During a migraine attack, the monoclonal antibody eptinezumab (Lundbeck) provides freedom from headache pain in as little as 1 hour after intravenous (IV) administration, new research shows.
New results from RELIEF, a randomized controlled trial of patients with migraine, showed that participants who received IV eptinezumab were more likely to be free of their most bothersome symptom (MBS) at 1 hour compared with those who received placebo.
Eptinezumab also provided rapid relief from nausea. Thirty minutes after treatment, more than one third of the patients who received the monoclonal antibody were free of nausea. In comparison, about one quarter of the patients who received placebo were free of nausea in that time.
“This rapid efficacy by the monoclonal antibody eptinezumab would seem to support a peripherally driven migraine pain and nausea mechanism,” said study investigator Paul K. Winner, DO, senior director of Premiere Research Institute and attending neurologist at the Palm Beach Headache Center, in West Palm Beach, Florida.
Winner presented the findings at the virtual American Headache Society (AHS) Annual Meeting 2021.
Eptinezumab targets the calcitonin gene–related peptide (CGRP) ligand and was approved last year by the US Food and Drug Administration for migraine prevention in adults.
Previous results from the RELIEF study showed that when administered during an attack, eptinezumab yielded higher rates of freedom from headache pain and the absence of MBS at 2 hours in comparison with placebo.
In the current study, investigators analyzed RELIEF data to identify the earliest points at which response to eptinezumab separated from response to placebo in terms of freedom from headache pain and absence of MBS.
RELIEF participants were aged 18 to 75 years and had experienced migraine from 4 to 15 days per month during the 3 months before screening. All were randomly assigned to receive either IV eptinezumab 100 mg (n = 238) or IV placebo (n = 242).
Participants presented to the site with a moderate to severe migraine attack. Treatment was administered within 1 to 6 hours of onset.
Patients were required to have abstained from any headache medication and to have been symptom free for 24 hours before migraine onset. They were only permitted to take the study medication 2 hours after migraine onset.
The infusion was completed in 30 minutes. Participants remained in the study center for 4 hours. Symptoms were recorded every 30 minutes up to 4 hours post infusion; recordings continued through the subsequent 48-hour period.
Results showed that the earliest separation between the treatments on the primary endpoints was at 1 hour.
At that time point, the rate of headache pain freedom was 9.7% for the eptinezumab group, vs 4.1% for the placebo group (P < .05).
Also at 1 hour, 33.2% of the active-treatment group was free of the MBS, vs 22.1% of the group that received placebo ( P < .05). The between-group separation continued through 48 hours.
The investigators also examined treatment effect on individual migraine-associated symptoms.
At 1 hour, eptinezumab separated from placebo for absence of photophobia (29.4% vs 17.0%; P < .05) and absence of phonophobia (41.2% vs 27.2%; P < .05). Separation from placebo for absence of nausea occurred at 30 minutes (36.7% vs 25.4%; P < .05).
In addition, the use of rescue medication was more prevalent among patients who received placebo than among patients who received eptinezumab throughout the study.
Not Practice Changing
Commenting on the findings for Medscape Medical News, Brian E McGeeney, MD, a neurologist at Brigham and Women’s Hospital, Boston, Massachusetts, said the study’s main strength is its demonstration of an early effect of infused CGRP ligand–targeting antibody on acute migraine symptoms for patients with episodic migraine.
“As migraine prophylaxis is initiated or changed when the patient is not doing well, the acute effect would be welcome,” said McGeeney, who was not involved with the research.
“In practice, the patient and practitioner will have knowledge that initiation of eptinezumab has a quick enough action to have migraine-abortive properties in those initiating prophylaxis,” he added.
However, a study weakness was the exclusion of patients with chronic migraine, McGeeney noted. In addition, the absolute improvement numbers at early periods were small.
“There is no question that eptinezumab works, but the modest separation of the earliest outcome measures becomes statistically significant because of the large number of subjects in the study,” he said.
Although quick onset of treatment effect is an advantage in migraine therapeutic prophylaxis, “the need for an infusion often limits quick execution, and this study will likely not change practice,” said McGeeney.
Questions worth investigating in the future include whether the acute effect is maintained on repeated administration of eptinezumab and to what extent this effect applies to those with more frequent attacks, such as patients with chronic migraine, he concluded.
The study was funded by H. Lundbeck. Winner has received compensation from AbbVie, Amgen, Biohaven, Lilly, Lundbeck, Novartis, and Teva and has received research support from AbbVie, Amgen, AZ, Biogen, Lilly, Lundbeck, Novartis, Supernus, and Teva. McGeeney has reported no relative financial relationships.
American Headache Society (AHS) Annual Meeting 2021: Abstract IOR-09. Presented June 3, 2021.
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