Abstract
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
| Original language | English |
|---|---|
| Pages (from-to) | 570-576 |
| Number of pages | 7 |
| Journal | Archives of Dermatology |
| Volume | 142 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - May 2006 |
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ASJC Scopus subject areas
- Dermatology
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Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris : PEMPULS trial. / Mentink, Leon F.; Mackenzie, Maria W.; Tóth, Gábor G.; Laseur, Marianne; Lambert, Frank P G; Veeger, Nic J G M; Cianchini, Giuseppe; Pavlović, Miloš D.; Jonkman, Marcel F.
In: Archives of Dermatology, Vol. 142, No. 5, 05.2006, p. 570-576.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris
T2 - PEMPULS trial
AU - Mentink, Leon F.
AU - Mackenzie, Maria W.
AU - Tóth, Gábor G.
AU - Laseur, Marianne
AU - Lambert, Frank P G
AU - Veeger, Nic J G M
AU - Cianchini, Giuseppe
AU - Pavlović, Miloš D.
AU - Jonkman, Marcel F.
PY - 2006/5
Y1 - 2006/5
N2 - 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
AB - 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
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U2 - 10.1001/archderm.142.5.570
DO - 10.1001/archderm.142.5.570
M3 - Article
VL - 142
SP - 570
EP - 576
JO - Archives of Dermatology
JF - Archives of Dermatology
SN - 0003-987X
IS - 5
ER -