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Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis

BACKGROUND: Autoimmune disorders including nephropathies have been reported more frequently in alemtuzumab-treated multiple sclerosis (MS) patients than in the general population. OBJECTIVE: Describe instances of autoimmune nephropathy in alemtuzumab-treated MS patients. METHODS: Cases were identifi...

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Autores principales: Phelps, Richard, Winston, Jonathan A, Wynn, Daniel, Habek, Mario, Hartung, Hans-Peter, Havrdová, Eva Kubala, Markowitz, Glen S, Margolin, David H, Rodriguez, Claudio E, Baker, Darren P, Coles, Alasdair J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681440/
https://www.ncbi.nlm.nih.gov/pubmed/30986126
http://dx.doi.org/10.1177/1352458519841829
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author Phelps, Richard
Winston, Jonathan A
Wynn, Daniel
Habek, Mario
Hartung, Hans-Peter
Havrdová, Eva Kubala
Markowitz, Glen S
Margolin, David H
Rodriguez, Claudio E
Baker, Darren P
Coles, Alasdair J
author_facet Phelps, Richard
Winston, Jonathan A
Wynn, Daniel
Habek, Mario
Hartung, Hans-Peter
Havrdová, Eva Kubala
Markowitz, Glen S
Margolin, David H
Rodriguez, Claudio E
Baker, Darren P
Coles, Alasdair J
author_sort Phelps, Richard
collection PubMed
description BACKGROUND: Autoimmune disorders including nephropathies have been reported more frequently in alemtuzumab-treated multiple sclerosis (MS) patients than in the general population. OBJECTIVE: Describe instances of autoimmune nephropathy in alemtuzumab-treated MS patients. METHODS: Cases were identified from safety monitoring within the alemtuzumab relapsing-remitting multiple sclerosis (RRMS) clinical development program (CDP) or post-marketing, or following off-label use. RESULTS: As of 16 June 2017, 16 autoimmune nephropathies have occurred following alemtuzumab treatment for MS. The incidence of autoimmune nephropathies was 0.34% within the CDP (5/1485 patients). The five CDP cases (one of anti-glomerular basement membrane (anti-GBM) disease, two of membranous glomerulonephropathy, and two of serum anti-GBM antibody without typical anti-GBM disease) were identified early, responded to conventional therapy (where needed), and had favorable outcomes. Three of 11 cases outside the CDP occurred following off-label alemtuzumab use prior to approval for RRMS and were all anti-GBM disease. Diagnosis was delayed in one of these three cases and another did not receive appropriate treatment; all three cases resulted in end-stage renal failure. All anti-GBM disease cases with documented urinalysis demonstrated prior microscopic hematuria. CONCLUSION: Close monitoring of alemtuzumab-treated MS patients facilitates diagnosis and treatment early in the nephropathy course when preservation of renal function is more likely.
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spelling pubmed-66814402019-09-16 Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis Phelps, Richard Winston, Jonathan A Wynn, Daniel Habek, Mario Hartung, Hans-Peter Havrdová, Eva Kubala Markowitz, Glen S Margolin, David H Rodriguez, Claudio E Baker, Darren P Coles, Alasdair J Mult Scler Original Research Papers BACKGROUND: Autoimmune disorders including nephropathies have been reported more frequently in alemtuzumab-treated multiple sclerosis (MS) patients than in the general population. OBJECTIVE: Describe instances of autoimmune nephropathy in alemtuzumab-treated MS patients. METHODS: Cases were identified from safety monitoring within the alemtuzumab relapsing-remitting multiple sclerosis (RRMS) clinical development program (CDP) or post-marketing, or following off-label use. RESULTS: As of 16 June 2017, 16 autoimmune nephropathies have occurred following alemtuzumab treatment for MS. The incidence of autoimmune nephropathies was 0.34% within the CDP (5/1485 patients). The five CDP cases (one of anti-glomerular basement membrane (anti-GBM) disease, two of membranous glomerulonephropathy, and two of serum anti-GBM antibody without typical anti-GBM disease) were identified early, responded to conventional therapy (where needed), and had favorable outcomes. Three of 11 cases outside the CDP occurred following off-label alemtuzumab use prior to approval for RRMS and were all anti-GBM disease. Diagnosis was delayed in one of these three cases and another did not receive appropriate treatment; all three cases resulted in end-stage renal failure. All anti-GBM disease cases with documented urinalysis demonstrated prior microscopic hematuria. CONCLUSION: Close monitoring of alemtuzumab-treated MS patients facilitates diagnosis and treatment early in the nephropathy course when preservation of renal function is more likely. SAGE Publications 2019-04-15 2019-08 /pmc/articles/PMC6681440/ /pubmed/30986126 http://dx.doi.org/10.1177/1352458519841829 Text en © The Author(s), 2019 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research Papers
Phelps, Richard
Winston, Jonathan A
Wynn, Daniel
Habek, Mario
Hartung, Hans-Peter
Havrdová, Eva Kubala
Markowitz, Glen S
Margolin, David H
Rodriguez, Claudio E
Baker, Darren P
Coles, Alasdair J
Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
title Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
title_full Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
title_fullStr Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
title_full_unstemmed Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
title_short Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
title_sort incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
topic Original Research Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681440/
https://www.ncbi.nlm.nih.gov/pubmed/30986126
http://dx.doi.org/10.1177/1352458519841829
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