FDA approves Skyrizi for plaque psoriasis

AbbVie announced that the FDA approved Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In clinical trials, Skyrizi produced high rates of durable skin clearance – most people (82 and 81 percent) treated with Skyrizi achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).

The approval of Skyrizi is supported by results from AbbVie's global Phase III psoriasis program, which assessed the safety and efficacy of Skyrizi in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo. The frequency of adverse events through one year was similar to events observed during the first 16 weeks. The most common adverse events associated with Skyrizi included upper respiratory infections (13 percent), headache (3.5 percent), fatigue (2.5 percent), injection site reactions (1.5 percent) and tinea infections (1.1 percent).

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