- Trial di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con il placebo sull’efficacia e la sicurezza di apremilast nei pazienti con psoriasi lieve-moderata.
- Apremilast si è dimostrato efficace nella psoriasi lieve-moderata e il profilo di sicurezza è in linea con i dati già noti.
Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.
To evaluate apremilast 30 mg twice daily for mild-to-moderate psoriasis.
Phase 3, double-blind, placebo-controlled study in adults with mild-to-moderate psoriasis inadequately controlled or intolerant to ≥1 topical psoriasis therapy (NCT03721172 >>http://clinicaltrials.gov/show/NCT03721172). The primary endpoint was the achievement of static Physician Global Assessment score of 0 (clear) or 1 (almost clear) and ≥2-point reduction at week 16.
Five hundred ninety-five patients were randomized (apremilast: 297; placebo: 298). The primary endpoint was met, with a significantly greater static Physician Global Assessment response rate observed at week 16 in the apremilast group compared with the placebo group (21.6% vs. 4.1%; p <0.0001). All secondary endpoints were met with the achievement of body surface area-75 (33.0% vs. 7.4%), body surface area ≤3% (61.0% vs. 22.9%), ≥4-point reduction in Whole Body Itch Numeric Rating Scale (43.2% vs. 18.6%), Scalp Physician Global Assessment 0 or 1 and ≥2-point reduction (44.0% vs. 16.6 %), and changes from baseline in body surface area, Psoriasis Area and Severity Index, and Dermatology Life Quality Index (all p <0.0001). The most commonly reported adverse events (≥5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.
The study lacked an active-comparator arm.
Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.