New medication for migraine?
Two studies just released are the first to test monoclonal antibodies for the prevention of migraine in patients with frequent attacks (up to 14 days per month). Both antibodies are directed against the lynchpin molecule in migraine: calcitonin gene-related peptide, or CGRP.
In the first study, supported by Alder Biopharmaceuticals, patients with frequent migraines were given a single IV dose of a drug called ALD403. Over the following 24 weeks those who received the drug had an average of 5.6 fewer migraine days per month, a 66% decrease, compared to 4.6 fewer days per month for those who received a placebo (52%). 16% of those who received the drug had no migraine days at 12 weeks, while none of those who received the placebo were free from migraine at that point.
In the other study, supported by Arteaus, patients received biweekly subcutaneous injections of a drug called LY2951742 for 12 weeks. Those who received the drug had an average of 4.2 fewer migraine days per month at 12 weeks (a 63% decrease), while those who received placebo had 3 fewer migraine days per month (42%). Side effects included pain at the injection site, upper respiratory tract infections and abdominal pain, but overall the drug was considered to be safe and well-tolerated.
These are potentially very exciting results. Existing gold standard acute migraine treatments such as the triptans (e.g. Imigran) work by blocking the effects of CGRP. It has been known since the mid-1990s that CGRP is an important neurotransmitter in migraine attacks, and several attempts have been made to develop drugs that selectively block the action of CGRP and thereby stop migraines in their tracks; unfortunately none of these drugs has yet made it to market, in some cases because of unexpected adverse effects on liver function in a tiny proportion of patients.
This new type of medication for migraine contains monoclonal antibodies designed to block CGRP over longer timescales and thereby to reduce or prevent migraine attacks altogether. The reduction in the number of migraine attacks seen in these studies is both statistically and clinically meaningful, and the fact that some patients were rendered free from attacks is particularly impressive.
It is early days and one must be cautious. The placebo responses in these trials was higher than usual, and we’ll need to see these results reproduced in larger Phase III studies. Ultimately of course there will be questions of cost if and when approval is sought to use these types of medicines on the NHS.
Despite these cautions, however, this is another encouraging development for those who suffer from migraine, as we are being given another glimpse of the future of the management of this under-diagnosed, under-treated and often debilitating neurological disorder.
Dr Mark Weatherall
Dr Weatherall is a Consultant Neurologist at Charing Cross and Ealing Hopsitals. He has a special interest in the diagnosis and treatment of headaches and sees private patients in Harrow, Kensington and Great Missenden. Click on the logo below for more information and contact details
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