Fremanezumab demonstrates efficacy, safety for migraine

Researchers reported no statistically significant differences between Ajovy and placebo for the treatment of posttraumatic headache among adults enrolled in a phase 2 study that evaluated the safety and efficacy of Ajovy.

“We observed similar results for the change in disability as measured by the Headache Impact Test, as well as patient satisfaction, as determined by the Patient Global Impression of Change rating,” Egilius L.H. Spierings, MD, PhD, founder, medical director and investigator of the the Boston Headache Institute and MedVadis Research Corporation at Boston PainCare, said during the presentation.

Spierings presented the study results at the American Headache Society Virtual Annual Scientific Meeting. The researchers assessed the safety and efficacy of Ajovy (fremanezumab-vfrm, Teva Pharmaceuticals) as a 675 mg dose given subcutaneously once a month for posttraumatic headaches in adult patients.

The phase 2 study involved a 12-week placebo-controlled sample period followed by 12 weeks of open-label treatment with Ajovy in one arm. A second arm received Ajovy for the duration of the study.

The sample included 85 patients with new or significantly worsening headaches following a minor traumatic brain injury or concussion. Spierings and colleagues evaluated the patients at baseline and compared their change in headache days of moderate or severe intensity after 12 weeks of treatment.

The mean age of patients in the placebo group was 43.8 years and 42.5 years in the fremanezumab group. Both cohorts included more than 50% women as well as a majority of white patients (90% or greater). Overall, the patients experienced head trauma 8 to 9 years prior to the study and an average of 18 moderate to severe headache days and 23 to 24 days headache days of any severity per month since.

The researchers observed decreases in the monthly mean number of headache days of at least moderate severity in both the Ajovy treatment arm (3.6 fewer days) and the placebo arm (5.1 fewer days), though the data were not statistically significant. The placebo group experienced, on average, a change in disability scores of -10.8 from baseline during the 12-week period compared to the Ajovy group, which saw an average decrease in disability score of -6.9. Additionally, the percentage of patients with a change from baseline in the Patient Global Impression of Change score for placebo and Ajovy groups was 30% vs. 33% at month one, 45% vs. 41% at month two and 50% vs. 35% at month three.

The researchers reported that “all but one” of the adverse events in the placebo group were mild or moderate. They reported no deaths during the study period and no “meaningful changes” in laboratory and clinical analyses.

“Despite being administered at a higher dose than labeled for migraine prevention, the safety data for Ajovy 675 mg subcutaneously monthly was comparable to placebo and consistent with the known safety profile of the medication,” Spierings said.