Fremanezumabの慢性片頭痛患者に対する治療成績，安全性について

抄録

(Background)

Fremanezumab is a humanized IgGΔa/kappa monoclonal antibody developed for the prevention of migraine. It selectively binds to the calcitonin gene–related peptide (CGRP), which is considered to be intrinsically involved in the pathology of migraine, thereby inhibiting the binding of two isomers (α– and β–CGRP) to CGRP receptors and suppressing the activation of the trigeminal system. In Japan, marketing approval for fremanezumab was obtained for the indication of “inhibition of migraine attacks” in June 2021. Two dosing regimens, once every 12 weeks (quarterly) and once every 4 weeks (monthly), are available.

(Clinical studies)

In a global phase 3 study in patients with chronic migraine (CM) (the HALO CM study), least squares mean ± standard deviation changes from baseline in the monthly average number of headache days of at least moderate severity (average during the 12–week period after the first dose), the primary endpoint, were −4.3 ± 0.3 days in the fremanezumab 675mg quarterly group (Q group) and −4.6 ± 0.3 days in the fremanezumab 225mg monthly group (M group). These were significantly shorter than the −2.5 ± 0.3 days in the placebo group (P group), thus demonstrating the superiority of fremanezumab to placebo (p < 0.0001, Wilcoxon rank–sum test). Common adverse drug reactions in the fremanezumab groups were injection site pain, induration, and erythema, of which most were mild or moderate. In the Japan–Korea joint phase 2b/3 study in patients with CM in Japan and Korea conducted after the HALO CM study, changes from baseline in the monthly average number of headache days of at least moderate severity (average during the 12–week period after the first dose), the primary endpoint, were −4.1 ± 0.4 days in the Q group and −4.1 ± 0.4 days in the M group. These were significantly shorter than the −2.4 ± 0.4 days in the P group, again demonstrating the superiority of fremanezumab over placebo (p < 0.001, ANCOVA). Adverse drug reactions observed in the fremanezumab groups were injection site pruritus, pain, induration, and erythema, and many of these reactions were mild or moderate.

Conclusion

The results of these two studies in patients with CM were similar regardless of race or region. Quarterly and monthly subcutaneous administration of fremanezumab to such patients is expected to become a new treatment option.