DOI: 10.1177/03331024261462833 ISSN: 0333-1024

Fremanezumab for the preventive treatment of migraine in Chinese adults: A Phase 3, randomized controlled trial with an open-label extension

Shengyuan Yu, Hui Su, Hebo Wang, Meiyun Zhang, Steve Barash, Glenn Chen, Gloria Yiu, Juline Bryson, Yoel Kessler, Yael Carmeli Schwartz, Zipi Roth-Ben Arie, Michal Benedek-Segal, Xiaoping Ning
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Aim

Fremanezumab is approved for migraine prevention in Europe, the United States (US), Japan, South Korea, and several other countries; however, there are no data available on fremanezumab as a migraine preventive treatment in a Chinese population. This study evaluated the efficacy and safety of fremanezumab in Chinese adults with migraine.

Methods

This randomized, multicenter, Phase 3 trial consisted of a 4-week screening period, a 12-week double-blind period (DBP), and a 12-week open-label extension (OLE). Chinese adults with episodic and chronic migraine were randomized 1:1:2 to receive fremanezumab monthly (225 mg), fremanezumab quarterly (675 mg), or matched monthly placebo during the DBP. During the OLE, all participants received fremanezumab monthly (225 mg). The primary endpoint was mean change from baseline in monthly migraine days (MMD) during the DBP. Secondary endpoints included mean change from baseline in migraine days during the first 4 weeks of treatment and in monthly number of days with acute headache medication use during the DBP. Similar endpoints were assessed during the OLE. Safety assessments included, but were not limited to, adverse event (AE) reporting.

Results

In total, 365/454 screened participants were randomized to fremanezumab (n = 182 [monthly, n = 91; quarterly, n = 91]) or placebo (n = 183). Significantly greater changes from baseline in MMD were observed with fremanezumab versus placebo during the DBP (−4.6 vs −2.8; p  < 0.0001) and in mean migraine days during the first 4 weeks of treatment (−4.5 vs −2.2; p  < 0.0001). The mean change from baseline in days of acute headache medication use during the DBP was −3.0 with fremanezumab and −1.1 for placebo ( p  < 0.0001). During the OLE, the mean change from baseline in MMD was −6.8 and −7.2 for those assigned to fremanezumab and placebo, respectively, during the DBP. The percentage of participants with any AE was similar between fremanezumab and placebo groups during the DBP (47% vs 43%); serious AEs were infrequent (fremanezumab, 1%; placebo, <1%). Similar trends in AEs were observed during the OLE.

Conclusion

In this study, fremanezumab demonstrated significant improvements over placebo with respect to reductions in MMD and days with acute headache medication use, with these reductions being maintained over the OLE. Fremanezumab demonstrated a favorable safety profile, with no safety signals. These results are comparable to pivotal adult trials in Europe and the US, supporting the use of fremanezumab in Chinese adults living with migraine.

Clinical trial pre-registration

ClinicalTrials.gov identifier: NCT05458011; submitted: 11 July 2022; first participant enrolled: 30 September 2022; available at: https://clinicaltrials.gov/study/NCT05458011 ; first submitted: 11 July 2022).

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