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