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©The Author(s) 2018.
World J Gastroenterol. Sep 28, 2018; 24(36): 4093-4103
Published online Sep 28, 2018. doi: 10.3748/wjg.v24.i36.4093
Published online Sep 28, 2018. doi: 10.3748/wjg.v24.i36.4093
Table 2 Characteristics of randomized, placebo-controlled trials evaluating the efficacy of ustekinumab in Crohn’s disease
Study (reference) | Patients | Endpoints | Intervention parameters | Outcomes |
Sandbornetal[58] | 25 | Clinical response at week 4/week 8 | 90 mg SC week 0-3→Placebo SC week 8-11 | Ustekinumab: 53%/49% Placebo: 30%/40% |
26 | Placebo SC week 0-3→90mg SC week 8-11 | |||
26 | 4.5 mg/Kg IV week 0→Placebo IV week 8 | |||
27 | Placebo IV week 0→4.5 mg/Kg IV week 8 | |||
27 (primary or secondary non-responders to infliximab) | Clinical response at week 8 | 90 mg SC | 43% | |
4.5 mg/kg IV | 54% | |||
Sandborn et al[59] (CERTIFI) Induction | 131 | Clinical response at week 6 | 1 mg/kg IV | 36.60% |
132 | 3 mg/kg IV | 34.10% | ||
131 | 6 mg/kg IV | 39.70% | ||
132 | Placebo IV | 23.50% | ||
Sandborn et al[59] (CERTIFI) Maintenance | 145 Responders | Clinical response at week 22 | 90 mg SC | 69.40% |
72 Ustekinumab | Placebo SC | 42.50% | ||
73 Placebo | Clinical remission at week 22 | 90 mg SC | 41.70% | |
Placebo SC | 27.40% | |||
Feagan et al[60] UNITI-1 induction | 245 | Clinical response at week 6 | 130 mg IV | 34.30% |
249 | 6 mg/kg IV | 33.70% | ||
247 | Placebo IV | 21.50% | ||
Feagan et al[60] UNITI-2 induction | 209 | Clinical response at week 6 | 130 mg IV | 51.70% |
209 | 6 mg/kg IV | 55.50% | ||
210 | Placebo IV | 28.70% | ||
Feagan et al[60] IM- UNITI maintenance | 132 | Clinical remission at week 44 | 90 mg SC every 8 wk | 53.10% |
132 | 90 mg SC every 12 wk | 48.80% | ||
133 | Placebo SC | 35.90% | ||
Sandborn et al[63] (IM- UNITI long term extension) | 1281 | Clinical remission at week 92 | 90 mg SC every 8 wk | 74.40% |
90 mg SC every 12 wk | 72.60% | |||
Subjects with prior dose adjustment | 53.50% | |||
All ustekinumab treated | 67.50% | |||
Sands et al[62] (IM-UNITI patients with dose adjustment following loss of response) | 51 | Clinical response [CR-100]1 | Placebo to 90 mg SC ustekinumab every 8 wk | 71% |
29 | Ustekinumab 90 mg SC every 12 wk to ustekinumab 90 mg SC every 8 wk | 55% | ||
28 | No dose adjustment | 46% | ||
Sands et al[62] (IM-UNITI non-responders during induction phase having an additional SC dose) | 467 | Clinical response 8 wk after one additional dose | Additional dose of 90 mg SC | 50.50% |
Clinical remission 8 wk after one additional dose | 28.90% | |||
Rutgeerts et al[61] Induction week 8 | 155 | SES-CD Change from baseline, mean (SD) | 130 mg IV/6 mg/kg | -2.8 (8.10)a |
97 | Placebo IV | -0.7 (4.97) | ||
Rutgeerts et al[61] Maintenance week 44 | 47 | SES-CD Change from baseline, mean (SD) | 90mg SC every 12 wk | -1.5 (4.22) |
74 | 90mg SC every 8 wk | -3.8 (6.02) | ||
51 | Placebo SC | -2.0 (5.35) |
- Citation: Aggeletopoulou I, Assimakopoulos SF, Konstantakis C, Triantos C. Interleukin 12/interleukin 23 pathway: Biological basis and therapeutic effect in patients with Crohn's disease. World J Gastroenterol 2018; 24(36): 4093-4103
- URL: https://www.wjgnet.com/1007-9327/full/v24/i36/4093.htm
- DOI: https://dx.doi.org/10.3748/wjg.v24.i36.4093