Real-world clinical outcomes, prognostic factors, and safety profile of upadacitinib in patients with inflammatory bowel disease

Table 1 Demographics and disease-related characteristics of 87 patients initiating upadacitinib, n (%)

Characteristics	n = 87
Age in years, mean (SD)	40.1 (12.9)
Male sex	44 (50.6)
Disease duration in years, median (IQR)	6 (2.5-13)
IBD type
Crohn’s disease	43 (49.4)
Ulcerative colitis	42 (48.3)
Indeterminate colitis	1 (1.1)
Pouchitis	1 (1.1)
Montreal classification
UC - E (1/2/3)	4 (9.5)/17 (40.5)/21 (50.0)
CD - A (1/2/3)	3 (7.0)/32 (74.4)/8 (18.6)
CD - L (1/2/3)	16 (37.2)/6 (14.0)/21 (48.8)
CD- B (1/2/3)	23 (53.5)/18 (41.9)/2 (4.6)
CD -L4	4 (9.3)
CD - p	12 (27.9)
History of IBD-related surgery in CD	17 (39.5)
Extraintestinal manifestations	44 (50.6)
Articular manifestations	34 (39.1)
Dermatologic manifestations	16 (18.4)
Occular manifestations	2 (2.3)
Hepatobiliary manifestations	0 (0.0)
Other	9 (10.3)
Prior AT exposure	86 (98.9)
Number of prior AT-0/1/2/3/4	1 (1.1)/23 (26.4)/35 (40.2)/26 (29.9)/2 (2.3)
Median number of prior advanced therapies, (IQR)	2 (1-3)
Prior anti-TNF exposure	79 (90.8)
Prior ustekinumab exposure	43 (49.4)
Prior vedolizumab exposure	21 (24.1)
Prior tofacitinib exposure	8 (9.2)
Concomitant corticosteroids at initiation	35 (40.2)

CD: Crohn’s disease; IBD: Inflammatory bowel disease; IQR: Interquartile range; TNF: Tumor necrosis factor; UC: Ulcerative colitis; AT: Advanced therapy.

Table 2 Cox regression of factors associated with upadacitinib discontinuation and discontinuation or intensification in patients with ulcerative colitis (n = 42)

n = 42	Univariate			Multivariate
Discontinuation (17 events)	HR	95%CI	P value	HR	95%CI	P value
Smoking	9.40	1.51-58.6	0.016	11.37	1.64-78.95	0.014
CRP (mg/L)	1.08	1.01-1.16	0.023	1.09	1.01-1.18	0.029
Discontinuation or intensification (27 events)	HR	95%CI	P value	HR	95%CI	P value
Female	0.21	0.05-0.94	0.041	0.20	0.05-0.91	0.037
Extensive colitis (E3)	2.95	0.92-9.42	0.068	3.30	1.03-10.58	0.045

CI: Confidence interval; CRP: C-reactive protein; HR: Hazard ratio.

Table 3 Logistic regression of factors associated with endoscopic remission (n = 23)

Characteristics	Univariate			Multivariate
	OR	95%CI	P value	OR	95%CI	P value
Female	2.75	0.76-9.95	0.123	5.92	1.10-32.0	0.039
Crohn’s disease	0.37	0.10-1.36	0.135	0.17	0.03-0.93	0.041

CI: Confidence interval; OR: Odds ratio.