Efficacy and safety of ME3183, an oral phosphodiesterase 4 inhibitor, in patients with plaque psoriasis

Abstract Background There is an unmet need for oral psoriasis medications with improved efficacy and safety. Objective We evaluated the efficacy and safety of oral ME3183, a novel phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis. Methods This was a randomized, double‐blind, placebo‐controlled study with a 16‐week double‐blind treatment period. Patients were randomly assigned (1:1:1:1:1) to oral ME3183 5 mg twice daily (BID), 10 mg once daily (QD), 7.5 mg BID, 15 mg QD or placebo. Results In total, 132 patients were randomly assigned to ME3183 5 mg BID (26 patients), 10 mg QD (26 patients), 7.5 mg BID (26 patients), 15 mg QD (27 patients) and placebo (27 patients). The proportions of patients achieving ≥75% reduction in baseline Psoriasis Area and Severity Index scores at Week 16 (primary endpoint) were 58.3%, 32.0%, 61.5% and 52.0% in each ME3183 group, respectively, versus 14.8% in the placebo group (all p < 0.01 vs. placebo, except for the 10 mg QD group). The most common adverse events across the ME3183 groups were diarrhoea (16.0%–38.5%), nausea (7.7%–30.8%) and headache (7.7%–42.3%). Conclusions ME3183 should be further investigated as a safe and effective treatment alternative for moderate to severe plaque psoriasis.