One year after the third and fourth quarterly infusions, those administered the 300-mg dose of eptinezumab reported reductions of 5.2 monthly migraine days, compared to 4.0 days for patients in the placebo group.
Stephen D. Silberstein, MD
New 1-year efficacy data from PROMISE 1, a phase 3 clinical trial in patients with episodic migraine, has revealed that patients reported further reductions in monthly migraine days after their third and fourth quarterly infusions of the trial drug, eptinezumab.
Presented at the American Headache Society’s 60th Annual Scientific Meeting, in San Francisco, California, the calcitonin gene-related peptide (CGRP) inhibitor lowered monthly migraine days by 4.3 (baseline, 8.0) for patients treated with the 300-mg dose following the first infusion. Comparatively, those treated with placebo experienced reductions of 3.2 days (P = .0001).
One year after the third and fourth quarterly infusions, those administered the 300-mg dose of eptinezumab reported reductions of 5.2 monthly migraine days, compared to 4.0 for patients in the placebo group. As a note, the therapy’s efficacy was not statistically compared against placebo.
“The encouraging and consistent results from the PROMISE 1 trial showing that eptinezumab provided both immediate and long-term efficacy over a period of a year, reinforce our confidence in eptinezumab’s potential to be a meaningful new treatment option for migraine prevention,” said Robert Azelby, the chief executive officer of Alder, in a statement. "These data further validate the significance of our clinical program and underscore Alder’s commitment to transform the treatment paradigm for migraine prevention for patients whose quality of life is severely impacted by this debilitating disease.”
Additionally, roughly 31% of patients achieved a 100% reduction of migraine days from baseline, on average per month, compared to about 21% for patients given placebo. Altogether, the double-blind, placebo-controlled trial randomized 888 qualified patients to receive either eptinezumab (300 mg, 100 mg, or 30 mg), or placebo infusion, once-weekly for 12 weeks. All patients had previously experienced at least 14 headache days per month, with 4 of such headaches meeting the criteria for migraine.
“These data are very encouraging, especially for the majority of my patients who have struggled to find relief from traditional treatment options and have discontinued use either due to lack of efficacy or side effects,” Stephen D. Silberstein, MD, a professor of neurology and the director of the Jefferson Headache Center, at Thomas Jefferson University, said in a statement. “I look forward to the promise of a potential treatment that not only shows a strong efficacy profile but also demonstrates that the benefit may even further improve after each dose.”
The safety profile remained consistent, as no new safety findings were observed with the third and fourth quarterly infusions. The most commonly reported adverse events, happening at a rate of ≥2.0% across all eptinezumab treatment groups, and greater than that of placebo were: upper respiratory tract infection (10.5%), nasopharyngitis (6.8%), fatigue (3.2%), diarrhea (2.3%) and oropharyngeal pain (2.0%).
Previously, the therapy reported an average reduction of ≥50% monthly migraine days from baseline in 70.7% of patients, compared to just 58.7% for patients given placebo through months 6 to 12. That was an 8.9% improvement from mean reductions reported during the first 2 quarterly doses of therapy. Another 51.5% of eptinezumab patients reached a mean monthly migraine day reduction of ≥75% from baseline, while only 38.7% of patients given placebo reported that rate. That being a 12.8% improvement on the reduction rate reported by patients given therapy in the first 2 quarterly doses.
The therapy is also being investigated in the phase 3 PROMISE 2 trial. In January 2018, Alder Biopharmaceuticals, the developer, announced that the therapy also met all its key secondary endpoints in that study.
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