Sustained reductions in migraine days, moderate

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