Prevention and Management of Infusion-Associated Reactions in the Comparison of Alemtuzumab and Rebif(®) Efficacy in Multiple Sclerosis (CARE-MS) Program.

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.

Efficacy and safety of alemtuzumab in multiple sclerosis and impact on nursing role.

Alemtuzumab, a humanized monoclonal antibody, has shown efficacy for relapsing-remitting multiple sclerosis (MS) in phase 2 and phase 3 trials. Compared with subcutaneous interferon beta-1a, alemtuzumab significantly reduced the risk for accumulation of disability and the rate of relapse, and improved mean disability level from baseline. Notable safety and tolerability concerns include infusion-associated reactions, infections of predominantly mild-to-moderate severity, and autoimmune adverse events, principally thyroid disorders and immune thrombocytopenia. As emerging therapies such as alemtuzumab are approved for the treatment of MS, nurses specializing in the care of MS patients will make increasingly significant contributions to the education of patients, caregivers, and other health-care providers about these therapies' efficacy, tolerability, safety, and administration. This article reviews the phase 2 and phase 3 efficacy and safety results for alemtuzumab, with an emphasis on the role of nurses in communication about this treatment option for those with MS.

Establishing the Eden Alternative™ in Australia and New Zealand.

The Eden Alternative™ is a philosophy of personal, organisational and environmental transformation founded by Dr. William Thomas, a Harvard trained geriatrician. He wanted to create a living environment in existing aged care institutions to eliminate loneliness, helplessness and boredom from the lives of residents, which he argued were the plagues of ageing that account for the bulk of their suffering. The Eden Alternative™ is a contemporary approach to long-term care, designed to combat these plagues of ageing, by incorporating companionship, a sense of purpose, variety and spontaneity into the day-to-day experience of aged care residents. Creating a warm, loving and caring 'home' that enriches the lives of all who live and work in it, is the overarching goal of The Eden Alternative™. The locus of decision-making is with the resident, which ensures the right of each resident to a life worth living. This exemplar outlines the inception and growth of The Eden Alternative™ in Australia and New Zealand.

Refusals and delay of immunization within southwest Alberta. Understanding alternative beliefs and religious perspectives.

BACKGROUND: Immunization is a necessary component of well child services within public health. Despite the documented effectiveness of vaccines, some parents choose to refuse or delay immunization for their children. Adherence to different beliefs has affected immunization coverage in one Regional Health Authority in Southwest Alberta. METHODS: This qualitative study involved exploratory, descriptive open-ended interviews with a sample of 47. The sample included people of Dutch ethnic background, Hutterites, and parents and practitioners who engage in alternative health beliefs and practices. RESULTS: Major findings include: 1) among the Dutch, most noted their decision to refuse to immunize was based on religious beliefs; 2) the Hutterites' decision not to immunize was due to their experiences with adverse reactions but was further supported by their use of alternative health; and, 3) the alternative health group are more concerned with the safety of vaccines with regard to the short- and long-term effects on their children's health. DISCUSSION: All three groups conveyed a common concern of child health and safety. Educational initiatives need to be implemented to allay parents' fears. Community development activities with individuals of the groups included here who support immunization will increase acceptance of immunization.