The EMA and MHRA are worried about the safety of alemtuzumab and today [12th April 2019] announced a temorary restriciton on alemtuzumab prescribing. They have not revealed new side effects. Rather I supsect the steady drip-drip of serious, and often very rare, side effects has broken their confidence in the liberal licence that alemtuzumab currently enjoys. They cite these concerns:
- immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body);
- problems with the heart and blood vessels occurring within 1–3 days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck);
- severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
They are conducting a detailed review and, have suggested that:
“ during this review, [alemtuzumab] treatment in new patients should only be initiated in adult patients with highly active relapsing remitting multiple sclerosis (RRMS), despite a full and adequate course of treatment with at least two other disease modifying treatments (DMTs), or in adult patients with highly active RRMS where all other DMTs are contraindicated or otherwise unsuitable. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their prescriber.”
Personally, I think it is appropriate to raise these concerns. Alemtuzumab can cause serious side effects. Patients and neurologists need to take these seriously and weigh them against the severity of disease. But I think that it is excessive to ask patients to fail two disease modifying drugs before being able to access the benefits of the drug. We will see what the final opinion is!