Ustekinumab biosimilar shows potential against moderate-to-severe psoriasis

Outcomes are similar among patients with moderate-to-severe psoriasis who continued treatment with ustekinumab and those who switched to BAT2206, a drug being developed as a biosimilar of ustekinumab, according to a study.

“Equivalent efficacy and comparable safety results of BAT2206 and ustekinumab in patients with moderate-to-severe psoriasis up to week 28 (treatment period [TP] 1) have been reported previously,” the authors said. “TP2 (post week 28 to 52) results are presented here.”

A total of 528 patients who achieved Psoriasis Area and Severity Index response (≥75) at week 28 entered TP2. Qualified patients in the ustekinumab group from TP1 were rerandomized 1:1 to ustekinumab-BAT2206 or ustekinumab-ustekinumab groups, while qualified patients in the BAT2206 group continued using the biosimilar.

In TP2, the authors assessed secondary efficacy endpoints, pharmacokinetics, safety, and immunogenicity at weeks 32, 40, 44, and 52.

Of the patients who entered TP2, 133 were assigned to ustekinumab-ustekinumab, 131 to ustekinumab-BAT2206, and 264 to BAT2206-BAT2206 groups.

No significant differences in secondary efficacy endpoints and adverse events were observed across all three groups. No notable differences were also noted in the ustekinumab serum concentrations. Furthermore, immunogenicity was similar, and switching from ustekinumab to BAT2206 did not result in increased immunogenicity.

This study was limited by the lack of collected data after week 52, according to the authors.