Journal
NEUROLOGY
Volume 77, Issue 6, Pages 573-579Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e318228bec5
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Funding
- MS Society of the United Kingdom
- Academy of Medical Sciences (UK)
- Bayer Schering Pharma
- Teva Pharmaceutical Industries Ltd.
- Merck Serono
- Biogen Idec
- Burden Trust
- Myelin Project
- Silverman Foundation
- Cancer Research UK
- Tourettes Syndrome Association USA
- British Heart Foundation
- Medical Research Council
- Wellcome Trust
- Economic and Social Research Council
- Bristol Research into Alzheimer's Care of the Elderly
- Genzyme Corporation
- Medical Research Council [G0801418B] Funding Source: researchfish
- National Institute for Health Research [CL-2008-14-004] Funding Source: researchfish
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Objective: To define the rate, timing, and clinical risk factors for the development of autoimmune disease (AID) after alemtuzumab treatment for multiple sclerosis (MS). Methods: We analyzed prospective clinical and serologic data from 248 patients with MS treated with alemtuzumab, with median follow-up of 34.3 months (range 6.7-107.3). Results: Novel AID developed in 22.2%. Thyroid AID was most frequent (15.7%). A range of hematologic, renal, and dermatologic AID were also observed as was asymptomatic development of novel autoantibodies. AID was seen from 2 weeks after initial treatment and was most frequent 12-18 months after first treatment. No new cases of AID were identified 60 months or more after initial treatment and risk of AID was independent of total alemtuzumab dose or interval of dosage. While established risk factors for AID including sex and age had no impact on AID frequency, both family history (odds ratio = 7.31, 95% confidence interval 3.02-17.68) of AID and a personal smoking history (odds ratio = 3.05, 95% confidence interval 1.50-6.19) were predictive of AID expression. Conclusions: Cumulative risk for AID in MS following alemtuzumab is 22.2%, most frequent between 12 and 18 months following first dose and evident for up to 5 years. Individual risk is modified by smoking and family history, which should be incorporated within the counseling process prior to treatment. Classification of evidence: This study provides Class IV evidence that the risk of AID after alemtuzumab treatment for MS is time-limited and modified by external factors. Neurology (R) 2011;77:573-579
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