Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris

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

Research output: Contribution to journalArticle

74 Citations (Scopus)

Abstract

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 maintenancephase PV. Trial Registration: clinicaltrials.gov Identifier: NCT00429533.

Original languageEnglish (US)
Pages (from-to)25-32
Number of pages8
JournalArchives of Dermatology
Volume144
Issue number1
DOIs
StatePublished - Jan 2008

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Dapsone
Pemphigus
Controlled Clinical Trials
Glucocorticoids
Placebos
Maintenance
Therapeutics
Steroids
Direct Fluorescent Antibody Technique
Cytotoxins
Prednisone
Pharmaceutical Preparations
Multicenter Studies
Outpatients
Outcome Assessment (Health Care)
Physicians
Biopsy

ASJC Scopus subject areas

  • Dermatology

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Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris. / Werth, Victoria P.; Fivenson, David; Pandya, Amit G.; Chen, Diana; Rico, M. Joyce; Albrecht, Joerg; Jacobus, David.

In: Archives of Dermatology, Vol. 144, No. 1, 01.2008, p. 25-32.

Research output: Contribution to journalArticle

Werth, Victoria P. ; Fivenson, David ; Pandya, Amit G. ; Chen, Diana ; Rico, M. Joyce ; Albrecht, Joerg ; Jacobus, David. / Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris. In: Archives of Dermatology. 2008 ; Vol. 144, No. 1. pp. 25-32.
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abstract = "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 maintenancephase PV. Trial Registration: clinicaltrials.gov Identifier: NCT00429533.",
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