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