Fremanezumab Shown to Improve Headache-Related Disability Outcomes in Patients With Chronic and Episodic Migraines

Both quarterly and monthly fremanezumab treatment was shown to clinically improve headache-related disability outcomes in patients with either chronic migraines (CM) or episodic migraines (EM) and reported inadequate response to 2 to 4 classes of migraine preventative medications, according to a study presented at the 2019 annual meeting of the American Neurological Association (ANA) earlier this month.

Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP), has shown effectiveness as a preventative treatment of migraine in adults. Migraine has been identified as the second leading cause of years lived with disability worldwide.

Researchers conducted a 12-week, double-blind study, FOCUS, which served as the first and largest study of a migraine preventative treatment in a difficult-to-treat population of adults with both EM and CM and documented inadequate response to other preventative medications. In the FOCUS study, exploratory endpoints on headache-related disability were assessed through the 6-item Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) questionnaire. A total of 838 patients (509 of whom had CM and 329 of whom had EM) were randomized 1:1:1 to quarterly fremanezumab followed by placebo (month 1, 675 mg fremanezumab; month 2 and 3, placebo), monthly fremanezumab (month 1, 675 mg in patients with CM or 225 mg in patients with EM; months 2 and 3, 225 mg), or matched monthly placebo.

Covariance model analysis was used to determine changes in HIT-6 and MIDAS scores from baseline during the 4 weeks after administration of the third dose of study drug

Results from the FOCUS study revealed a significantly greater reduction from baseline during the 4 weeks after study drug administration in the HIT-6 score for both quarterly and monthly fremanezumab dosing regimens versus placebo in the overall population, as well as the 2 subgroups:

• The overall population least-squares mean (LSM) standard error (SE) change from baseline was —5.2 (0.55) for quarterly fremanezumab and –6.1 (0.54) for monthly fremanezumab versus placebo (P <.0001).
• The CM subgroup LSM change from baseline was —3.8 (0.61) for quarterly fremanezumab and –5.1 (0.60) for monthly fremanezumab versus placebo (–2.2 [0.54]; P <.0068).
• The EM subgroup LSM change from baseline was —6.2 (1.05) for quarterly fremanezumab and –6.6 (1.03) for monthly fremanezumab versus placebo (–2.3 [1.00]; P <.0001).

The MIDAS score exhibited similar, significant reductions from baseline for both quarterly and monthly fremanezumab regimens in terms of LSM change both quarterly (−19.7 [3.29]) and monthly (−24.7 [3.24]) versus placebo (−7.0 [3.24]) in the overall population (P ≤.0002). Similar changes were seen in the CM subgroup quarterly (−13.2 [4.64]) and monthly (−21.6 [4.61]) versus placebo (−0.8 [4.77]; P ≤.0162), and in the EM subgroup quarterly (−23.3 [2.96]) and monthly (−24.6 [2.90]) versus placebo (−12.2 [2.82]; P <.0001).

The FOCUS Study results revealed a definite reduction in headache and migraine severity through HIT-6 and MIDAS assessments, which highlights the efficacy of both quarterly and monthly fremanezumab in providing clinically relevant improvements for each studied demographic.

Reference

Ferrari MD, Ning X, Galic M, et al. Improvements in headache-related disability with fremanezumab treatment in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive medications in the randomized, placebo-controlled FOCUS study. Presented at: American Neurological Association, ANA 2019 Annual Meeting; October 13-15, 2019; St. Louis, MO. Abstract 195.