Table 1. Study characteristics and efficacy outcomes.

RCT: randomized controlled trials; CMH: Cochran-Mantel-Haenszel; CD: Crohn's disease; CIs: confidence intervals; SEC-CD: simple endoscopic score for Crohn’s disease; OLE: open-label extension; SF score: stool frequency score; AP score: abdominal pain score

First author	Year	Study design	Sample size	Dosage and frequency of upadacitinib	Duration	Primary outcome	Outcome measure	Efficacy outcome
Sandborn WJ [14]	2020	RCT	220	3 mg BID, 6 mg BID, 12 mg BID, 24 mg BID, 24 mg QID	52 weeks	16th week of clinical remission, 12th or 16th week of endoscopic remission	Multiple comparison process and modeling, as well as the Cochran-Mantel-Haenszel test, with a 2-sided threshold of 10%	Adjusted risk differences for clinical remission with Cochran-Mantel-Haenszel (CMH) corrections and their corresponding 95% confidence intervals (CIs) were as follows: 3 mg twice-daily arm 2.5 (95% CI: -12.3 to 17.3); 6 mg twice-daily arm: 16.2 (95% CI: -2.0 to 34.3); 12-mg twice-daily arm: 0.5 (95% CI: -14.1 to 15.0); 24 mg twice-daily arm: 11.2 (95% CI: -6.1 to 28.5); 24 mg once-daily arm: 4.1 (95% CI: -11.5 to 19.6). For endoscopic remission, CMH-adjusted risk differences with their corresponding 95% CIs were as follows: 3 mg twice-daily arm: 9.9 (95% CI: -0.3 to 20.1); 6 mg twice-daily arm: 7.4 (95% CI: -1.6 to 16.4); 12 mg twice-daily arm: 7.7 (95% CI: -1.5 to 16.8); 24 mg twice-daily arm; 21.0 (95% CI: 6.8 to 35.2); 24 mg once daily arm: 13.6 (95% CI: 1.8 to 25.5)
D’Haens G [15]	2022	RCT	107	15 mg QD, 30 mg QD, extended dose 30 mg QD	30 weeks	Clinical remission was consistently maintained at a rate of 2.8 per 1.0 across all groups from week 0 to month 30. Similarly, endoscopic response remained stable in all groups, with rates of 68%, 67%, and 40%, respectively, at month 24	Clinical remission, defined as an SF score of less than or equal to 2.8 and an AP score of less than or equal to 1.0, and endoscopic remission, defined as an SES-CD score of 4 or lower with a reduction of more than 2 points from the CELEST study baseline, and no subscore exceeding 1 were the criteria used for assessment	At the outset of the CELEST OLE study (week 0), clinical remission rates of 2.8/1.0 were attained by 61% of patients in the upadacitinib 15 mg group, 57% in the 30 mg group, and 45% in the upadacitinib dose-escalated group. In the upadacitinib 15 mg and 30 mg groups, these rates were sustained up to month 30 for 61% and 54% of patients, respectively. Within the dose-escalated group, 55% of patients achieved clinical remission at month 30 (as shown in Figure 1), with a median time of 254 days (range: 31-824 days) until dose escalation. The proportion of patients achieving endoscopic remission (ranging from 44% to 55%) exhibited an increase during the initial 12 months of the CELEST OLE study across all three groups based on observed case analysis. This achievement was maintained at 24 months for patients receiving upadacitinib 15 mg and 30 mg once daily, whereas it declined among patients in the dose-escalated group
Friedberg S [16]	2023	Prospective cohort	40	82% 45 mg/dL; 17.5% 15 mg/dL	8 weeks	Clinical remission at weeks 2, 4, or 8	Simple Clinical Colitis Activity Index and the Harvey-Bradshaw Index, as well as C-reactive protein and fecal calprotectin	Out of the 11 patients without any small intestine involvement in their Crohn's disease (CD), 80% of those who initially had active disease achieved both clinical response and remission by week 8. Likewise, among those with CD affecting the small intestine (L1 or L3), 75% and 66.7% of patients, respectively, achieved clinical response and remission