Game changer: How Janus kinase inhibitors are reshaping the landscape of ulcerative colitis management

Table 1 Phase 3 efficacy trials of Janus kinase inhibitors in ulcerative colitis¹

Clinical trial			Patients, n	Dose	Primary outcome	Response vs placebo
Tofacitinib	Sandborn et al[17] (2017)	OCTAVE Induction 1	598	Placebo (122)	Clinical remission at week 8	8.2%
				10 mg (476)		18.5% (P = 0.007)
		OCTAVE Induction 2	541	Placebo (112)		3.6%
				10 mg (429)		16.6% (P < 0.001)
		OCTAVE Sustain	593	Placebo (198)	Clinical remission at week 52	11.1%
				5 mg (198)		34.3% (P < 0.001)
				10 mg (197)		40.6% (P < 0.001)
Filgotinib	Feagan et al[18] (2021)	SELECTION Induction A	659	Placebo (137)	Clinical remission at week 10	15.3%
				100 mg (277)		19.1% (P = 0.337)
				200 mg (245)		26.1% (P = 0.015)
		SELECTION Induction B	689	Placebo (142)		4.2%
				100 mg (285)		9.5% (P = 0.064)
				200 mg (262)		11.5% (P = 0.01)
		SELECTION Maintenance	664	Placebo (89)	Clinical remission at week 58	13.5%
				100 mg (172)		23.8% (P = 0.420)
				Placebo (98)		11.2%
				200 mg (199)		37.2% (P < 0.001)
Upadacitinib	Danese et al[19] (2022)	U-ACHIEVE Induction	473	Placebo (154)	Remission at week 8	4.5%
				45 mg (319)		26.0% (P < 0.001)
		U-ACCOMPLISH	515	Placebo (174)		4.0%
				45 mg (341)		33.4% (P < 0.001)
		U-ACHIEVE Maintenance	451	Placebo (149)	Remission at week 52	12.1%
				15 mg (148)		42.6% (P < 0.001)
				30 mg (154)		51.9% (P < 0.001)

¹Clinical remission was defined as a total Mayo score of ≤ 2, with no subscore > 1 and a rectal bleeding subscore of 0 in all studies. Filgotinib studies required a 1-point decrease in stool frequency from induction baseline for a subscore of 0 or 1. The Physician Global Assessment was removed from the upadacitinib studies due to subjectivity concerns.