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 Neurology School of Medicine University of Zagreb and University Hospital Center Zagreb Croatia

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

Sanofi Cambridge MA USA Cerevance Inc Boston MA USA

Sanofi Cambridge MA USA Sunovion Pharmaceuticals Marlborough MA USA

School of Medicine University of Cambridge Cambridge UK

Mult Scler. 2019 Aug;25(9):1206-1208. doi: 10.1177/1352458519851219. PubMed

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