title: Comparison of Efficacy and Safety of Ciclosporin to Prednisolone in the Treatment of Erythema Nodosum Leprosum: Two Randomised, Double Blind, Controlled Pilot Studies in Ethiopia.
abstract: BACKGROUND
  Erythema Nodosum Leprosum (ENL) is a serious complication of leprosy. It is normally treated with high dose steroids, but its recurrent nature leads to prolonged steroid usage and associated side effects. There is little evidence on the efficacy of alternative treatments for ENL, especially for patients who have become steroid resistant or have steroid side effects. These two pilot studies compare the efficacy and side effect profile of ciclosporin plus prednisolone against prednisolone alone in the treatment of patients with either new ENL or chronic and recurrent ENL.
  
  
  RESULTS
  Thirteen patients with new ENL and twenty patients with chronic ENL were recruited into two double-blinded randomised controlled trials. Patients were randomised to receive ciclosporin and prednisolone or prednisolone treatment only. Patients with acute ENL had a delay of 16 weeks in the occurrence of ENL flare-up episode, with less severe flare-ups and decreased requirements for additional prednisolone. Patients with chronic ENL on ciclosporin had the first episode of ENL flare-up 4 weeks earlier than those on prednisolone, as well as more severe ENL flare-ups requiring 2.5 times more additional prednisolone. Adverse events attributable to prednisolone were more common that those attributable to ciclosporin.
  
  
  CONCLUSIONS
  This is the first clinical trial on ENL management set in the African context, and also the first trial in leprosy to use patients' assessment of outcomes. Patients on ciclosporin showed promising results in the management of acute ENL in this small pilot study. But ciclosporin, did not appear to have a significant steroid-sparing effects in patients with chronic ENL, which may have been due to the prolonged use of steroids in these patients in combination with a too rapid decrease of steroids in patients given ciclosporin. Further research is needed to determine whether the promising results of ciclosporin in acute ENL can be reproduced on a larger scale.
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Saba M
authors.initials: SM
authors.lastname: Lambert
authors.affiliation: All Africa Leprosy Rehabilitation and Training (ALERT) Center, Addis Ababa, Ethiopia.
authors.forename: Shimelis D
authors.initials: SD
authors.lastname: Nigusse
authors.affiliation: All Africa Leprosy Rehabilitation and Training (ALERT) Center, Addis Ababa, Ethiopia.
authors.forename: Digafe T
authors.initials: DT
authors.lastname: Alembo
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Walker
authors.affiliation: School of Health Sciences, University of Southampton, Southampton, United Kingdom.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Nicholls
authors.affiliation: All Africa Leprosy Rehabilitation and Training (ALERT) Center, Addis Ababa, Ethiopia.
authors.forename: Munir H
authors.initials: MH
authors.lastname: Idriss
authors.affiliation: Data Management, Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia.
authors.forename: Lawrence K
authors.initials: LK
authors.lastname: Yamuah
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Diana N J
authors.initials: DN
authors.lastname: Lockwood
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004893:Erythema Nodosum / Q000188:drug therapy* / Q000209:etiology; D005002:Ethiopia; D005260:Female; D006801:Humans; D007917:Leprostatic Agents / Q000008:administration & dosage*; D015440:Leprosy, Lepromatous / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007917:Leprostatic Agents; D016572:Cyclosporine; D011239:Prednisolone