The chronic severity of migraine has been reduced with an experimental drugEptinezumab significantly decreases the impact of chronic migraine on daily functioning at weeks 4 to 12 following a single infusion, according to results reported at the annual meeting of 39 American Academy of Neurology, 2017, held in Boston, MA.
The eptinezumab drug has considerably reduced the number of days of migraine in patients suffering from chronic migraine.The Phase IIb study assessed variations in head-6 impact test scores (HIT-6) from baseline to week 12 in migraine patients Chronic (CM) up to ≥75%, ≥ 50%, ≥25% and 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 his colleagues reported the results.
Eptinezumab, formerly called ALD403, is an experimental monoclonal antibody.
The analysis included 588 adults with CM who were randomized to eptinezumab or placebo. All patients had ≥ 15 headaches every 28 days, including ≥ 5 migraine attacks and ≥ 8 days of migraine.
Subjects completed the HIT-6 questionnaires at random and again at 4 and 12 weeks. HIT-6 provides a validated measure of the impact of headache on daily functioning through such questions as: "In the past 4 weeks, how many times have headaches limited your ability to Focus on daily work or activities? "
Reduction of migraine days in patients treated with eptinezumab
The primary endpoint was the percentage of patients achieving a 75% reduction in migraine days per month from baseline to week 12.
More significantly, more patients achieved RR ≥ 75% and ≥ 50% with 300 milligrams (33% and 57%) or 100 milligrams (31% and 55%) of eptinezumab than those with Placebo (21% and 41%) for 12 weeks after treatment.
At randomization, HIT-6 scores averaged 64.5. HIT-6 scores for 75% of respondents receiving a study dose at week 4 were 50.9 (-13.6). The scores were maintained at 12 weeks at 52.2 (-12.3). HIT-6 scores for 50% of respondents were 57.1 to 4 weeks and 56.6 to 12 weeks. Minimal changes in HIT-6 scores were observed for ≥25% or
All doses of eptinezumab were well tolerated and no serious adverse events were reported.
"These data suggest that the response rates associated with eptinezumab treatment result in a reduction in head impact impact measured by HIT-6, reflecting improved function and Quality of life, "said Dr. Lipton.
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