Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris: PEMPULS trial.
OBJECTIVE
To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris.


METHODS
A randomized, placebo-controlled trial.


METHODS
International European, multicenter outpatient and inpatient study.


METHODS
Of the 20 enrolled patients, 11 were randomized to the dexamethasone pulse (DP) group and 9 to the placebo pulse (PP) group.


METHODS
Oral dexamethasone in 300-mg pulses or PPs 3 days per month. During the intervention, the DP and PP groups received conventional treatment with prednisolone, 80 mg/d, which was tapered across 19 weeks, and azathioprine sodium, 3 mg/kg per day, until the end of the study. Monthly pulses were continued until prednisolone treatment was tapered to 0 mg.


METHODS
Number of patients in remission, time to and duration of remission, cumulative prednisolone dose, and occurrence of adverse events during 1 year of follow-up.


RESULTS
Eight of the 11 DP-treated patients and all 9 PP-treated patients achieved remission. Mean time to remission was 173 days with DP and 176 days with PP. The mean duration of remission within the first year was 151 days for DP and 141 days for PP. Mean cumulative prednisolone dose was 5300 mg for DP and 4882 mg for PP. Weight gain (>5% of baseline) occurred in 8 DP-treated patients compared with 1 PP-treated patient (P<.01). We found no statistically significant difference (P>.05) of an adjuvant effect of DP on remission of pemphigus vulgaris.


CONCLUSIONS
In patients with new pemphigus vulgaris disease activity, there was no benefit of oral DP therapy given in addition to conventional treatment.


BACKGROUND
clinicaltrials.gov Identifier: NCT00127764.
Mentink
Leon F
LF
Center for Blistering Diseases, Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Mackenzie
Maria W
MW
Tóth
Gábor G
GG
Laseur
Marianne
M
Lambert
Frank P G
FP
Veeger
Nic J G M
NJ
Cianchini
Giuseppe
G
Pavlovic
Milos D
MD
Jonkman
Marcel F
MF
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001379:Azathioprine / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010392:Pemphigus / Q000188:drug therapy* / Q000473:pathology; D011239:Prednisolone / Q000008:administration & dosage; D020551:Pulse Therapy, Drug; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D003907:Dexamethasone; D011239:Prednisolone; D001379:Azathioprine