Amgen has reported positive top-line results from the ADVANCE trial of Otezl (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis.
The multi-centre, randomised, placebo-controlled, double-blind ADVANCE (PSOR-022) Phase III trial evaluated the efficacy and safety of Otezla in 595 patients with psoriasis, a serious, chronic inflammatory disease that causes raised, red, scaly patches on the skin.
For the study, the subjects were randomised 1:1 to receive Otezla 30mg twice daily or placebo for the first 16 weeks. All patients were then given Otezla during an open-label extension phase up to week 32.
The primary endpoint of the trial was the percentage of patients with static Physician’s Global Assessment (sPGA) at week 16.
The study showed that oral Otezla 30mg, when given twice daily, achieved a statistically significant improvement compared with placebo in the primary endpoint.
The week 16 secondary endpoints of achieving at least a 75% improvement from baseline in the percent of affected body surface area (BSA), a change in BSA total score from baseline, and a change in Psoriasis Area and Severity Index (PASI) total score from baseline, were each also statistically significant to assess the treatment effect of Otezla compared with placebo.
Amgen Research and Development executive vice-president David Reese said: “Many patients with mild-to-moderate plaque psoriasis who use topical therapies still have challenges managing their psoriasis.
“We look forward to discussions with the FDA about the potential to bring Otezla, which has already been prescribed to hundreds of thousands of patients with moderate-to-severe psoriasis, to more patients who may need additional therapeutic options.”
The adverse events observed in the trial were consistent with the known safety profile of Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP).