Currently, a report on a death due to a cerebellar hemorrhage after administration of the MS drug Alemtuzumab is causing attention. The case occurred back in December 2016 and was known for a long time in professional circles, but in view of the current reports, I think it makes sense to discuss the case again in the context of treatment with Alemtuzumab.Alemtuzumab is an antibody that is directed against the molecule CD52 on the surface of T and B cells and plays an important role in the therapy of highly active multiple sclerosis. The antibody is also an interesting option because many patients can achieve a longer period of therapy-free remission after just two infusion cycles. Therefore, the antibody is of interest both in terms of its effectiveness and in terms of its ease of use. The problematic side: Alemtuzumab has a side effect profile that requires special attention. From clinical studies, we know that the intravenous administration of Alemtuzumab can lead to infusion-related side effects. In the weeks after administration, patients are more susceptible to infectious diseases and autoimmune diseases of the thyroid and the hematopoietic system can occur over time.
The drug has been used in Germany since 2013 – so we now have very extensive practical experience and fairly reliable information about the side effect profile in everyday use. In this regard, the Paul Ehrlich Institute also published a bulletin last summer that summarized the side effect profile of Alemtuzumab in its previous practical use in MS. As expected, thyroid diseases (in 46 cases) were seen relatively frequently, but they are generally well treatable. A decrease in platelets (Thrombocyte = blood platelet, responsible for clotting) was recorded in a total of 38 patients. Interestingly, it was shown that the reduction in blood platelets can also occur relatively soon after the infusion and not only as originally thought 1 – 2 years after the first infusion. The drop in platelets was also the reason for the aforementioned death – a 34-year-old MS patient died of this coagulation disorder due to a cerebellar hemorrhage. This case occurred in December 2016, but has now been reported again in the German Medical Journal and has drawn attention to the side effect profile of Lemtrada®.
The lesson to be learned from the side effects observed in reality is that the rigid monitoring required after infusions with Alemtuzumab is absolutely sensible and important. It is recommended to control blood count and kidney values as well as the urine status at least 48 months after the last infusion. Even if this seems annoying and you feel good as a patient, this recommendation is of great importance. Because only in this way can it be ensured that the potential autoimmune side effects, even if they only occur rarely, are recognized in time and can be subjected to effective treatment.
Another interesting insight that could be gained from the clinical everyday observation of Alemtuzumab was that several cases of Listeria infections occurred in the first months after the Lemtrada administration. From this it was derived the recommendation that patients who are treated with the drug should avoid raw or insufficiently cooked meat, soft cheese or non-pasteurized dairy products until one month after the treatment.
As far as infusion-related side effects are concerned, these do make up the largest number of undesirable events, but they are generally well manageable. In practical application with appropriate premedication, we hardly observe any problems with the infusion.
