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
; 86(1): 77-85, 2022 01.
Article
en En
| MEDLINE
| ID: mdl-34343599
ABSTRACT
BACKGROUND:
Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.OBJECTIVE:
To evaluate apremilast 30 mg twice daily for mild-to-moderate psoriasis.METHODS:
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.RESULTS:
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 < .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 < .0001). The most commonly reported adverse events (≥ 5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.LIMITATIONS:
The study lacked an active-comparator arm.CONCLUSION:
Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
/
3_ND
Problema de salud:
1_doencas_nao_transmissiveis
/
3_diarrhea
Asunto principal:
Psoriasis
/
Antiinflamatorios no Esteroideos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
Aspecto:
Patient_preference
Límite:
Adult
/
Humans
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2022
Tipo del documento:
Article