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Safety: SC Induction Study (GRAVITI)
GRAVITI 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 347 patients in the GRAVITI trial2
| TREMFYA®400 mg SC q4w | TREMFYA®400 mg SC q4w | Placebo* | |
| Safety analysis set, N | 115 | 115 | 117 | |
| Average duration of follow-up, weeks | 47.0 | 48.0 | 30.0 | |
| Average exposure, # of administrations | 6.8 | 11.8 | 7.1 | |
| Total patient-years of follow-up | 103.5 | 105.7 | 67.3 | |
| Deaths | 1† | 0 | 0 | |
| Patients with 1 or more: | ||||
| AEs, N (%) | 95 (82.6%) | 92 (80.0%) | 77 (65.8%) | |
| Events per 100 patient-years follow-up | 307.2 | 327.2 | 413.0 | |
| SAEs, N (%) | 15 (13.0%) | 9 (7.8%) | 16 (13.7%) | |
| Events per 100 patient-years follow-up | 15.5 | 13.2 | 37.1 | |
| AEs leading to discontinuation, N (%) | 4 (3.5%) | 3 (2.6%) | 10 (8.5%) | |
| Events per 100 patient-years follow-up | 6.8 | 2.8 | 14.9 | |
| Infections,‡ N (%) | 56 (48.7%) | 47 (40.9%) | 36 (30.8%) | |
| Events per 100 patient-years follow-up | 91.8 | 70.0 | 81.7 | |
| Serious infections, N (%) | 2 (1.7%) | 1 (0.9%) | 0 | |
| Adverse events of interest | ||||
| Subjects with 1 or more: | ||||
| Active tuberculosis | 0 | 0 | 0 | |
| Malignancy | ||||
| NMSC | 1 (0.9%)§ | 0 | 0 | |
| Malignancy (excluding NMSC) | 0 | 0 | 0 | |
| Anaphylactic or serum sickness–like reactions | 0 | 0 | 0 | |
| Opportunistic infections | 0 | 0 | 1 (0.9%) | |
| Major adverse cardiovascular events | 0 | 0 | 0 | |
| Venous thromboembolism | 0 | 0 | 1 (0.9%) | |
| Hepatic disorder adverse events|| | 6 (5.2%) | 5 (4.3%) | 5 (4.3%) |
GRAVITI 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 347 patients in the GRAVITI trial2
| TREMFYA®400 mg SC | Placebo* | |
| Safety analysis set, N | 115 | 117 | |
| Average duration of follow-up, weeks | 47.0 | 30.0 | |
| Average exposure, # of administrations | 6.8 | 7.1 | |
| Total patient-years of follow-up | 103.5 | 67.3 | |
| Deaths | 1† | 0 | |
| Patients with 1 or more: | |||
| AEs, N (%) | 95 (82.6%) | 77 (65.8%) | |
| Events per 100 patient-years follow-up | 307.2 | 413.0 | |
| SAEs, N (%) | 15 (13.0%) | 16 (13.7%) | |
| Events per 100 patient-years follow-up | 15.5 | 37.1 | |
| AEs leading to discontinuation, N (%) | 4 (3.5%) | 10 (8.5%) | |
| Events per 100 patient-years follow-up | 6.8 | 14.9 | |
| Infections,‡ N (%) | 56 (48.7%) | 36 (30.8%) | |
| Events per 100 patient-years follow-up | 91.8 | 81.7 | |
| Serious infections, N (%) | 2 (1.7%) | 0 | |
| Adverse events of interest | |||
| Subjects with 1 or more: | |||
| Active tuberculosis | 0 | 0 | |
| Malignancy | |||
| NMSC | 1 (0.9%)§ | 0 | |
| Malignancy (excluding NMSC) | 0 | 0 | |
| Anaphylactic or serum sickness–like reactions | 0 | 0 | |
| Opportunistic infections | 0 | 1 (0.9%) | |
| Major adverse cardiovascular events | 0 | 0 | |
| Venous thromboembolism | 0 | 1 (0.9%) | |
| Hepatic disorder adverse events|| | 6 (5.2%) | 5 (4.3%) |
| TREMFYA®400 mg SC | Placebo* | |
| Safety analysis set, N | 115 | 117 | |
| Average duration of follow-up, weeks | 48.0 | 30.0 | |
| Average exposure, # of administrations | 11.8 | 7.1 | |
| Total patient-years of follow-up | 105.7 | 67.3 | |
| Deaths | 0 | 0 | |
| Patients with 1 or more: | |||
| AEs, N (%) | 92 (80.0%) | 77 (65.8%) | |
| Events per 100 patient-years follow-up | 327.2 | 413.0 | |
| SAEs, N (%) | 9 (7.8%) | 16 (13.7%) | |
| Events per 100 patient-years follow-up | 13.2 | 37.1 | |
| AEs leading to discontinuation, N (%) | 3 (2.6%) | 10 (8.5%) | |
| Events per 100 patient-years follow-up | 2.8 | 14.9 | |
| Infections,‡ N (%) | 47 (40.9%) | 36 (30.8%) | |
| Events per 100 patient-years follow-up | 70.0 | 81.7 | |
| Serious infections, N (%) | 1 (0.9%) | 0 | |
| 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 | 0 | 0 | |
| Opportunistic infections | 0 | 1 (0.9%) | |
| Major adverse cardiovascular events | 0 | 0 | |
| Venous thromboembolism | 0 | 1 (0.9%) | |
| Hepatic disorder adverse events|| | 5 (4.3%) | 5 (4.3%) |
*Includes all placebo subjects excluding data after a subject is rescued with guselkumab.2
†There was 1 death reported through Week 12. The fatal AE of gunshot wound in a participant in the guselkumab 100 mg SC q8w treatment group was not self-inflicted (non-suicidal) and was considered not related to study intervention by the investigator.2
‡Infections are based on MedDRA system organ class Infections and Infestations.2
§Basal cell carcinoma.
||Most were liver enzyme elevations; none were serious and only 1 led to discontinuation of study agent.2
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.
SAFETY: Adverse Reactions (GRAVITI)
Most common adverse reactions occurring in ≥3% of patients through Week 48 in GRAVITI1
TREMFYA®400 mg SC q4w 100 mg SC q8w* | TREMFYA®400 mg SC q4w 200 mg SC q4w† | PlaceboN=117 | ||
| Respiratory tract infections,‡ n (%) | 44 (38.3) | 35 (30.4) | 30 (25.6) | |
| Abdominal pain,§ n (%) | 14 (12.2) | 16 (13.9) | 8 (6.8) | |
| Injection site reactions,|| n (%) | 5 (4.3) | 4 (3.5) | 0 | |
| Fatigue, n (%) | 3 (2.6) | 4 (3.5) | 0 | |
| Headache,¶ n (%) | 7 (6.1) | 9 (7.8) | 5 (4.3) | |
| Arthralgia, n (%) | 6 (5.2) | 5 (4.3) | 4 (3.4) | |
| Diarrhea, n (%) | 6 (5.2) | 4 (3.5) | 3 (2.6) | |
| Gastroenteritis, n (%) | 4 (3.5) | 2 (1.7) | 1 (0.9) |
TREMFYA®400 mg SC q4w 100 mg SC q8w* | PlaceboN=117 | |
| Respiratory tract infections,‡ n (%) | 44 (38.3) | 30 (25.6) |
| Abdominal pain,§ n (%) | 14 (12.2) | 8 (6.8) |
| Injection site reactions,|| n (%) | 5 (4.3) | 0 |
| Fatigue, n (%) | 3 (2.6) | 0 |
| Headache,¶ n (%) | 7 (6.1) | 5 (4.3) |
| Arthralgia, n (%) | 6 (5.2) | 4 (3.4) |
| Diarrhea, n (%) | 6 (5.2) | 3 (2.6) |
| Gastroenteritis, n (%) | 4 (3.5) | 1 (0.9) |
TREMFYA®400 mg SC q4w 200 mg SC q4w† | PlaceboN=117 | |
| Respiratory tract infections,‡ n (%) | 35 (30.4) | 30 (25.6) |
| Abdominal pain,§ n (%) | 16 (13.9) | 8 (6.8) |
| Injection site reactions,|| n (%) | 4 (3.5) | 0 |
| Fatigue, n (%) | 4 (3.5) | 0 |
| Headache,¶ n (%) | 9 (7.8) | 5 (4.3) |
| Arthralgia, n (%) | 5 (4.3) | 4 (3.4) |
| Diarrhea, n (%) | 4 (3.5) | 3 (2.6) |
| Gastroenteritis, n (%) | 2 (1.7) | 1 (0.9) |
*TREMFYA® 400 mg as a subcutaneous injection at Weeks 0, 4, and 8, followed by TREMFYA® 100 mg as a subcutaneous injection at Week 16 and every 8 weeks thereafter.
†TREMFYA® 400 mg as a subcutaneous injection at Weeks 0, 4, and 8, followed by TREMFYA® 200 mg as a subcutaneous injection at Week 12 and every 4 weeks thereafter.
‡Respiratory tract infections include bronchitis, COVID-19, H1N1 influenza, influenza, influenza-like illness, nasopharyngitis, pneumonia, respiratory tract infection, tonsillitis, upper respiratory tract infection, and viral upper respiratory tract infection.
§Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper.
||Injection site reactions includes application site hypersensitivity, application site pruritus, injection site edema, injection site erythema, injection site hemorrhage, injection site mass, injection site rash, injection site reaction, and injection site swelling.
¶Headache includes headache and tension headache.
q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.