AAN 2025 | Efficacy and tolerability of fremanezumab in the prevention of episodic and chronic migraine

There are three main Phase III trials on fremanezumab in the prevention treatment of episodic migraine and chronic migraine. There is the HALO-EM and HALO-CM trial, which have been carried out respectively in patients affected by episodic migraine and by chronic migraine with at most one prior therapeutic failure. These studies, double-blind randomized, demonstrated a meaningful reduction in monthly migraine days and monthly headache days in the two populations with a good proportion of patient responders. Responders mean at least 50% reduction in the monthly migraine days in the last months of treatment compared to baseline. The patients reducing monthly headache days demonstrated also a significant improvement in quality of life, a significant decrease in the number of days using analgesics, and also a decrease in the disability related to migraine as measured by MIDAS and HIT-6. But the Phase III randomized control study includes also a study which is called FOCUS, which has been carried out by patients affected by chronic migraine or episodic migraine with from two to four prior therapeutic failures. This study is very interesting for the clinician because this patient resembles those that we every day see in our clinical practice. And indeed, also in the study, the results were highly statistically significant for both the primary endpoint and the secondary endpoint. So the FOCUS trial demonstrated a meaningful reduction in monthly migraine days, monthly headache days, days using analgesics, disability, and also a very interesting statistically significant reduction in terms of 50% response rate. But what the three trials have demonstrated is that there is also a proportion of patients who have a super response. What does super response mean? It means a reduction by at least 75% of migraine frequency compared to baseline. And there is also a small but not negligible proportion of patients who are absolute responders who show a 100% improvement in migraine frequency compared to baseline. Lastly, but it’s very important, the tolerability was very good. No safety issue emerged, so the efficacy and tolerability ratio was indeed very good, and this accounts for the high adherence of the patient to these treatments.

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