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

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.

• Authors: Robert J Pariser, Joan Paul, Stefanie Hirano, Cyndi Torosky, Molly Smith
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 68 Issue 5 Pg. 765-73 (May 2013) ISSN: 1097-6787 [Electronic] United States
• PMID: 23276549 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal, Humanized
• Placebos
• Tumor Necrosis Factor-alpha
• Adalimumab

Topics

• Adalimumab
• Anti-Inflammatory Agents (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
• Biopsy
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Placebos
• Quality of Life
• Sarcoidosis (drug therapy, pathology)
• Skin Diseases (drug therapy, pathology)
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)