DX15
Durable Efficacy of Alemtuzumab on MRI Disease Activity over 6 Years in Treatment-Naive RRMS Patients with Highly Active Disease: Care-MS I Extension

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
Anthony Traboulsee, MD , University of British Columbia, Vancouver, BC, Canada
Michael Barnett, PhD, MD , University of Sydney, Sydney, NSW, Australia
Regina Berkovich, MD, PhD , University of Southern California, Keck School of Medicine, Los Angeles, CA
Aaron Boster, MD , OhioHealth Neurological Physicians, Columbus, OH
Giancarlo Comi, MD , University Vita-Salute San Raffaele, Milan, Italy
Christopher Laganke, MD , North Central Neurology Associates, Cullman, AL
Daniel Pelletier, MD , Keck School of Medicine of University of Southern California, Los Angeles, CA
Alex Rovira, MD , Vall d'Hebron University Hospital, Barcelona, Spain
Sven Schippling, MD , Neuroimmunology and Multiple Sclerosis Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland
Barry A Singer, MD , MS Center for Innovations in Care, Missouri Baptist Medical Center, St. Louis, MO
David H Margolin, MD, PhD , Sanofi Genzyme, Cambridge, MA
Sourav Santra, PhD , Cytel, Cambridge, MA
Douglas L Arnold, MD , Montreal Neurological Institute, McGill University, Montreal, QC, Canada
on behalf of the CARE-MS I and CAMMS03409 Investigators, n/a , MA



Background: Patients with relapsing-remitting multiple sclerosis (RRMS) with highly active disease (HAD) from CARE-MS I (NCT00530348) who were treatment-naive at baseline showed significantly reduced disease activity with alemtuzumab versus SC IFNB-1a over 2 years. An extension study (NCT00930553) has previously demonstrated durable efficacy on clinical and MRI outcomes over 5 years in these patients in the absence of continuous treatment. Patients have now completed 6 years of follow-up.

Objectives: To evaluate 6-year MRI outcomes (2 years of core study plus 4 years of extension) in CARE-MS I alemtuzumab-treated patients with HAD who were treatment-naive at baseline.

Methods: Patients received 2 courses of alemtuzumab 12 mg/day IV (baseline: 5 consecutive days; 12 months later: 3 consecutive days), with as-needed alemtuzumab retreatment for relapse or MRI activity, or another disease-modifying therapy (DMT) per investigator’s discretion. HAD was defined as ≥2 relapses in the year before randomization and ≥1 gadolinium (Gd)-enhancing lesion. MRI scans were conducted at baseline and annually thereafter. Endpoints included proportion of patients free of MRI disease activity (no Gd-enhancing T1 or new/enlarging T2 hyperintense lesions), and proportion free of new T1 hypointense lesions.

Results:

99 of the 105 (94%) patients with highly active RRMS who received alemtuzumab in the 2-year core study entered the extension; of these, 92 (93%) remained on study 4 years later (Year 6). In each extension year, most patients were free of Gd-enhancing T1 lesions (Year 3: 86%, Year 4: 82%, Year 5: 82%, Year 6: 83%) and free of new/enlarging T2 lesions (Year 3: 69%, Year 4: 66%, Year 5: 67%, Year 6: 62%). Consistent with these results, most patients were free of MRI disease activity in each extension year (Year 3: 68%, Year 4: 65%, Year 5: 67%, Year 6: 61%). Over the same period, a majority of patients were free of new T1 hypointense lesions (Year 3: 85%, Year 4: 83%, Year 5: 84%, Year 6: 78%). These efficacy results were achieved despite 63% of patients receiving no additional alemtuzumab treatment and no other DMT.

Conclusions: Durable efficacy on MRI outcomes was observed with alemtuzumab through 6 years in RRMS patients with HAD, consistent with findings for the overall study population. Based on these findings, alemtuzumab may provide a unique approach in this patient population, offering durable efficacy in the absence of continuous treatment.

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