Clinical outcomes in a randomized controlled study comparing azathioprine and prednisolone versus prednisolone alone in the treatment of severe leprosy type 1 reactions in Nepal

Marlowe, S.N.S., Hawksworth, R.A., Butlin, C.R., Nicholls, P and Lockwood, D.N.J. (2004) Clinical outcomes in a randomized controlled study comparing azathioprine and prednisolone versus prednisolone alone in the treatment of severe leprosy type 1 reactions in Nepal. Transactions of the Royal Society of Tropical Medicine and Hygiene, 98 (10), 602-609. (doi:10.1016/j.trstmh.2003.12.013).

Abstract

The ILEP nerve function impairment and reaction research programme (INFIR 2) was a group of clinical trials conducted to identify second-line treatments for severe leprosy type 1 reactions (T1R). This paper presents the clinical results of one of these trials in which azathioprine was used in combination with short-course prednisolone to ascertain if the combination was effective in controlling the symptoms and signs of reaction. Forty patients were alternately assigned to a 12-week treatment with either AP (12 weeks azathioprine at 3 mg/kg/d plus 8 week reducing course prednisolone starting at 40 mg/d) or P (12-week reducing course prednisolone starting at 40 mg/d). Evaluation included serial quantitative clinical assessments. The overall frequency of side effects was similar in both groups. Results show that there was no difference in clinical outcome in the AP and P groups and a similar number of patients in each group required extra prednisolone for worsening clinical features. We conclude that a 12-week course of azathioprine at 3 mg/kg/day plus an 8 week reducing course of prednisolone starting at 40 mg/d is as effective as a 12 week reducing course of prednisolone starting at 40 mg/d and that the combination therapy is well-tolerated in severe leprosy T1R patients.

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