Table 4.
Time to onset of injection-site reactions in pooled EVOLVE-1, EVOLVE-2 and REGAIN (placebo-controlled analysis set)
| n | All | Immediate response (< 60 min) | Acute reaction (1 to 6 h) | Delayed reaction (6 to 14 h) | Reaction > 14 days | Total on day of injection | Total after day of injection | |||
|---|---|---|---|---|---|---|---|---|---|---|
| On day of injection | After day of injection | |||||||||
| IS pain, n (%) | Placebo | 1451 | 134 (9.2) | 130 (97.0) | 0 (0.0) | 3 (2.2) | 1 (0.7) | 0 (0.0) | 133 (99.3) | 1 (0.7) |
| GMB 120 mg | 705 | 70 (9.9) | 62 (88.6) | 3 (4.3) | 1 (1.4) | 3 (4.3) | 1 (1.4) | 66 (94.3) | 4 (5.7) | |
| GMB 240 mg | 730 | 84 (11.5) | 71 (84.5) | 3 (3.6) | 6 (7.1) | 3 (3.6) | 1 (1.2) | 80 (95.2) | 4 (4.8) | |
| Unspecified ISR, n (%) | Placebo | 1451 | 14 (1.0) | 13 (92.9) | 1 (7.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 14 (100.0) | 0 (0.0) |
| GMB 120 mg | 705 | 22 (3.1) | 8 (36.4) | 5 (22.7) | 5 (22.7) | 4 (18.2) | 0 (0.0) | 18 (81.8) | 4 (18.2) | |
| GMB 240 mg | 730 | 44 (6.0) | 13 (29.5) | 14 (31.8) | 13 (29.5) | 4 (9.1) | 0 (0.0) | 40 (90.9) | 4 (9.1) | |
| IS erythema, n (%) | Placebo | 1451 | 20 (1.4) | 18 (90.0) | 1 (5.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 19 (95.0) | 1 (5.0) |
| GMB 120 mg | 705 | 20 (2.8) | 7 (35.0) | 5 (25.0) | 4 (20.0) | 4 (20.0) | 0 (0.0) | 16 (80.0) | 4 (20.0) | |
| GMB 240 mg | 730 | 28 (3.8) | 7 (25.0) | 11 (39.3) | 4 (14.3) | 6 (21.4) | 0 (0.0) | 22 (78.6) | 6 (21.4) | |
| IS pruritus, n (%) | Placebo | 1451 | 2 (0.1) | 2 (100.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (100.0) | 0 (0.0) |
| GMB 120 mg | 705 | 15 (2.1) | 3 (20.0) | 3 (20.0) | 6 (40.0) | 3 (20.0) | 0 (0.0) | 12 (80.0) | 3 (20.0) | |
| GMB 240 mg | 730 | 24 (3.3) | 2 (8.3) | 10 (41.7) | 5 (20.8) | 7 (29.2) | 0 (0.0) | 17 (70.8) | 7 (29.2) | |
Abbreviations:GMB galcanezumab, IS injection-site, ISR injection-site reaction, n number of patients with non-missing reaction timings
Note: All values are for ISR during the double-blind treatment phase from study start up to 6 months for EVOLVE-1 and EVOLVE-2 and up to 3 months for REGAIN