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Victoria P. Werth, MD; David Fivenson, MD; Amit G. Pandya, MD; Diana Chen, MD; M. Joyce Rico, MD; Joerg Albrecht, MD; David Jacobus, MD

Arch Dermatol. 2008;144(1):25-32.

Objective  To determine the efficacy of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris (PV).

Design  A randomized, double-blind, placebo-controlled study with a crossover arm for those who failed treatment.

Setting  A US multicenter outpatient study.

Patients  A total of 19 subjects enrolled among 5 centers, 9 randomized to receive dapsone and 10 to receive placebo. Inclusion criteria were biopsy and direct immunofluorescence-proven PV controlled with glucocorticoids and/or cytotoxic agents, disease in maintenance phase, and aged 18 to 80 years. Physicians had tried at least 2 tapers of glucocorticoids unsuccessfully and had 30 days of stable steroid dosage. Treatment for any patient unable to taper glucocorticoids by more than 25% within 4 months was declared a failure, and the patient was allowed to switch to the opposite medication while maintaining the double-blind.

Main Outcome Measure  The ability of patients to taper to 7.5 mg/d or less within 1 year of reaching the maximum dosage of the study drug.

Results  Of the 9 patients receiving dapsone, 5 were successfully treated, 3 failed treatment, and 1 dropped out of the study. Of the 10 patients receiving placebo, 3 were successfully treated, and 7 failed treatment. This primary end point favored the dapsone-treated group but was not statistically significant (P = .37). Four patients who failed treatment while receiving placebo were switched to treatment with dapsone. Of these, 3 were successfully treated after switching to dapsone treatment, and 1 failed treatment. We found that, overall, 8 of 11 patients (73%) receiving dapsone vs 3 of 10 (30%) receiving placebo reached the primary outcome of a prednisone dosage of 7.5 mg/d or less.

Conclusion  This trial demonstrates a trend to efficacy of dapsone as a steroid-sparing drug in maintenance-phase PV.

Trial Registration  clinicaltrials.gov Identifier: NCT00429533

Author Affiliations: Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia (Drs Werth and Albrecht); Philadelphia VA Medical Center, Philadelphia (Dr Werth); Henry Ford Health System, Detroit, Michigan (Dr Fivenson); Department of Dermatology, University of Texas Southwestern Medical Center, Dallas (Dr Pandya); Department of Dermatology, Northwestern Memorial Hospital, Chicago, Illinois (Dr Chen); Department of Dermatology, New York University, New York, New York (Dr Rico); and Jacobus Pharmaceutical Co, Princeton, New Jersey (Dr Jacobus). Dr Fivenson is now in private practice in Ann Arbor, Michigan. Dr Chen is now with the Connetics Corp, Palo Alto, California. Dr Rico is now with Astellas Pharma, Deerfield, Illinois. Dr Albrecht is now with John H. Stroger Jr Hospital of Cook County, Chicago.

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