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FDA Approves New Therapy for Psoriasis

The FDA approved Skyrizi (risankizumab-rzaa), for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

An interleukin-23 inhibitor, Skyrizi is administered by two 150-mg subcutaneous injections every 12 weeks following 2 loading doses at week 0 and 4. Patients can administer the injections themselves after training or can elect to have the therapy administered in an office setting.

In 2 clinical trials, ultIMMa-1 and ultIMMa-2, 82% and 81% of participants achieved 90% skin clearance after 1 year of treatment, and 56% and 60% achieved 100% skin clearance, respectively.

The most common adverse events associated with treatment included upper respiratory infections (13%), headache (3.5%), fatigue (2.5%), injection site reactions (1.5%), and tinea infections (1.1%). Patients are required to be evaluated for tuberculosis prior to starting treatment.

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