Celgene reported positive results from its Phase 4 UNVEIL clinical trial that evaluated Otezla (apremilast) in patients with moderate plaque psoriasis with a body surface area (BSA) of 5-10%.
The results were recently presented at the American Academy of Dermatology’s Annual Meeting in Orlando, Florida.
UNVEIL was a multicenter, randomized, double-blind, Phase 4 clinical trial (NCT02425826) that evaluated the effectiveness and safety of 16 weeks of treatment with Otezla (30 mg twice daily), compared to a placebo in 221 patients with moderate plaque psoriasis who had never been on systemic and biologic therapy.
Moderate plaque psoriasis is defined as involving 5% to 10% of body surface area and a static Physician’s Global Assessment (sPGA) of 3.
At the start of the study, 80% of patients had been treated with topical therapies. The primary outcome measure of the study was the mean percentage change from baseline in the body surface area (BSA) multiplied by the static Physician’s Global Assessment (sPGA) at week 16.
This composite tool used in clinical trials, called Physician’s Global Assessment and Body Surface Area (PGAxBSA), measures the effect of treatments in patients with psoriasis.
The results showed that at week 16, Otezla-treated patients had statistically significant improvements from baseline on the PGAxBSA scores compared to placebo-treated patients (-48.1 vs. -10.2, respectively).
Also, 35.1% of Otezla-treated patients achieved a 75% or greater improvement in PGAxBSA score, compared to 12.3% of placebo-treated patients.
A PSA score of 0 (clear skin) or 1 (almost clear skin) was achieved in more patients treated with Otezla compared to those treated with a placebo drug (30.4% vs. 9.6%, respectively — a statistically significant difference).
Of the patients with scalp psoriasis (167 patients), more Otezla-treated individuals achieved a Scalp Physician’s Global Assessment score of 0 (clear skin) or 1 (minimal), compared to those treated with a placebo (38.0% vs. 20.0%, respectively).
“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,” Bruce Strober, professor and chair of the Department of Dermatology at UConn Health, said in a press release. “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.”
More Otezla-treated patients reported being satisfied with the treatment than patients treated with a placebo. The scores, based on the Treatment Satisfaction Questionnaire (a generic measure of treatment satisfaction for medication), showed that Otezla was rated significantly higher than the placebo for global satisfaction (63.2% vs. 48.7%, respectively) and effectiveness (57.3% vs. 38.8%, respectively).
There were no differences between the two treatment groups regarding convenience or side effects.
The most commonly reported treatment-related adverse events greater in Otezla-treated patients compared to placebo were headache, diarrhea, nausea, vomiting, and infection of the upper respiratory tract.
There were no new safety signals observed, and tolerability data for Otezla was consistent with that reported in previous clinical trials in psoriasis or psoriatic arthritis.
Otzela is a selective inhibitor of the enzyme phosphodiesterase 4 (PDE4). It reduces spontaneous production of inflammatory TNF-alpha from human rheumatoid synovial cells. The drug helps to control the inflammation associated with psoriasis and reduces symptoms of the condition.
The U.S. Food and Drug Administration (FDA) approved Otezla as a treatment for certain types of psoriasis and psoriatic arthritis in 2014.
In October 2016, the U.K.’s National Institute for Health and Care Excellence (NICE) recommended Otezla for adults with chronic plaque psoriasis in England and Wales.