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Fremanezumab is explored as a preventive treatment approach for migraine.
Migraine is a complex neurologic disorder that is characterized primarily by recurrent attacks of pulsating headache. Fremanezumab is being investigated as a preventive treatment for migraine. In this phase 3 trial, the author evaluated the efficacy, safety, and side-effect profile of Fremanezumab and revealed that Fremanezumab, given monthly or quarterly as subcutaneous injections, was useful for the preventive treatment of chronic migraine.
Fremanezumab is explored as a preventive treatment approach for migraine. This phase 3 trial involved comparison of two Fremanezumab dose regimens with placebo for chronic migraine prevention.
Patients were divided in a 1:1:1 ratio to obtained 675 mg Fremanezumab monthly at the beginning and 225 mg at weeks 4 and 8, 675 mg Fremanezumab quarterly at beginning and placebo at weeks 4 and 8 and matching placebo through subcutaneous injection. The average change from baseline in the mean number of headache days per month throughout the 12 weeks following the first dose was considered as a primary endpoint.
Out of total 1130 patients, 375, 379 and 376 were randomized to placebo, Fremanezumab monthly, and Fremanezumab quarterly groups, respectively with 13.3, 12.8, and 13.2 mean number of baseline headache days, respectively. The least-squares mean (±SE) decrease in the mean number of headache days per month noticed was 4.3±0.3, 4.6±0.3 and 2.5±0.3 for Fremanezumab quarterly, Fremanezumab monthly, and placebo, respectively. Further, the Fremanezumab-quarterly, Fremanezumab-monthly, and placebo groups exhibited 38%, 41%, and 18% of patients with a decrease of at least 50% in the mean number of headache days. Five patients from each Fremanezumab group and three from placebo group exhibited abnormalities of hepatic function.
According to the study findings, Fremanezumab shows a preventive approach to chronic migraine management. However, injection-site reactions were common. Further research is required to assess Fremanezumab long-term safety and durability.
N Engl J Med. 2017 Nov 30;377(22):2113-2122
Fremanezumab for the Preventive Treatment of Chronic Migraine
Stephen D. Silberstein et al.
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