Author: Hans-Christoph Diener, from the University Duisburg-Essen in Germany.
In this month’s video, I would like to cover new developments in the treatment of migraine. We have three new market launches of new drugs in Europe. They have been available in the United States for some time.
Three New Drugs for Europe
The first one is atogepant, a small molecule for migraine prevention. The standard dose is 60 mg once daily. We have excellent efficacy studies, both for episodic and chronic migraine, and this drug also is effective in a subgroup of patients with medication overuse chronic migraine. The drug has a good safety profile, but it has slightly more side effects than monoclonal antibodies, in particular, nausea and insomnolence, because atogepant crosses the blood-brain barrier.
The third new launch in Europe is liquid celecoxib 120 mg. There are two large, multicenter, randomized, double-blind studies showing superiority over placebo for pain-free at 2 hours, with a success rate of about 36%-46% compared with 20%-23%.
Until now, we have unfortunately no comparative studies with triptans. This is a possible alternative for patients for whom oral medications — for example, triptans — are not sufficiently effective or lead to side effects.
My next topic is medication overuse headache. We have the first dedicated, randomized trial for patients with chronic migraine and medication overuse headache. This study compared 70 mg of erenumab and 140 mg of erenumab compared to placebo.
There were 584 patients randomized, and the primary endpoint was no longer meeting the criteria for medication overuse headache after 6 months. There was a significant benefit seen for the high dose of erenumab at 69% vs placebo at 52%. The low dose of erenumab was not statistically superior to placebo. Now, this is important because it’s the first dedicated study on the efficacy of a monoclonal antibody in medication overuse headache.
A frequently asked question is whether monoclonal antibodies are effective in the prevention of vestibular migraine. There is now a small study with 40 patients comparing galcanezumab and placebo, and it showed a significant benefit of galcanezumab compared to placebo.
CGRP Drugs Review and MAb Safety
There is an excellent review in The Lancet on CGRP-directed drugs for the acute treatment as prophylaxis for migraine, including monoclonal antibodies and gepants, such as rimegepant, ubrogepant, or atogepant.
This review reminds us of important contraindications for the CGRP-directed drugs. These is a history of serious cardiovascular and cerebrovascular events, severe liver dysfunction, severe renal syndrome, and pregnancy and lactation. The most common side effect of monoclonal antibodies is constipation, and of gepants, it’s somnolence and nausea. Rare, potential side effects of monoclonal antibodies are alopecia, osteoporosis, and impaired wound healing.
We also have a very important study from the United States Medicare system on the cardiovascular safety of monoclonal antibodies in elderly patients with migraine. They compared more than 5000 patients who were treated with a monoclonal antibody and 4000 patients who were treated with onabotulinumtoxinA. The period was between 2018 and 2023.
The good news is there were no differences for cardiovascular events including myocardial infarction or stroke between monoclonal antibodies and onabotulinumtoxinA, which means these drugs are obviously very safe in elderly people with migraine.