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Published on: March 25, 2016
Marked neutropenia: Significant but rare in people with multiple sclerosis after alemtuzumab treatment
David Baker1, Gavin Giovannoni1, Klaus Schmierer1
1Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.
Background:
Alemtuzumab is a CD52-specific monoclonal antibody that markedly depletes T and B lymphocytes and inhibits relapsing multiple sclerosis (MS). However, polymorphonuclear neutrophils also express CD52 and can be depleted by alemtuzumab, thereby potentially contributing to the infections that develop post-alemtuzumab treatment. Surprisingly, however, the degree of neutrophil depletion in MS was not included in the pivotal trial reports.
Methods:
The regulatory submission of the Comparison of Alemtuzumab and Rebif® Efficacy in MS 1 and 2 trials was obtained from the European Medicines Agency through Freedom of Information. The data relating to neutrophils was extracted.
Results:
Data extraction from the submission was straightforward. In year one 72/811 (8.9%) and in year two 116/808 (14.4%) people with MS (pwMS) developed neutropenia. The degree of neutropenia was generally mild, and only 5/811 (0.6%) in year 1 and 12/808 (1.5%) in year 2 developed grade 3-4 toxicity (< 1.0 × 109/L). Two pwMS developed severe neutropenia-related adverse events.
Conclusions:
Treatment with alemtuzumab induces neutropenia, which is mild in the large majority of pwMS treated. Leucocyte levels following alemtuzumab should be monitored as a marker of efficacy and safety; persistent neutropenia may require treatment.
