title: A Randomized Controlled Double Blind Trial of Ciclosporin versus Prednisolone in the Management of Leprosy Patients with New Type 1 Reaction, in Ethiopia.
abstract: BACKGROUND
  Leprosy Type 1 (T1R) reactions are immune-mediated events leading to nerve damage and preventable disability affecting hands, feet and eyes. Type 1 Reactions are treated with oral corticosteroids. There is little evidence on alternative treatments for patients who do not respond to steroids or experience steroid adverse effects. We report the results of a randomized controlled trial testing the efficacy and adverse effect profile of ciclosporin and prednisolone (CnP) in comparison to prednisolone only (P) in patients with new T1R in Ethiopia. Ciclosporin is a potent immunosuppressant. Outcomes were measured using a clinical severity score, recurrence rate, adverse events and quality of life.
  
  
  RESULTS
  Seventy three patients with new T1R were randomized to receive CnP or P for 20 weeks. Recovery rates in skin signs was similar in both groups (91% vs 88%). Improvements in nerve function both, new and old, sensory (66% vs 49%) and motor (75% vs 74%) loss were higher (but not significantly so) in the patients on CnP. Recurrences rates of T1R (85%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients CnP, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were similar in patients in the two treatment arms of the study. Both groups had a significant improvement in their quality of life after the study, measured by the SF-36.
  
  
  CONCLUSIONS
  This is the first double-blind RCT assessing ciclosporin, in the management of T1R in Africa. Ciclosporin could be a safe alternative second-line drug for patients with T1R who are not improving with prednisolone or are experiencing adverse events related to prednisolone. This study illustrates the difficulty in switching off leprosy inflammation. Better treatment agents for leprosy patients with reactions and nerve damage are needed.
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.|All Africa Leprosy Rehabilitation and Training (ALERT) Centre, Addis Ababa, Ethiopia.
authors.forename: Saba M
authors.initials: SM
authors.lastname: Lambert
authors.affiliation: All Africa Leprosy Rehabilitation and Training (ALERT) Centre, Addis Ababa, Ethiopia.
authors.forename: Digafe T
authors.initials: DT
authors.lastname: Alembo
authors.affiliation: All Africa Leprosy Rehabilitation and Training (ALERT) Centre, Addis Ababa, Ethiopia.
authors.forename: Shimelis D
authors.initials: SD
authors.lastname: Nigusse
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: Stephen L
authors.initials: SL
authors.lastname: Walker
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; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019468:Disease Management; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005002:Ethiopia; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007918:Leprosy / Q000150:complications / Q000188:drug therapy* / Q000276:immunology* / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D011788:Quality of Life; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D011239:Prednisolone