A Phase 3, Randomized, Double-blind, Active-controlled Clinical Study to Compare BAT2206, a Ustekinumab Biosimilar, with Ustekinumab Reference Product in Patients with Moderate-to-severe Psoriasis: Treatment Period 2 Results (Post Week 28 to Week 52)
Description
Background: BAT2206 is being developed as a ustekinumab (UST) biosimilar. Objectives: Equivalent efficacy and comparable safety results of BAT2206 and UST in patients with moderate-to-severe psoriasis up to Week 28 (treatment period [TP] 1) have been reported previously. TP2 (post Week 28 to 52) results are presented here. Methods: Patients achieving Psoriasis Area and Severity Index response (≥PASI-75) at Week 28 entered TP2. Qualified patients of the UST group in TP1 were re-randomized 1:1 into UST-BAT2206 or UST-UST groups, while qualified patients of the BAT2206 group continued with BAT2206 (BAT2206-BAT2206 group). In TP2, secondary efficacy endpoints, pharmacokinetics, safety, and immunogenicity were assessed at Week 32, 40, 44, and 52. Results: 528 patients entered TP2, of which 133, 131, and 264 were assigned to UST-UST, UST-BAT2206, and BAT2206-BAT2206 groups, respectively. The secondary efficacy endpoints and the adverse events showed no obvious differences across all three groups. There were no notable differences in the UST serum concentrations. Immunogenicity was comparable, and the switching from UST to BAT2206 did not lead to an increased immunogenicity. Limitations: No data collected after Week 52. Conclusion: Outcomes were comparable among the groups in TP2, with no impact from the UST-to-BAT2206 switch.