AbbVie announced positive topline data from a phase 3 study evaluating the efficacy and safety of risankizumab (Skyrizi) compared with secukinumab (Cosentyx; Novartis) in adult patients with moderate to severe plaque psoriasis.

The 52-week, multicenter, open-label, active-comparator study included 327 adult patients randomized 1:1 to receive either risankizumab 150mg (n=164) administered at baseline, week 4, then every 12 weeks thereafter, or secukinumab 300mg (n=163) administered at baseline, on weeks 1, 2, 3 and 4, then every 4 weeks thereafter. The co-primary end points were Psoriasis Area and Severity Index (PASI 90) response at week 16 and 52, defined as a patient that achieved a 90% reduction from baseline in the PASI score. Ranked secondary end points at week 52 included PASI 100, Static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1), and PASI 75.

Findings from the study showed that risankizumab demonstrated superiority to secukinumab, with a significantly greater proportion of patients achieving a PASI 90 response at week 52 (87% vs 57%; P <.001). At week 16, risankizumab was found to be noninferior to secukinumab with a PASI 90 response of 74% vs 66%, respectively. Moreover, all ranked secondary end points showed risankizumab to be superior to secukinumab.

The safety profile of risankizumab was found to be consistent with that observed in previous clinical studies. Both treatment arms demonstrated comparable rates of adverse reactions; the most common adverse reactions included nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea.

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“Head-to-head data like these are crucial to help patients and their doctors make informed treatment decisions,” said Michael Severino, MD, vice chairman and president, AbbVie. “We are pleased to add these results to the growing body of evidence supporting [risankizumab] as a differentiated treatment option for adults living with psoriasis.”

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