Rafael Arroyo González1, Mariko Kita2, Heidi Crayton3, Eva Havrdova4, David H Margolin5, Stephen L Lake5, Gavin Giovannoni6. 1. Department of Neurology, Hospital Universitario Quirónsalud, Madrid, Spain. 2. Virginia Mason Hospital & Seattle Medical Center, Seattle, WA, USA. 3. Multiple Sclerosis Center of Greater Washington, Vienna, VA, USA. 4. MS Center, Department of Neurology, First Faculty of Medicine, Charles University, Prague, Czech Republic. 5. Sanofi Genzyme, Cambridge, MA, USA. 6. Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Abstract
BACKGROUND:Alemtuzumab was superior on clinical and magnetic resonance imaging (MRI) outcomes versus subcutaneous interferon beta-1a in phase 3 trials in patients with relapsing-remitting multiple sclerosis. OBJECTIVE: To examine quality-of-life (QoL) outcomes in the alemtuzumab phase 3 trials. METHODS:Patients who were treatment naive (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis I [CARE-MS I]) or had an inadequate response to prior therapy (CARE-MS II) received annual courses of alemtuzumab 12 mg/day at baseline (5 days) and Month 12 (3 days) or subcutaneous interferon beta-1a 44 µg three times/week. QoL was measured every 6 or 12 months using Functional Assessment of Multiple Sclerosis (FAMS), European Quality of Life-5 Dimensions (EQ-5D) and its visual analog scale (EQ-VAS), and 36-Item Short-Form Survey (SF-36). RESULTS: Statistically significant improvements from baseline with alemtuzumab were observed on all three QoL instruments at the earliest post-baseline assessment and sustained through Year 2. Statistically significant greater QoL improvements over subcutaneous interferon beta-1a were seen at all time points in CARE-MS II with FAMS, EQ-VAS and SF-36 physical component summary, and in CARE-MS I with FAMS. CONCLUSION: Patients treated with alemtuzumab had improvements in physical, mental, and emotional QoL regardless of treatment history. Improvements were significantly greater with alemtuzumab versus subcutaneous interferon beta-1a on both disease-specific and general measures of QoL.
RCT Entities:
BACKGROUND:Alemtuzumab was superior on clinical and magnetic resonance imaging (MRI) outcomes versus subcutaneous interferon beta-1a in phase 3 trials in patients with relapsing-remitting multiple sclerosis. OBJECTIVE: To examine quality-of-life (QoL) outcomes in the alemtuzumab phase 3 trials. METHODS:Patients who were treatment naive (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis I [CARE-MS I]) or had an inadequate response to prior therapy (CARE-MS II) received annual courses of alemtuzumab 12 mg/day at baseline (5 days) and Month 12 (3 days) or subcutaneous interferon beta-1a 44 µg three times/week. QoL was measured every 6 or 12 months using Functional Assessment of Multiple Sclerosis (FAMS), European Quality of Life-5 Dimensions (EQ-5D) and its visual analog scale (EQ-VAS), and 36-Item Short-Form Survey (SF-36). RESULTS: Statistically significant improvements from baseline with alemtuzumab were observed on all three QoL instruments at the earliest post-baseline assessment and sustained through Year 2. Statistically significant greater QoL improvements over subcutaneous interferon beta-1a were seen at all time points in CARE-MS II with FAMS, EQ-VAS and SF-36 physical component summary, and in CARE-MS I with FAMS. CONCLUSION:Patients treated with alemtuzumab had improvements in physical, mental, and emotional QoL regardless of treatment history. Improvements were significantly greater with alemtuzumab versus subcutaneous interferon beta-1a on both disease-specific and general measures of QoL.
Entities:
Keywords:
Alemtuzumab; CD52 antigen; disease-modifying therapy; interferon beta-1a; multiple sclerosis; quality of life
Authors: Eva Havrdova; Jeffrey A Cohen; Dana Horakova; Ivana Kovarova; Eva Meluzinova Journal: Ther Clin Risk Manag Date: 2017-10-16 Impact factor: 2.423
Authors: Rafael Arroyo; Denise P Bury; Jennifer D Guo; David H Margolin; Maria Melanson; Nadia Daizadeh; David Cella Journal: Mult Scler Date: 2019-05-30 Impact factor: 6.312
Authors: Dayo Afolabi; Christo Albor; Lukasz Zalewski; Dan R Altmann; David Baker; Klaus Schmierer Journal: Mult Scler Date: 2017-08-17 Impact factor: 6.312