Cancer drug shows promise for multiple sclerosisBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7469 (Published 05 November 2012) Cite this as: BMJ 2012;345:e7469
Two manufacturer sponsored phase III trials suggest that alemtuzumab, an anti-CD52 monoclonal antibody that is licensed to treat leukaemia, may help control multiple sclerosis. Both trials lasted two years and compared alemtuzumab with interferon beta-1a, which is considered first line treatment. One trial looked at 563 patients who had not yet undergone treatment for multiple sclerosis, whereas the other trial looked at 840 people, some of whom had not responded to previous treatment with interferon beta-1a or glatiramer. The second trial tested 12 mg and 24 mg doses of alemtuzumab against interferon⇑.
In the first trial, 22% (82/376) of patients who received alemtuzumab relapsed within two years, compared with 40% (75/187) of those who received interferon beta-1a. In the second trial, 35% (147/426) of patients who received 12 mg alemtuzumab relapsed compared with 51% (104/202) of those who received interferon beta-1a. No difference was seen in the first trial in sustained accumulation of disability (an increase of at least one point on the expanded disability status scale over six months). In the second trial, however, this outcome also improved with alemtuzumab (40 patients (20%) with interferon beta-1a v 54 (13%) with alemtuzumab; hazard ratio 0.58, 95% CI 0.38 to 0.87).
Potential adverse events are serious but treatable. People taking the drug need to be carefully monitored for thyroid disorders, which were seen in 16-19% of patients, as well as immune thrombocytopenia, seen in 1%. Nearly all patients had reactions associated with infusion, most commonly headache, rash, nausea, and fever. Two thirds of patients had infections, which were deemed serious in up to 2% of those taking the tested drug. Between 1% and 4% of participants taking alemtuzumab stopped taking it because of adverse events.
The drug has been used off label for a while, but recently the manufacturer withdrew it from EU and US markets and is seeking approval for treatment of relapsing multiple sclerosis. A linked editorial voices concern that when the drug reappears on the market it may be more expensive (doi:10.1016/S0140-6736(12)61776-0).
Cite this as: BMJ 2012;345:e7469