Outcomes
The primary endpoint of the study, mean change from baseline (28-day pretreatment period) in the monthly average number of headache days of at least moderate severity during the 12-week treatment period, has been previously described [16]. Herein, post hoc analyses were conducted to assess the impact of fremanezumab in patients with and without MO. Patients were grouped based on the presence or absence of baseline MO, which was defined as use of acute headache medication on ≥15 days, migraine-specific acute medication on ≥10 days, or combination medications for headache on ≥10 days during the 28-day pretreatment period [17].
The following outcomes were assessed in patients with and without MO based on mean change from baseline (28-day pretreatment period) in the: monthly average number of headache days of at least moderate severity during the 12-week treatment period; monthly average number of migraine days during the 12-week treatment period; and monthly average number of days of any acute headache medication use. Also assessed was the proportion of patients with a ≥ 50% reduction from baseline (28-day pretreatment period) in the monthly average number of headache days of at least moderate severity during the 12-week treatment period; mean change from baseline (day 0) in scores on the six-item Headache Impact Test (HIT-6; scores range from 36 to 78, with higher scores indicating greater impact of headache on functional status and well-being) [18] at 4 weeks after the last dose of study drug; mean change from baseline (day 0) in domain scores on the Migraine-Specific Quality of Life (MSQoL) questionnaire (domains assessed: role function–restrictive [RFR; seven items on how migraines limit daily activities], role function–preventive [RFP; four items on how migraines prevent these activities], emotional function [EF; three items on the emotional effects of migraines]; scores range from 0 to 100, with higher scores indicating better health-related quality of life) [19] at 4 weeks after the last dose of study drug; and mean change from baseline (day 0) in scores on the nine-item Patient Health Questionnaire (PHQ-9; scores range from 0 to 27, with depression severity categorized as no or minimal [0 to 4], mild [5 to 9], moderate [10 to 14], moderately severe [15 to 19], and severe [20 to 27]) [20] at 4 weeks after the last dose of study drug.
Additionally, patients with MO at baseline were assessed for reversion to no MO, where reversion was defined as no longer meeting criteria for MO over the 12-week period, or continued MO during the 12-week treatment period. Outcomes assessed in these subgroups included those previously described.