title: Prevention and Management of Infusion-Associated Reactions in the Comparison of Alemtuzumab and Rebif(®) Efficacy in Multiple Sclerosis (CARE-MS) Program.
abstract: BACKGROUND
  Alemtuzumab is a humanized monoclonal antibody approved in several countries for treatment of relapsing-remitting multiple sclerosis (RRMS). This report summarizes the experience with infusion-associated reactions (IARs) in two phase 3 trials of alemtuzumab in RRMS and examines skilled nursing interventions in IAR prevention and management.
  
  
  METHODS
  In the Comparison of Alemtuzumab and Rebif(®) Efficacy in Multiple Sclerosis (CARE-MS) studies, patients with RRMS (treatment naive [CARE-MS I] or with inadequate response [defined as at least one relapse] to previous therapy [CARE-MS II]) received intravenous infusions of alemtuzumab 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Patients were monitored for IARs during and after each infusion. An IAR was defined as any adverse event occurring during any infusion or within 24 hours after infusion.
  
  
  RESULTS
  The IARs affected 90.1% of patients receiving alemtuzumab. The most common IARs were headache, rash, pyrexia, nausea, and flushing; most were mild to moderate in severity. Management of IARs consisted of infusion interruption or rate reduction, pharmacologic therapies, and continual patient education and support. Medication administration before and during alemtuzumab infusion reduced IAR severity. Forty-five of 972 alemtuzumab-treated patients (4.6%) required interruption of the first treatment course (ie, infusions did not occur on consecutive days); of these, 24 (53.3%) were still able to complete the first and second full treatment courses.
  
  
  CONCLUSIONS
  Nurses played an invaluable role in the detection and management of IARs in the CARE-MS studies. Best practices for management of IARs associated with alemtuzumab include patient and caregiver education, medication to lessen IAR severity, infusion monitoring, and discharge planning.
authors: Christina
authors: C
authors: Caon
authors: Marie
authors: M
authors: Namey
authors: Cathy
authors: C
authors: Meyer
authors: Lori
authors: L
authors: Mayer
authors: Pedro
authors: P
authors: Oyuela
authors: David H
authors: DH
authors: Margolin
authors: Marco
authors: M
authors: Rizzo