The EMA has made the sensible decision to lift its previous temporaray restriction and allow alemtuzumab to be used first-line in the treatment of MS. But, because of the new sawety concerns noted last year, the eligibility criteria are more stringent. So:
Alemtuzumab should now only be used as a single disease-modifying therapy in adults with relapsing‑remitting multiple sclerosis with:
- highly active disease despite a full and adequate course of treatment with at least one disease-modifying therapy or
- rapidly evolving severe disease defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared to a recent MRI.
And its use is contraindicated in:
- evere active infections until complete resolution
- uncontrolled hypertension
- history of angina pectoris, myocardial infarction, stroke or dissection of the cervicocephalic arteries
- coagulopathy, on antiplatelet or on anti-coagulant therapy
- concomitant autoimmune diseases other than multiple sclerosis
Read the full advice here.