Posted on behalf of Duncan Graham-Rowe.
It is what multiple sclerosis sufferers have long hoped for, a drug that can not only halt the progression of nerve damage caused by the disease but also reverse it (see ‘Antibody offers hope for multiple sclerosis treatment‘). Yet as the monoclonal antibody alemtuzumab clears its last hurdle before clinical approval it now seems clear it will come at a price.
According to the results of the Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) I and II, two phase III clinical trials published in The Lancet today, 78% and 65% of patients on alemtuzumab, respectively, remained free of relapse after two years, compared with 47% on a standard therapy, interferon beta-1a (marketed as Rebif). CARE-MS II also found that on average patients taking alemtuzumab had less disability at the end of the study than when they started, while those on interferon beta-1a experienced a worsening.
Further evidence of a reversal comes in the form of MRI scans of patients brains, says Alasdair Coles, lead author of the papers and a clinician at the University of Cambridge. In both trials patients on alemtuzumab showed significantly less brain volume loss, a proxy measure for tissue damage caused by MS. “In fact, the rate of brain atrophy after alemtuzumab approached the rate you would see in a healthy person,” he says.
But MS sufferers’ gain could prove to be a loss for leukemia patients. Alemtuzumab is already on the market for treating B-cell chronic lymphocytic leukemia. Yet in August Genzyme, the Cambridge, Massachusetts-based, company that makes the drug, voluntarily withdrew Alemtuzumab from the market. Genzyme cites commercial reasons, but with the recent trend of clinicians using the drug off-label to treat their MS patients ahead of clinical approval, its withdrawal seems a telltale sign of an impending price hike.
Even so this is good news for MS patients. There is no cure for the disease, which occurs when the body’s own immune system attacks the myelin sheath that normally protects the nerves and speeds up neurological signals in the brain and spinal cord, and so far alemtuzumab is the only drug to show signs of reversing this damage. What’s more it can do so after just two intravenous infusions given a year apart.
“These trial results show that alemtuzumab is a robust and effective treatment for multiple sclerosis, both in people with multiple sclerosis which has never been treated, and those whose disease has already ‘broken through’ standard treatment,” says Coles. With clinical approval expected both in Europe and the US as early as next summer, research will continue to evaluate its long-term efficacy.