Table 2.
Proportion of patients with RF-R functional impairment and MIDAS disability at month 3 (double-blind) and month 6 (open-label)
| Measure | PBO | GMB | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RF-R functional impairment | N | Minimally/not | Mildly | Moderately | Severely | Extremely | N | Minimally/not | Mildly | Moderately | Severely | Extremely |
| EM, n (%) | ||||||||||||
| Baseline | 132 | 3 (2.27)a | 5 (3.79)a | 30 (22.73)d | 53 (40.15)e | 41 (31.06)e | 137 | 1 (0.73)a | 3 (2.19)a | 41 (29.93)d | 62 (45.26)e | 30 (21.90)d |
| Month 3* | 127 | 9 (7.09)b | 22 (17.89)c | 53 (41.73)e | 24 (18.90)c | 19 (14.96)c | 135 | 36 (26.67)d | 27 (20.00)c | 41 (30.37)e | 24 (17.78)c | 7 (5.19)b |
| Month 6 | 125 | 53 (42.40)e | 31 (24.80)d | 28 (22.40)d | 9 (7.20)b | 4 (3.20)a | 131 | 41 (31.30)e | 35 (26.72)d | 44 (33.59)e | 7 (5.34)a | 4 (3.05)a |
| CM, n (%) | ||||||||||||
| Baseline | 98 | 1 (1.02)a | 4 (4.08)a | 18 (18.37)c | 36 (36.73)e | 39 (39.80)e | 95 | 0 (0.00) a | 1 (1.05)a | 22 (23.16)d | 36 (37.89)e | 36 (37.89)e |
| Month 3* | 95 | 5 (5.26)b | 7 (7.37)b | 17 (17.89)c | 40 (42.11)e | 26 (27.37)d | 88 | 13 (14.77)c | 14 (15.91)c | 37 (42.05)e | 10 (11.36)c | 14 (15.91)c |
| Month 6 | 89 | 10 (11.24)c | 20 (22.47)d | 26 (29.21)d | 20 (22.47)d | 13 (14.61)c | 86 | 22 (25.58)d | 14 (16.28)c | 25 (29.07)d | 19 (22.09)d | 6 (6.98)b |
| MIDAS disability | Little/no | Mild | Moderate | Severe | Very severe | Little/no | Mild | Moderate | Severe | Very severe | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EM, n (%) | ||||||||||||
| Baseline | 132 | 9 (6.82)b | 7 (5.30)b | 20 (15.15)c | 45 (34.09)e | 51 (38.64)e | 137 | 13 (9.49)b | 12 (8.76)b | 18 (13.14)c | 35 (25.55)d | 59 (43.07)e |
| Month 3* | 127 | 15 (11.81)c | 14 (11.02)c | 30 (23.62)d | 34 (26.77)d | 34 (26.77)d | 135 | 44 (32.59)e | 22 (16.30)c | 23 (17.04)c | 32 (23.70)d | 14 (10.37)c |
| Month 6 | 125 | 53 (42.74)e | 21 (16.94)c | 29 (23.39)d | 12 (9.68)b | 9 (7.26)b | 131 | 54 (41.22)e | 19 (14.50)c | 23 (17.56)c | 21 (16.03)c | 14 (10.69)c |
| CM, n (%) | ||||||||||||
| Baseline | 98 | 7 (7.14)b | 4 (4.08)a | 8 (8.16)b | 17 (17.35)c | 62 (63.27)e | 95 | 5 (5.26)b | 4 (4.21)a | 10 (10.53)c | 19 (20.00)c | 57 (60.00)e |
| Month 3* | 95 | 7 (7.37)b | 6 (6.32)b | 11 (11.58)c | 22 (23.16)d | 49 (51.58)e | 88 | 16 (18.18)c | 11 (12.50)c | 10 (11.36)c | 22 (25.00)d | 29 (32.95)e |
| Month 6 | 89 | 17 (19.10)c | 9 (10.11)c | 14 (15.73)c | 18 (20.22)d | 31 (34.83)e | 86 | 18 (21.43)d | 14 (16.67)c | 10 (11.90)c | 22 (26.19)d | 20 (23.81)d |
All data are presented as n (%)
CM chronic migraine, EM episodic migraine, GMB galcanezumab, MIDAS Migraine Disability Assessment, n number of patients with observation, N number of patients in each population cohort at different timepoints, n number of patients with observation, PBO placebo, RF-R Role Function-Restrictive, * indicates a significant difference (p < 0.05) between treatment groups in the proportions of patients across functional impairment or disability categories at the given timepoint, based on Fisher’s exact test
In the open-label period (Month 6), all patients were treated with GMB, including the patients who received PBO in the double-blind period
Cut-offs: a = 0–5%; b = 5–10%; c = 10–20%; d = 20–30%; e ≥30%