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.

Table 2 Studies for the use of Golimumab, Tofacitinib and Vedolizumab for the treatment of ulcerative colitis

Trial	Clinical scenario	Drug	Dosage	Patients(n)	Follow-up(wk)	Outcome and P value
PURSUIT- SC Sandborn et al[23]	Moderate- to-severe active UC	Golimumab	100/50 mg SC 200/100 mg SC 400/200 mg SC (2 wk apart)	71 331 331	6	Clinical response at week 6 (placebo/GLM 200/100 mg/GLM 400/200mg) - 30.3%/51.0%/54.9% (P < 0.0001, P < 0.0001) Clinical remission at week 6 - 6.4%/17.8%/17.9% (P < 0.0001, P < 0.0001)
PURSUIT- Maintenance Sandborn et al[24]	Moderate- to-severe active UC	Golimumab	50 mg SC 100 mg SC (every 4 wk)	151 151	54	Clinical response at week 54 (placebo/GLM 50 mg/GLM100 mg) - 31.2%/47.0%/49.7% (P = 0.010, P < 0.001) Clinical remission at weeks 30 and 54 - 15.6%/23.2%/27.8% (P = 0.122, P = 0.004)
Sandborn et al[32]	Moderate- to-severe active UC	Tofacitinib	0.5 mg, 3 mg, 10 mg, 15 mg oral (twice daily for 8 wk)	31/33/33/ 49	8	Clinical response at week 8 (placebo/0.5 mg/3 mg/10 mg/15 mg) - 42%/32%/48%/61%/78% (P = 0.39, P = 0.55, P = 0.10, P < 0.001) Clinical remission at week 8 -10%/13%/33%/48%/41% (P = 0.76, P = 0.001, P < 0.001, P < 0.001) Endoscopic remission at week 8 -2%/10%/18%/30%/27% (P = 0.14, P = 0.001, P < 0.001, P < 0.001)
Gemini 1 Feagan et al[41]	Moderate- to-severe active UC	Vedolizumab	300 mg IV (at weeks 0, 2 and then every 8 or 4 wk)	Cohort 1 (225) Cohort 2 (521)	52	Clinical response at week 6 (placebo/Vedolizumab) - 25.5%/47.1% (P < 0.001) Clinical remission at week 6 - 5.4%/16.9% (P = 0.001) Clinical remission at week 52 (placebo/Vedolizumab every 8 wk/Vedolizumab every 4 wk) - 15.9%/41.8%/44.8% (P < 0.001, P < 0.001)

UC: Ulcerative colitis; GLM: Golimumab.