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FDA Approves Celgene's PDE4 Inhibitor Otezla for the Treatment of Plaque Psoriasis in Adults

Otezla (apremilast) is an oral, selective phosphodiesterase 4 (PDE4) inhibitor for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

The FDA has approved a new indication for Celgene Corporation’s Otezla (apremilast), an oral, selective phosphodiesterase 4 (PDE4) inhibitor. Otezla is now approved 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, a chronic inflammatory dermatologic condition that afflicts more than 125 million people worldwide.

The FDA approved Otezla based primarily on safety and efficacy results from the ESTEEM 1 and ESTEEM 2 multi-center, randomized, double-blind, placebo-controlled studies. The two trials involved adult patients with moderate to severe plaque psoriasis who had 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 who were candidates for phototherapy or systemic therapy.

In the trials, approximately 1,250 patients “were randomized 2:1 to receive either Otezla 30 mg twice daily or placebo after an initial five-day titration period, for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo patients were switched to Otezla 30 mg twice daily through week 32, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial Otezla randomization and PASI-75 response.”

Treatment with Otezla was associated with “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,” according to a news release announcing the drug’s approval.

In trials that assessed the safety of Otezla treatment in 1,426 patients, the most commonly observed adverse events associated with treatment were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.

Patients should inform their doctor if they have a history of depression or suicidal behavior before starting treatment with Otezla, and should inform their doctor if these conditions or other mood changes develop or worsen while taking Otezla. Physicians should also regularly monitor patients for weight gain.

Otezla may be used in patients treatment-naïve and treatment-experienced patients, including those previously treated with biologic agents or conventional systemic agents.

M. Shane Chapman, MD, Section Chief of Dermatology at Dartmouth-Hitchcock Medical Center, said Otezla “offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments. In clinical trials, Otezla reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis.”

Treatment with Otezla may also be an attractive option for clinicians and patients because “the product labeling does not require routine laboratory monitoring,” said Chapman.

“Psoriasis is a serious autoimmune disorder commonly associated with comorbidities,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “Effectively treating psoriasis is an important part of managing a patient's overall health. Having a new treatment like Otezla is important so patients can have more options and can work closely with their providers to find what works best for them.”

Otezla was first approved by the FDA in March 2014 for the treatment of adults with active psoriatic arthritis.