The Food and Drug Administration ( FDA ) has approved Otezla ( Apremilast ), 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. Psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response, affects more than 125 million people worldwide.
Otezla offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments.
In clinical trials, Otezla has reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis.
The approval of Otezla was based primarily on safety and efficacy results from two multicenter, 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 greater than or equal to 10%, static Physician Global Assessment ( sPGA ) of greater than or equal to 3 ( moderate or severe disease ), Psoriasis Area and Severity Index ( PASI ) score greater than or equal to 12, and candidates for phototherapy or systemic therapy.
Otezla offers a valuable treatment option for a spectrum of plaque psoriasis patients: patients who are treatment-naïve as well as patients who are treatment-experienced, including those previously treated with biologic agents or conventional systemic agents.
In the ESTEEM studies, Otezla 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 Apremilast was assessed in 1,426 patients from three clinical trials. Side effects of Apremilast were 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.
Patients taking Otezla should have their weight checked regularly. ( Xagena )
Source: Celgene, 2014