Skyrizi(risankizumab-rzaa)

Skyrizi (risankizumab-rzaa) was approved on April 23, 2019, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is also indicated for the treatment of active psoriatic arthritis (PsA) in adults. A pediatric study waiver was granted for ages 0 to <5 years due to the rarity of juvenile psoriatic arthritis in this age group, and a deferral for ages 5 to 17 years as the product was ready for adult approval and pediatric studies were not yet completed.

In clinical trials for plaque psoriasis, a sPGA 0 or 1 response rate of 61% was observed. For psoriatic arthritis, an ACR20 Response Rate of 33.4% and an ACR50 Response Rate of 11.3% were reported. The dosage for both plaque psoriasis and psoriatic arthritis is 150 mg. The median baseline PASI score for enrolled subjects was 17.8, and the median baseline BSA was 20%.

Common adverse reactions (≥ 1%) included upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. The overall infections rate was 22.1%, with serious infections reported at ≤ 0.4%. Hepatic events incidence was 5.4%. A postmarketing study final report is due by March 2026.