High dose oral prednisone vs. prednisone plus azathioprine for the treatment of oral pemphigus: a retrospective, bi-centre, comparative study.

BACKGROUND

Steroids are considered the cornerstone in the treatment of pemphigus vulgaris. However, subsequent morbidity of their use has led to the development of combined therapeutic protocols, using steroid sparing agents.

OBJECTIVES

The aim of this study was to compare tolerability and efficacy of high dose oral prednisone daily, vs. low dose oral prednisone on alternate days plus azathioprine every day (Lever's mini treatment: LMT) in oral pemphigus.

PATIENTS AND METHODS

Data of 36 patients with oral pemphigus vulgaris, treated with either 1.5 mg/kg/day of oral prednisone daily, or LMT were re-evaluated and statistically analysed. Primary endpoints were time required to control disease activity, prednisone dose required until the end of consolidation phase, cumulative prednisone dose and rates of remission. Secondary endpoints were time to complete (CR) or partial remission (PR) on/off therapy, treatment-associated morbidity and days of hospitalization.

RESULTS

Both treatments resulted in high rates of clinical response. The mean prednisone dose required until the end of consolidation phase, and until CR or PR, on/off minimal therapy, was significantly lower in LMT group. However, the mean time required until the control of disease activity and CR or PR, for the same group, was significantly higher. Adverse events were more frequent among patients under daily prednisone. Mean time of hospitalization was also longer in the latter group.

CONCLUSIONS

Both treatments seem efficacious. Rapidly progressive lesions necessitate high prednisone dose for early and adequate control of the disease. Patients with impaired physical status, especially those with relatively stable lesions, at baseline might safely and effectively be treated with LMT.