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Response to ciclosporin treatment in Ethiopian and Nepali patients with severe leprosy Type 1 reactions

Response to ciclosporin treatment in Ethiopian and Nepali patients with severe leprosy Type 1 reactions
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.
leprosy, ciclosporin, reversal reaction, treatment outcome, Ethiopia, Nepal
0035-9203
1004-1012
Marlowe, S.N.S.
63463e84-4d1e-4387-8cd6-1653a002a96e
Leekassa, R.
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Bizuneh, E.
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Knuutilla, J.
77bcfcd8-6257-4833-a06c-5a9cb3e76ba5
Ale, P.
ba48bf27-d9dd-4daa-b96f-1b27eaa7cd85
Bhattarai, B.
dffd9dd3-348d-4356-8dda-5b830bf983a5
Sigdel, H.
3772a371-0511-420f-9198-bf0830cb80e4
Anderson, A.
c3371376-d35e-4984-9658-b2ac80b5f5b3
Nicholls, P.G.
b569acda-01e1-4022-93ef-efce28ea7ddd
Johnston, A.
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Holt, D.
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Lockwood, D.N.J.
075da765-b070-4e35-aa82-84ead70f22f1
Marlowe, S.N.S.
63463e84-4d1e-4387-8cd6-1653a002a96e
Leekassa, R.
83551b24-89ca-4a69-9d83-24c8c3b26b85
Bizuneh, E.
5f939e40-573e-4970-af6e-7422e68c754b
Knuutilla, J.
77bcfcd8-6257-4833-a06c-5a9cb3e76ba5
Ale, P.
ba48bf27-d9dd-4daa-b96f-1b27eaa7cd85
Bhattarai, B.
dffd9dd3-348d-4356-8dda-5b830bf983a5
Sigdel, H.
3772a371-0511-420f-9198-bf0830cb80e4
Anderson, A.
c3371376-d35e-4984-9658-b2ac80b5f5b3
Nicholls, P.G.
b569acda-01e1-4022-93ef-efce28ea7ddd
Johnston, A.
2c3d6549-ffa2-4e7b-9812-91aadc0adee6
Holt, D.
9a1da5d8-7310-41b6-ac36-bdf56896acab
Lockwood, D.N.J.
075da765-b070-4e35-aa82-84ead70f22f1

Marlowe, S.N.S., Leekassa, R., Bizuneh, E., Knuutilla, J., Ale, P., Bhattarai, B., Sigdel, H., Anderson, A., Nicholls, P.G., Johnston, A., Holt, D. and Lockwood, D.N.J. (2007) Response to ciclosporin treatment in Ethiopian and Nepali patients with severe leprosy Type 1 reactions. Transactions of the Royal Society of Tropical Medicine and Hygiene, 101 (10), 1004-1012. (doi:10.1016/j.trstmh.2006.11.010).

Record type: Article

Abstract

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.

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More information

Published date: October 2007
Keywords: leprosy, ciclosporin, reversal reaction, treatment outcome, Ethiopia, Nepal

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Local EPrints ID: 59017
URI: http://eprints.soton.ac.uk/id/eprint/59017
ISSN: 0035-9203
PURE UUID: ab117fdf-93c0-4046-9ef0-40cee03005ea

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Date deposited: 21 Aug 2008
Last modified: 15 Mar 2024 11:13

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Contributors

Author: S.N.S. Marlowe
Author: R. Leekassa
Author: E. Bizuneh
Author: J. Knuutilla
Author: P. Ale
Author: B. Bhattarai
Author: H. Sigdel
Author: A. Anderson
Author: P.G. Nicholls
Author: A. Johnston
Author: D. Holt
Author: D.N.J. Lockwood

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