Table 4.
Key safety findings by dose among randomized and treated CD patients
| Through week 8 of UNITI-1 and UNITI-2 | Through week 44 or time of dose adjustment in IM-UNITI | |||||||
|---|---|---|---|---|---|---|---|---|
| Ustekinumab | Ustekinumabb | |||||||
| Placebo | 130 mg IV | 6 mg/kg IV | Combined | Placebo SCa,b | 90 mg SC q12w | 90 mg SC q8w | Combined | |
| Number of patients randomized and treated | 466 | 471 | 470 | 941 | 133 | 132 | 131 | 263 |
| Mean weeks of follow-up | 8.18 | 8.22 | 8.16 | 8.19 | 32.0 | 36.6 | 35.2 | 35.9 |
| Number (%) of patients with: | ||||||||
| AEs | 282 (60.5) | 275 (58.4) | 284 (60.4) | 559 (59.4) | 111 (83.5) | 106 (80.3) | 107 (81.7) | 213 (81.0) |
| SAEs | 28 (6.0) | 23 (4.9) | 25 (5.3) | 48 (5.1) | 20 (15.0) | 16 (12.1) | 13 (9.9) | 29 (11.0) |
| Infectionsc | 108 (23.2) | 92 (19.5) | 111 (23.6) | 203 (21.6) | 66 (49.6) | 61 (46.2) | 63 (48.1) | 124 (47.1) |
| Serious infectionsc | 6 (1.3) | 7 (1.5) | 8 (1.7) | 15 (1.6) | 3 (2.3) | 7 (5.3) | 3 (2.3) | 10 (3.8) |
| D/C study drug due to AEs | 19 (4.1) | 8 (1.7) | 8 (1.7) | 16 (1.7) | 8 (6.0) | 10 (7.6) | 4 (3.1) | 14 (5.3) |
q8w every 8 weeks, q12w every 12 weeks, AEs adverse events, CD Crohn’s disease, D/C discontinuation, IV intravenous, SAEs serious adverse events, SC subcutaneous
aPatients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into the maintenance study
bIncludes data up to the time of dose adjustment (i.e., time of meeting loss-of-response criteria)
cInfection as assessed by the investigator