Document Detail


Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris.
MedLine Citation:
PMID:  18209165     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Victoria P Werth; David Fivenson; Amit G Pandya; Diana Chen; M Joyce Rico; Joerg Albrecht; David Jacobus
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Archives of dermatology     Volume:  144     ISSN:  1538-3652     ISO Abbreviation:  Arch Dermatol     Publication Date:  2008 Jan 
Date Detail:
Created Date:  2008-01-22     Completed Date:  2008-02-05     Revised Date:  2013-05-03    
Medline Journal Info:
Nlm Unique ID:  0372433     Medline TA:  Arch Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  25-32     Citation Subset:  AIM; IM    
Affiliation:
Department of Dermatology, University of Pennsylvania, 2 Rhodes Pavilion, 3600 Spruce St, Philadelphia, PA 19119, USA. werth@mail.med.upenn.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00429533
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Aged
Aged, 80 and over
Anti-Infective Agents / administration & dosage*
Cross-Over Studies
Dapsone / administration & dosage*
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Male
Maximum Tolerated Dose
Middle Aged
Pemphigus / diagnosis*,  drug therapy*
Prednisone / administration & dosage*
Probability
Reference Values
Risk Assessment
Severity of Illness Index
Treatment Outcome
Grant Support
ID/Acronym/Agency:
K24 AR002207/AR/NIAMS NIH HHS; K24-AR 02207/AR/NIAMS NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 53-03-2/Prednisone; 80-08-0/Dapsone
Comments/Corrections
Comment In:
Arch Dermatol. 2008 Jan;144(1):100-1   [PMID:  18209175 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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