Alemtuzumab Infusion Experience
Alemtuzumab is a humanized anti-CD52 monoclonal antibody, approved in the USA in November of 2014 for relapsing remitting multiple sclerosis. The efficacy of alemtuzumab was demonstrated in the CARE-MS I and II trials.
Alemtuzumab is administered by intravenous infusion once daily over a 5-day course, followed one year later by intravenous infusion once daily over a 3-day course.
Alemtuzumab causes cytokine release resulting in infusion reactions, some of which may be serious and life threatening.
In clinical trials, infusion associated reactions (IARs) were defined as any adverse event occurring during or within 24 hours of alemtuzumab infusion. 92% of alemtuzumab treated patients experienced mild to moderate IARs, 3% of patients experienced serious IARs. The most common IARs with alemtuzumab are rash, headache, and pyrexia. Other reported IARs include nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, dysguesia, chest discomfort, tachycardia, dyspepsia, dizziness, and pain. Within the clinical trials, anaphylaxis or serious reactions that required treatment discontinuation were very rare.
To describe the IARs in patients treated with alemtuzumab at the infusion center at the OMRF-Multiple Sclerosis Center of Excellence in Oklahoma City.
We identified 11 patients with multiple sclerosis that received alemtuzumab at our center. The patients were all females between 33 and 55 years of age. All patients had an inadequate response to at least 2 disease-modifying therapies.
The infusion protocol included premedication with H1/H2 antagonists and antipyretics each day prior to alemtuzumab infusion. Methylprednisolone was administered intravenously prior to the first 3 infusion days. Symptomatic medication was available as needed during or after infusions. Patients were monitored for IARs during and 2 hours after completion of each alemtuzumab infusion.
All patients completed the 5 days of treatment without interruptions. 5 patients had no IARs. Rash was observed in 4 patients, headache in 3 patients, back ache in 2 patients, itching in one patient, and transient tight feeling in the chest in one patient. All IARs were mild and resolved with symptomatic medication prior to discharge.
Alemtuzumab is an effective alternative for the management of relapsing forms of multiple sclerosis. In our experience, alemtuzumab infusions are generally well tolerated and IARs are consistent with findings in the core studies.