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.