Patient-reported outcomes with and without MO
During the 12-week treatment period, the LS mean (standard error) change from baseline in HIT-6 scores was significantly greater with fremanezumab versus placebo, regardless of MO at baseline (with MO: quarterly LS mean − 6.0 [0.7], monthly − 6.9 [0.6] vs placebo − 4.5 [0.7]; Table 2; without MO: quarterly − 7.0 [0.7], monthly − 6.8 [0.6] vs placebo − 4.5 [0.6]; Table 2).
Table 2 Change from baseline in patient-reported outcome measures with and without MO
CM With MO CM Without MO
Fremanezumab Fremanezumab
Quarterly(n = 201) Monthly(n = 198) Placebo(n = 188) Quarterly(n = 174) Monthly(n = 177) Placebo(n = 188)
HIT-6
 LSM (SE) −6.0 (0.7) −6.9 (0.6) −4.5 (0.7) −7.0 (0.7) − 6.8 (0.64) −4.5 (0.6)
  LSMD (SE) − 1.5 (0.7) −2.4 (0.7) −2.4 (0.7) − 2.3 (0.7)
  P value 0.0356 0.0009 0.0006 0.0012
MSQoL, RFR
 LSM (SE) 19.6 (1.8) 21.4 (1.8) 14.7 (1.9) 21.9 (2.0) 21.6 (2.0) 14.5 (1.9)
  LSMD (SE) 4.9 (2.0) 6.7 (2.0) 7.4 (2.1) 7.1 (2.1)
  P value 0.0142 0.0008 0.0005 0.0008
MSQoL, RFP
 LSM (SE) 17.5 (1.7) 18.4 (1.6) 14.2 (1.7) 16.4 (1.7) 14.2 (1.7) 10.2 (1.7)
  LSMD (SE) 3.2 (1.8) 4.2 (1.8) 6.2 (1.8) 3.9 (1.8)
  P value 0.0696 0.0200 0.0007 0.0290
MSQoL, EF
 LSM (SE) 20.2 (2.0) 22.0 (1.9) 17.3 (2.0) 22.4 (2.1) 19.7 (2.1) 16.7 (2.1)
  LSMD (SE) 2.9 (2.2) 4.7 (2.2) 5.7 (2.3) 3.0 (2.3)
  P value 0.1833 0.0305 0.0118 0.1873
PHQ-9
 LSM (SE) −2.8 (0.4) −2.3 (0.4) −2.4 (0.4) −2.6 (0.4) −2.3 (0.4) −1.6 (0.4)
  LSMD (SE) −0.5 (0.4) 0.0 (0.4) −1.0 (0.4) −0.7 (0.4)
  P value 0.2679 0.9678 0.0155 0.0922
CM Chronic migraine, EF Emotional function, HIT-6 Six-item Headache Impact Test, LSM Least-squares mean, LSMD Least-squares mean difference, MO Medication overuse, MSQoL Migraine-Specific Quality of Life, RFP Role function–preventive, RFR Role function–restrictive, PHQ-9 Patient Health Questionnaire-9, SE Standard error
LSMD was determined in comparison to placebo
Improvement in MSQoL domain scores was observed in patients with MO (RFR: quarterly 19.6 [1.8], monthly 21.4 [1.8] vs placebo 14.7 [1.9]; RFP: quarterly 17.5 [1.7], monthly 18.4 [1.6] vs placebo 14.2 [1.7]; EF: quarterly 20.2 [2.0], monthly 22.0 [1.9] vs placebo 17.3 [2.0]; Table 2). In the fremanezumab quarterly with MO group, the RFR domain score change from baseline compared with placebo was significant; the RFP and EF domain score changes were not significantly different from placebo (Table 2). All changes from baseline in MSQoL domain scores in the fremanezumab monthly group were significantly different compared with placebo (Table 2). Similarly, in patients without MO, improvements in MSQoL domain scores were observed (RFR: quarterly 21.9 [2.0], monthly 21.6 [2.0] vs placebo 14.5 [1.9]; RFP: quarterly 16.4 [1.7], monthly 14.2 [1.7] vs placebo 10.2 [1.7]; EF: quarterly 22.4 [2.1], monthly 19.7 [2.1] vs placebo 16.7 [2.1]; Table 2). All MSQoL domain scores in the fremanezumab quarterly without MO group were significantly different compared with placebo (Table 2). In the fremanezumab monthly without MO group, RFR and RFP domain score changes from baseline were significant compared with placebo; no significant difference in the EF domain score was observed (Table 2).
Reductions in PHQ-9 scores were observed, regardless of MO at baseline (with MO: quarterly − 2.8 [0.4], monthly − 2.3 [0.4] vs placebo − 2.4 [0.4]; without MO: quarterly − 2.6 [0.4], monthly − 2.3 [0.4] vs placebo − 1.6 [0.4]; Table 2). Numerically larger reductions were generally observed in the fremanezumab-treated groups compared with placebo; however, the only significant difference was observed in patients without MO in the fremanezumab quarterly group compared with placebo (Table 2).