Abstract: Herpes Infection Risk Reduced with Acyclovir Prophylaxis After Alemtuzumab (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Sibyl E Wray, MD , Hope Neurology, Knoxville, TN, USA, Knoxville, TN

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: Alemtuzumab showed efficacy superior to subcutaneous interferon beta-1a (SC IFNB-1a) among relapsing-remitting multiple sclerosis (RRMS) patients in the CARE-MS I and II studies. Acyclovir prophylaxis was introduced midway through the CARE-MS trials at the recommendation of the Data Monitoring Committee due to an increase in mucocutaneous herpes infections after alemtuzumab, most often during the first post-treatment month.

Objectives: To evaluate whether prophylactic treatment with acyclovir during the first month following alemtuzumab treatment is effective in reducing the risk of herpetic infections.

Methods: CARE-MS comprised two 2-year phase 3 trials, in treatment-naïve RRMS patients (CARE-MS I) and in active RRMS patients who had experienced disease activity while on prior therapy (CARE-MS II). Patients received alemtuzumab 12 mg intravenously on 5 days at entry and on 3 days 12 months later or IFNB-1a 44 µg SC 3× weekly. After a protocol amendment in January 2009, patients received oral acyclovir 200 mg twice daily during each alemtuzumab infusion and for 28 days thereafter.

Results: During 2 years of follow up, the overall incidence of any herpetic infection was higher in the alemtuzumab 12 mg group (16.0%) than the IFNB-1a group (2.0%). The most commonly reported events in the alemtuzumab 12 mg group was oral herpes (9.2% of patients), compared with 1.5% of patients in the IFNB-1a group. During the first course of alemtuzumab 12 mg, 205/811 (25.3%) patients received prophylactic acyclovir, which reduced the incidence of herpes infections during the first month (1/205 patients; 0.5%) compared with no prophylaxis (28/606 patients; 4.6%). During the second course, 521/789 (66.0%) patients in the alemtuzumab 12 mg group received acyclovir, and the incidence of herpes infections during the first month following alemtuzumab was again lower in patients who received prophylaxis than in those who did not (4 [0.8%] vs 7 patients [2.6%], respectively).

Conclusions: Overall, these data suggest that prophylactic treatment with acyclovir for 1 month following each alemtuzumab treatment course is effective in reducing the risk of herpetic infections.

DX60 Herpes Infection Risk Reduced with Acyclovir Prophylaxis After Alemtuzumab