Table 1.

Efficacy of Janus kinase inhibitors in pivotal randomized controlled trials in ulcerative colitis or Crohn’s disease

Target	Drug	Clinical trials	Primary endpoint	Outcomes
Ulcerative colitis
Pan JAKa inhibitor	Tofacitinib	Phase 2 (induction) OCTAVE I [16]	Clinical response at 8 weeks	The clinical response to tofacitinib was 0.5 (32%), 3 (48%), 10 (61%), and 15 mg (78%) compared with 42% of the placebo group
		OCTAVE II [16]	Clinical remission at 8 weeks	18.5% of the patients in the tofacitinib group versus 8.2% in the placebo group
		OCTAVE Sustain [16]	Clinical remission at 52 weeks	5 mg BID (34.3%) and tofacitinib 10 mg BID (40.6%) vs placebo (11.1%) (p < 0.001)
JAKa selective inhibitor	Filgotinib	Phase 2b/3 SELECTION trial (induction) [32]	Clinical remission at 10 weeks	Filgotinib (47%) versus placebo (23%; p = 0.0077) 26.1% vs 15.3%, p = 0.0157) and biologic-experienced (11.5% vs 4.2%; p = 0.0103) placebo
		Phase 2b/3 SELECTION trial (maintenance) [32]	Clinical remission at 58 weeks	Filgotinib 100 mg (19.1% biologic naive and 9.5% biologic experienced) and 200 mg (26.1% biologic naïve and 11.5% biologic experienced) were in clinical remission compared to placebo (15.3% biologic naive and 4.2% biologic experienced)
	Upadacitinib	Phase 2b U-ACHIEVE (induction) [28]	Clinical remission at 8 weeks	Higher clinical remission rates were noted in the treatment arm compared with none in the placebo arm (7.5 mg: 8.5%, p = 0.052; 15 mg: 14.3%, p = 0.013; 30 mg: 13.5%, p = 0.011; and 45 mg: 19.6%, p=0.002)
		Phase 3 U-ACCOMPLISH (induction) [29]	Clinical remission at 8 weeks	Higher proportion of patients receiving upadacitinib 45 mg daily 33.5% versus placebo 4.1% (p < 0.001)
		Phase 3 (maintenance) [29]	Clinical remission at 52 weeks	Patients receiving 15 mg and 30 mg versus placebo achieved clinical remission (42.3% and 51.7% vs 12.1%)
Crohn’s disease
Pan JAKa	Tofacitinib	Phase 2 (induction) [18]	Clinical response at 4 weeks	No statistically significant differences were noted in clinical response between the tofacitinib and placebo
		Phase 2b (induction) [19]	Clinical remission at 8 weeks
		Phase 2b (maintenance) [19]	Clinical remission at 26 weeks
JAKa 1 selective inhibitor	Filgotinib	Phase 2b FITZROY (induction) [35]	Clinical remission at 10 weeks	Higher proportion of patients receiving filgotinib compared with placebo in both the biologic-naive (26.1% vs 15.3%, p = 0.0157) and biologic-experienced (11.5% vs 4.2%; p = 0.0103) arms
		Phase 3 DIVERSITY trial (induction)	Clinical remission at 10 weeks	Pending results
		Phase 3 DIVERSITY trial (maintenance)	Clinical remission at 58 weeks	Pending results
	Upadacitinib	Phase 2 CELEST trial (induction) [30]	Clinical remission at 16 weeks	Clinical remission was achieved by 13% of patients receiving 3 mg upadacitinib, 27% of patients receiving 6 mg upadacitinib (p < 0.1 vs placebo), 11% of patients receiving 12 mg upadacitinib, and 22% of patients receiving 24 mg upadacitinib twice daily, and by 14% of patients receiving 24 mg upadacitinib once daily vs 11% of patients receiving placebo
		Phase 2, CELEST trial (maintenance) [31]	Clinical remission at 52 weeks	Efficacy was maintained for most endpoints through Week 52

BID twice daily, JAK Janus kinase