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

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


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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


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