Biological therapy for ulcerative colitis: An update

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.