Secukinumab biosimilar BAT2306 versus reference secukinumab in patients with moderate-to-severe plaque psoriasis: a multicentre, double-blind, randomised, active-controlled, phase 3 trial.

In 30 seconds

This phase 3, multicentre, double-blind, randomised trial compared the biosimilar BAT2306 to reference secukinumab in 502 patients with moderate-to-severe plaque psoriasis. The primary endpoint was met, showing similar efficacy with a least square mean difference in PASI scores of 1.549 at week 8, within the equivalence margins set by regulatory agencies.

Key findings

• The percentage change in PASI scores was similar between BAT2306 and secukinumab at week 8, with a mean difference of 1.549.
• At week 12, the mean difference in PASI scores was -0.349, remaining within the equivalence margins.
• 75% of patients experienced treatment-emergent adverse events, primarily upper respiratory tract infections and nasopharyngitis.
• The study included 502 patients, with 72% being male and 65% Asian.

Why it matters

The findings support the use of BAT2306 as a biosimilar to secukinumab, potentially enhancing treatment accessibility for patients with moderate-to-severe plaque psoriasis without compromising efficacy or safety.