Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.
J Am Acad Dermatol
; 83(1): 96-103, 2020 Jul.
Article
en En
| MEDLINE
| ID: mdl-32032692
ABSTRACT
BACKGROUND:
Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp.OBJECTIVE:
To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis.METHODS:
This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16.RESULTS:
There were 303 randomized patients (placebo n = 102; apremilast n = 201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (43.3% vs 13.7%), Scalp Itch NRS (47.1% vs 21.1%), and Whole Body Itch NRS (45.5% vs 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs -3.8; all P < .0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%).LIMITATIONS:
Patients with mild disease were not enrolled.CONCLUSION:
Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Psoriasis
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Dermatosis del Cuero Cabelludo
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Talidomida
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Antiinflamatorios no Esteroideos
Tipo de estudio:
Clinical_trials
Límite:
Female
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Humans
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Male
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2020
Tipo del documento:
Article