Promising biological therapies for ulcerative colitis: A review of the literature

Table 1 Clinical trials evaluating the efficacy of anti-tumor necrosis factor α agents in ulcerative colitis patients

Drug	Trial	Study population	Protocol	Follow-up (wk)	Outcome
Infliximab	ACT 1 Rutgeerts et al[5]	121	5 mg/kg iv at 0, 2, 6,	54	69.4% (P < 0.001) clinical response at week 8
			and every 8 wk		45.5% (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
		122	10 mg/kg iv at 0, 2, 6,	54	61.5% (P < 0.001) clinical response at week 8
			and every 8 wk		44.3% (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]	121	5 mg/kg iv at 0, 2, 6,	30	64.5% (P < 0.001) clinical response at week 8
			and every 8 wk		47.1% (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
		120	10 mg/kg iv at 0, 2, 6,	30	69.2% (P < 0.001) clinical response at week 8
			and every 8 wk		60.0% (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
Adalimumab	ULTRA1 Reinisch et al[17]	130	80/40 mg sc	8	51.5% clinical response at week 8
			80 mg at week 0, 40 mg at week 2, 4 and 6		10.0% (P = 0.833) clinical remission at week 8
		130	160/80 mg sc		54.6% clinical response at week 8
			160 mg at week 0, 80 mg at week 2, 40 mg at week 4 and 6		18.5% (P = 0.031) clinical remission at week 8
	ULTRA2 Sandborn et al[6]	248	160/80 mg sc	52	16.5% (P = 0.019) clinical remission at week 8
			160 mg at week 0, 80 mg at week 2, and then 40 mg every other week		17.3% (P = 0.004) clinical remission at week 52
	ULTRA3 Colombel et al[18]	360	40 mg sc every other week	208	63.6% remission per partial Mayo score at week 208
Golimumab	PURSUIT-SC[20]	253	200/100 mg sc 2 wk apart	6	51.6% (P < 0.0001) clinical response at week 6
					17.8% (P < 0.0001) clinical remission at week 6
		257	400/200 mg sc 2 wk apart	6	54.9% (P < 0.0001) clinical response at week 6
					17.9% (P < 0.0001) clinical remission at week 6
	PURSUIT-M[7]	151	50 mg sc every 4 wk	54	47% (P = 0.010) clinical response at week 54
					23.2% clinical remission at week 54
		151	100 mg sc every 4 wk	54	49.7% (P < 0.001) clinical response at week 54
					27.8% (P = 0.004) clinical remission at week 54

Clinical response was defined as a decrease from baseline in the total Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1. Clinical remission was defined as a total Mayo score of ≤ 2 points, with no individual subscore exceeding 1 point. iv: Intravenously; sc: Subcutaneously; ACT: Active Ulcerative Colitis Trials; ULTRA: Ulcerative Colitis Long-term Remission and Maintenance with Adalimumab; PURSUIT-SC: The Program of Ulcerative Colitis Research Studies Utilizing an Investigation Treatment, which was divided into Subcutaneous phases; PURSUIT-M: The Program of Ulcerative Colitis Research Studies Utilizing an Investigation Treatment, which was divided into Maintenance phases.

Table 2 Clinical trials evaluating the efficacy of Janus kinase inhibitor and integrin antagonists in ulcerative colitis patients

Drug	Trial	Study population	Protocol	Follow-up (wk)	Outcome
Tofacitinib	Sandborn et al[21]	31	0.5 mg po twice daily	8	32% (P = 0.39) clinical response at week 8
					13% (P = 0.76) clinical remission at week 8
		33	3 mg po twice daily	8	48% (P = 0.55) clinical response at week 8
					33% (P = 0.01) clinical remission at week 8
		33	10 mg po twice daily	8	61% (P = 0.10) clinical response at week 8
					48% (P < 0.001) clinical remission at week 8
		49	15 mg po twice daily	8	78% (P < 0.001) clinical response at week 8
					41% (P < 0.001) clinical remission at week 8
Vedolizumab	GEMINI 1[32]	225	300 mg iv at weeks 0, 2 and 6	6	47.1% (P < 0.001) clinical response at week 6
					16.9% (P = 0.00) clinical remission at week 6
		122	300 mg iv at week 0, 2, 6 and every 4 wk	52	44.8% (P < 0.001) clinical remission at week 52
		125	300 mg iv at week 0, 2, 6 and every 8 wk	52	41.8% (P < 0.001) clinical remission at week 52
Etrolizumab	Vermeire et al[35]	39	100 mg sc at week 0, 4 and 8	10	21% (P = 0.0040) clinical remission at week 10
		39	420 mg sc loading dose then 300 mg at week 2, 4, and 8	10	10% (P = 0.048) clinical remission at week 10

po: Perorally; iv: Intravenously; sc: Subcutaneously.