Adverse Events (Maintenance)
Summary of treatment-emergent adverse events through Week 44 (up to dose adjustment) in the maintenance study2
Randomized TREMFYA®*100 mg SC q4w | Randomized placebo(Induction Responder) | |
| N (treated patients)† | 186 | 192 |
| Average duration of follow-up, weeks | 40.5 | 34.0 |
| Patients with 1 or more: | ||
| Adverse events, n (%) | 120 (64.5%) | 131 (68.2%) |
| Serious adverse events, n (%) | 5 (2.7%) | 1 (0.5%) |
| Infections,‡ n (%) | 59 (31.7%) | 63 (32.8%) |
| Serious infections,‡ n (%) | 1 (0.5%) | 0 |
Randomized TREMFYA®200 mg SC q8w | Randomized placebo(Induction Responder) | |
| N (treated patients)† | 190 | 192 |
| Average duration of follow-up, weeks | 39.2 | 34.0 |
| Patients with 1 or more: | ||
| Adverse events, n (%) | 133 (70.0%) | 131 (68.2%) |
| Serious adverse events, n (%) | 12 (6.3%) | 1 (0.5%) |
| Infections,‡ n (%) | 59 (31.1%) | 63 (32.8%) |
| Serious infections,‡ n (%) | 2 (1.1%) | 0 |
*Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.1
†Randomized patients in the maintenance study.2
‡Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.2
Randomized TREMFYA®*100 mg SC q8w | 200 mg SC q4w | Randomized placebo(Induction Responder) | |
| N (treated patients)† | 186 | 190 | 192 |
| Average duration of follow-up, weeks | 40.5 | 39.2 | 34.0 |
| Patients with 1 or more: | |||
| Adverse events, n (%) | 120 (64.5%) | 133 (70.0%) | 131 (68.2%) |
| Serious adverse events, n (%) | 5 (2.7%) | 12 (6.3%) | 1 (0.5%) |
| Infections,‡ n (%) | 59 (31.7%) | 59 (31.1%) | 63 (32.8%) |
| Serious infections,‡ n (%) | 1 (0.5%) | 2 (1.1%) | 0 |
*Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.2
†Randomized patients in the maintenance study.2
‡Infections were defined as any adverse event that was coded to the MedDRA system organ class Infections and Infestations.2
Adverse reactions occurring in ≥3% of patients through Week 441 and at a higher rate than placebo
TREMFYA®*100 mg SC q8w (N=186) n (%) | TREMFYA®*200 mg SC (N=190) | PlaceboN=192 | |
| Injection site reactions† | 2 (1.1%) | 17 (8.9%) | 2 (1%) |
| Arthralgia | 8 (4.3%) | 15 (7.9%) | 13 (6.8%) |
| Upper respiratory tract infection | 6 (3.2%) | 13 (6.8%) | 8 (4.2%) |
*Patients receiving TREMFYA® 100 mg at Week 16 and every 8 weeks thereafter or TREMFYA® 200 mg at Week 12 and every 4 weeks thereafter.2
†TREMFYA® 200 mg was administered as two 100-mg injections.
Adverse reactions of special interest – malignancy data2
TREMFYA®100 mg SC q8w Randomized (total patients) | PlaceboRandomized (total patients) | |
| Analysis set: UC maintenance randomized safety§ | 186 | 192 |
| All malignancies|| | 0 | 4 (2.1%)# |
| Nonmelanoma skin cancer | 0 | 2 (1.0%) |
| Malignancies other than nonmelanoma skin cancer | 0 | 2 (1.0%) |
TREMFYA®200 mg SC q4w Randomized (total patients) | PlaceboRandomized (total patients) | |
| Analysis set: UC maintenance randomized safety§ | 190 | 192 |
| All malignancies|| | 1 (0.5%)¶ | 4 (2.1%)# |
| Nonmelanoma skin cancer | 0 | 2 (1.0%) |
| Malignancies other than nonmelanoma skin cancer | 1 (0.5%) | 2 (1.0%) |
TREMFYA®*100 mg SC q8w Randomized (total patients) | TREMFYA®*200 mg SC q4w Randomized (total patients) | PlaceboRandomized (total patients) | |
| Analysis set: UC maintenance randomized safety§ | 186 | 190 | 192 |
| All malignancies|| | 0 | 1 (0.5%)¶ | 4 (2.1%)# |
| Nonmelanoma skin cancer | 0 | 0 | 2 (1.0%) |
| Malignancies other than nonmelanoma skin cancer | 0 | 1 (0.5%) | 2 (1.0%) |
§Includes data up to the time of dose adjustment for subjects who had a dose adjustment.
||There were an additional 3 participants in the all-treated analysis set with malignancies.2
¶There was an additional malignancy in the nonrandomized TREMFYA® 200-mg q4w group (clear cell renal carcinoma).2
#There was an additional malignancy in the nonrandomized placebo group (breast cancer) and in another participant in the placebo to TREMFYA® dose adjustment group (squamous cell carcinoma).2
q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
