Safety and efficacy of oral fusidic acid as a steroid-sparing agent in the treatment of lepra reactions : A randomized controlled assessor-blinded clinical trial

ABSTRACT

BACKGROUND: Lepra reactions occur in 10-30% of patients with leprosy. The standard of treatment is prednisone. However , prolonged steroid use may cause side effects such as osteoporosis, hypertension, hyperlipidemia, atherosclerosis and infections. Fusidic acid targets cytokine systems responsible for the production of Type 1 lepra reaction (T1R) and erythema nodosum leprosum (ENL). It may be given as a steroid-sparing agent in treating lepra reactions. OBJECTIVE: To determine the safety and efficacy of fusidic acid as a steroid-sparing agent in the treatment of  Type 1 and Type 2  lepra reactions. METHODS: A randomized controlled trial was conducted on 67 subjects with lepra reactions, aged 18-60, each assigned to receive either prednisone or prednisone + fusidic acid for 12 weeks. Severity of lepra reactions were graded quantitatively using a modified scale by Walker et al and van Brakel et al, and qualitatively using modified National Leprosy Control Program (NLCP) Guidelines at baseline, weeks 2,4,6,8,10 and 12. Doses of prednisone needed to control lepra reactions were also noted at each follow up and statistical analyses were done . Adverse reactions were noted. RESULT: Sixty subjects (89.55%) completed the study. The prednisone + fusidic acid group had lower quantitative and qualitative scores compared to the prednisone group. There were significant differences between the two groups for the quantitative severity scores (p=1.44x10-11) and qualitative severity grading (p=9.36x10-14) at week 12. The mean dose of prednisone was 21.5 mg in the prednisone group and 2 mg in the prednisone + fusidic acid group at week 12 (p=1.01x10-12). No adverse reactions were reported. CONCLUSION: Fusidic acid tablet 250mg/tab two tablets three times a day is an effective and safe steroid-sparing agent for the treatment of lepra reactions.