“Mucosal healing” in ulcerative colitis: Between clinical evidence and market suggestion

Table 1 Randomized clinical trial of biologic agent in ulcerative colitis and the relative mucosal healing rates

Ref.	Patients (n)	Treatment protocol duration	Evaluation timefrom baseline	MH rate
Rutgeerts et al[32]	728	IFX 5 or 10 mg/kg every 8 wk	Week 8	60.7% IFX
		Placebo		32.3% placebo
		30 wk (ACT2)	Week 30	50.6% IFX
				27.4% placebo
		54 wk (ACT1)	Week 54	46.0% IFX
				18.2% placebo
Panaccione et al[50]	231	AZA 2.5 mg/kg	Week 16	37% AZA
		IFX 5 mg/kg		55% IFX
		IFX 5 mg/kg + AZA 2.5 mg/kg		63% AZA + IFX
		16 wk
Sandborn et al[25]	494	ADA 160/80 and then 40 mg eow	Week 8	41.1% ADA
		Placebo		31.7% placebo
		52 wk	Week 52	25.0% ADA
				15.4% placebo
Reinisch et al[43]	390	ADA 160/80 mg or 80/40 mg at weeks 0 and 2 followed by 40 mg at weeks 4 and 6	Week 8	46.9% ADA (160/80)
		Placebo		37.7% ADA (80/40)
				41.5% placebo
		52 wk	Week 52	54% ADA
Feagan et al[44]	225	VED 300 mg at week 0 and 2 and then every 4 or 8 wk	Week 6	40.7% VED
		Placebo		24.8% placebo
		52 wk	Week 52	56% VED (every 4 wk)
				51.6% VED (every 8 wk)
				19.8% placebo
Sandborn et al[45,46]	774	GOL 400/200 or 200/100 mg at weeks 0 and 2 followed by 50 mg or 100 mg every 4 wk	Week 6	45.1% GOL (400/200)
		Placebo		42.3% GOL (200/100)
				28.7% placebo
		54 wk	Week 54	42.4% GOL100 every 4 wk
				41.7% GOL 50 every 4 wk
				26.6% placebo

MH: Mucosal healing; IFX: Infliximab; ADA: Adalimumab; AZA: Azathioprine; VED: Vedolizumab; GOL: Golimumab.