Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study

Table 4 Change from baseline in other patient-reported outcomes at weeks 8 and 52–intent-to-treat population

PRO measure	Baseline	Change from baseline
	n (%) or mean ± SD	N	Week 8, n (%) or mean ± SD	P value	N	Week 52, n (%) or mean ± SD	P value
EQ-5D-5L	0.78 (0.17)	83	0.05 (0.17)	0.021	65	0.06 (0.24)	0.049
SIBDQ
Total score	4.26 (1.08)	83	0.60 (1.08)	< 0.001	65	0.71 (1.24)	< 0.001
Social function	4.40 (1.91)	82	0.93 (1.78)	< 0.001	64	1.09 (2.11)	< 0.001
Emotional function	4.32 (0.78)	83	0.23 (0.82)	0.013	65	0.20 (0.93)	0.093
Bowel symptoms	4.25 (1.33)	83	0.69 (1.50)	< 0.001	65	0.93 (1.66)	< 0.001
Systemic symptoms	4.11 (1.63)	83	0.63 (1.33)	< 0.001	65	0.68 (1.56)	< 0.001
FACIT-F
Fatigue subscale	30.10 (13.76)	83	3.78 (12.29)	0.006	65	5.41 (13.87)	0.003
Physical fatigue	17.67 (6.59)	83	2.44 (6.27)	< 0.001	65	3.86 (7.11)	< 0.001
Social impact of fatigue	20.69 (5.02)	82	0.52 (3.97)	0.234	65	1.32 (4.60)	0.024
Emotional fatigue	15.37 (4.71)	83	1.10 (4.24)	0.021	65	2.06 (5.26)	0.002
Functional fatigue	15.65 (5.54)	83	2.07 (5.43)	< 0.001	65	2.58 (6.36)	0.002
Trial outcome index	63.42 (24.02)	83	8.29 (21.79)	< 0.001	65	11.85 (24.85)	< 0.001
FACT-G total score	69.38 (16.99)	82	6.16 (15.58)	< 0.001	65	9.82 (18.58)	< 0.001
FACIT-F total score	99.48 (29.04)	82	9.99 (26.34)	< 0.001	65	15.23 (30.64)	< 0.001
MOS Sleep
Sleep problems index I	40.46 (19.16)	83	-4.14 (15.89)	0.020	65	-6.56 (16.21)	0.002
Sleep problems index II	42.30 (19.69)	83	-3.47 (15.66)	0.047	65	-4.92 (16.75)	0.021
Sleep disturbance scale	41.52 (25.58)	83	-3.67 (20.82	0.112	65	-4.22 (22.30)	0.132
Snoring scale	30.22 (33.08)	81	0.00 (24.49)	1.000	63	2.54 (25.78)	0.437
Short of breath scale	11.06 (19.37)	83	2.41 (21.50)	0.310	65	3.08 (19.12)	0.199
Sleep adequacy	42.13 (26.96)	83	8.07 (26.01)	0.006	65	11.69 (26.31)	< 0.001
Somnolence scale	43.12 (27.35)	83	-1.37 (22.42)	0.581	65	-4.00 (25.24)	0.206
Sleep quantity	6.73 (1.41)	82	0.13 (1.29)	0.371	63	0.34 (1.31)	0.042
WPAI1
Work time missed (%)	18.9 (31.1)	48	-6.7 (30.9)		37	-9.4 (35.0)
Work impairment while working (%)	39.5 (28.5)	46	-14.8 (33.1)		38	-14.5 (35.8)
Overall work impairment (%)	44.2 (30.1)	42	-16.2 (30.2)		35	-14.5 (34.4)
Activity impairment (%)	46.0 (31.9)	83	-16.9 (29.8)		64	-16.7 (33.6)
VOLP
Any paid work productivity loss in the past x months (%)	45 (76.3)	58	-5 (-4.6)		47	-17 (-16.7)
Paid work productivity loss in the past x months (hours)	98.5 (122.7)	51	13.5 (127.8)		42	-42.2 (115.7)
Any unpaid work productivity loss in the past 7 d (%)	20 (29.0)	61	-8 (-9.3)		48	-7 (-1.9)
Unpaid work productivity loss in the past 7 d (hours)	3.9 (11.6)	61	-3.4 (12.4)		48	-1.9 (14.8)
Any costs of lost productivity in the past x month (%)	47 (79.7)	58	-5 (-7.3)		47	-15 (-11.6)
Total costs of lost productivity in the past x months ($)	6075.8 (8890.9)	51	-1328 (5594.9)		42	-1998 (7299.7)

¹Due to health.

EQ-5D-5L: EuroQol 5-Dimensions, 5 Levels; CI: Confidence interval; FACIT-F: Functional Assessment Chronic Illness Therapy-Fatigue; MOS: Medical Outcomes Study; PRO: Patient-reported outcome; SIBDQ: Short Quality of Life in Inflammatory Bowel Disease Questionnaire.