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  1. Basil Sharrack1,
  2. Lori Mayer2,
  3. Alasdair Coles3,
  4. Hans-Peter Hartung4,
  5. Eva Havrdova5,
  6. Krzysztof Selmaj6,
  7. David Margolin7,
  8. Alastair Compston3
  1. 1Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield
  2. 2Central Texas Neurology Consultants, MS Clinic of Central Texas, Round Rock, TX, USA
  3. 3University of Cambridge School of Clinical Medicine, Cambridge, UK
  4. 4Heinrich-Heine University, Düsseldorf, Germany
  5. 5First Medical Faculty, Charles University in Prague, Prague, Czech Republic
  6. 6Medical University of Łódź, Poland
  7. 7Genzyme, a Sanofi company, Cambridge, MA, USA


In the 2-year, phase 3 CARE-MS studies of alemtuzumab in patients with relapsing-remitting multiple sclerosis, infusion-associated reactions (IARs) were the most common adverse events. Here we report on IARs during 4-year follow-up. Patients who were treatment-naive (CARE-MS I; NCT00530348) or with inadequate efficacy response to prior therapy (CARE-MS II; NCT00548405) received 2 annual courses of alemtuzumab 12 mg, and as-needed retreatment in an extension study (NCT00930553). Patients received methylprednisolone on the first 3 days of each course. IARs were any adverse event occurring between start of infusion and within 24 hours after end of infusion. 742/811 alemtuzumab-treated patients entered extension. Over 4 years, 70.4% received only 2 initial treatment courses; 22.6% and 6.1% received 3 and 4 courses, respectively. IARs were most frequent in Course 1 (84.7%) versus Courses 2 (68.5%), 3 (65.7%), and 4 (71.1%); frequency decreased on infusion Days 2 and 3 versus Day 1. IARs were predominantly mild to moderate; none led to study withdrawal or death. Serious IAR incidence was 3.1%. Most common IARs were skin disorders (predominantly rash), headache, pyrexia, and nausea. One confirmed anaphylaxis and one non-anaphylactoid hypotension event resolved with treatment. Effective IAR management included premedication, infusion monitoring, symptomatic treatment, and infusion interruption/adjustment.

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