Comparing the efficacy and safety of biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis: 24-week results of a phase 3, multicenter, double-blind, randomized, parallel-group study

BACKGROUND: This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in patients with active psoriatic arthritis. RESEARCH DESIGN AND METHODS: This study comprised a 24-week initial treatment period 1. Patients were randomly assigned (1:2:1) into three groups: Ref-GLM, BAT2506, or start with Ref-GLM and switch to BAT2506 at week 24. The assessment of therapeutic equivalence between BAT2506 and Ref-GLM via percentage of patients achieving an American College of Rheumatology 20 (ACR 20) response at Week 14 was the primary endpoint. RESULTS: 351 patients were randomized into the BAT2506 group and 353 patients in those groups that started the treatment with Ref-GLM. The 90% confidence interval (CI; -2.91, 7.63) and 95% CI (-3.92, 8.64) for the common risk difference in ACR 20 response between the BAT2506 group and groups that started the treatment with Ref-GLM fully fell within predefined equivalence margins supporting efficacy equivalence between BAT2506 and Ref-GLM at Week 14. Comparable safety, PK, and immunogenicity profiles were observed for BAT2506 and Ref-GLM groups. CONCLUSIONS: Data supported equivalence efficacy and comparable pharmacodynamics, PK, safety, and immunogenicity profiles between BAT2506 and Ref-GLM till Week 24. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier NCT05046431.