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

doi:10.1016/j.jaad.2012.10.056

Journal of the American Academy of Dermatology

Volume 68, Issue 5, May 2013, Pages 765-773

https://doi.org/10.1016/j.jaad.2012.10.056 Get rights and content

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.

Section snippets

Methods

This was a single-center, investigator-initiated, prospective, randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of adalimumab in improving the clinical features of patients with cutaneous sarcoidosis. To be eligible for the study, patients had to have at least one of the accepted forms of chronic, indurated, cutaneous sarcoidosis (eg, lupus pernio, nodular, subcutaneous, annular, angiolupoid, plaque, papular, lichenoid, psoriasiform) and skin histopathology

Study patient population

Most patients were African American women (Table II). Patients in group 2 were somewhat older than those in group 1 (mean ages 52.6 and 46 years, respectively); however, individuals in group 1 had a longer duration of disease than those in group 2 (mean of 9.8 vs 5.6 years, respectively). All but 1 patient had extracutaneous involvement. One patient in group 2 was lost to follow-up after week 4 (Fig 1).

Treatment efficacy (double-blind phase)

Efficacy data are shown in Table III. The cutaneous parameters showed a trend toward

Discussion

During the double-blind, placebo-controlled phase of this study, there was a trend toward improvement of the cutaneous lesions in patients in group 1, who received adalimumab, compared with those in group 2, who received placebo, as reflected in the PGA score, target lesion area and volume, and DLQI scores. The patient self-assessment visual analog scale score did not show such a trend. To some extent, this result may have been a result of some patients' apparent confusion in marking the scale,

Conclusion

This study provides reasonably strong evidence for the efficacy and safety of adalimumab in the treatment of the cutaneous lesions of sarcoidosis for the dose and duration of treatment administered. Larger controlled trials for this and for other purported treatments of cutaneous sarcoidosis are needed for such conclusions to be truly evidence-based.

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: Adalimumab, placebo, and partial funding was supplied by Abbott Immunology.

: Conflicts of interest: None declared.

: Reprints not available from the authors.

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

Background

Objective

Methods

Results

Limitations

Conclusions

Section snippets

Methods

Study patient population

Treatment efficacy (double-blind phase)

Discussion

Conclusion

J Am Acad Dermatol

Clin Chest Med

Semin Arthritis Rheum

Chest

Sarcoidosis–scientific progress and clinical challenges

Nat Rev Rheumatol

Sarcoidosis: a comprehensive review and update for the dermatologist, part I: cutaneous disease

J Am Acad Dermtol

Cutaneous sarcoidosis manifesting as extensive verrucous plaques

Int J Dermatol

Epidemiology of sarcoidosis: new frontiers to explore

Curr Opin Pulm Med

Racial differences in sarcoidosis incidence: a 5-year study in a health maintenance organization

Am J Epidemiol

Incidence of clinically identified sarcoidosis in a northwest United States population

Sarcoidosis Vasc Diffuse Lung Dis

Sarcoidosis: epidemiology and prognosis: a 15-year European study

Am Rev Respir Dis

Sarcoidosis: a comprehensive review and update for the dermatologist, part II: extracutaneous disease

J Am Acad Dermtol

Evidence-based therapy for cutaneous sarcoidosis

Drugs

Efficacy of apremilast in chronic cutaneous sarcoidosis

Arch Dermatol

Infliximab therapy in patients with chronic sarcoidosis and pulmonary involvement

Am J Respir Crit Care Med

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