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Title: | Best Practices for Long-Term Monitoring and Follow-Up of Alemtuzumab-Treated MS Patients in Real-World Clinical Settings | Authors: | Barclay, Krista Carruthers, Robert Traboulsee, Anthony Bass, Ann D. LaGanke, Christopher Bertolotto, Antonio Boster, Aaron Celius, Elisabeth G. de Seze, Jerome Dela Cruz, Dionisio Habek, Mario Lee, Jong-Mi Limmroth, Volker Meuth, Sven G. Oreja-Guevara, Celia Pagnotta, Patricia Vos, Cindy Ziemssen, Tjalf Baker, Darren P. VAN WIJMEERSCH, Bart |
Issue Date: | 2019 | Publisher: | FRONTIERS MEDIA SA | Source: | FRONTIERS IN NEUROLOGY, 10 (Art N° 253) | Abstract: | Multiple sclerosis (MS) is a chronic autoimmune neurological disease that typically affects young adults, causing irreversible physical disability and cognitive impairment. Alemtuzumab, administered intravenously as 2 initial courses of 12 mg/day (5 consecutive days at baseline, and 3 consecutive days 12 months later), resulted in significantly greater improvements in clinical and MRI outcomes vs. subcutaneous interferon beta-1a over 2 years in patients with active relapsing-remitting MS (RRMS) who were either treatment-naive (CARE-MS I; NCT00530348) or had an inadequate response to prior therapy (CARE-MS II; NCT00548405). Efficacy with alemtuzumab was maintained over 7 years in subsequent extension studies (NCT00930553; NCT02255656), in the absence of continuous treatment and with a consistent safety profile. There is an increased incidence of autoimmune events in patients treated with alemtuzumab (mainly thyroid events, but also immune thrombocytopenia and nephropathy), which imparts a need for mandatory safety monitoring for 4 years following the last treatment. The risk management strategy for alemtuzumab-treated patients includes laboratory monitoring and a comprehensive patient education and support program that enables early detection and effective management of autoimmune events, yielding optimal outcomes for MS patients. Here we provide an overview of tools and techniques that have been implemented in real-world clinical settings to reduce the burden of monitoring for both patients and healthcare providers, including customized educational materials, the use of social media, and interactive online databases for managing healthcare data. Many practices are also enhancing patient outreach efforts through coordination with specialized nursing services and ancillary caregivers. The best practice recommendations for safety monitoring described in this article, based on experiences in real-world clinical settings, may enable early detection and management of autoimmune events, and help with implementation of monitoring requirements while maximizing the benefits of alemtuzumab treatment for MS patients. | Notes: | [Barclay, Krista] Vancouver Coastal Hlth, Vancouver, BC, Canada. [Carruthers, Robert; Traboulsee, Anthony] Univ British Columbia, Vancouver, BC, Canada. [Bass, Ann D.] Neurol Ctr San Antonio, San Antonio, TX USA. [LaGanke, Christopher] North Cent Neurol Associates, Cullman, AL USA. [Bertolotto, Antonio] Azienda Osped Univ San Luigi, Orbassano, Italy. [Boster, Aaron] OhioHlth Neurol Phys, Columbus, OH USA. [Celius, Elisabeth G.] Univ Oslo, Oslo Univ Hosp Ulleval, Oslo, Norway. [Celius, Elisabeth G.] Univ Oslo, Inst Clin Med, Oslo, Norway. [de Seze, Jerome] Strasbourg Univ, Clin Res Ctr CIC, INSERM 1434, Strasbourg, France. [Dela Cruz, Dionisio] Imperial Coll Healthcare NHS Trust, London, England. [Habek, Mario] Univ Zagreb, Sch Med, Zagreb, Croatia. [Habek, Mario] Univ Med Ctr, Zagreb, Croatia. [Lee, Jong-Mi] Stanford Healthcare, Palo Alto, CA USA. [Limmroth, Volker] Klin Neurol & Palliat Med, Cologne, Germany. [Meuth, Sven G.] Univ Hosp Muenster, Neurol Clin, Inst Translat Neurol, Munster, Germany. [Oreja-Guevara, Celia] Hosp Clin San Carlos, Inst Invest Sanitaria, Madrid, Spain. [Pagnotta, Patricia] Neurol Associates, Maitland, FL USA. [Vos, Cindy] Revalidatie & MS Ctr, Overpelt, Belgium. [Ziemssen, Tjalf] Univ Clin Carl Gustav Carus, Ctr Clin Neurosci, Dresden, Germany. [Baker, Darren P.] Sanofi, Cambridge, MA USA. [Van Wijmeersch, Bart] Hasselt Univ, Rehabil & MS Ctr Overpelt, Hasselt, Belgium. | Keywords: | relapsing-remitting multiple sclerosis;disease-modifying therapy;alemtuzumab;anti-CD52 monoclonal antibody;monitoring;autoimmune events;best practices;real-world settings | Document URI: | http://hdl.handle.net/1942/30213 | ISSN: | 1664-2295 | e-ISSN: | 1664-2295 | DOI: | 10.3389/fneur.2019.00253 | ISI #: | 000462039000002 | Rights: | 2019 Barclay, Carruthers, Traboulsee, Bass, LaGanke, Bertolotto, Boster, Celius, Seze, Cruz, Habek, Lee, Limmroth, Meuth, Oreja-Guevara, Pagnotta, Vos, Ziemssen, Baker and Wijmeersch. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2020 |
Appears in Collections: | Research publications |
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barclay 1.pdf | Published version | 2.66 MB | Adobe PDF | View/Open |
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