An analysis of the open-label PREVAIL trial demonstrated a magnitude of therapeutic effect for eptinezumab that was either maintained or improved with subsequent infusions.
Egilius L.H. Spierings, MD, PhD
Treatment with eptinezumab is associated with substantial improvements in Headache Impact Test (HIT-6) score1 and migraine-related burden,2 according to results from the ongoing, open-label PREVAIL study.
Findings from the study, which is evaluating the long-term safety of repeat doses of 300 mg eptinezumab (ALD403; Alder) every 3 months in patients with chronic migraine, were presented at the 2019 American Headache Society Annual Meeting, July 11-14, in Philadelphia, Pennsylvania.
Eptinezumab is an investigational monoclonal antibody that targets calcitonin gene-related peptide. The drug, which is delivered via quarterly infusion, is currently under review by the FDA for the preventive treatment of episodic and chronic migraine.
The PREVAIL trial (NCT02985398) consists of 2 treatment phases, with a primary phase consisting of 4 infusions, and a secondary phase including up to an additional 4 infusions. The HIT-6 was used to evaluate patient-reported outcomes on headache impact before and after treatment, while the Migraine Disability Assessment (MIDAS) was used to measure patient-reported impact of migraine on daily functioning, including work/school responsibilities, household productivity, and social activity.
The HIT-6 was administered at baseline and at months 1, 3, 6, 9, and 12, while MIDAS was captured at baseline and months 3, 6, 9, and 12.
In total, data were collected from 128 patients in the primary treatment phase. Mean HIT-6 total scores decreased from 65.2 at baseline to 57.1 (-8.0) at month 1, with reductions generally similar through months 3 through 12 (month 12 mean, 56.9 [±8.69]; change from baseline, -8.3), all of which were significant (P <.001).
Notably, at baseline, 92.2% of patients reported severe life impact based on HIT-6 scores; that percentage dropped to 41.3% at month 6 and 43% at month 12. The percentage of patients who reported little to no life impact at baseline was less than 1%; that number increased to 21.5% at month 6 and 21.9% at month 12.
As for MIDAS, mean total score at baseline was 56.8, which decreased to 20 (mean change -36.3) at month 3, and continued to decrease through months 6 and 9. Changes were general maintained at month 12, with all reductions from baseline statistically significant (P <.001).
At baseline, 84.4% of patients had MIDAS scores that indicates severe disability, with 5.5% reported little to no disability. At month 3, 26.8% of patients reported severe disability, and those reported little to no disability increased to 43.1%, with results maintained through months 6 through 12. Overall, the majority of patients reported mild to no disability at months 3 through 12, demonstrating a clinically meaningful reduction in migraine-related burden on their work, home, and social lives.
Notably, the magnitude of therapeutic effect was either maintained or improved with subsequent infusions of eptinezumab through month 12 in both assessments.
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1. Spierings E, Biondi D, Hirman J, Horblyuk R, Cady R. reduced impact of headaches after migraine preventive treatment with eptinezumab in patients with chronic migraine: Results from the PREVAIL open-label safety study. Presented at: 2019 American Headache Society Annual Meeting. July 11-14, 2019; Philadelphia, PA. Poster 16.
2. Kudrow D, Berman G, Kassel E, et al. Eptinezumab treatment for migraine prevention reduces migraine disability in patients with chronic migraine: An analysis from the PREVIAL open-label safety study. Presented at: 2019 American Headache Society Annual Meeting. July 11-14, 2019; Philadelphia, PA. Poster 17.