TABLE 3.

Major RCTs including JAK inhibitors for CD treatment.

Drug	RCT identifier	Patient number	Treatment phase	Duration	Dose	End point	Results
Tofacitinib	NCT00615199 (101)	139	Induction	4 weeks	1, 5, 15 mg, bid	Clinical response at week 4	A clinical response was observed in 36% (p = 0.467), 58% (p = 0.466), and 46% (p ≥ 0.999) of patients given the 1, 5, and 15 mg doses of tofacitinib, compared with 47% of patients given placebo.
	NCT01393626 (20)	280	Induction	8 weeks	5, 10 mg, bid	Clinical response-100 or clinical remission at week 8	At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0 with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p = 0.325 and 0.392 for 5 and 10 mg twice daily vs. placebo).
	NCT01393626 (20)	180	Maintenance	26 weeks	5, 10 mg, bid	Clinical response-100 or clinical remission at week 26	The proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p = 0.130 for 10 mg twice daily vs. placebo).
	NCT01470599 (102)	150	Maintenance	48 weeks	5 (patients in clinical remission), 10 mg (not in clinical remission), bid	Serious adverse effects and maintained remissions at week 48	Crohn’s disease worsening was the most frequent adverse event for tofacitinib 5 (33.9%) and 10 mg b.d. (19.3%). Patients not in remission at baseline, receiving 10 mg b.d., had higher rates of serious adverse events (19.3%) and discontinuation attributed to insufficient clinical response (30.7%) vs. 5 mg b.d. (8.1% and 9.7, respectively).
Upadacitinib	NCT02365649 (39)	220	Induction	16 weeks	3, 6, 12, 24 mg, bid; 24 mg, qd	Clinical remission at week 16 and endoscopic remission at week 12 or week 16	Upadacitinib did not significantly improve clinical remission at week 16 at any dose (with the exception of 6 mg at the p < 0.1 level). Endoscopic remission at week 12 was increased compared with placebo for doses of 3 mg (p < 0.1), 12 mg (p < 0.1), 24 mg bid (p < 0.01) and 24 mg qd (p < 0.05), in a dose-dependent manner.
	NCT02365649 (39)	180	Maintenance	52 weeks	3, 6, 12 mg, bid; 24 mg qd	Clinical and endoscopic remission at week 52	Patients receiving the 12 mg bid dose had the highest, although non-significant, responses compared with the other upadacitinib doses.
Filgotinib	NCT02048618 (30)	174	Induction	10 weeks	200 mg, qd	Clinical remission	60 (47%) of 128 patients treated with filgotinib 200 mg achieved clinical remission at week 10 vs. 10 (23%) of 44 patients treated with placebo (p = 0.0077).