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PROMISE-1: Migraine nipped in the bud with eptinezumab drip

Jairia Dela Cruz
21 Dec 2020

Intravenous eptinezumab has demonstrated early and sustained migraine-preventive effects with a favourable safety profile in adult patients with episodic migraine (EM), according to the 1-year results of the phase III PROMISE-1* study.

“These data confirm and extend the positive results of the 12-week primary analysis … [and suggest] that the calcitonin gene–related peptide (CGRP)-targeted monoclonal antibody eptinezumab can provide clinically meaningful migraine reductions for patients with EM,” the investigators said.

In total, 888 patients (mean age, 39.8 years; 84.3 percent female; 83.8 percent white) received four infusions of eptinezumab at 30 mg (n=219), 100 mg (n=223), or 300 mg (n=224), or placebo (n=222), administered 12 weeks apart, on day 0, then weeks 12, 24, and 36.

As early as the first day after the first dosing, eptinezumab 100 mg and 300 mg produced marked reductions in migraine episodes compared with placebo during the initial 12-week evaluation period. The percentages of patients with migraine decreased by 52 percent with 100 mg, 55 percent with 300 mg, and 27 percent with placebo. [Cephalalgia 2020;40:241-254]

Mean monthly migraine days dropped consistently throughout the study. For example, there was a reduction of 3.9 days in the 100-mg group and 4.3 days in the 300-mg group versus 3.2 days with placebo during the first 12 weeks alone. The corresponding reductions seen during weeks 13–24, 25–36, and 37–48 were 4.5, 4.7, and 4.5 days with 100 mg eptinezumab, 4.8, 5.1, and 5.3 days with 300 mg, and 3.8, 4.0, and 4.0 days with placebo. [Clin Ther 2020;42:2254-2265.E3]

The number of patients with a ≥50- or ≥75-percent reduction in migraine frequency was numerically higher among actively treated patients than among dose who received placebo for each 12-week interval during the entire study. There was no difference in the proportion of those who achieved a ≥50-percent reduction across the eptinezumab groups.

Of note, the responses were better during the second half of the study (weeks 24–48) relative to the first half (weeks 1–24).

Eptinezumab was well tolerated throughout the study. Adverse events, including upper respiratory tract infection, nasopharyngitis, sinusitis, dizziness, nausea, and fatigue, were similar across dosing periods. No serious tolerability signals emerged with continued dosing.

“The sustained preventive benefit of eptinezumab observed in this study may contribute to improved persistence with therapy, as does the acceptable tolerability profile,” given that lack of efficacy and the occurrence of adverse effects are the common reasons cited for the discontinuation of migraine-preventive medications, according to the investigators.

Additionally, there are merits to a longer dosing interval, they continued. Patients, specifically, say that such an approach is more convenient, with fewer treatments to keep track of. Compared with monthly, quarterly administration also yields greater savings in terms of medication costs. [J Headache Pain 2019;20:50]

Likewise, physicians prefer administration every 12 weeks, mostly because of the potential for improved adherence, reduced monthly injection burden, and fewer injection-days, the investigators pointed out.

“Additional research will provide greater insight into the potential benefits of eptinezumab and other migraine preventive measures designed to reduce or eliminate the need for daily therapy,” they said.

*Prevention of Migraine via Intravenous ALD403 Safety and Efficacy 1

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