Otezla(apremilast)

Otezla (apremilast) is indicated for adult patients with active psoriatic arthritis, adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, and adult patients with oral ulcers associated with Behçet’s Disease. The drug received approval on July 19, 2019, and December 20, 2021.

In clinical trials for psoriatic arthritis, Otezla demonstrated an ACR20 response rate of 38%, compared to 19% for placebo. The ACR50 response rate was 16% for Otezla versus 6% for placebo, and the ACR70 response rate was 4% for Otezla compared to 1% for placebo. The mean change in HAQ-DI score from baseline was -0.244.

Safety findings in psoriatic arthritis trials included a depression or depressed mood incidence of 1.0% for Otezla and 0.8% for placebo. Serious depression occurred in 0.2% of Otezla patients and 0% of placebo patients. Suicidal ideation and behavior were reported in 0.2% of Otezla patients and 0% of placebo patients. Discontinuation due to depression or depressed mood was 0.3% for Otezla and 0% for placebo.