Biological therapy for ulcerative colitis: An update

Table 1 Summary of ACT1, ACT2, ULTRA1 and ULTRA2 trials for moderate-to-severe ulcerative colitis

Trial	Clinical scenario	Drug	Dosage	Patients(n)	Follow-up (wk)	Outcome and P value
ACT1 Rutgeerts et al[12]	Moderate- to-severe active UC	Infliximab	5 mg/kg IV 10 mg/kg IV (intravenously at weeks 0, 2, and 6 and then every eight weeks)	121 122	54	Clinical response at week 8 (placebo/5 mg/10 mg) -37.2%/69.4%/61.5% (P < 0.001, P < 0.001) Clinical remission at week 8 -14.9%/38.8%/32.0% (P < 0.001, P = 0.002) Clinical remission at week 54 -8.9%/25.7%/16.4% (P = 0.006, P = 0.149)
ACT2 Rutgeerts et al[12]	Moderate- to-severe active UC	Infliximab	5 mg/kg IV 10 mg/kg IV	121 120	30	Clinical response at week 8 (placebo/5 mg/10 mg) -29.3%/64.5%/69.2% (P < 0.001, P < 0.001) Clinical remission at week 8 -5.7%/33.9%/27.5% (P < 0.001, P < 0.001) Clinical remission at week 30 -3.3%/18.3%/27.3% (P = 0.010, P < 0.001)
ULTRA1 Reinisch et al[15]	Moderate- to-severe active UC	Adalimumab	160/80 mg SC (160 mg at week 0, 80 mg at week 2, 40 mg at weeks 4 and 6) 80/40 mg SC (80 mg at week 0, 40 mg at weeks 2, 4 and 6)	130 130	8	Clinical remission at week 8 (placebo/ADA160/80mg/ADA80/40 mg) - 9.2%/18.5%/10.0% (P = 0.031, P = 0.833)
ULTRA2 Sandborn et al[16]	Moderate- to-severe active UC	Adalimumab	160/80 mg SC (160 mg at week 0, 80 mg at week 2, and then 40 mg every other week)	248	52	Clinical remission at week 8 (placebo/ADA) - 9.3%/16.5% (P = 0.019) Clinical remission at week 52 - 8.5%/17.3% (P = 0.004)

UC: Ulcerative colitis; ADA: Adalimumab.