The Food and Drug Administration (FDA) has approved 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.
The drug, marketed under the name Otezla, was approved by the FDA in March to treat adults with active psoriatic arthritis (PsA).
Otezla is the first and only PDE4 inhibitor approved for the treatment of plaque psoriasis. In immune cells, the PDE4 enzyme plays a pivotal role in inflammation by modulating levels of a chemical messenger called cyclic AMP (cAMP). The degradation of cAMP to AMP can result in affecting levels of inflammatory mediators.
Psoriasis is a noncontagious, chronic autoimmune disease that affects the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis causes patches of thick red skin and silvery scales typically found on the elbows, knees, scalp, lower back, face, palms, and feet. These scales can also affect fingernails, toenails, and the mouth. There are different types of psoriasis, but the most common is called plaque psoriasis.
According to the National Psoriasis Foundation, as many as 7.5 million Americans have psoriasis.
Approval Comes After Two Controlled Studies
The approval of Otezla for this new indication was based primarily on safety and efficacy results from two multi-center, randomized, double-blind, placebo-controlled studies conducted in adult patients with moderate to severe plaque psoriasis.
Clinical trials of apremilast were conducted under the direction of Dr. Mark Lebwohl, a professor and chairman of the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York. Lebwohl told Healthline, “Apremilast is the first oral drug approved for psoriasis in decades. Several injectable drugs have been introduced for psoriasis in recent years. This adds a safe, useful therapeutic option for patients with this debilitating condition.”
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 should also have their weight checked regularly.
In clinical trials, side effects reported from Otezla included diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.