Table 3.
Efficacy assessments at Week 252 among randomized patients who entered the LTE
| Ustekinumab |
||||
|---|---|---|---|---|
| 90mg SC q12wa | 90 mg SC q8w |
|||
| 90 mg SC q8wa | Previous dose adjustmentb | Combined | ||
|
| ||||
| N | 84 | 82 | 71 | 153 |
| Clinical remissionc, n/N (%) | 38/84 (45.2%) | 45/82 (54.9%) | 31/71 (43.7%) | 76/153 (49.7%) |
| Clinical remission among TNF antagonist-naïve patientsc, n/N (%) | 15/38 (39.5%) | 23/39 (59.0%) | 16/28 (57.1%) | 39/67 (58.2%) |
| Clinical remission in TNF antagonist failure patientsc, n/N (%) | 13/32 (40.6%) | 12/27 (44.4%) | 11/32 (34.4%) | 23/59 (39.0%) |
| Clinical remission and not receiving corticosteroids at Week 252c,d n/N (%) | 34/84 (40.5%) | 42/82 (51.2%) | 25/71 (35.2%) | 67/153 (43.8%) |
| Clinical remission and not receiving corticosteroids at Week 252 among patients in remission at Week 252 n/N | 34/38 (89.5%) | 42/45 (93.3%) | 25/31 (80.6%) | 67/76 (88.2%) |
| Clinical responsec, n/N (%) | 45/84 (53.6%) | 47/82 (57.3%) | 33/71 (46.5%) | 80/153 (52.3%) |
| CDAI | ||||
| Mean (SD) change from maintenance baseline | −10.1 (112.18) | −13.6 (107.65) | 6.4 (126.54) | −4.3 (116.83) |
| CRP | ||||
| Mean (SD) change from maintenance baseline | 1.67 (14.845) | −1.11 (12.784) | 3.78 (23.605) | 1.16 (18.699) |
| Normalized CRPe at Week 252 | 23/61 (37.7%) | 20/56 (35.7%) | 22/56 (39.3%) | 42/112 (37.5%) |
| Concomitant CD medications | ||||
| Patients not receiving corticosteroids at Week 252 among those receiving corticosteroids at maintenance baselined | 25/34 (73.5%) | 22/34 (64.7%) | 19/38 (50.0%) | 41/72 (56.9%) |
| Patients receiving ustekinumab monotherapy without immunomosupressants at Week 252 | 32/48 (66.7%) | 39/54 (72.2%) | 27/40 (67.5%) | 66/94 (70.2%) |
CD, Crohn’s disease; CDAI, Crohn’s disease activity index; CRP, c-reactive protein; IV, intravenous; LTE, long-term extension q12w, every 12 weeks; q8w, every 8 weeks; SD, standard deviation; TNF, tumor necrosis factor
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).
Patients who had a Crohn’s disease-related surgery due to lack of efficacy of study agent (with the exception of minor procedures such as drainage of an superficial abscess or seton placement), discontinuation of study agent due to lack of efficacy or due to an adverse event indicated to be of worsening Crohn’s disease prior to the designated analysis timepoint are considered not to be in clinical remission/response, regardless of their CDAI score. Patients who had insufficient data at the designated analysis timepoint were considered not to be in clinical remission/response.
Patients who had a missing value in corticosteroids use at designated analysis timepoint had their last value carried forward
Number and percentage of patients with normalized CRP at Week 252 among those with abnormal CRP at induction baseline.
Abnormal CRP is defined as CRP value >3 mg/L.