The posthoc findings from the pivotal studies further support eptinezumab (Vyepti; Lundbeck, Deerfield, IL), as a preventive treatment for migraine disease with onset of action day 1 and showed that it reduce use of acute treatment in people with medication-overuse headache (MOH). Participants treated with eptinezumab reduced overuse of acute headache medication within 1 month of initial treatment, and this reduction was sustained over 6 months. Half of the participants receiving eptinezumab were consistently below MOH thresholds for the whole 6-month treatment period, experiencing complete resolution of the MOH diagnosis.
This posthoc closed testing analysis of the Promise 1 (NCT02559895) and Promise 2 (NCT02974153) studies looked at the percentage of participants experiencing a migraine, using progressively smaller time intervals, starting with the primary time point (weeks 1-12; days 1-84). For both studies and both doses, all tests from day 84 working backwards to day 1 alone achieved nominal statistical significance (p<.05), indicating that eptinezumab was effective beginning on day 1 postinfusion. The response to eptinezumab treatment was sustained for 3 months following the initial dose in both pivotal studies.
A separate posthoc subgroup analysis of the study showed that for participants diagnosed with both chronic migraine and medication-overuse headache (MOH), eptinezumab consistently reduced the use of acute headache medications in participants with chronic migraine to levels below MOH thresholds over 6 months.
The recommended dose is 100 mg every 3 months; some participants may benefit from a dose of 300 mg. Administered via a 30-minute intravenous (IV) infusion every 3 months, eptinezumab is the first and only IV treatment for migraine prevention.
"We are pleased to present new data at AHS about medication-overuse headache, a complex-to-treat condition in which patients experience chronic headaches as a result of overuse of acute treatments being used to help manage their migraine,” said Roger Cady, MD, head of Neurology Medical, Lundbeck Seattle Biopharmaceuticals. “The latest findings for Vyepti build on previous evidence and further highlight how this new quarterly migraine prevention therapy may help patients with both chronic migraine and medication-overuse headache.”
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