PHILADELPHIA –, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.
Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.
The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.
Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.
The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.
Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.
Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.
SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.