Abstract: Durable Effects of Alemtuzumab on Relapse Rate Over Time in CARE-MS II (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Lily Jung Henson, MD , Swedish Issaquah, Issaquah, WA, USA, Issaquah, WA

Douglas L Arnold, MD , Montreal Neurological Institute, McGill University, and NeuroRx Research, Montreal, Quebec, Canada, Montreal, QC, Canada

Jeffrey A Cohen, MD , Mellen Center, Cleveland Clinic, Cleveland, OH, USA, Cleveland, OH

Alasdair J Coles, MD , University of Cambridge, Cambridge, UK, Cambridge, United Kingdom

Christian Confavreux, MD , University Claude Bernard, Lyon, France, Lyon, France

Edward J Fox, MD , MS Clinic of Central Texas, Round Rock, TX, USA, Round Rock, TX

Hans-Peter Hartung, MD , Heinrich-Heine University, Dusseldorf, Germany, Dusseldorf, Germany

Eva Havrdova, MD, PhD , Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic, Prague, Czech Republic

Krzysztof Selmaj, MD, PhD , Medical University of Lodz, Lodz, Poland, Lodz, Poland

Howard L Weiner, MD , Brigham and Women's Hospital Center for Neurologic Diseases, Boston, MA, USA, Boston, MA

Tamara A Miller, MD , Advanced Neurology of Colorado, Ft Collins, CO, USA, Ft Collins, CO

Cary L Twyman, MD , Associates in Neurology PSC, Lexington, KY, USA, Lexington, KY

Stephen L Lake, ScD , Genzyme, Cambridge, MA, USA, Cambridge, MA

David H Margolin, MD , Genzyme, Cambridge, MA, USA, Cambridge, MA

Michael A Panzara, MD , Genzyme, Cambridge, MA, USA, Cambridge, MA

Alastair Compston, MD , University of Cambridge, Cambridge, UK, Cambridge, United Kingdom

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Background: In CARE-MS II, alemtuzumab reduced the relapse rate over 2 years compared with subcutaneous interferon beta-1a (SC IFNB-1a) (0.26 vs. 0.52; 49% reduction; P < 0.0001) in active RRMS patients who had experienced disease activity on prior therapy.

Objectives: Evaluate the effects of alemtuzumab on relapse rate over time in the CARE-MS II study.

Methods: Active RRMS patients who had relapsed on prior therapy were randomized to receive alemtuzumab 12 mg intravenously on 5 days at study start and on 3 days 1 year later or SC IFNB-1a 44 µg 3-times weekly. Relapse events were required to last ≥48 h, required objective signs as assessed by blinded raters, and were adjudicated by an independent committee.

Results: Alemtuzumab’s superior effect on relapse reduction was statistically significant (P = 0.046) within 4 months of initiating treatment and was maintained throughout the study period. Compared with IFNB-1a, alemtuzumab reduced the relapse rate by 54% in Year 1 (P < 0.0001) and 41% in Year 2 (i.e., Months 12 to 24) (P = 0.0017). Percentage of patients experiencing relapse in the alemtuzumab group versus the IFNB-1a group were 12% vs 29% through Month 6, 24% vs 43% through Month 12, and 35% vs 51% through Month 24. Analysis of cumulative monthly relapses among patients receiving alemtuzumab showed that its effect on relapse rate was consistent throughout the 24 months of the study.

Conclusions: Alemtuzumab suppressed relapses more effectively than high-dose, high-frequency SC IFNB-1a in active RRMS patients who had experienced disease activity on previous therapy. The greater effect of alemtuzumab on relapse rate became significant within 4 months of treatment initiation and was durable throughout the 2-year study period.

DX38 Durable Effects of Alemtuzumab on Relapse Rate Over Time in CARE-MS II