Response to ciclosporin treatment in Ethiopian and Nepali patients with severe leprosy Type 1 reactions.
Leprosy type 1 reactions (T1R) are immune-mediated events with inflammation of peripheral nerves and skin. We report the clinical outcomes of a closely monitored open prospective trial in which eight Nepali and 33 Ethiopian patients with T1Rs were treated with an Indian generic formulation of ciclosporin (Cn; 5-7.5 mg/kg/day) for 12 weeks and followed up for 24 weeks after starting treatment. Outcomes were measured using a clinical severity score. Among the Nepalis, 75-100% improved in all acute clinical parameters; 67-100% patients maintained improvement, except for those with acute sensory nerve impairment among whom 67% relapsed after stopping treatment. The skin lesions of all Ethiopians on 5 mg/kg/day of Cn improved and 50-60% had peripheral nerve function improvement. Most Ethiopians needed a higher dose of Cn to improve nerve impairment and neuritis, and 50-78% of them developed worse clinical severity scores when Cn was stopped. Four Ethiopians and two Nepalis developed elevated serum creatinine levels on 7.5 mg/kg/day Cn, and three (9%) Ethiopians developed treatable hypertension. This suggests that Cn monotherapy is an effective treatment for severe T1R with few adverse effects. A dose of 5 mg/kg/day seems efficacious in Nepalis, but a higher dose may be required in Ethiopian patients.
London School of Hygiene and Tropical Medicine, Keppel Street, London, UK. snsmarlowe@doctors.org.uk
S N S
SN
Marlowe
R
R
Leekassa
E
E
Bizuneh
J
J
Knuutilla
P
P
Ale
B
B
Bhattarai
H
H
Sigdel
A
A
Anderson
P G
PG
Nicholls
A
A
Johnston
D
D
Holt
D N J
DN
Lockwood
D000293:Adolescent; D000328:Adult; D016572:Cyclosporine / Q000494:pharmacology / Q000627:therapeutic use*; D005002:Ethiopia / Q000453:epidemiology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D007918:Leprosy / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009390:Nepal / Q000453:epidemiology; D011446:Prospective Studies; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine