Background Alemtuzumab is a monoclonal antibody directed against the CD52 antigen on T- and B-lymphocytes indicated in adult patients with relapsing remitting multiple sclerosis (RRMS).
Purpose To assess safety, reason for switching, compliance with the protocol and with the criteria for use.
Material and methods Retrospective observational study of all patients treated with alemtuzumab since it was included in the formulary.
Some of the variables collected were: treatment history, Extended Expanded Disability Status Scale (EDSS), presence of antibodies against JC virus (anti-JCV), adverse effects experienced during infusion and reason for switching.
According to the established recommendations, the use of alemtuzumab is approved when patients with RRMS and appropriate treatment with immunomodulators presents a high-activity disease, or when they present a fast and aggressive course of the disease and alemtuzumab is a better choice than natalizumab or fingolimod.
Results Thirteen patients were treated (11 females), with an average of age of 38.77±8.49 years. At the beginning of the treatment eight patients had anti-JCV antibodies, mean EDSS was 2.21 points and the mean number of drugs used before was 2.62. Among the patients reviewed, 10 had been previously treated with natalizumab and 5five with fingolimod.
The reason for switching in eight patients was the development of anti-JVC antibodies that conditioned the continuation with natalizumab, despite this the drug was able to control the disease. The anti-JVC index exceeded 1.5 in all cases and was higher than 3.5 in four of them. In four patients the change was conditioned by a high activity of the disease and in two by the fast and aggressive course of the disease.
The main adverse events were: headache (n=11), skin rash (nine), fatigue (four), fever (one) and insomnia (two).
Conclusion Alemtuzumab is a safe alternative in the treatment of RRMS. The adverse effects experienced during the infusion were mild and remitted in all cases without major complications.
All patients treated with alemtuzumab fulfilled the criteria for use.
No conflict of interest
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