Oral antimycobacterial therapy in chronic cutaneous sarcoidosis: a randomized, single-masked, placebo-controlled study.

Drake WP, Oswald-Richter K, Richmond BW, Isom J, Burke VE, Algood H, Braun N, Taylor T, Pandit KV, Aboud C, Yu C, Kaminski N, Boyd AS, King LE
JAMA Dermatol. 2013 149 (9): 1040-9

PMID: 23863960 · PMCID: PMC3927541 · DOI:10.1001/jamadermatol.2013.4646

IMPORTANCE - Sarcoidosis is a chronic granulomatous disease for which there are limited therapeutic options. This is the first randomized, placebo-controlled study to demonstrate that antimycobacterial therapy reduces lesion diameter and disease severity among patients with chronic cutaneous sarcoidosis.

OBJECTIVE - To evaluate the safety and efficacy of once-daily antimycobacterial therapy on the resolution of chronic cutaneous sarcoidosis lesions.

DESIGN AND PARTICIPANTS - A randomized, placebo-controlled, single-masked trial on 30 patients with symptomatic chronic cutaneous sarcoidosis lesions deemed to require therapeutic intervention.

SETTING - A tertiary referral dermatology center in Nashville, Tennessee.

INTERVENTIONS - Participants were randomized to receive either the oral concomitant levofloxacin, ethambutol, azithromycin, and rifampin (CLEAR) regimen or a comparative placebo regimen for 8 weeks with a 180-day follow-up.

MAIN OUTCOMES AND MEASURES - Participants were monitored for absolute change in lesion diameter and decrease in granuloma burden, if present, on completion of therapy.

OBSERVATIONS - In the intention-to-treat analysis, the CLEAR-treated group had a mean (SD) decrease in lesion diameter of -8.4 (14.0) mm compared with an increase of 0.07 (3.2) mm in the placebo-treated group (Pā€‰=ā€‰.05). The CLEAR group had a significant reduction in granuloma burden and experienced a mean (SD) decline of -2.9 (2.5) mm in lesion severity compared with a decline of -0.6 (2.1) mm in the placebo group (Pā€‰=ā€‰.02).

CONCLUSIONS AND RELEVANCE - Antimycobacterial therapy may result in significant reductions in chronic cutaneous sarcoidosis lesion diameter compared with placebo. These observed reductions, associated with a clinically significant improvement in symptoms, were present at the 180-day follow-up period. Transcriptome analysis of sarcoidosis CD4+ T cells revealed reversal of pathways associated with disease severity and enhanced T-cell function following T-cell receptor stimulation.

TRIAL REGISTRATION - clinicaltrials.gov Identifier: NCT01074554.

MeSH Terms (24)

Administration, Oral Adult Aged Anti-Bacterial Agents Azithromycin CD4-Positive T-Lymphocytes Chronic Disease Drug Therapy, Combination Ethambutol Female Follow-Up Studies Humans Levofloxacin Male Middle Aged Ofloxacin Rifampin Sarcoidosis Severity of Illness Index Single-Blind Method Skin Diseases Transcriptome Treatment Outcome Young Adult

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