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Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis.
Bissonnette, Robert; Pariser, David M; Wasel, Norman R; Goncalves, Joana; Day, Robert M; Chen, Rongdean; Sebastian, Michael.
Afiliación
  • Bissonnette R; Innovaderm Research Inc, Montreal, Quebec, Canada. Electronic address: rbissonnette@innovaderm.ca.
  • Pariser DM; Eastern Virginia Medical School and Virginia Clinical Research Inc, Norfolk, Virginia.
  • Wasel NR; Probity Medical Research and Stratica Medical, Edmonton, Alberta, Canada.
  • Goncalves J; Celgene Corporation, Summit, New Jersey.
  • Day RM; Celgene Corporation, Summit, New Jersey.
  • Chen R; Celgene Corporation, Summit, New Jersey.
  • Sebastian M; Gemeinschaftspraxis Mahlow, Mahlow, Germany.
J Am Acad Dermatol ; 75(1): 99-105, 2016 Jul.
Article en En | MEDLINE | ID: mdl-27021239
ABSTRACT

BACKGROUND:

Difficult-to-treat palmoplantar psoriasis has a disproportionately negative impact on quality of life.

OBJECTIVE:

We evaluated the efficacy and safety of apremilast in palmoplantar psoriasis.

METHODS:

A post hoc analysis of data pooled from phase IIb (PSOR-005) and phase III (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1 and 2) clinical studies was conducted to determine the effect of apremilast 30 mg twice daily versus placebo at week 16 in a subset of patients with moderate to severe plaque psoriasis with active palmoplantar psoriasis (baseline Palmoplantar Psoriasis Physician Global Assessment [PPPGA] score ≥1).

RESULTS:

Significantly more patients taking apremilast with moderate to severe palmoplantar psoriasis (baseline PPPGA score ≥3) achieved PPPGA score 0 (clear) or 1 (almost clear) compared with placebo at week 16 (48% vs 27%; P = .021). At week 16, 46% of the apremilast group with baseline PPPGA score 1 or higher achieved a PPPGA score of 0 versus 25% of the placebo group (P < .001); 59% of the apremilast group had a PPPGA score of 0 or 1 with 1-point or more improvement versus 39% receiving placebo (P < .001).

LIMITATIONS:

This post hoc analysis was limited to 16 weeks and did not assess palmoplantar pustules, lesion localization, or surface area involvement.

CONCLUSION:

Apremilast may be a useful oral treatment option for patients with moderate to severe palmoplantar plaque psoriasis.
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Psoriasis / Talidomida / Inhibidores de Fosfodiesterasa 4 / Dermatosis del Pie / Dermatosis de la Mano Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Am Acad Dermatol Año: 2016 Tipo del documento: Article

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Psoriasis / Talidomida / Inhibidores de Fosfodiesterasa 4 / Dermatosis del Pie / Dermatosis de la Mano Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Am Acad Dermatol Año: 2016 Tipo del documento: Article