Randomized Controlled Trial of Adjuvant Oral Dexamethasone Pulse Therapy in Pemphigus Vulgaris

Abstract

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 (Ͼ5% of baseline) occurred in 8 DPtreated patients compared with 1 PP-treated patient (PϽ.01).We found no statistically significant difference (PϾ.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.

Pemphigus. S2 Guideline for diagnosis and treatment – guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV)

“…13,14 Still, more evidence is needed and steroid pulse therapy should be reserved for refractory pemphigus patients…”

Role of Corticosteroids in Oral Lesions

“…Two prospective controlled trials explored the effect of i. v. corticosteroid pulses in addition to oral prednisolone but did not observe statistical differences between treatment groups (Femiano 2002;Mentink 2006). …”

Current Management of Pemphigus

“…Bunlardan birinde yüksek doz oral prednisolon (125 mg/gün) alan grupla üç haftalık intravenöz betametazon (20 mg/gün 4 gün) ve aralarda 50 mg/gün oral prednisolon kombinasyonu karşılaştırıl-mış ve pulse protokolünün hızlı iyileşme süresi ve daha az yan etki gibi avantajları saptanmıştır (13). Yeni tanı konmuş pemfigus vulgarisli hastaların alındığı diğer çalışmada ise konvansiyonel tedaviye (oral prednisolon ve azatioprin kombinasyonu) intravenöz pulse deksametazon (300 mg/gün 3 gün süre ile) ilave edimesinin bir yarar sağlamadığı saptanmıştır (14). İntravenöz pulse kortikosteroid tedavisinin etkinliğine ve yan etki profiline dair başka kontrolsüz çalışmalar ve olgu sunumları da var- …”