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PROMISE‐2 trial in chronic migraine: Eptinezumab has achieved meaningful reductions in migraine activity as early as day 1


Calcitonin gene‐related peptide ( CGRP ) plays an important role in migraine pathophysiology. Eptinezumab, a humanized, anti‐CGRP monoclonal antibody with 100% bioavailability following intravenous administration, selectively and potently inhibits CGRP.

Researchers have evaluated effects of Eptinezumab on migraine activity from day 1 postinfusion through weeks 4 and 12 in subjects with chronic migraine.

Adults with chronic migraine were randomized ( 1:1:1 ) to Eptinezumab 100, 300 mg, or placebo. Following a 28‐day baseline run‐in with an eDiary to confirm headache frequency, infusions were administered on day 0 and at week 12.

The primary endpoint was change from baseline in frequency of monthly migraine days ( MMD ) over weeks 1‐12.
A key secondary endpoint was the percentage of subjects with a migraine on day 1 postinfusion. Other secondary endpoints included the average percentage of subjects with a migraine on any given day over each of the first 4 weeks postinfusion ( weeks 1, 2, 3, and 4 ) and the MMD over each month ( weeks 1‐4, 5‐8, and 9‐12 ).

Efficacy analysis included 1072 subjects.

Mean baseline MMD in the 100‐mg, 300‐mg, and placebo groups were 16.1, 16.1, and 16.2, respectively.

Mean reductions from baseline in MMD over weeks 1‐12 were −7.7.

The average percent of subjects with a migraine on any given day during the baseline period in the 100‐mg, 300‐mg, and placebo groups was 57.5%, 57.4%, and 58.0%, respectively.

The percent of subjects with a migraine on day 1 postinfusion was 28.6% ( -50.3% [ p=0.0001 ] ) and 27.8% ( -51.6% [ p less than 0.0001 ] ) with Eptinezumab 100 and 300 mg, respectively, versus 42.3% ( -27.1% ) with placebo.

Similar reductions in the average percent of subjects with a migraine on any given day was observed over each of the first 4 weeks postinfusion ( weeks 1, 2, 3, and 4 ).

In conclusion, a single infusion of Eptinezumab has significantly reduced MMD for 3 months in subjects with chronic migraine.
The preventive benefit was obseved as early as day 1, when the percent of subjects with a migraine was reduced by approximately 50% following Eptinezumab infusion. ( Xagena )

Source: American Headache Society ( AHS ) Annual Meeting, 2018

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