Celgene's Otezla Approved for Moderate to Severe Plaque Psoriasis

The FDA has approved Celgene's Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is the first and only PDE4 inhibitor approved for the treatment of plaque psoriasis. The approval was based primarily on safety and efficacy results from the ESTEEM trials, in which Otezla treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI scores at week 16. Moreover, sPGA scores of clear to almost clear were demonstrated in both studies.

Side effects included diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. Before starting Otezla, patients should inform their doctor if they have a history of depression or suicidal behavior and if these conditions or other mood changes develop or worsen while taking Otezla. Additionally, patients should have their weight checked regularly.