Understanding the positive benefit:risk profile of alemtuzumab in relapsing multiple sclerosis: perspectives from the Alemtuzumab Clinical Development Program

Therapeutics and Clinical Risk Management
Eva HavrdovaEva Meluzinova

Abstract

The introduction of high-efficacy therapies for relapsing-remitting multiple sclerosis has driven re-evaluation of treatment goals and benefit:risk considerations in treatment choice. In the alemtuzumab Phase II and III clinical trials, patients treated with alemtuzumab 12 mg versus subcutaneous interferon beta-1a demonstrated significantly reduced annualized relapse rates and improved magnetic resonance imaging outcomes, and were significantly more likely to achieve no evidence of disease activity and reduction in brain volume loss. In two of the studies, alemtuzumab-treated patients had a significantly reduced risk of 6-month confirmed disease worsening, compared with subcutaneous interferon beta-1a. Benefits were maintained throughout 5 years, with a majority of patients receiving no alemtuzumab retreatment or other disease-modifying therapy. Trial results support alemtuzumab's manageable, consistent safety profile in relapsing-remitting multiple sclerosis. Infusion-associated reactions, the most frequent adverse events (AEs), can be minimized by corticosteroid pretreatment, monitoring, and symptomatic management. Other AEs include infections and autoimmune events. Oral anti-herpes prophylaxis should be initiated on the firs...Continue Reading

Citations

Jun 1, 2018·Expert Opinion on Drug Safety·Antonio Riccardo BuonomoIvan Gentile
May 17, 2019·Expert Review of Neurotherapeutics·Laura De GiglioCarlo Pozzilli
Jun 21, 2020·International Journal of Molecular Sciences·Madeline BrossEvanthia Bernitsas
Jul 16, 2020·The Journal of Clinical Endocrinology and Metabolism·Alina SovetkinaNiamh Martin
Apr 4, 2019·Nature Reviews. Neurology·Dalia Rotstein, Xavier Montalban
Jan 9, 2018·Expert Opinion on Biological Therapy·Jennifer R EvanFrancesca Bagnato
Nov 12, 2020·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·Eslam ShoshaSarah A Morrow
Jun 11, 2019·Seminars in Cancer Biology·Masahiro Yasunaga

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Methods Mentioned

BETA
biopsy
contraception

Clinical Trials Mentioned

NCT00050778
NCT00530348
NCT00548405
NCT00930553

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