Long-term clinical outcomes with filgotinib in ulcerative colitis: 12-month results from the FILGUITO study

Table 1 Baseline characteristics of patients in the FILGUITO registry (n = 104)

Characteristic	Value
Demographics
Age (year)	40.7 (29.5-51.0)
Male sex	59 (56.7)
Disease duration (year)	11.1 (5.0-14.0)
Disease characteristics
Disease extent
Extensive colitis	54 (51.9)
Left-sided colitis	39 (37.5)
Proctitis	11 (10.6)
Smoking status
Never smoker	63 (60.6)
Former smoker	29 (27.9)
Current smoker	12 (11.5)
Extraintestinal manifestations	32 (30.8)
Laboratory parameters, mean (IQR)
C-reactive protein (mg/L)	3.4 (1.1-8.9); median 5 (2-16)
Fecal calprotectin (μg/g)	820 (450-1800); median 2000 (755.8-2392.5)
AST (U/L)	22 (18-30)
ALT (U/L)	24 (17-33)
Hemoglobin (g/dL)	13.1 (11.7-14.3)
Leukocytes (× 103/μL)	7.2 (5.8-9.8)
Neutrophils (× 103/μL)	4.8 (3.5-7.1)
Platelets (× 103/μL)	270 (230-310)

Data are presented as median (IQR) for continuous variables and n (%) for categorical variables. AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.

Table 2 Previous treatment exposure in patients initiating filgotinib

Treatment	n (%)
Infliximab	77 (74.0)
Adalimumab	37 (35.6)
Golimumab	9 (8.7)
Vedolizumab	32 (30.8)
Ustekinumab	26 (25.0)
Tofacitinib	17 (16.3)
Maintenance of 5-ASA	83 (79.8)
Previous varicella zoster virus vaccination	56 (53.8)
Concomitant corticosteroids	35 (33.6)
Concomitant immunomodulators	11 (10.6)

Table 3 Effectiveness and safety results

Timepoint	Baseline (n = 104)	8 weeks (n = 97)	16 weeks (n = 77)	6 months (n = 70)	12 months (n = 58)	P value1
Mayo Partial Index	6 (5-7)	2 (1-3); P < 0.0012	1 (0.5-2.5); P < 0.0012	0 (0-2.5); P < 0.0012	0 (0-1); P < 0.0012	< 0.001
CRP (mg/L)	5 (2-16)	2.2 (1.0-6.1); P = 0.0142	1.8 (1-4.2); P = 0.0242	1.7 (1-4); P = 0.0302	1 (0.2-3.3); P = 0.0042	< 0.001
Calprotectin (μg/g)	2000 (755.8-2392.5)	402.3 (94.5-2000.0); P = 0.0012	274 (76.2-1365.3); P < 0.001)2	229.5 (65.3-1066.3); P < 0.001)2	153 (21.3-569.0); P < 0.001)2	< 0.001
Clinical remission	-	59 (60.8); P < 0.0013	47 (61.0); P < 0.0013	43 (61.4); P < 0.0013	35 (60.3); P > 0.0013
Clinical-biochemical remission	-	32 (33.0); P < 0.0013	29 (37.6); P < 0.0013	27 (38.6); P < 0.0013	18 (31.0); P < 0.0013
Steroid-free remission	-	-	-	42 (60.0); P = 0.0393	33 (56.9); P = 0.2113
Clinical improvement	-	76 (77.9)	57 (80.7)	57 (80.7)	51 (87.2)
Urgency endoscopic scale	6 (3-8)	2 (0-4.8); P = 0.1183	0 (0-4); P = 0.0053	0 (0-4); P = 0.0033	0 (0-1.5); P = 0.0013	< 0.001
Treatment discontinuation		12 (11.5)	19 (18.2)	19 (18.2)	23 (22.1)

¹Friedman test for related samples for two-factor ranked variance analysis.

²Pairwise comparisons of Friedman test.

³McNemar test for related samples.

Data are presented as median (IQR) for continuous variables and n (%) for categorical variables. CRP: C-reactive protein.