Many of you may have noticed, but especially patients who have been treated with Lemtrada, are concerned that the European Medicines Agency (EMA) initiated a safety procedure on April 11, 2019 to assess the benefit-risk ratio of Alemtuzumab in its approved field of application.
Until this evaluation process is completed, the therapy should only be used in patients with (highly) active relapsing MS, where previous attempts at treatment with at least two alternative immunotherapies have not worked. Such a recommendation is effectively a suspension of treatment until the process is complete. Understandably, many patients who were treated with ‘Alemtuzumab in the past are now confused and asking questions.
What exactly happened or what is the reason for initiating the safety procedure? Well, it is known that Lemtrada is not a “simple” drug. After administration, there is a risk that autoimmune diseases will occur – hence, regular laboratory checks must be carried out up to 4 years after the last infusion. Autoimmune diseases of the thyroid are relatively common, problems in the blood-forming system or in internal organs are very rare, but dangerous if they are not detected in time. On the other hand, the therapy is very effective – after several years of experience with the drug, one can see that the patients who respond to the therapy remain very stable (even without further therapy) for a long time and the MS is well controlled over the years. Therefore, despite all known risks, the benefits of the medication have so far been in the foreground.
What is concerning from my point of view about the current findings on drug safety is less the occurrence of further autoimmune phenomena, such as the occurrence of autoimmune liver damage, especially since these could be identified by laboratory controls. Serious safety concerns are primarily based on the observation of cerebrovascular events (strokes, cerebral hemorrhages) that were closely related in time to the Alemtuzumab infusions. In total, 13 strokes (mainly due to brain hemorrhages) including dissections of brain arteries occurred over the past few years, some of which were also fatal. In most cases, these events occurred 1 – 3 days after the first Lemtrada infusion. Experts are currently debating the exact mechanism, but a basic connection with the drug is likely.
Therefore, until it is officially clarified whether the current measures to minimize risk are sufficient and effective, new treatments should be avoided. Patients who are already being treated with the drug and benefiting from it can continue the treatment in consultation with their doctor. Specifically, this means that patients who have already received the first cycle can also receive the second cycle – provided they agree. On the one hand, vascular complications occurred during the first infusion cycle and safety measures regarding autoimmune side effects must also be carried out for a further 4 years after the first infusion cycle. Switching to another drug – especially if a response to Lemtrada is observed – does not bring any real advantage. For those whose Lemtrada doses are longer ago and who are in the phase of therapy-free remission, the advice is not to get caught up in the excitement and to carry out the laboratory controls to minimize risk as planned.
In principle, it cannot be ruled out that Lemtrada will lose its approval due to the current findings, or may only be available as a reserve medication. Admittedly, I would find this unfortunate, as the concept of induction therapy, which was first introduced with Alemtuzumab in the therapy of MS, is of great interest – and in fact has worked very well for many patients (especially at the beginning of the disease).
