US-based Celgene has reported positive results in a Phase IV trial (Unveil) that evaluates its oral, phosphodiesterase 4 (PDE4) inhibitor Otezla (apremilast) in patients with moderate plaque psoriasis with a body surface area (BSA) of 5% to 10%.
The trial includes 221 patients and has evaluated the clinical efficacy and safety of oral Otezla 30mg twice-daily in comparison with placebo at week 16 of the trial.
The patients involved in the trial were also defined as a static Physician's Global Assessment (sPGA) of 3, who were naïve to systemic and biologic therapy.
At the study baseline, more than 80% of patients enrolled in the trial had previously received topical therapy.
The primary endpoint of the randomised, controlled study involves the mean percentage change from baseline in the product of PGA and BSA (PGA×BSA) at week 16 of the trial.
UConn Health department of dermatology professor and chair Dr Bruce Strober said: “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.
“While most trials focus on moderate-to-severe plaque psoriasis, this is the first randomised clinical trial of patients with moderate plaque psoriasis, and the results provide encouraging data for patients.”
According to Celgene, patients who received Otezla during week 16 of the Unveil trial had a significantly greater improvement in mean percentage change from baseline in PGA×BSA, compared with those who received placebo.
The study has also found that around 5% of the patients taking Otezla have been reported with adverse events.