Table 6.
Key safety findings in CD studies, by baseline IMM use
| Induction (through week 8) | Maintenance (through week 44) | |||||||
|---|---|---|---|---|---|---|---|---|
| Placeboa | Ustekinumabb | Placeboa | Ustekinumabb | |||||
| +IMM | −IMM | +IMM | −IMM | +IMM | −IMM | +IMM | −IMM | |
| Number of patients treated | 195 | 429 | 410 | 952 | 70 | 136 | 112 | 223 |
| Mean weeks of follow-up | 8.2 | 8.1 | 8.1 | 8.2 | 27.2 | 24.7 | 33.4 | 30.3 |
| Percentage of patients with one or more: | ||||||||
| AEs | 56.4 | 66.0 | 57.8 | 62.6 | 77.1 | 81.6 | 72.3 | 79.8 |
| SAEs | 8.7 | 5.4 | 3.9 | 5.9 | 11.4 | 11.8 | 9.8 | 9.9 |
| Infectionsc | 26.2 | 22.4 | 18.8 | 23.1 | 40.0 | 41.9 | 41.1 | 42.6 |
| Deaths | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Phase II (only controlled IV patientsin population 1; through week 28), CERTIFI (through week 36), UNITI-1 and UNITI-2 (through week 8 for patients who entered IM-UNITI; through week 20 for patients who did not enter IM-UNITI, IM-UNITI (through week 44)
AEs adverse events, CD Crohn’s disease, IMM immunomodulators, IV intravenous, SAEs serious adverse events
IMMs included 6-mercaptopurine, azathioprine, or methotrexate
aIncludes data up to the time of early escape or crossover
bIncludes data from the first ustekinumab dose onward for patients who escaped early or crossed over from placebo
cInfection as assessed by the investigator