Editorial
Copyright ©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
Table 2 Characteristics of randomized, placebo-controlled trials evaluating the efficacy of ustekinumab in Crohn’s disease
Study (reference)PatientsEndpointsIntervention parametersOutcomes
Sandbornetal[58]25Clinical response at week 4/week 890 mg SC week 0-3→Placebo SC week 8-11Ustekinumab: 53%/49% Placebo: 30%/40%
26Placebo SC week 0-3→90mg SC week 8-11
264.5 mg/Kg IV week 0→Placebo IV week 8
27Placebo IV week 0→4.5 mg/Kg IV week 8
27 (primary or secondary non-responders to infliximab)Clinical response at week 890 mg SC43%
4.5 mg/kg IV54%
Sandborn et al[59] (CERTIFI) Induction131Clinical response at week 61 mg/kg IV36.60%
1323 mg/kg IV34.10%
1316 mg/kg IV39.70%
132Placebo IV23.50%
Sandborn et al[59] (CERTIFI) Maintenance145 RespondersClinical response at week 2290 mg SC69.40%
72 UstekinumabPlacebo SC42.50%
73 PlaceboClinical remission at week 2290 mg SC41.70%
Placebo SC27.40%
Feagan et al[60] UNITI-1 induction245Clinical response at week 6130 mg IV34.30%
2496 mg/kg IV33.70%
247Placebo IV21.50%
Feagan et al[60] UNITI-2 induction209Clinical response at week 6130 mg IV51.70%
2096 mg/kg IV55.50%
210Placebo IV28.70%
Feagan et al[60] IM- UNITI maintenance132Clinical remission at week 4490 mg SC every 8 wk53.10%
13290 mg SC every 12 wk48.80%
133Placebo SC35.90%
Sandborn et al[63] (IM- UNITI long term extension)1281Clinical remission at week 9290 mg SC every 8 wk74.40%
90 mg SC every 12 wk72.60%
Subjects with prior dose adjustment53.50%
All ustekinumab treated67.50%
Sands et al[62] (IM-UNITI patients with dose adjustment following loss of response)51Clinical response [CR-100]1Placebo to 90 mg SC ustekinumab every 8 wk71%
29Ustekinumab 90 mg SC every 12 wk to ustekinumab 90 mg SC every 8 wk55%
28No dose adjustment46%
Sands et al[62] (IM-UNITI non-responders during induction phase having an additional SC dose)467Clinical response 8 wk after one additional doseAdditional dose of 90 mg SC50.50%
Clinical remission 8 wk after one additional dose28.90%
Rutgeerts et al[61] Induction week 8155SES-CD Change from baseline, mean (SD)130 mg IV/6 mg/kg-2.8 (8.10)a
97Placebo IV-0.7 (4.97)
Rutgeerts et al[61] Maintenance week 4447SES-CD Change from baseline, mean (SD)90mg SC every 12 wk-1.5 (4.22)
7490mg SC every 8 wk-3.8 (6.02)
51Placebo SC-2.0 (5.35)