PHILADELPHIA – , according to a poster presented at the annual meeting of the American Academy of Neurology.
Dr. Peter McAllister
To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).
The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.
In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).
In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).
“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.
“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”
This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.
SOURCE: McAllister P et al. AAN 2019. P1.10-011.