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J Am Acad Dermatol. 2013 May;68(5):765-73. doi: 10.1016/j.jaad.2012.10.056. Epub 2012 Dec 28.

A double-blind, randomized, placebo-controlled trial of adalimumab in the treatment of cutaneous sarcoidosis.

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1
Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, USA.

Abstract

BACKGROUND:

Many medications, including tumor necrosis factor antagonists, have been anecdotally reported to be effective in treating cutaneous sarcoidosis, but controlled study is lacking.

OBJECTIVE:

We sought to determine if adalimumab is a safe and effective treatment for cutaneous sarcoidosis.

METHODS:

Adalimumab or placebo was administered to 10 and 6 patients, respectively, in double-blind, randomized fashion for 12 weeks, followed by open-label treatment for an additional 12 weeks, followed by 8 weeks of no treatment. Assessments were made of cutaneous lesions, quality-of-life issues, laboratory findings, pulmonary function, and radiographic findings.

RESULTS:

At the end of the 12-week, double-blind phase, there was improvement in a number of cutaneous findings in the adalimumab-treated patients (group 1) relative to placebo recipients (group 2), most notably in target lesion area (P = .0203). At the end of the additional 12-week open-label phase, significant improvement relative to baseline was found for target lesion area (P = .0063), target lesion volume (P = .0225), and Dermatology Life Quality Index score (P = .0034). No significant changes were seen in pulmonary function tests, radiographic findings, or laboratory studies. After 8 weeks off treatment, there was some loss of this improvement.

LIMITATIONS:

Standardized, validated measures for cutaneous sarcoidosis are lacking. There may be observer bias in the open-label portion of this study. The small size of this study makes it difficult to generalize results.

CONCLUSIONS:

Adalimumab, at the dose and duration of treatment used in this study, is likely to be an effective and relatively safe suppressive treatment for cutaneous sarcoidosis.

PMID:
23276549
DOI:
10.1016/j.jaad.2012.10.056
[Indexed for MEDLINE]

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