title: Alemtuzumab Use in Clinical Practice: Recommendations from European Multiple Sclerosis Experts.
abstract: Alemtuzumab (Lemtrada™) is a humanized monoclonal antibody approved in more than 50 countries. Within the European Union, alemtuzumab is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features; in the USA, the indication states that alemtuzumab should generally be reserved for the treatment of patients with relapsing forms of multiple sclerosis who have had an inadequate response to two or more disease-modifying therapies (DMTs). In clinical trials, alemtuzumab demonstrated efficacy in treatment-naïve patients with active RRMS and those relapsing on prior DMTs, with a consistent and manageable safety and tolerability profile. The European Union indication provides physicians with significant flexibility regarding treatment decisions, affording the opportunity for individualized treatment. Thus, alemtuzumab may be an appropriate treatment choice across a broad range of patients with RRMS, including, for example, treatment-naïve patients with active disease, patients with highly active disease, or for patients relapsing on prior DMTs. There are several practicalities to consider when using alemtuzumab, including the unique dosing regimen, administered via intravenous infusion on 5 consecutive days at baseline and on 3 consecutive days 12 months later, and as-needed retreatment (3 consecutive days at least 12 months after the last course) in cases of disease recurrence. Additionally, routine monthly monitoring is required for up to 48 months after the last infusion to promptly identify potentially serious autoimmune adverse events. Given these considerations, it is beneficial to gain insight into how alemtuzumab is being used in the real-world clinical setting. Here, we report recommendations from European multiple sclerosis experts regarding best practices for alemtuzumab treatment, including management of adverse events and compliance with ongoing safety monitoring requirements.
authors.affiliation: Clinical Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria. thomas.berger@i-med.ac.at.
authors.forename: Thomas
authors.initials: T
authors.lastname: Berger
authors.affiliation: Department of Neurology and Rehabilitation, University of Tampere Medical School and Tampere University Hospital, Tampere, Finland.
authors.forename: Irina
authors.initials: I
authors.lastname: Elovaara
authors.affiliation: Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.
authors.forename: Sten
authors.initials: S
authors.lastname: Fredrikson
authors.affiliation: St Vincent's University Hospital, Dublin, Ireland.
authors.forename: Chris
authors.initials: C
authors.lastname: McGuigan
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Moiola
authors.affiliation: Haukeland University Hospital and University of Bergen, Bergen, Norway.
authors.forename: Kjell-Morten
authors.initials: KM
authors.lastname: Myhr
authors.affiliation: Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Celia
authors.initials: C
authors.lastname: Oreja-Guevara
authors.affiliation: Institute of the Human Brain, Russian Academy of Sciences, St. Petersburg, Russia.
authors.forename: Igor
authors.initials: I
authors.lastname: Stoliarov
authors.affiliation: Department of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany.
authors.forename: Uwe K
authors.initials: UK
authors.lastname: Zettl
mesh_terms: D000074323:Alemtuzumab / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D005060:Europe; D006801:Humans; D009103:Multiple Sclerosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000074323:Alemtuzumab