Oral apremilast (Otezla, Celgene) received FDA approval for the treatment of patients with moderate-to-severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
In phase III studies, the oral, selective inhibitor of phosphodiesterase 4 (PDE4) resulted in significant and clinically meaningful improvements in plaque psoriasis.
Apremilast, which also demonstrated a consistent safety and tolerability profile across clinical trials, is the first and only PDE4 inhibitor approved for the treatment of plaque psoriasis.
“Apremilast offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments. In clinical trials, Apremilast reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis,” explains M. Shane Chapman, MD, section chief of dermatology at Dartmouth-Hitchcock Medical Center. “Because the product labeling does not require routine laboratory monitoring, oral apremilast may be a welcome new option for patients and physicians looking for a different treatment experience."
The approval of this indication for apremilast was based primarily on safety and efficacy results from 2 multi-center, randomized, double-blind, placebo-controlled studies - ESTEEM 1 and ESTEEM 2 - conducted in adult patients with moderate-to- severe plaque psoriasis: body surface area (BSA) involvement of ≥10%, static Physician Global Assessment (sPGA) of ≥3 (moderate or severe disease), Psoriasis Area and Severity Index (PASI) score ≥12, and candidates for phototherapy or systemic therapy.
In the ESTEEM studies, oral apremilast treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI scores at week 16. Clinical improvement as measured by sPGA scores of clear to almost clear were also demonstrated in both studies.
The safety of oral apremilast was assessed in 1,426 patients from 3 clinical trials. Side effects of the medication included diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. Before starting oral apremilast, 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 the medicine. Patients taking oral apremilast should have their weight checked regularly.
Oral apremilast was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis.
