Bessissow T, Nguyen GC, Tarabain O, Peyrin-Biroulet L, Foucault N, McHugh K, Ruel J. Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study. World J Gastroenterol 2022; 28(34): 5058-5075 [PMID: 36160646 DOI: 10.3748/wjg.v28.i34.5058]
Corresponding Author of This Article
Talat Bessissow, FRCP (C), MD, MSc, Associate Professor, Department of Medicine, McGill University Health Center, 1650 Avenue Cedar, Montreal H3G 1A4, Quebec, Canada. talat.bessissow@mcgill.ca
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Observational Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Sep 14, 2022; 28(34): 5058-5075 Published online Sep 14, 2022. doi: 10.3748/wjg.v28.i34.5058
Table 1 Baseline patient and disease characteristics
Characteristics
N
n (%) or mean ± SD
Age
94
42.5 (15.3)
Gender
Male
94
56 (59.6)
BMI (kg/m2)
91
25.4 (4.5)
Race
American Indian/Alaska Native
94
1 (1.1)
Asian
5 (5.3)
White
88 (93.6)
Employment status
Disability
2 (2.1)
Employed (fulltime, part time < 35 h/week)
63 (67.0)
Homemaker
3 (3.2)
Retired
12 (12.8)
Student
6 (6.4)
Temporary leave of absence
1 (1.1)
Unemployed
6 (6.4)
Unknown
1 (1.1)
Tobacco use
Current smoker
94
2 (2.1)
Former smoker
34 (36.2)
Never smoked
55 (58.5)
Unknown
3 (3.2)
Alcohol use
Non-drinker
94
20 (21.3)
Ex-drinker
5 (5.3)
Light (less than 2 drinks per day)
61 (64.9)
Moderate (2-4 drinks per day)
5 (5.3)
Unknown
3 (3.2)
Age at UC diagnosis (yr)
98
34.5 (15.3)
Disease duration (yr)
98
7.9 (8.0)
Family history of UC
No
98
59 (60.2)
Yes
20 (20.4)
Unknown
19 (19.4)
Montreal classification of extent of UC
E2
97
55 (56.7)
(prior 3 mo)
E3
42 (43.3)
Mayo Endoscopic Subscore
1
90
1 (1.1)
(prior 3 mo)
2
66 (73.3)
3
23 (25.6)
Endoscopy (prior 6 mo)
Yes
98
91 (92.9)
UC-related ED visit (prior 6 mo)
Yes
98
13 (13.3)
UC-related hospitalization (prior 6 mo)
Yes
98
12 (12.2)
Previous biologic use
Yes
44
5 (11.4)
Medication use:
Corticosteroids
98
63 (64.3)
Since UC diagnosis to prior 6 mo
Imuran (azathioprine)
37 (37.8)
6-MP
8 (8.2)
5-ASA
83 (84.7)
Methotrexate
5 (5.1)
Cyclosporine
1 (1.0)
Medication use:
Corticosteroids
98
61 (62.2)
Since prior 6 mo to current
Imuran (azathioprine)
39 (39.8)
6-MP
5 (5.1)
5-ASA
67 (68.4)
Methotrexate
8 (8.2)
Cyclosporine
0 (0.0)
Table 2 Patient Health Questionnaire–9 items at week 8 and week 52/final visit
Outcome
ITT
Completers
Baseline (n = 94)
Week 8 (n = 94)
Week 52/final visit (n = 73)
Baseline (n = 48)
Week 8 (n = 48)
Week 52/final visit (n = 47)
PHQ-9 total score
n
94
82
65
48
43
44
mean ± SD
8.8 (6.3)
6.8 (5.3)
6.5 (5.6)
8.2 (6.7)
5.8 (5.6)
4.6 (4.3)
Median
8.0
6.0
5.0
5.0
5.0
3.0
Min, Max
0.0, 26.0
0.0, 26.0
0.0, 22.0
1.0, 26.0
0.0, 26.0
0.0, 15.0
Change from baseline
n
82
65
43
44
mean ± SD
-2.2 (6.1)
-2.4 (7.1)
-2.5 (6.1)
-3.4 (6.8)
P value
0.002
0.008
0.010
0.002
PHQ-9 category, n (%)
Minimal
35 (37.2)
31 (37.8)
28 (43.1)
23 (47.9)
21 (48.8)
25 (56.8)
Mild
23 (24.5)
30 (36.6)
18 (27.7)
8 (16.7)
14 (32.6)
11 (25.0)
Moderate
18 (19.1)
14 (17.1)
11 (16.9)
9 (18.8)
4 (9.3)
7 (15.9)
Moderately severe
11 (11.7)
4 (4.9)
7 (10.8)
4 (8.3)
2 (4.7)
1 (2.3)
Severe
7 (7.4)
3 (3.7)
1 (1.5)
4 (8.3)
2 (4.7)
0 (0.0)
P value
0.280
0.681
0.610
0.542
PHQ-9: Yellow flag category, n (%)
36 (38.3)
21 (25.6)
19 (29.2)
17 (35.4)
8 (18.6)
8 (18.2)
P value
0.028
0.083
0.021
0.059
PHQ-9: Red flag category, n (%)
Yes
18 (19.1)
7 (8.5)
8 (12.3)
8 (16.7)
4 (9.3)
1 (2.3)
P value
0.013
0.134
0.180
0.034
Table 3 Association between clinical response/remission and improvement in Patient Health Questionnaire–9 items total score at week 52/final visit–intent-to-treat and completers populations
Analysis population
Parameter
Model coefficient (SE)
Est. odds ratio (95%CI)
P value
Clinical response
ITT
Baseline PHQ-9 total score
0.17 (0.06)
1.19 (1.05-1.34)
0.005
Clinical response at week 52: Yes versus No
0.30 (0.65)
1.35 (0.38-4.84)
0.648
UC duration (years)
0.11 (0.05)
1.11 (1.00-1.24)
0.051
Completers
Baseline PHQ-9 total score
0.20 (0.10)
1.22 (1.00-1.48)
0.049
Clinical response at week 52: Yes versus No
-1.29 (1.29)
0.28 (0.02-3.43)
0.317
UC duration (years)
0.14 (0.08)
1.15 (0.98-1.35)
0.079
Clinical remission
ITT
Baseline PHQ-9 total score
0.28 (0.09)
1.33 (1.11-1.59)
0.002
Clinical remission at week 52: Yes versus No
2.07 (0.88)
7.94 (1.42-44.41)
0.018
UC duration (years)
0.11 (0.06)
1.11 (1.00-1.24)
0.054
Completers
Baseline PHQ-9 total score
0.22 (0.11)
1.24 (1.00-1.53)
0.045
Clinical remission at week 52: Yes versus No
1.39 (1.07)
4.00 (0.50-32.37)
0.193
UC duration (years)
0.14 (0.08)
1.15 (0.98-1.36)
0.095
Table 4 Change from baseline in other patient-reported outcomes at weeks 8 and 52–intent-to-treat population
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)
Table 5 Overview of adverse events–safety population
Events (n = 55)
Patients (n = 98)
All AEs
55
18 (18.4%)
Severe AEs
10 (18.2%)
5 (5.1%)
AEs related to study drug
17 (30.9%)
12 (12.2%)
Mild
5 (29.4%)
4 (4.1%)
Moderate
6 (35.3%)
6 (6.1%)
Severe
4 (23.5%)
2 (2.0%)
Not provided
2 (11.8%)
2 (2.0%)
Serious AEs
27 (49.1%)
7 (7.1%)
Number of patients with AEs
Resulting in hospitalization
6 (6.1%)
Resulting in study drug discontinuation
15 (15.3%)
Malignancy in patients ≤ 30 yr
0
0
Death
0
0
Citation: Bessissow T, Nguyen GC, Tarabain O, Peyrin-Biroulet L, Foucault N, McHugh K, Ruel J. Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study. World J Gastroenterol 2022; 28(34): 5058-5075