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Adjuvant Therapy for Bullous Pemphigoid: No Benefit

Classic teaching recommends the addition of an immunosuppressive agent, such as azathioprine, to systemic corticosteroids as the initial treatment of bullous pemphigoid. To date only two controlled studies have looked at adjuvant therapy in the treatment of this disease: one found azathioprine to be steroid-sparing, and the other found the same benefit with plasma exchange. However, neither study was well-blinded, and both were small and observer-biased in favor of finding steroid-sparing effects of the adjuvants. Although also unblinded, a new, more carefully conducted study avoids some of these and other methodologic flaws.

This multicenter, randomized study evaluated whether adding azathioprine or plasma exchange to conventional doses of prednisolone is beneficial. One hundred patients were randomly assigned to receive oral prednisolone (1 mg/kg per day) for 28 days alone or combined with either oral azathioprine (2 to 2.5 mg/kg per day) or four large-volume plasma exchanges. On day 28, the prednisolone dosage was decreased on a standard schedule to a daily dose of 0.5 mg/kg at 3 months and 0.2 mg/kg at 6 months. Ninety-eight patients were evaluable.

There was no significant difference in the number of patients achieving complete remission in the three groups at 28 days (71% with prednisolone alone, 80% with prednisolone and azathioprine, and 71% with prednisolone and plasma exchange) or at 6 months (42%, 39%, and 29%, respectively). Although severe complications were more common in the group given azathioprine, most adverse effects could be attributed to corticosteroid use. Despite the study's restriction to relatively healthy persons, the overall death rate was 14.3%.

Comment: The results of this well-done study suggest that currently available adjunctive immunosuppressive agents should not be added to systemic corticosteroids in the treatment of bullous pemphigoid. Furthermore, with a death rate approaching 15%, patients with this disease warrant close attention.

— Dover

Published in Journal Watch Dermatology March 1, 1993

Citation(s):

Guillaume JC et al. Controlled trial of azathioprine and plasma exchange in addition to prednisolone in the treatment of bullous pemphigoid. Arch Dermatol 1993 Jan 129 49-53.

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