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 (≥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:A total of 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 3 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.