Comparison of the efficacy and safety of minocycline and clofazimine in chronic and recurrent erythema nodosum leprosum - a randomized clinical trial.

Abstract

BACKGROUND\nManagement of chronic/recurrent erythema nodosum leprosum (ENL) is challenging. The majority of these patients become steroid-dependent and suffer from the adverse effects of long-term corticosteroid use. Minocycline has shown promising results in a small series of chronic/ recurrent ENL patients.\n\n\nOBJECTIVES\nTo compare the efficacy and safety of minocycline and clofazimine in patients with chronic/recurrent ENL.\n\n\nMETHODS\nIn this prospective randomized clinical trial, 60 participants with chronic/recurrent ENL were randomized (1:1) to receive either minocycline 100mg once daily or clofazimine 100mg thrice daily for 12\u2009weeks along with prednisolone according to WHO protocol and followed up for 6 months. The outcome measures were mean time for initial control of ENL, proportion of patients having a recurrence of ENL, mean time for recurrence after initial control, additional prednisolone requirement and frequency of adverse events.\n\n\nRESULTS\nInitial control of ENL was achieved earlier in the minocycline group as compared to the clofazimine group (2.97 ±\u20091.9\u2009weeks vs 4 ±\u20091.96\u2009weeks respectively; p-0.048). The number of participants having ENL flares/recurrences during the study period was comparable in both groups (71.4% in clofazimine vs 55.2% in minocycline group; p-0.2). The participants in the minocycline group remained in remission for a longer duration after initial control of ENL as compared to the clofazimine group (p-0.001). Mean additional prednisolone dose required for control of ENL flares/recurrences was also comparable in both groups (p-0.09). The minocycline group had fewer side effects than the clofazimine group (p-0.047).\n\n\nCONCLUSIONS\nMinocycline led to a rapid and sustained improvement of ENL episodes with fewer adverse events showing a superior efficacy to clofazimine.\n\n\nCLINICAL TRIAL REGISTRATION NUMBER\nCTRI/2018/07/014965 http://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=26994&EncHid=&userName=CTRI/2018/07/014965 This article is protected by copyright. All rights reserved.