The phase IIb study evaluated changes in scores on the Headache Impact Test-6 (HIT-6) from baseline to week 12 in chronic migraine (CM) patients achieving ≥75%, ≥50 percent, ≥25 percent, and <25 percent response rate (RR) following a single intravenous infusion of eptinezumab, 300 milligrams, 100 milligrams, 30 milligrams, or 10 milligrams, or placebo.
The RR was measured as the reduction in migraine days per month.
Dr. Richard Lipton, of the Albert Einstein College of Medicine in New York, and colleagues reported the findings.
Eptinezumab, formerly called ALD403, is an investigational monoclonal antibody.
The analysis included 588 adults with CM who were randomized to eptinezumab or placebo. All patients had headaches on ≥15 of every 28 days, including ≥5 migraine attacks and ≥8 migraine days.
Subjects completed HIT-6 questionnaires at randomization and again at 4 and 12 weeks. HIT-6 provides a validated measure of headache impact on daily functioning through questions such as: "In the past 4 weeks, how often did headaches limit your ability to concentrate on work or daily activities?"
Reduction in migraine days higher for eptinezumab-treated patients
The primary endpoint was the percent of patients achieving a 75 percent reduction in migraine days per month from baseline to week 12.
Significantly more patients achieved a ≥75 percent and ≥50 percent RR with 300 milligrams (33 percent and 57 percent) or 100 milligrams (31 percent and 55 percent) of eptinezumab than those with placebo (21 percent and 41 percent) for 12 weeks post-treatment.
At randomization, HIT-6 scores averaged 64.5. HIT-6 scores for 75 percent responders receiving any study dose at week 4 were 50.9 (-13.6). Scores were sustained at 12 weeks at 52.2 (-12.3). HIT-6 scores for 50 percent responders were 57.1 at 4 weeks and 56.6 at 12 weeks. Minimal changes in HIT-6 scores were seen for ≥25 percent or <25 percent responders.
All doses of eptinezumab were well tolerated, and no serious treatment-related adverse events were reported.
"These data suggest that the response rates associated with eptinezumab treatment translate into reductions in headache impact as measured by HIT-6, reflecting improvement in function and quality of life," Dr. Lipton said.