Table 1.

Summary of the major clinical trials on ustekinumab, vedolizumab, and tofacitinib in CD and UC

	Indication	Ustekinumab vs. placebo	Comments
CD	Clinical response	* 36.6% (p = 0.02), 34.1% (p = 0.06), and 39.7% (p = 0.005) for 1, 3, and 6 mg/kg ustekinumab, respectively, vs. 23.5% placebo at week 6 [24] ** 75% ustekinumab vs. 25% placebo (p = 0.03) at week 7 [20]	* CERTIFI trial: regimen: 1, 3, or 6 mg ustekinumab per kg body weight or placebo at week 0 [24]; trial included patients who had failed TNF-α inhibitors only ** Regimen: 7 times weekly SC injections (3 mg/kg) ustekinumab or placebo
	Clinical remission	No difference at week 6 [20, 24]
	Maintenance of response	69.4% ustekinumab vs. 42.5% placebo (p < 0.001) [24]	CERTIFI trial: SC ustekinumab (90 mg) or placebo at weeks 8 and 16; maintenance phase only included responders to ustekinumab at week 6 of induction phase [24]
	Maintenance of remission	41.7% ustekinumab vs. 27.4% placebo (p = 0.03) [24]
	Indication	Tofacitinib vs. placebo	Comments
UC	Clinical response	78% tofacitinib vs. 42% placebo (p < 0.001) [42] OR: 4.18 (1.75–10.02) (p = 0.001) [43]	Regimen: 15 mg PO twice daily [42, 43]; response rates not significantly different for the 0.5-, 3-, and 10-mg regimens Endoscopic remission observed with 3 mg (18%; p = 0.01), 10 mg (30%; p < 0.001), and 15 mg (27%; p < 0.001) tofacitinib vs. placebo (2%) [42]
	Clinical remission	* RR: 33% for 3 mg (p = 0.01), 48% for 10 mg (p < 0.001), 41% for 15 mg tofacitinib (p < 0.001) vs. 10% placebo [42] ** OR: 5.23 (2.14–12.75) (p < 0.001) [43]	* Regimens: 3, 10, and 15 mg PO twice daily [42] ** Regimen: 15 mg PO twice daily [43]
	Indication	Vedolizumab vs. placebo	Comments
CD	Clinical response	* 31.4% vedolizumab vs. 25.7% placebo at week 6 (p = NS) [70] ** 46.8% vedolizumab vs. 24.8% placebo (p < 0.0001) [71]	* GEMINI-II trial: regimen: IV vedolizumab 300 mg at weeks 0 and 2 [70] ** GEMINI-III trial: regimen: IV vedolizumab 300 mg at weeks 0, 2, and 6; the response and remission results are significant for patients with prior anti-TNF failure (shown) and the overall study population but not for anti-TNF-naive patients [71]
	Clinical remission	* 14.5% vedolizumab vs. 6.8% placebo at week 6 (p = 0.02) [70] ** 26.6% vedolizumab vs. 12.1% placebo at week 10 (p = 0.001) [71]
	Maintenance of response	* 43.5% vedolizumab every 8 weeks (p = 0.01), 45.5% vedolizumab every 4 weeks (p = 0.005) vs. 30.1% placebo [70]	* Regimen: IV vedolizumab 300 mg every 4 or 8 weeks; includes patients with an initial drop in CDAI >70 response to vedolizumab only; the results were also significant for maintenance of glucocorticoid-free remission [70]
	Maintenance of remission	* 39.0% vedolizumab every 8 weeks (p < 0.001), 36.4% vedolizumab every 4 weeks (p = 0.004) vs. 21.6% placebo [70]
	Indication	Vedolizumab vs. placebo	Comments
UC	Clinical response	47.1% vedolizumab vs. 25.5% placebo (p < 0.001) [72]	GEMIN-I trial: IV vedolizumab 300 mg at weeks 0 and 2; response was evaluated at week 6; vedolizumab was also shown to significantly induce mucosal healing (40.9%, p = 0.001) as compared to placebo (24.8%) at week 6
	Clinical remission	41.8% vedolizumab vs. 15.9% placebo (p < 0.001) [72]
	Maintenance of remission	41.8% (every 8 weeks) and 44.8% (every 4 weeks) vs. 15.9% placebo at week 52 (both p < 0.001) [72]	Regimen: IV vedolizumab 300 mg every 4 or 8 weeks

The number of asterisks indicates which comments in the right column refer to which study in the left column. SC = Subcutaneously; OR = odds ratio; PO = per os; NS = not significant; IV = intravenously.