug antibody development to week 24 favored YLB113 (0.8 vs. 8.3%). Conclusions This study demonstrated biosimilarity of YLB113 to the RP regarding efficacy, safety, and immunogenicity in patients with moderate-to-severe RA. Based on the same mechanism of action, biosimilarity could be extrapolated to other therapeutic indications approved for etanercept. Trial registration EudraCT Number: 2015-002,809-12.

【 授权许可】

Unknown