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811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients

BACKGROUND: Leprosy is a chronic granulomatous infectious disease caused by Mycobacterium leprae. Type 1 lepra reactions (T1R) are delayed hypersensitivity (Type IV) reactions which if not treated promptly leads to disability affecting eyes, hands and feet. IL-17 A which is produced mainly by inflam...

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Autor principal: Mitra, Debdeep
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6254982/
http://dx.doi.org/10.1093/ofid/ofy210.818
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author Mitra, Debdeep
author_facet Mitra, Debdeep
author_sort Mitra, Debdeep
collection PubMed
description BACKGROUND: Leprosy is a chronic granulomatous infectious disease caused by Mycobacterium leprae. Type 1 lepra reactions (T1R) are delayed hypersensitivity (Type IV) reactions which if not treated promptly leads to disability affecting eyes, hands and feet. IL-17 A which is produced mainly by inflammatory T helper 17 cells is up regulated in patients of Lepra reaction. Conventionally oral corticosteroids steroids have been the main stay in the management of Type 1 lepra reactions. This novel biologic drug is a targeted therapy which blocks the offending interleukin molecule without any serious adverse effects. We report the results of this randomized control study wherein an immuno-modulator biologic molecule has been safely used to treat an inflammatory reaction in a chronic infectious disease. Outcomes were measured using recurrence rate, a clinical severity score, quality of life, and adverse events. METHODS: Seventy-four patients with new T1R were randomized to receive Secukinumab (a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A) or Prednisolone for 20 weeks. IL-17 A levels were correlated before and after the intervention. RESULTS: Recovery rates in skin signs was similar in both groups (92% vs. 87%). Improvements in nerve function both, new and old, sensory (67% vs. 48%) and motor (73% vs. 76%) loss were higher (but not significantly so) in the patients on Secukinumab. Recurrences rates of lepra reaction (25%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients on Secukinumab, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were much lesser with Secukinumab as compared with Prednisolone alone. Both groups had a significant improvement in their quality of life after the study, measured by the Short form survey SF-36. CONCLUSION: This is the first double-blind randomized control trial assessing Secukinumab, in the management of lepra reaction. It could be a safe alternative second-line drug for patients with leprosy reactions who are not improving with prednisolone or are experiencing adverse events related to prednisolone. IL-17A levels could be an important diagnostic marker to diagnose and prognosticate cases of Type 1 Lepra reaction, which if not treated in time can lead to irreversible nerve damage. DISCLOSURES: All authors: No reported disclosures.
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spelling pubmed-62549822018-11-28 811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients Mitra, Debdeep Open Forum Infect Dis Abstracts BACKGROUND: Leprosy is a chronic granulomatous infectious disease caused by Mycobacterium leprae. Type 1 lepra reactions (T1R) are delayed hypersensitivity (Type IV) reactions which if not treated promptly leads to disability affecting eyes, hands and feet. IL-17 A which is produced mainly by inflammatory T helper 17 cells is up regulated in patients of Lepra reaction. Conventionally oral corticosteroids steroids have been the main stay in the management of Type 1 lepra reactions. This novel biologic drug is a targeted therapy which blocks the offending interleukin molecule without any serious adverse effects. We report the results of this randomized control study wherein an immuno-modulator biologic molecule has been safely used to treat an inflammatory reaction in a chronic infectious disease. Outcomes were measured using recurrence rate, a clinical severity score, quality of life, and adverse events. METHODS: Seventy-four patients with new T1R were randomized to receive Secukinumab (a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A) or Prednisolone for 20 weeks. IL-17 A levels were correlated before and after the intervention. RESULTS: Recovery rates in skin signs was similar in both groups (92% vs. 87%). Improvements in nerve function both, new and old, sensory (67% vs. 48%) and motor (73% vs. 76%) loss were higher (but not significantly so) in the patients on Secukinumab. Recurrences rates of lepra reaction (25%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients on Secukinumab, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were much lesser with Secukinumab as compared with Prednisolone alone. Both groups had a significant improvement in their quality of life after the study, measured by the Short form survey SF-36. CONCLUSION: This is the first double-blind randomized control trial assessing Secukinumab, in the management of lepra reaction. It could be a safe alternative second-line drug for patients with leprosy reactions who are not improving with prednisolone or are experiencing adverse events related to prednisolone. IL-17A levels could be an important diagnostic marker to diagnose and prognosticate cases of Type 1 Lepra reaction, which if not treated in time can lead to irreversible nerve damage. DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2018-11-26 /pmc/articles/PMC6254982/ http://dx.doi.org/10.1093/ofid/ofy210.818 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Mitra, Debdeep
811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients
title 811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients
title_full 811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients
title_fullStr 811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients
title_full_unstemmed 811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients
title_short 811. A Randomized Controlled Trial of Prednisolone vs. Interleukin 17 A Inhibitor Secuinumab in the Management of Type 1 Lepra Reaction in Leprosy Patients
title_sort 811. a randomized controlled trial of prednisolone vs. interleukin 17 a inhibitor secuinumab in the management of type 1 lepra reaction in leprosy patients
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6254982/
http://dx.doi.org/10.1093/ofid/ofy210.818
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