Giancarlo Comi1, Raed Alroughani2, Aaron L Boster3, Ann D Bass4, Regina Berkovich5, Óscar Fernández6, Ho Jin Kim7, Volker Limmroth8, Jan Lycke9, Richard Al Macdonell10, Basil Sharrack11, Barry A Singer12, Patrick Vermersch13, Heinz Wiendl14, Tjalf Ziemssen15, Alan Jacobs16, Nadia Daizadeh16, Claudio E Rodriguez16, Anthony Traboulsee17. 1. Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy. 2. Department of Medicine, Amiri Hospital, Sharq, Kuwait. 3. OhioHealth Neurological Physicians, Columbus, OH, USA. 4. Neurology Center of San Antonio, San Antonio, TX, USA. 5. Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA. 6. Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain. 7. Research Institute and Hospital, National Cancer Center, Goyang, South Korea. 8. Klinik für Neurologie und Palliativmedizin, Cologne, Germany. 9. Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden. 10. Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia. 11. NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK. 12. MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA. 13. Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France. 14. Department of Neurology, University of Münster, Münster, Germany. 15. Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany. 16. Sanofi, Cambridge, MA, USA. 17. Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada.
Abstract
BACKGROUND: Alemtuzumab is given as two annual courses. Patients with continued disease activity may receive as-needed additional courses. OBJECTIVE: To evaluate efficacy and safety of additional alemtuzumab courses in the CARE-MS (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis) studies and their extensions. METHODS: Subgroups were based on the number of additional alemtuzumab courses received. Exclusion criteria: other disease-modifying therapy (DMT); <12-month follow-up after last alemtuzumab course. RESULTS: In the additional-courses groups, Courses 3 and 4 reduced annualized relapse rate (12 months before: 0.73 and 0.74, respectively; 12 months after: 0.07 and 0.08). For 36 months after Courses 3 and 4, 89% and 92% of patients were free of 6-month confirmed disability worsening, respectively, with 20% and 26% achieving 6-month confirmed disability improvement. Freedom from magnetic resonance imaging (MRI) disease activity increased after Courses 3 and 4 (12 months before: 43% and 53%, respectively; 12 months after: 73% and 74%). Safety was similar across groups; serious events occurred irrespective of the number of courses. CONCLUSION: Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2. How this compares to outcomes if treatment is switched to another DMT instead remains unknown.
BACKGROUND:Alemtuzumab is given as two annual courses. Patients with continued disease activity may receive as-needed additional courses. OBJECTIVE: To evaluate efficacy and safety of additional alemtuzumab courses in the CARE-MS (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis) studies and their extensions. METHODS: Subgroups were based on the number of additional alemtuzumab courses received. Exclusion criteria: other disease-modifying therapy (DMT); <12-month follow-up after last alemtuzumab course. RESULTS: In the additional-courses groups, Courses 3 and 4 reduced annualized relapse rate (12 months before: 0.73 and 0.74, respectively; 12 months after: 0.07 and 0.08). For 36 months after Courses 3 and 4, 89% and 92% of patients were free of 6-month confirmed disability worsening, respectively, with 20% and 26% achieving 6-month confirmed disability improvement. Freedom from magnetic resonance imaging (MRI) disease activity increased after Courses 3 and 4 (12 months before: 43% and 53%, respectively; 12 months after: 73% and 74%). Safety was similar across groups; serious events occurred irrespective of the number of courses. CONCLUSION: Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2. How this compares to outcomes if treatment is switched to another DMT instead remains unknown.
Authors: Isa Ahmed AlSharoqi; Mohamed Aljumah; Saeed Bohlega; Cavit Boz; Abdelkader Daif; Salam El-Koussa; Jihad Inshasi; Murat Kurtuncu; Thomas Müller; Chris Retief; Mohammad Ali Sahraian; Vahid Shaygannejad; Ilham Slassi; Karim Taha; Magd Zakaria; Per Soelberg Sørensen Journal: Neurol Ther Date: 2020-04-15