An open, multicenter, randomized clinical study in patients with bullous pemphigoid comparing methylprednisolone and azathioprine with methylprednisolone and dapsone

Abstract

Background

Current treatment of bullous pemphigoid (BP) is based on the long-term use of topical and/or systemic corticosteroids associated with a high rate of adverse events and increased mortality.

Objective

To study the corticosteroid-sparing potential of azathioprine and dapsone.

Method

A prospective, multicenter, randomized, non-blinded clinical trial that compares efficacy and safety of two parallel groups of BP patients treated with oral methylprednisolone 0.5 mg/kg/d in combination with either azathioprine 1.5-2.5 mg/kg/d or dapsone 1.5 mg/kg/d. Nine German and Austrian departments of dermatology included 54 patients based on clinical lesions, positive direct immunofluorescence (IF) microscopy and detection of serum autoantibodies by indirect IF microscopy, immunoblotting or ELISA. The primary end point was time until complete tapering of methylprednisolone, the most important secondary end point the cumulative corticosteroid dose.

Results

In eight patients (5 azathioprine, 3 dapsone), methylprednisolone could be discontinued after a median time of 251 days in the azathioprine and 81 days in the dapsone group. The median cumulative corticosteroid dose was 2,654 mg for azathioprine compared to 1,917 mg for dapsone (p=0.06). The median number of days when corticosteroids were applied was 148 and 51, respectively (p=0.24). No significant difference in the number of adverse events was seen between the treatment arms. Four patients (8%) died within the observation period of 12 months.

Conclusions

Due to the lower than intended number of patients, results of primary and secondary endpoints were not or only barely significant. Dapsone appeared to have a moderately higher corticosteroid-sparing potential compared to azathioprine. The combination regimen of both drugs with oral methylprednisolone is associated with a relatively low one-year mortality in this vulnerable patient population.

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