Active RRMS Patients Show Disability Improvements in Each Functional System Following Treatment with Alemtuzumab: Results from Care-MS II Extension

Friday, June 1, 2018: 2:34 PM
209 (Nashville Music City Center)
Samuel F Hunter, MD, PhD , Advanced Neurosciences Institute, Franklin, TN
Rany A Aburashed, DO , Institute for Neurosciences and Multiple Sclerosis, Owosso, MI
Raed Alroughani, MD , Amiri Hospital, Sharq, Kuwait
Steven M Bromley, MD, FAAN , South Jersey MS Center, Audubon, NJ
Dominique Dive, MD, PhD , University Hospital Centre of Liege, Liege, Belgium
Guillermo Izquierdo, MD , Virgen Macarena University Hospital, Seville, Spain
Ho Jin Kim, MD , Research Institute and Hospital of National Cancer Center, Goyang, Korea, Republic of (South)
Jan Lycke, MD , Sahlgrenska University Hospital, Gothenburg, Sweden
Richard AL Macdonell, MD , Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia
Carlo Pozzilli, MD , Sapienza University of Rome, Rome, Italy
Basil Sharrack, MD, PhD , Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
Patrick Vermersch, MD , University of Lille, Lille, France
Andreas Lysandropoulos, MD, PhD , Sanofi, Naarden, Netherlands
Luke Chung, MD, MPH , Sanofi, Cambridge, MA
Nadia Daizadeh, PhD , Sanofi, Cambridge, MA
Heinz Wiendl, MD , University of Munster, Munster, Germany
on behalf of the CARE-MS II and CAMMS03409, Investigators , on behalf of the CARE-MS II and CAMMS03409 Investigators, NA, NJ

Background: In CARE-MS II (NCT00548405), alemtuzumab (12 mg/day, baseline: 5 days; 12 months later: 3 days) significantly improved clinical and MRI outcomes versus SC IFNB-1a over 2 years in RRMS patients with an inadequate response to prior therapy at baseline. A significantly greater percentage of alemtuzumab-treated patients also achieved 6-month confirmed disability improvement (CDI) versus SC IFNB-1a. Durable efficacy of alemtuzumab was demonstrated in a 4-year extension (NCT00930553).

Objectives: To assess the effect of alemtuzumab on disability improvement at the level of functional systems (FS) scores of the Expanded Disability Status Scale (EDSS) in CARE-MS II patients over 6 years.

Methods: Assessments: percentage of patients achieving stable/improved EDSS score (≤0.5-point change/≥1.0-point decrease from baseline mean [SD] EDSS score, 2.7 [1.2]), stable/improved FS score (0-point change/≥1.0-point decrease from baseline FS score), and 6-month CDI (≥1.0-point EDSS decrease confirmed over 6 months in patients with baseline score ≥2.0). In patients who achieved 6-month CDI over 6 years (n=297), assessments included percentage with EDSS score (<4; ≥4), number of improved FS per patient, and percentage with stable/improved FS scores.

Results: Of the 393 patients who entered the extension, 338 (86%) remained on study through Year 6. At Year 6, 77% of the patients showed stable/improved EDSS scores versus baseline, and 75%–85% showed stability/improvement across all FS. Through Year 6, 43% achieved 6-month CDI; 96% of these patients had an EDSS score <4. The majority of patients (>70%) achieved improvements in >1 FS (improvement in 2 FS: 29.4%; 3 FS: 24.6%; and ≥4 FS: 16.7%). Improvements were observed in each FS; the percentage of patients showing improvements was the highest in the sensory (48%), pyramidal (44%), and cerebellar (44%) FS; 21%–25% showed improvements in the brainstem, cerebral, visual, and bowel/bladder FS.

Conclusions: At Year 6, the majority (75%–85%) of alemtuzumab-treated patients from CARE-MS II had improved/stable scores across all FS of the EDSS. The robustness of these results is underscored by the high retention rate observed in the extension (86% of patients remained on study through Year 6). Improvements were seen for each of the FS in patients who achieved 6-month CDI, with more than 70% showing improvements in >1 FS, indicating a broad treatment effect with alemtuzumab in improving multiple aspects of disability.  

Study Support: Sanofi and Bayer Healthcare Pharmaceuticals