Table 2 |.
Serious adverse events, infections and malignancies reported in maintenance and/or open-label extension trials
| Agent | Serious adverse events | Infections | Malignancies |
|---|---|---|---|
| Ustekinumab | |||
| UNITI-IM93 (phase III CD) | Placebo: 20/133 (15%) 90mg every 12weeks: 16/106 (12.1%) 90mg every 8weeks: 13/131 (9.9%) |
Any Placebo: 66/133 (49.6%) 90mg every 12weeks: 61/106 (46.2%) 90mg every 8weeks: 63/131 (48.1%) Serious Placebo: 3/111 (2.3%) 90mg every 12weeks: 7/106 (5.3%) 90mg every 8weeks: 3/131 (2.3%) |
Basal cell carcinoma Placebo: 1 90mg every 8weeks: 1 |
| UNIFI109 (phase III UC) | Placebo: 17/175 (9.7%) 90mg every 12weeks: 13/172 (7.6%) 90mg every 8weeks: 15/176 (8.5%) |
Any Placebo: 81/175 (46.3%) 90mg every 12weeks: 58/172 (33.7%) 90mg every 8weeks: 86/176 (48.9%) Serious Placebo: 4/175 (2.3%) 90mg every 12weeks: 6/172 (3.5%) 90mg every 8weeks: 3/176 (1.7%) |
Excluding non-melanoma skin cancer Placebo: 0 90mg every 12 weeks: 1/172 (0.6%) 90mg every 8 weeks: 1/176 (0.6%) |
| SEAVUE96 (phase III CD)a | Adallmumab: 32/195 (16.4%) Ustekinumab: 25/191 (13.1%) |
Any Adallmumab: 79/195 (40.5%) Ustekinumab: 65/191 (34.0%) Serious Adalimumab: 5/195 (2.6%) Ustekinumab: 4/191 (2.1%) |
Adalimumab: 1/195 (0.5%, basal cell carcinoma) Ustekinumab: 0 |
| Risankizumab | |||
| M15–993 (ref. 129) (phase II CD)b | Period 2: 18 (62.5) Period 3: 9 (20.8) Periods 1–3: 46 (42.2) |
Any Period 2: 37 (128.5) Period 3: 32 (73.9) Periods 1–3: 107 (98.1) Serious Period 2: 1 (3.5) Period 3: 1 (2.3) Periods 1–3: 5 (4.6) |
None |
| M15–989 (ref. 156) and M16–000 (ref. 156) (phase II and III open-label extension CD)c | 23 (35.4%); 24.6 | Any 48 (73.8%); 112 Serious 6 (9.2%); 4.2 |
None |
| FORTIFY99 (phase III CD)d | 360mg: 21.0 180mg: 19.5 Placebo: 19.3 |
Serious 360mg: 6.0 180mg: 3.0 Placebo: 5.0 |
Not reported |
| Guselkumab | |||
| GALAXI104 (phase II CD)e | ≥1 serious adverse events 200mg IV followed by 100mg SC: 6 (8.2%) 600 mg IV followed by 200 mg SC: 5 (6.8%) 1,200mg IV followed by 200mg SC: 5 (6.8%) |
≥1 infection 200 mg IV followed by 100 mg SC: 25 (34.2%) 600mg IV followed by 200mg SC: 30 (41.1%) 1,200mg IV followed by 200 mg SC: 25 (34.2%) ≥1serious infection 200mg IV followed by 100mg SC: 2 (2.7%) 600mg IV followed by 200mg SC: 2 (2.7%) 1,200mg IV followed by 200mg SC: 1 (1.4%) |
Not reported |
CD, Crohn’s disease; IV, intravenous; SC, subcutaneous; UC, ulcerative colitis.
a
Adalimumab and ustekinumab administered at approved doses.
b
Period 2 (week 26, n=101); period 3 (week 52, n = 62); periods 1–3 (weeks 12–52, n=115); data expressed as number of events per 100 patient-years.
c
184weeks (n = 65, 167 patient-years); data expressed as number of patients (%); events per 100 patient-years.
d
52 weeks; data expressed as exposure adjusted event rates per 100 patient-years.
e
48 weeks.