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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2019
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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. |
format | Online Article Text |
id | pubmed-6681440 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
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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