16 Febbraio 2022
Linda Stein Gold, Kim Papp, David Pariser, Lawrence Green, Neal Bhatia, Howard Sofen, Lorne Albrecht, Melinda Gooderham, Mindy Chen, Maria Paris, Yao Wang, Kristina Callis Duffin

Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial

J Am Acad Dermatol. 2022 Jan;86(1):77-85

Key messages

  • 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 >> 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.

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