FDA has approved Otezla (apremilast, Celgene) for treating moderate-to-severe plaque psoriasis in patients who are considered candidates for systemic therapy or phototherapy.
Apremilast is an oral, selective inhibitor of phosphodiesterase 4 (PDE4). The drug is the first and only PDE4 inhibitor indicated for the treatment of plaque psoriasis, the most common manifestation of psoriasis. Psoriasis is a chronic inflammatory disease of the skin that stems from an uncontrolled immune response.
Previously, in March 2014, apremilast was approved by FDA for the treatment of active psoriatic arthritis in adult patients. Approximately 10% to 20% of patients suffering from plaque psoriasis also have active psoriatric arthritis.
Scott Smith, president of inflammation & immunology for Celgene, commented that the new drug “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.”
FDA in large part based their decision to approve apremilast on findings from two phase 3, multicenter, double-blind, placebo-controlled clinical trials, ESTEEM 1 and ESTEEM 2. The Psoriasis Area and Severity Index was used to measure the effect of apremilast on plaque psoriasis among the roughly 1250 participating study subjects.
At week 16 of the studies, patients being treated with apremilast were observed to have a clinically meaningful, significant improvement in their condition. Also, on the static Physician’s Global Assessment, patients treated with the drug scored “clear” to “almost clear” of the raised red patches of skin covered with silvery white scales that characterize plaque psoriasis.
Before beginning a regimen of apremilast, patients should inform their physician if they have a history of depression or suicidal behavior. They should further inform their physician if these conditions or other mood changes develop or worsen while they are taking apremilast.
The National Psoriasis Foundation estimates that psoriasis is the most common autoimmune disease in the United States, affecting 7.5 million people. It is estimated that 125 million people have psoriasis worldwide.