Biosimilar as safe, effective as ustekinumab in plaque psoriasis

The biosimilar BAT2206 demonstrates similar efficacy, safety, pharmacokinetics, and immunogenicity to its reference drug, ustekinumab (UST), in a recent phase III trial.

A total of 278 adult patients with moderate-to-severe plaque psoriasis were included in this randomized, double-blind, phase III study, which sought to compare the efficacy and safety of BAT2206 with UST at two treatment periods.

The investigators randomly allocated eligible patients to receive BAT2206 45 or 90 mg or UST until week 28 in treatment period 1 (TP1), depending on their baseline body weight. The percent change from baseline in Psoriasis Area and Severity Index (PASI) score to week 8 or 12 was the primary endpoint. Secondary endpoints were safety, pharmacokinetics, and immunogenicity.

The least squares mean difference for PASI score was 0.964 at week 8 and 1.774 at week 12. The least squares mean difference confidence intervals were all completely within the predefined equivalence margins. In addition, the results for all secondary endpoints were similar between the two groups.

“BAT2206 and UST were comparable in terms of efficacy, safety, pharmacokinetics, and immunogenicity,” the investigators said.

“Owing to the length limit, this article only described the findings from TP1,” they noted.

BAT2206 is a proposed biosimilar to reference UST.