Table 2.
Number of randomized patients who discontinued study agent during the LTE (through final Week 252 dosing visit)
| Placebo SCa | Ustekinumab 90 mg q12wa | Ustekinumab 90 mg q8wa | Prior dose adjustmentb | |
|---|---|---|---|---|
|
| ||||
| N | 61 | 84 | 82 | 71 |
| Patients who discontinued, N | 61 (100%) | 39 (46.4%) | 34 (41.5%) | 40 (56.3%) |
| Reason for discontinuation | ||||
| Adverse events | 7 (11.5%) | 14 (16.7%) | 10 (12.2%) | 13 (18.3%) |
| Due to a worsening of CD | 3/7 (42.9%) | 10/14 (71.4%) | 5/10 (50.0%) | 6/13 (46.2%) |
| Lack of efficacy | 5 (8.2%) | 7 (8.3%) | 4 (4.9%) | 9 (12.7%) |
| Protocol violation | 0 | 1 (1.2%) | 1 (1.2%) | 1 (1.4%) |
| Study terminated by sponsor | 0 | 0 | 0 | 0 |
| Physician decision | 0 | 1 (1.2%) | 3 (3.7%) | 1 (1.4%) |
| Lost to follow-up | 1 (1.6%) | 2 (2.4%) | 1 (1.2%) | 1 (1.4%) |
| Withdraw of consent for administration of study agent | 4 (6.6%) | 12 (14.3%) | 11 (13.4%) | 11 (15.5%) |
| Death | 0 | 1 (1.2%) | 0 | 2 (2.8%) |
| Placebo patients discontinued due to study unblinding (after Week 44 analysis complete) | 44 (72.1%) | NA | NA | NA |
CD, Crohn’s disease; IV, intravenous; NA, not applicable; LTE, long-term extension; q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous
Patients who were in clinical response to ustekinumab IV induction dosing, were randomized in the maintenance study, and did not meet loss of response criteria from Week 8 through Week 32.
Patients who were in clinical response to ustekinumab induction dosing, were randomized in the maintenance study, met loss of clinical response criteria from Week 8 through Week 32, and initiated ustekinumab 90 mg SC q8w (for patients initially randomized to placebo SC or ustekinumab 90 mg SC q12w) or continued ustekinumab 90 mg SC q8w (for patients initially randomized to ustekinumab 90 mg SC q8w).