BOSTON—Erenumab reduces the number of mi- graine days per month in patients with episodic migraine, according to a study presented at the 69th Annual Meeting of the American Academy of Neurology.
The treatment also reduces the use of acute migraine
medication and improves function.
Erenumab is a fully human monoclonal antibody developed to block the pathway of calcitonin gene-related
peptide (CGRP). The treatment showed promise in a
phase II study in patients with episodic migraine and
in a phase II study of patients with chronic migraine,
according to Peter Goadsby, MD, PhD, Professor of
Neurology at the University of California, San Francisco
School of Medicine.
A Test of Two Doses
Dr. Goadsby and colleagues conducted a phase III
study of 955 participants to examine whether erenumab would be an effective preventive treatment for
episodic migraine. Eligible patients had between four
and 14 migraine days per month and were allowed to
take one concomitant migraine medication. Patients
who previously had failed two preventive medications
were excluded. After screening, patients underwent
a four-week baseline period during which they kept
electronic migraine diaries. The investigators then randomized patients in groups of equal size to placebo,
70 mg of subcutaneous erenumab, or 140 mg of subcutaneous erenumab. The treatment period lasted for
As has been the case in many studies of migraine
during the past 25 years, the typical patient in this study
was a 41-year-old Caucasian woman, said Dr. Goadsby.
Slightly more than half of participants had no previous
exposure to a preventive therapy. The mean number of
migraine days in all treatment groups was eight, and the
mean number of headache days was nine. The treatment
groups were well balanced.
Treatment Reduced Medication Use
During the last three months of treatment, the mean
number of monthly migraine days decreased by 3. 2
for patients receiving 70 mg of erenumab and by 3. 7
for patients receiving 140 mg of erenumab, compared
with 1. 8 for patients receiving placebo. The difference
between the active and control arms was statistically significant. The rate of participants who had a 50% reduction in migraine attacks was 26.6% for controls, 43% for
patients receiving the 70-mg dose, and 50% for patients
receiving the 140-mg dose.
The use of acute medicines decreased by 1. 1 days
for patients receiving 70 mg of erenumab and by 1.6
days for patients receiving 140 mg, compared with a
decrease of 0.2 days for patients receiving placebo. Using the Migraine Physical Function Impact Diary, participants in the 70-mg group reported that the impact of
migraine on everyday activities decreased by 5. 5 points.
Participants in the 140-mg group reported a 5.9-point
reduction in this end point. Participants in the placebo
group reported a 3.3-point reduction. Physical impairment decreased by 4. 2 points for the 70-mg group and
by 4. 8 points for the 140-mg group versus 2. 4 points
for the placebo group.
Erenumab was well tolerated, and none of the serious adverse events appeared to be related to treatment.
The most common adverse event was injection-site reactions. About 6% of the entire cohort developed antibodies to erenumab, including 8% in the 70-mg group and
3.2% in the 140-mg group. One patient receiving 70
mg had a neutralizing antibody, and no patients in the
140-mg group had neutralizing antibodies.
The study results are exciting, said Dr. Goadsby. In
the future, treatments that target the CGRP pathway
could be provided to migraineurs who do not respond
to or cannot tolerate the current therapies, he added.
The trial was sponsored by Amgen, and Dr. Goadsby
previously has consulted for the company. NR
Erenumab May Reduce
Headache Days in Episodic Migraine
The monoclonal antibody appears to reduce the impact of migraine on everyday
activity and physical function.