Table 1.
Summary of patient characteristics of randomized patients in the maintenance study at maintenance baseline (Week 0) and of randomized patients entering the LTE at Week 44
| Patient characteristics at maintenance baseline (Week 0) for all randomized patients | |||
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| |||
| Placeboa | Ustekinumab 90 mg q12w | Ustekinumab 90 mg q8w | |
|
| |||
| N | 133 | 132 | 132 |
| Median CDAI | 135.0 | 134.0 | 127.0 |
| Median IBDQ | 167.0 | 172.0 | 176.5 |
| Median CRP (mg/L) | 4.28 | 5.16 | 4.46 |
| Patients in clinical remission at maintenance baseline. | |||
| N | 80 (60.2%) | 80 (60.6%) | 80 (60.6%) |
| Patients receiving corticosteroids at maintenance | 51 | 46 | 53 |
| baseline (P.Eq dose; excluding budesonide) (mg/day) | |||
| Mean (SD) | 18.3 (11.01) | 18.7 (11.48) | 18.8 (10.37) |
| Immunosupressants | 47 (35.3%) | 52 (39.4%) | 44 (33.3%) |
| 6-MP/AZA | 38 (28.6%) | 44 (33.3%) | 31 (23.5%) |
| MTX | 9 (6.8%) | 8 (6.1%) | 13 (9.8%) |
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| Patient characteristics at Week 44 for randomized patients entering the LTE | |||
|
| |||
| Ustekinumab 90 mg q12w | Ustekinumab 90 mg q8w | Prior dose adjustment b | |
|
| |||
| N | 84 | 82 | 71 |
| Median CDAI | 95.5 | 70.5 | 130.0 |
| Median IBDQ | 189.0 | 185.5 | 171.0 |
| Median CRP | 3.5 | 3.7 | 4.0 |
| Patients in clinical remission | 65 (77.4%) | 69 (84.1%) | 45 (63.4%) |
| Patients receiving corticosteroids at maintenance | |||
| baseline (including budesonide) | 34/84 (40.5%) | 34/82 (41.5%) | 38/71 (53.5%) |
| Patients receiving corticosteroids at maintenance | |||
| baseline (P.Eq dose; excluding budesonide) (mg/day) | 25/84 (29.8%) | 26/82 (31.7%) | 30/71 (42.3%) |
| Mean (SD) | 15.7 (11.26) | 15.2 (9.01) | 18.6 (10.08) |
| Immunomodulatory drugs | 32 (38.1%) | 26 (31.7%) | 22 (31.0%) |
| 6-MP/AZA | 27 (32.1%) | 20 (24.4%) | 18 (25.4%) |
| MTX | 5 (6.0%) | 6 (7.3%) | 4 (5.6%) |
6-MP, 6- methyl prednisone, AZA, azathioprine, CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; IBDQ, Inflammatory Bowel Disease Questionnaire; IV, intravenous; LTE, long-term extension; MTX, methotrexate; P.Eq, prednisone equivalent, q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous; SD, standard deviation
Patients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into this maintenance study. Patients who were in clinical response to ustekinumab IV induction dosing, were randomized to receive study drugs on entry into this 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, met loss of clinical response criteria from Week 8 through Week 32, and initiated ustekinumab 90 mg SC q8w (for patients randomized to receive placebo SC or ustekinumab 90 mg SC q12w on entry into this maintenance study) or continue ustekinumab 90 mg SC q8w (for patients randomized to receive ustekinumab 90 mg SC q8w on entry into this maintenance study) in this maintenance study.