A Randomized Phase III Study to Compare Efficacy and Safety of BAT2206 (Proposed Ustekinumab Biosimilar) with Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis.

Background: BAT2206 is a proposed biosimilar to reference ustekinumab (UST, Stelara®).

Objectives: To compare the efficacy and safety of BAT2206 with UST at two treatment periods, i.e., a 28-week initial treatment period 1 (TP1) and a 24-week secondary TP2. This paper describes the results of TP1.

Methods: In this randomized, double-blind, Phase III study, adult patients with moderate to severe plaque psoriasis were randomized (1:1) to receive BAT2206 or UST until Week 28 in TP1. The primary endpoint was the percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 8 or 12. The secondary endpoints included safety, pharmacokinetics (PK), and immunogenicity parameters.

Results: 278 patients were each randomized into the BAT2206 or UST groups. At Weeks 8 and 12, the least squares (LS) mean difference (standard error) for percent CfB in PASI score was 0.964 (1.8952) and 1.774 (1.4912), respectively, and the LS mean difference confidence intervals all completely fell within the predefined equivalence margins. Comparable results were observed between the treatment groups for secondary endpoints.

Limitations: Owing to the length limit, this paper only described the findings from TP1.

Conclusions: BAT2206 and UST were comparable in terms of efficacy, safety, PK, and immunogenicity.