Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

Abstract

Objective:This study was performed to compare the efficacy and safety of methotrexate (MTX) plus prednisolone versus prednisolone monotherapy in patients with erythema nodosum leprosum (ENL).Methods:This comparative clinical study was performed in the Chittagong Medical College Hospital, Bangladesh from June 2018 to December 2019. Nineteen patients were selected according to inclusion criteria and randomly allocated to either the MTX plus prednisolone group (Group A, n = 10) or the prednisolone monotherapy group (Group B, n = 9). All patients were followed up until the end of the 6-month duration of therapy to observe the clinical outcomes and adverse effects.Results:All patients in both groups showed significant improvement (P = 0.005 and P = 0.008 in Group A and B, respectively). However, prednisolone-related adverse events were more frequent in Group B.Conclusion:The present study has demonstrated that a combination of prednisolone and MTX is a safer and more effective treatment than steroid monotherapy in ENL patients including the healing of nodules. However, this combination therapy did not appear to have a significant steroid-sparing effect, possibly because of the small sample size and short study period. Therefore, a well-designed multicenter randomized controlled trial is recommended for validation of MTX with prednisolone for the management of ENL.