Friday, 4 September 2015

Prevention of infusion reactions

Caon C, Namey M, Meyer C, Mayer L, Oyuela P, Margolin DH, Rizzo M.Prevention and Management of Infusion-Associated Reactions in the Comparison of Alemtuzumab and Rebif(®) Efficacy in Multiple Sclerosis (CARE-MS) Program.
Int J MS Care. ;17:191-8. doi: 10.7224/1537-2073.2014-030.

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 (fever), 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.


After Atemtuzumab there is administered, it starts to kill white blood cells and their contents are spewed into the blood. Many of these are cytokines and you get a storm of them and this causes existing/old lesions to re activate and so you get adverse infusion reactions. These are coming your way for the majority of people and whilst their severity are now limited by treatment with steroids as can be seen here there occur in about 90% of people and the best defense to mitigate this is to tell  you what is going to happen and monitor the infusion. The earlier you start the less lesions you will have but some of these cytokines like interleukin-six (Pyrexia) will induce effects irrespective of lesions. But why does this occur with alemtuzumab verses other immune depleter, because I am not aware that this was a feature of CD4 T cell depletion or of CD-20 B cell depletion, is it the content of CD8 T cells or monocytes that cause the problems

The FDA did not want to approve Alemtuzumab, because if was not blinded, but how can you blind effectively when the side effect is so high.

For the health professionals

McEwan L, Caon C, Chieffe C, Mayer L, Saldana-King T, Miller CE.Best Practices in Alemtuzumab Administration: Practical Recommendations for Infusion in Patients With Multiple Sclerosis.
J Infus Nurs. 2015 Aug. [Epub ahead of print]

With the growing complexity of multiple sclerosis (MS) care, nursing professionals have increasing responsibility in managing clinical disease and treatment. Nursing professionals and other health care providers play important roles in educating patients about disease-modifying therapy options, the course of therapy, and managing potential adverse effects. A panel of nursing and MS experts was convened and used a modified Delphi method to reach consensus on best-practice recommendations for alemtuzumab infusion in MS patients. This valuable clinical resource provides a practical guide for clinicians to optimize patient education and implement strategies for infusion-associated reaction prophylaxis and management when administering alemtuzumab.

2 comments:

  1. Alemtuzumab has been used in cancer treatment (CLL) for many years and at a lot higher dosages than 'Lemtrada' is for MS. Where are these side effects not seen in the cancer patients who were treated? Or did not one think to ask?

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    Replies
    1. People with CLL do not have demyelinated lesions and so I think this was the main shock when it was first used.....it is interesting that the project was not stopped at that early time point

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