Otezla Demonstrates Efficacy in Treatment-Naive Psoriasis Patients

Celgene Corporation announced positive results from the phase 4 UNVEIL clinical trial of apremilast (Otezla) in patients with moderate plaque psoriasis with a body surface area (BSA) of 5% to 10%, according to a press release.

The study assessed the efficacy and safety of apremilast 30-mg twice per day versus placebo for 16 weeks. Included in the trial were 221 patients with moderate plaque psoriasis who had not been previously treated with systemic and biologic therapy. At baseline, 80% of patients were administered prior topical treatments.

Patients were randomized 2:1 to receive treatment with apremilast or placebo, followed by an open-label extension phase where all patients were treated with apremilast through week 52.

The primary endpoint was the change from baseline in Physician’s Global Assessment (PGA) times BSA (PGAxBSA), which is an assessment used to measure a clinically meaningful response to psoriasis drugs, Celgene reported.

After 16 weeks, patients treated with apremilast had a more significant change from baseline PGAxBSA compared with placebo. The investigators also noted a 75% or greater improvement in PGAxBSA among 35.1% of patients treated with apremilast, while only 12.3% of patients achieved this, according to the press release.

Additionally, 30.4% of patients in the apremilast cohort achieved clear or almost clear skin at week 16, as measured by PGA.

For secondary endpoints, 38% of patients with scalp psoriasis treated with apremilast achieved a clear or minimal score by the Scalp Physician’s Global Assessment, compared with 20% of patients treated with placebo.

In a separate analysis, patients reported higher satisfaction and efficacy scores with apremilast over placebo, according to the press release. In terms of convenience, the patients in either cohort reported similar satisfaction.

Patients taking apremilast were more likely to experience diarrhea, headache, nausea, upper respiratory tract infection, and vomiting. Celgene reported the safety and tolerability of the drug was consistent with findings from 6 previous studies of apremilast in psoriasis and psoriatic arthritis, with no new safety concerns.

Apremilast is an oral small-molecule PDE4-inhibitor for cyclic adenosine monophosphase (cAMP), which is observed to increase intracellular cAMP levels that may modulate the production of inflammatory mediators, according to the release.

The drug is currently only approved to treat patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Apremilast is not indicated in patients with BSA involvement of less than 10% or static PGA less than 3, Celgene reported.

"Patients with moderate plaque psoriasis are often inadequately treated, and there remains an unmet medical need for safe and effective treatment options in this population," said Bruce Strober, MD, PhD, professor and chair of the Department of Dermatology at UConn Health. "While most trials focus on moderate to severe plaque psoriasis, this is the first randomized clinical trial of patients with moderate plaque psoriasis, and the results provide encouraging data for patients."