%0 Journal Article
%T Sustained reductions in migraine days, moderate
%A David W Dodick
%A Ernesto Aycardi
%A Marcelo E Bigal
%A Mirna McDonald
%A Pippa S Loupe
%A Rashmi B Halker Singh
%J Cephalalgia
%@ 1468-2982
%D 2019
%R 10.1177/0333102418772585
%X In phase 2 and 3 studies, fremanezumab, a monoclonal CGRP antibody, was an effective preventive treatment for high-frequency episodic migraine (HFEM) and chronic migraine (CM). Post-hoc analyses evaluated population-wise 50%, 75% and 100% responder rates, and the extent to which individual responders sustained a 50%, 75% and 100% reduction in migraine days, moderate-to-severe (M/S) headache days and days of acute medication use during all three treatment months of the fremanezumab phase 2 studies. HFEM patients received either placebo or three once-monthly injections of 225£¿mg or 675£¿mg. CM patients received either placebo or three once-monthly injections of 900£¿mg, or an initial loading dose of 675£¿mg and subsequent injections of 225£¿mg. Patients reported headache-related data daily using an electronic diary. In the HFEM study, the percent of patients on fremanezumab doses 225£¿mg and 675£¿mg were greater compared to the percent of placebo patients with sustained 50% reduction in migraine days (39% and 35% vs. 10% for placebo, both p£¿<£¿0.0001), M/S headache days (36% and 38% vs. 16% placebo, p£¿=£¿0.0017 and p£¿=£¿0.0007 respectively), and acute medication use days (36% and 27% vs. 8% placebo, p£¿<£¿0.0001 and p£¿=£¿0.0003). Likewise, although there were fewer patients with sustained 75% reduction, there were increases in the percent of patients on fremanezumab 225£¿mg and 675£¿mg in the HFEM study relative to placebo patients in migraine days (19% and 11% vs. 3% placebo, p£¿=£¿0.0002 and p£¿=£¿0.0176), M/S headache days (19% and 15% vs. 2% placebo, p£¿=£¿0.0001 and p£¿=£¿0.0011) and days of acute medication use (16% and 8% vs. 2% placebo, p£¿=£¿0.0005 and p£¿=£¿0.0377). In the CM study, there were increases in the percent of patients on fremanezumab 675/225£¿mg and 900£¿mg with 50% sustained reduction in M/S headache days (32% and 40% vs. 15% placebo, p£¿=£¿0.0058 and p£¿=£¿0.0002) and days of acute medication use (26% and 22% vs. 11% placebo, p£¿=£¿0.0098 and p£¿=£¿0.0492). There were also increases in the percent of patients on fremanezumab 675/225£¿mg and 900£¿mg compared to patients on placebo with 75% sustained reduction in M/S headache days (10% and 13% vs. 3%, p£¿=£¿0.0665 and p£¿=£¿0.0203). Few patients had 100% sustained reductions in these parameters in either study. Post-hoc results must be interpreted with caution; nonetheless, a statistically significant percentage of patients who initially responded to fremanezumab within 1 month sustained this response over the subsequent 2 months. Sustained reduction in individual patients may provide a novel patient-centric, clinically
%K Fremanezumab
%K monoclonal CGRP antibody
%K preventive migraine treatment
%K 50% responder rates
%K 75% responder rates
%K 100% responder rates
%K TEV-48125
%U https://journals.sagepub.com/doi/full/10.1177/0333102418772585