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Copyright ©The Author(s) 2015.
World J Gastrointest Pathophysiol. Nov 15, 2015; 6(4): 219-227
Published online Nov 15, 2015. doi: 10.4291/wjgp.v6.i4.219
Table 1 Clinical trials evaluating the efficacy of anti-tumor necrosis factor α agents in ulcerative colitis patients
DrugTrialStudy populationProtocolFollow-up (wk)Outcome
InfliximabACT 1 Rutgeerts et al[5]1215 mg/kg iv at 0, 2, 6,5469.4% (P < 0.001) clinical response at week 8
and every 8 wk45.5% (P < 0.001) clinical response at week 54
38.8% (P < 0.001) clinical remission at week 8
34.7% (P = 0.001) clinical remission at week 54
12210 mg/kg iv at 0, 2, 6,5461.5% (P < 0.001) clinical response at week 8
and every 8 wk44.3% (P < 0.001) clinical response at week 54
32.0% (P = 0.002) clinical remission at week 8
34.4% (P = 0.001) clinical remission at week 54
ACT 2 Rutgeerts et al[5]1215 mg/kg iv at 0, 2, 6,3064.5% (P < 0.001) clinical response at week 8
and every 8 wk47.1% (P < 0.001) clinical response at week 30
33.9% (P < 0.001) clinical remission at week 8
25.6% (P = 0.003) clinical remission at week 30
12010 mg/kg iv at 0, 2, 6,3069.2% (P < 0.001) clinical response at week 8
and every 8 wk60.0% (P < 0.001) clinical response at week 30
27.5% (P < 0.001) clinical remission at week 8
35.8% (P < 0.001) clinical remission at week 30
AdalimumabULTRA1 Reinisch et al[17]13080/40 mg sc851.5% clinical response at week 8
80 mg at week 0, 40 mg at week 2, 4 and 610.0% (P = 0.833) clinical remission at week 8
130160/80 mg sc54.6% clinical response at week 8
160 mg at week 0, 80 mg at week 2, 40 mg at week 4 and 618.5% (P = 0.031) clinical remission at week 8
ULTRA2 Sandborn et al[6]248160/80 mg sc5216.5% (P = 0.019) clinical remission at week 8
160 mg at week 0, 80 mg at week 2, and then 40 mg every other week17.3% (P = 0.004) clinical remission at week 52
ULTRA3 Colombel et al[18]36040 mg sc every other week20863.6% remission per partial Mayo score at week 208
GolimumabPURSUIT-SC[20]253200/100 mg sc 2 wk apart651.6% (P < 0.0001) clinical response at week 6
17.8% (P < 0.0001) clinical remission at week 6
257400/200 mg sc 2 wk apart654.9% (P < 0.0001) clinical response at week 6
17.9% (P < 0.0001) clinical remission at week 6
PURSUIT-M[7]15150 mg sc every 4 wk5447% (P = 0.010) clinical response at week 54
23.2% clinical remission at week 54
151100 mg sc every 4 wk5449.7% (P < 0.001) clinical response at week 54
27.8% (P = 0.004) clinical remission at week 54