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