Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, dose‐comparison study

摘要: Background  Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production. Objective  Assess apremilast efficacy safety in moderate severe plaque psoriasis. Methods  Phase II, 12-week, multicenter, double-blind, placebo-controlled, parallel-group, dose-comparison study 259 subjects randomized 1 : placebo, 20 mg QD or BID. Results  More receiving BID achieved ≥ 75% reduction Psoriasis Area Severity Index (PASI-75) vs. placebo (24.4% 10.3%; P = 0.023). A similar proportion PASI-75 at week 12 [9/87 (10.3%, each group)]. Mean per cent PASI from baseline was 17.4% for 30.3% (P = 0.021 placebo) 52.1% (P   90%) were mild did not lead discontinuation. Serious adverse events occurred four (panic attack, hospitalization rehabilitation, alcoholism, worsening psoriasis), one (knee surgery) (worsening psoriasis). The panic attack considered treatment-related; both cases psoriasis after medication No deaths opportunistic infections reported. Conclusion  Apremilast 12 weeks effective well tolerated with psoriasis.