During the past year, the MS drug Lemtrada was reviewed by the European Medicines Agency (EMA) for its benefit-risk ratio. The basis for this so-called §20 procedure were reports of serious side effects, in some cases leading to death. In addition to the already known autoimmune side effects of the substance, cases of myocardial infarctions, cerebral hemorrhages, dissections of cerebral arteries, and pulmonary alveolar hemorrhages were reported.
At the end of last year, the EMA communicated the result of the review – in January, the medical profession was informed of the resulting changes via a so-called “Red Hand Letter”. As far as the indication of Alemtuzumab is concerned, the new risk assessment has hardly changed anything. It can be used in patients with highly active disease who have not responded adequately to a previous drug. Furthermore, patients can also be treated directly with Alemtuzumab if there is rapidly progressive severe relapsing MS – this is defined by 2 relapses in one year and a corresponding lesion load in MRI.
However, what is new is the recommendation that the use of the drug should only take place in a hospital with the possibility of intensive medical care. This makes administration of Alemtuzumab in an outpatient setting, e.g., in a private practice, difficult.
Furthermore, the EMA has added uncontrolled hypertension, dissection of cerebral arteries, strokes, coronary heart disease and coagulation disorders or therapy with blood-thinning drugs in the medical history as additional contraindications for administration of the active ingredient – which is plausible against the background of the aforementioned events. However, existing autoimmune diseases are also mentioned as contraindications.
While cardiovascular diseases do not play a role in young MS patients, other autoimmune diseases are not uncommon in MS patients. For example, MS patients often suffer from an autoimmune hypothyroidism, the so-called Hashimoto’s thyroiditis. Although Hashimoto’s disease is usually easy and well treatable, it is an autoimmune disease and could therefore lead to uncertainty, for example if a therapy with Alemtuzumab is considered.
The review and new risk assessment of Lemtrada and the associated mistrust will probably lead to a decline in the use of the therapy in Germany and it will probably only be offered by specialized centers in the future. Given that Alemtuzumab represents the promising concept of pulsed immune reconstitution and that many, especially young patients with active MS have responded very well to this concept in my experience, this development is regrettable.
In my view, Lemtrada is not a “third-line drug” or a “last option”, but a concept that has its strengths especially in the early phase of the disease. Therefore, it would be important that, due to the current development, this therapeutic option continues to be widely available to selected patients.
