RRMS Patients with an Inadequate Response to a Prior Therapy Demonstrate Slowing of Brain Volume Loss over 5 Years Following Alemtuzumab Treatment

Thursday, June 2, 2016
Exhibit Hall
Daniel Pelletier, MD , University of Southern California, Los Angeles, CA
Gavin Giovannoni, MBBCh, PhD , Queen Mary University London, Barts and The London School of Medicine, London, United Kingdom
Douglas L Arnold, MD , McGill University, Montreal, QC, Canada
Sven Schippling, MD , University Hospital Zurich and University of Zurich, Zurich, Switzerland
David H Margolin, MD, PhD , Genzyme, a Sanofi company, Cambridge, MA
Karthinathan Thangavelu, PhD , Genzyme, a Sanofi company, Cambridge, MA
Anthony Traboulsee, MD, FRCPC , University of British Columbia, Vancouver, BC, Canada
Tina Walsh, n/a , Evidence Scientific, Philadelphia, PA

Background: Patients with active RRMS who had an inadequate response (≥1 relapse) to prior therapy at baseline demonstrated improved efficacy outcomes with alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a) over 2 years in the core CARE-MS II study (NCT00548405), including a greater reduction in brain volume (BV) loss. Improvements in clinical and MRI endpoints were durable through 5 years.

Objectives: This analysis examined the effect of alemtuzumab on BV change over 5 years in the ongoing CARE-MS II extension study (NCT00930553).

Methods: Patients randomized to alemtuzumab in the core study received 2 annual courses at Months 0 and 12. Patients could enter the extension study, with as-needed alemtuzumab retreatment for relapse and/or MRI lesion activity. Patients could receive another disease-modifying therapy (DMT) at the investigator’s discretion. Standardized MRI scans were acquired at baseline and annually thereafter, and BV loss was measured by relative brain parenchymal fraction change.

Results: Of 435 patients who received alemtuzumab in the CARE-MS II core study, 393 (93%) entered the extension. Of those, 91% remained on study through Year 5, 60% received no alemtuzumab retreatment since the initial 2 courses at core study baseline and Month 12, and 92% received no other DMT. Over 2 years, alemtuzumab reduced BV loss by 24% versus SC IFNB-1a. The slowing of BV loss observed with alemtuzumab in the core CARE-MS II study was maintained through Year 5. Median yearly BV loss continued to decrease below the Year 2 level in Years 3, 4, and 5: Year 1: –0.48%, Year 2: –0.22%, Year 3: –0.10%, Year 4: –0.19%, and Year 5: –0.07%.

Conclusions: Slowing of BV loss with alemtuzumab was maintained over 5 years, despite most patients not receiving treatment over the previous 4 years. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continued treatment for RRMS patients.

Study supported by Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals.