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PEMPULS Trial

Leon F. Mentink, MD; Maria W. Mackenzie, MD; Gábor G. Tóth, MD, PhD; Marianne Laseur, PharmD; Frank P. G. Lambert, MSc; Nic J. G. M. Veeger, MSc; Giuseppe Cianchini, MD, PhD; Milo D. Pavlovi, MD, PhD; Marcel F. Jonkman, MD, PhD

Arch Dermatol. 2006;142:570-576.

Objective  To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris.

Design  A randomized, placebo-controlled trial.

Setting  International European, multicenter outpatient and inpatient study.

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

Interventions  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.

Main Outcome Measures  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.

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

Trial Registration  clinicaltrials.gov Identifier: NCT00127764.

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