SAFETY: IV Induction Studies (GALAXI 2 & 3)
GALAXI safety profile–treatment-emergent adverse events through Week 482
The safety profile of TREMFYA® in moderately to severely active Crohn’s disease was evaluated in 1048 patients in the GALAXI clinical trial program2
TREMFYA®200 mg IV q4w | TREMFYA®200 mg IV q4w | STELARA® (ustekinumab)~6 mg/kg IV 90 mg SC q8w | Placebo* | ||
| All-treated safety analysis set, N | 296 | 299 | 300 | 153 | |
| Average duration of follow-up, weeks | 46.2 | 46.7 | 45.5 | 21.8 | |
| Average exposure, # of administrations | 6.6 | 11.3 | 5.5 | 5.1 | |
| Total patient-years of follow-up | 261.8 | 267.3 | 261.4 | 64.0 | |
| Deaths | 0 | 0 | 0 | 0 | |
| Patients with 1 or more: | |||||
| AEs, N (%) | 225 (76.0%) | 233 (77.9%) | 236 (78.7%) | 82 (53.6%) | |
| Events per 100 patient-years follow-up | 327.3 | 353.5 | 340.5 | 499.7 | |
| SAEs, N (%) | 32 (10.8%) | 21 (7.0%) | 35 (11.7%) | 16 (10.5%) | |
| Events per 100 patient-years follow-up | 14.9 | 9.7 | 18.4 | 32.8 | |
| AEs leading to discontinuation, N (%) | 21 (7.1%) | 19 (6.4%) | 22 (7.3%) | 13 (8.5%) | |
| Events per 100 patient-years follow-up | 8.4 | 7.5 | 8.8 | 20.3 | |
| Infections,† N (%) | 127 (42.9%) | 147 (49.2%) | 126 (42.0%) | 39 (25.5%) | |
| Events per 100 patient-years follow-up | 77.9 | 88.3 | 77.7 | 87.5 | |
| Serious infections, N (%) | 1 (0.3%) | 3 (1.0%) | 12 (4.0%) | 2 (1.3%) | |
| Events per 100 patient-years follow-up | 0.4 | 1.1 | 5.7 | 6.3 | |
| Adverse events of interest | |||||
| Subjects with 1 or more: | |||||
| Active tuberculosis | 1 (0.3%)‡ | 0 | 0 | 0 | |
| Malignancy | |||||
| NMSC | 0 | 0 | 0 | 0 | |
| Malignancy (excluding NMSC) | 0 | 1 (0.3%)§ | 0 | 0 | |
| Anaphylactic or serum sickness–like reactions | 0 | 0 | 2 (0.7%) | 0 | |
| Opportunistic infections | 1 (0.3%) | 2 (0.7%) | 0 | 1 (0.7%) | |
| Major adverse cardiovascular events | 1 (0.3%) | 0 | 0 | 0 | |
| Venous thromboembolism | 0 | 0 | 1 (0.3%) | 0 | |
| Hepatic disorder adverse events|| | 12 (4.1%) | 14 (4.7%) | 7 (2.3%) | 3 (2.0%) |
TREMFYA®200 mg IV | Placebo* | ||
| All-treated safety analysis set, N | 296 | 153 | |
| Average duration of follow-up, weeks | 46.2 | 21.8 | |
| Average exposure, # of administrations | 6.6 | 5.1 | |
| Total patient-years of follow-up | 261.8 | 64.0 | |
| Deaths | 0 | 0 | |
| Patients with 1 or more: | |||
| AEs, N (%) | 225 (76.0%) | 82 (53.6%) | |
| Events per 100 patient-years follow-up | 327.3 | 499.7 | |
| SAEs, N (%) | 32 (10.8%) | 16 (10.5%) | |
| Events per 100 patient-years follow-up | 14.9 | 32.8 | |
| AEs leading to discontinuation, N (%) | 21 (7.1%) | 13 (8.5%) | |
| Events per 100 patient-years follow-up | 8.4 | 20.3 | |
| Infections,† N (%) | 127 (42.9%) | 39 (25.5%) | |
| Events per 100 patient-years follow-up | 77.9 | 87.5 | |
| Serious infections, N (%) | 1 (0.3%) | 2 (1.3%) | |
| Events per 100 patient-years follow-up | 0.4 | 6.3 | |
| Adverse events of interest | |||
| Subjects with 1 or more: | |||
| Active tuberculosis | 1 (0.3%)‡ | 0 | |
| Malignancy | |||
| NMSC | 0 | 0 | |
| Malignancy (Excluding NMSC) | 0 | 0 | |
| Anaphylactic or serum sickness–like reactions | 0 | 0 | |
| Opportunistic infections | 1 (0.3%) | 1 (0.7%) | |
| Major adverse cardiovascular events | 1 (0.3%) | 0 | |
| Venous thromboembolism | 0 | 0 | |
| Hepatic disorder adverse events|| | 12 (4.1%) | 3 (2.0%) |
TREMFYA®200 mg IV | Placebo* | ||
| All-treated safety analysis set, N | 299 | 153 | |
| Average duration of follow-up, weeks | 46.7 | 21.8 | |
| Average exposure, # of administrations | 11.3 | 5.1 | |
| Total patient-years of follow-up | 267.3 | 64.0 | |
| Deaths | 0 | 0 | |
| Patients with 1 or more: | |||
| AEs, N (%) | 233 (77.9%) | 82 (53.6%) | |
| Events per 100 patient-years follow-up | 353.5 | 499.7 | |
| SAEs, N (%) | 21 (7.0%) | 16 (10.5%) | |
| Events per 100 patient-years follow-up | 9.7 | 32.8 | |
| AEs leading to discontinuation, N (%) | 19 (6.4%) | 13 (8.5%) | |
| Events per 100 patient-years follow-up | 7.5 | 20.3 | |
| Infections,† N (%) | 147 (49.2%) | 39 (25.5%) | |
| Events per 100 patient-years follow-up | 88.3 | 87.5 | |
| Serious infections, N (%) | 3 (1.0%) | 2 (1.3%) | |
| Events per 100 patient-years follow-up | 1.1 | 6.3 | |
| Adverse events of interest | |||
| Subjects with 1 or more: | |||
| Active tuberculosis | 0 | 0 | |
| Malignancy | |||
| NMSC | 0 | 0 | |
| Malignancy (Excluding NMSC) | 1 (0.3%)§ | 0 | |
| Anaphylactic or serum sickness–like reactions | 0 | 0 | |
| Opportunistic infections | 2 (0.7%) | 1 (0.7%) | |
| Major adverse cardiovascular events | 0 | 0 | |
| Venous thromboembolism | 0 | 0 | |
| Hepatic disorder adverse events|| | 14 (4.7%) | 3 (2.0%) |
STELARA® | Placebo* | ||
| All-treated safety analysis set, N | 300 | 153 | |
| Average duration of follow-up, weeks | 45.5 | 21.8 | |
| Average exposure, # of administrations | 5.5 | 5.1 | |
| Total subject-years of follow-up | 261.4 | 64.0 | |
| Deaths | 0 | 0 | |
| Patients with 1 or more: | |||
| AEs, N (%) | 236 (78.7%) | 82 (53.6%) | |
| Events per 100 patient-years follow-up | 340.5 | 499.7 | |
| SAEs, N (%) | 35 (11.7%) | 16 (10.5%) | |
| Events per 100 patient-years follow-up | 18.4 | 32.8 | |
| AEs leading to discontinuation, N (%) | 22 (7.3%) | 13 (8.5%) | |
| Events per 100 patient-years follow-up | 8.8 | 20.3 | |
| Infections,† N (%) | 126 (42.0%) | 39 (25.5%) | |
| Events per 100 patient-years follow-up | 77.7 | 87.5 | |
| Serious infections, N (%) | 12 (4.0%) | 2 (1.3%) | |
| Events per 100 patient-years follow-up | 5.7 | 6.3 | |
| Adverse events of interest | |||
| Subjects with 1 or more: | |||
| Active tuberculosis | 0 | 0 | |
| Malignancy | |||
| NMSC | 0 | 0 | |
| Malignancy (Excluding NMSC) | 0 | 0 | |
| Anaphylactic or serum sickness–like reactions | 2 (0.7%) | 0 | |
| Opportunistic infections | 0 | 1 (0.7%) | |
| Major adverse cardiovascular events | 0 | 0 | |
| Venous thromboembolism | 1 (0.3%) | 0 | |
| Hepatic disorder adverse events|| | 7 (2.3%) | 3 (2.0%) |
Most common adverse reactions occurring in ≥3% of patients:
- Through Week 12 in GALAXI 1,¶ 2, and 3, headache (including headache, migraine, and sinus headache) was reported in ≥3% of subjects treated with intravenous TREMFYA® and at a greater rate than placebo (3.4% TREMFYA®-treated subjects vs 1.9% placebo-treated subjects)1
27 patients who did not meet SES-CD criteria were removed from the primary efficacy analyses, but were included in the all-treated safety set.2
*Includes all placebo subjects excluding data after a subject is rescued with guselkumab.2
†Infections are based on MedDRA system organ class Infections and Infestations.2
‡Patient lived in a tuberculosis-endemic region.
§Follicular thyroid carcinoma.
||Most were liver enzyme elevations. There were 4 patients in the TREMFYA® groups who had hepatic events classified as either serious or leading to treatment discontinuation.2
¶GALAXI 1 was a randomized, double-blind, dose-ranging trial.
AEs=adverse events; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=nonmelanoma skin cancer; q4w=every 4 weeks; q8w=every 8 weeks; SAEs=serious adverse events; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease.
