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Eptinezumab provides ‘rapid, robust’ benefit in patients with migraine
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PHILADELPHIA — Patients who received eptinezumab, a monoclonal antibody that inhibits calcitonin gene-related peptide, had more migraine-free months than those who received placebo, according to study results presented at the American Headache Society Annual Scientific Meeting.
Researchers conducted two trials — PROMISE 1 (665 patients with approximately 8.6 monthly migraine days) and PROMISE 2 (1,072 patients with about 16.1 monthly migraine days). Participants in each trial were randomly assigned in an approximate 1:1:1 ratio to receive either a quarterly 100-mg dose or 300-mg dose of eptinezumab (Alder BioPharmaceuticals) or placebo.
Researchers found that over months 1 through 3 of the trials, between 10% and 17% of all patients who received eptinezumab were migraine-free during any given month and the frequency of migraine-free months increased with ensuring quarterly infusions.
Robert W. Azelby, president and CEO of Alder BioPharmaceuticals, called these results “robust” and “rapid” in an interview with Healio Primary Care.
“To me, that is a dramatic depth of response in people who suffer from debilitating migraine regularly,” he added.
Other eptinezumab data presented at the meeting included:
- PROMISE 2 participants who received eptinezumab reported greater improvements on each of the Headache Impact Test-6 (HIT-6) items than those who received placebo; had clinical benefits associated with HIT-6 that lasted at least through month 8; and had “meaningful improvements” in daily functioning, disease status, migraine frequency, severe headache frequency and quality of life.
- PROMISE 1 and PROMISE 2 participants reported a median drop of 50% or more in days that they used acute treatment for their migraine pain; and, through the second eptinezumab dose, a range of 4 to 9 in fewer monthly migraine days and 4.6 to 8.8 fewer monthly headache days.
- 128 participants of PREVAIL — an ongoing phase 3, open-label, 1-year trial evaluating the long-term safety of 300-mg doses of eptinezumab every 3 months — have reported “substantial reductions in HIT-6 score indicative of clinically meaningful relief of migraine burden on patient functioning.”
The PDUFA date for eptinezumab is Feb. 21, 2020, Azelby said.
If approved, the drug will be the first therapy anti-CGRP infusion therapy for migraine prevention that is taken quarterly, according an Alder BioPharmaceuticals press release. – by Janel Miller
References:
Early and sustained reduction in headache impact in people with CM After eptinezumab treatment: HIT-6 item analysis in the phase 3 PROMISE-2 trial. Submission ID: 672839.
Eptinezumab demonstrated early and sustained reductions in HIT-6 total score over time in patients with chronic migraine in the PROMISE-2 trial. Submission ID: 672820.
Eptinezumab reduces the frequency of acute medication usage in patients with episodic or chronic migraine. Submission ID: 672916.
Migraine-free months in patients with episodic or chronic migraine treated with eptinezumab: Results from the PROMISE-1 and PROMISE-2 trials. Submission ID: 672874.
Treatment with eptinezumab demonstrated meaningful improvements in patients with chronic migraine experiencing a high frequency of severe migraines. Submission ID: 672962.
Mechtler L, et al. Eptinezumab reduces the frequency of headaches and migraines in patients with episodic or chronic migraine: Results from the PROMISE 1 and PROMISE 2 trials.
Spierings E, et al. Reduced Impact of Headaches After Migraine Preventive Treatment with Eptinezumab in Patients with Chronic Migraine: Results from the PREVAIL Open-Label Safety Study.
All presented at: American Headache Society Annual Scientific Meeting; July 11-14, 2019; Philadelphia.
Disclosures: Azelby is CEO of Alder BioPharmaceuticals.