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Incidence, management, and outcomes of autoimmune nephropathies following alemtuzumab treatment in patients with multiple sclerosis
R. Phelps, JA. Winston, D. Wynn, M. Habek, HP. Hartung, EK. Havrdová, GS. Markowitz, DH. Margolin, CE. Rodriguez, DP. Baker, AJ. Coles,
Language English Country Great Britain
Document type Journal Article, Research Support, Non-U.S. Gov't
Grant support
G1100114
Medical Research Council - United Kingdom
- MeSH
- Alemtuzumab adverse effects MeSH
- Adult MeSH
- Glomerulonephritis chemically induced diagnosis epidemiology immunology MeSH
- Immunologic Factors adverse effects MeSH
- Incidence MeSH
- Hemorrhage chemically induced diagnosis epidemiology immunology MeSH
- Humans MeSH
- Glomerulonephritis, Membranous chemically induced diagnosis epidemiology immunology MeSH
- Follow-Up Studies MeSH
- Lung Diseases chemically induced diagnosis epidemiology immunology MeSH
- Multiple Sclerosis, Relapsing-Remitting drug therapy epidemiology MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
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.
Centre for Inflammation Research University of Edinburgh Edinburgh UK
Consultants in Neurology MS Center Northbrook IL USA
Department of Neurology 1st Medical Faculty Charles University Prague Czech Republic
Department of Neurology Medical Faculty Heinrich Heine University Düsseldorf Germany
Department of Pathology and Cell Biology Columbia University New York NY USA
Mount Sinai School of Medicine New York NY USA
Sanofi Cambridge MA USA Cerevance Inc Boston MA USA
Sanofi Cambridge MA USA Sunovion Pharmaceuticals Marlborough MA USA
References provided by Crossref.org
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- $a 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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