Table 2

Summary of pivotal trials for licensed JAK inhibitors in inflammatory bowel disease

		Trials	Treatment phase	n	Duration (weeks)	Primary outcome	Primary outcome findings
UC	Tofacitinib9	OCTAVE 1	Induction	598	8	Clinical remission* at week 8	Clinical remission in 18.5% (tofacitinib 10 mg bd) vs 8.2% (placebo), p=0.007.
		OCTAVE 2	Induction	541	8	Clinical remission at week 8	Clinical remission in 16.6% (tofacitinib 10 mg bd) vs 3.6% (placebo), p<0.001.
		OCTAVE SUSTAIN	Maintenance	593	52	Clinical remission at week 52	Clinical remission in 34.3% (tofacitinib 5 mg bd) vs 40.6% (tofacitinib 10 mg bd), vs 11.1% (placebo), p<0.001 for both comparisons with placebo.
	Filgotinib23	SELECTION STUDY A	Induction	659	10	Clinical remission at week 10	Clinical remission in 26.1% (filgotinib 200 mg od) vs 15.3% (placebo), p=0.0157.
		SELECTION STUDY B	Induction	689	10	Clinical remission at week 10	Clinical remission in 11.5% (filgotinib 200 mg od) vs 4.2% (placebo), p=0.0103.
		SELECTION	Maintenance	664	58	Clinical remission at week 58	Clinical remission in 37.2% (filgotinib 200 mg od) vs 11.2% (placebo), p<0.0001. Clinical remission was not significantly different between filgotinib 100 mg od and placebo at week 10 but was significant by week 58 (23.8% vs 13.5%, p=0.0420).
	Upadacitinib62	U-ACHIEVE	Induction	474	8	Clinical remission at week 8	Clinical remission in 26% (upadacitinib 45 mg od) vs 5% (placebo), p<0.0001.
		U-ACCOMPLISH	Induction	522	8	Clinical remission at week 8	Clinical remission in 34% (upadacitinib 45 mg od) vs 4% (placebo), p<0.0001.
		U-ACHIEVE	Maintenance	451	52	Clinical remission at week 52	Clinical remission in 52% (upadacitinib 30 mg od), 42% (upadacitinib 15 mg od), 12% (placebo), p<0.0001.
CD	Upadacitinib33	U-EXCEL	Induction	526	12	Clinical remission and endoscopic response at week 12†	Clinical remission in 49.5% (upadacitinib 45 mg od) vs 29.1% (placebo) and endoscopic response in 45.5% (upadacitinib 45 mg od) vs 13.1% (placebo). p<0.001 for both comparisons.
		U-EXCEED	Induction	495	12	Clinical remission and endoscopic response at week 12	Clinical remission in 38.9% (upadacitinib 45 mg od) vs 21.1% (placebo) and endoscopic response in 34.6% (upadacitinib 45 mg od) vs 3.5% (placebo). p<0.001 for both comparisons.
		U-ENDURE	Maintenance	502	52	Clinical remission and endoscopic response at week 52	Clinical remission in 47.6% (upadacitinib 30 mg od) vs 37.3% (upadacitinib 15 mg od) vs 15.1% (placebo) and endoscopic response in 40.1% (upadacitinib 30 mg od) vs 27.6% (upadacitinib 15 mg od) vs 7.3% (placebo). p<0.001 for all comparisons.

*Definition of clinical remission was similar across the UC trials and was defined as a total Mayo score of ≤2, with no subscore >1 and a rectal bleeding subscore of 0. For the filgotinib studies, a 1-point decrease in stool frequency from induction baseline for a subscore of 0 or 1 was required and for the upadacitinib studies, the Physician Global Assessment was removed due to subjectivity.
†Remission defined as CD activity index <150, and endoscopic response defined as a fall in Simple Endoscopic Score for CD score >50% from baseline.
bd, two times per day; CD, Crohn’s disease; JAK, Janus kinase; n, number of patients; od, once daily; UC, ulcerative colitis.;