Table 2.
Summary of injection-site reactions in pooled EVOLVE-1, EVOLVE-2, and REGAIN (placebo-controlled analysis set)
| Placebo (N = 1451) |
GMB 120 mg (N = 705) |
GMB 240 mg (N = 730) |
|
|---|---|---|---|
| Any/all ISRs, n (%) | 183 (12.6) | 128 (18.2) | 166 (22.7) |
| ISRs excluding pain, n (%) | 60 (4.1) | 70 (9.9) | 106 (14.5) |
| ISRs, n (%) | |||
| IS pain | 138 (9.5) | 71 (10.1) | 85 (11.6) |
| Unspecified ISR | 14 (1.0) | 22 (3.1) | 45 (6.2) |
| IS erythema | 20 (1.4) | 20 (2.8) | 29 (4.0) |
| IS pruritus | 2 (0.1) | 15 (2.1) | 24 (3.3) |
| IS bruising | 9 (0.6) | 4 (0.6) | 10 (1.4) |
| IS swelling | 1 (0.1) | 8 (1.1) | 4 (0.6) |
| IS rash | 2 (0.1) | 6 (0.9) | 4 (0.6) |
| IS induration | 1 (0.1) | 3 (0.4) | 3 (0.4) |
| IS discomfort | 3 (0.2) | 3 (0.4) | 2 (0.3) |
| IS hematoma | 7 (0.5) | 1 (0.1) | 3 (0.4) |
| IS hypersensitivity | 0 | 1 (0.1) | 3 (0.4) |
| IS mass | 0 | 3 (0.4) | 0 |
| IS haemorrhage | 2 (0.1) | 1 (0.1) | 1 (0.1) |
| IS inflammation | 0 | 1 (0.1) | 1 (0.1) |
| IS irritation | 3 (0.2) | 1 (0.1) | 1 (0.1) |
| IS urticarial | 1 (0.1) | 1 (0.1) | 1 (0.1) |
| IS discoloration | 0 | 0 | 1 (0.1) |
| IS oedema | 1 (0.1) | 1 (0.1) | 0 |
| IS papules | 0 | 1 (0.1) | 0 |
| IS vesicles | 0 | 0 | 1 (0.1) |
| IS warmth | 1 (0.1) | 0 | 0 |
Abbreviations:GMB galcanezumab, n number of participants within each specific category, IS injection-site, ISR injection-site reaction, N number of participants in the intent-to-treat population
Note: All values are for injection-site reactions 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