1Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
2Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
3Teikyo University Graduate School of Public Health, Tokyo, Japan
© Copyright 2024. Korean Association for the Study of Intestinal Diseases.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Funding Source
This study was supported by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical K.K.
Conflict of Interest
Kobayashi T reports support for this work from Mitsubishi Tanabe Pharma Corporation; institutional grants or contracts from AbbVie GK, Activaid, Alfresa Pharma Corporation, JMDC Inc., Gilead Sciences Inc., Nippon Kayaku Co. Ltd., Eli Lilly Japan K.K., Mochida Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd., Bristol-Myers Squibb, Mitsubishi Tanabe Pharma Corporation, Zeria Pharmaceutical Co. Ltd., Otsuka Holdings, EA Pharma Co. Ltd., JIMRO Co. Ltd., Kyorin Pharmaceutical Co. Ltd., and Google Asia Pacific Pte Ltd.; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Takeda Pharmaceutical Co. Ltd., Activaid, Alfresa Pharma Corporation, Zeria Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Pfizer Japan Inc., Janssen Pharmaceutical K.K., Thermo Fisher Diagnostics K.K., JIMRO Co. Ltd., and Galapagos; and payment for expert testimony from Janssen Pharmaceutical K.K., EA Pharma Co. Ltd., Kissei Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Activaid, Pfizer Japan Inc., Nippon Kayaku Co. Ltd., Alfresa Pharma Corporation, Kyorin Pharmaceutical Co. Ltd., AbbVie GK, Mochida Pharmaceutical Co. Ltd., and Mitsubishi Tanabe Pharma Corporation. Mizuno N, Sato N, Kawaguchi Y, Ikawa Y, and Komorita N report support for this work from Mitsubishi Tanabe Pharma Corporation and are employees of Mitsubishi Tanabe Pharma Corporation. Ishikawa H reports support for this work from Mitsubishi Tanabe Pharma Corporation. Except for that, no potential conflict of interest relevant to this article was reported.
Data Availability Statement
The data underlying this article will be shared upon reasonable request by the corresponding author.
Author Contributions
Conceptualization: Kobayashi T, Mizuno N, Sato N, Kawaguchi Y, Ikawa Y, Ishikawa H. Investigation: Kobayashi T, Mizuno N, Sato N, Kawaguchi Y, Ikawa Y, Ishikawa H. Methodology: Kobayashi T, Mizuno N, Sato N, Kawaguchi Y, Ikawa Y, Ishikawa H. Project administration: Mizuno N. Visualization: Kobayashi T, Mizuno N, Sato N, Kawaguchi Y, Ikawa Y, Komorita N, Ishikawa H. Writing – original draft: Kobayashi T, Mizuno N. Writing – review and editing: Kobayashi T, Mizuno N, Sato N, Kawaguchi Y, Ikawa Y, Komorita N, Ishikawa H. Approval of the final manuscript: All authors.
Additional Contributions
The authors thank all respondents for completing the questionnaire and QLife Inc. who assisted with the administration of the questionnaire. The authors also thank Tamio Kan, Yasuo Shiga, and Naoko Himeno of iStat, Inc. for planning and analyzing the conjoint analysis and Annirudha Chillar, MD, PhD, of Cactus Life Sciences (part of Cactus Communications) for providing medical writing support, which was funded by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical K.K.
Characteristic | Total (n=365) | |
---|---|---|
Sex | Female | 243 (66.6) |
Age (yr) | Mean ± SD | 42.9 ± 11.8 |
< 40 | 149 (40.8) | |
40–59 | 187 (51.2) | |
≥ 60 | 29 (7.9) | |
Age at diagnosis (yr) | Mean ± SD | 33.8 ± 12.2 |
< 40 | 246 (67.4) | |
40–59 | 110 (30.1) | |
≥ 60 | 9 (2.5) | |
Disease duration (yr) | Mean ± SD | 9.2 ± 8.8 |
<1 | 17 (4.7) | |
1–5 | 157 (43.0) | |
≥6 | 191 (52.3) | |
Extent of disease | Pancolitis | 204 (55.9) |
Left-sided colitis | 75 (20.5) | |
Proctitis | 73 (20.0) | |
Unknown | 13 (3.6) | |
Disease status (most severe symptoms/current symptomsa) | ||
Stool frequency score | 0 (Same as usual/no change) | 3 (0.8)/140 (38.4) |
1 (1–2 stools more than usual) | 10 (2.7)/122 (33.4) | |
2 (3–4 stools more than usual) | 25 (6.8)/63 (17.3) | |
3 (≥ 5 stools more than usual) | 327 (89.6)/40 (11.0) | |
Rectal bleeding score | 0 (No blood seen) | 14 (3.8)/309 (84.7) |
1 (Streaks of blood with stool less than half the time) | 46 (12.6)/37 (10.1) | |
2 (Obvious blood with stool most of the time) | 106 (29.0)/17 (4.7) | |
3 (Mostly blood) | 199 (54.5)/2 (0.5) | |
Abdominal pain | None | 26 (7.1)/251 (68.8) |
Mild | 50 (13.7)/89 (24.4) | |
Moderate | 131 (35.9)/23 (6.3) | |
Severe | 158 (43.3)/2 (0.5) | |
Bowel urgency (No. of days in the past 3 days) | 0 | 13 (3.6)/258 (70.7) |
1 | 19 (5.2)/51 (14.0) | |
2 | 16 (4.4)/20 (5.5) | |
3 | 317 (86.8)/36 (9.9) | |
Prior treatment (n = 150)b,c | Topical agents (5-ASA/steroid) | 284 (77.8) |
Steroids (oral/injection) | 242 (66.3) | |
Thiopurines | 135 (37.0) | |
Advanced therapies | 169 (46.3) | |
Anti-TNFα antibodies | 159 (43.6) | |
α4β7 integrin inhibitor | 56 (15.3) | |
Anti-IL-12/IL-23 antibody | 41 (11.2) | |
JAK inhibitors | 63 (17.3) | |
Calcineurin inhibitors | 43 (11.8) | |
Route of administration of prior biologicsc | Intravenous infusion | 114 (76.0) |
Subcutaneous injection (hospital) | 70 (46.7) | |
Subcutaneous injection (self-administration) | 49 (32.7) | |
Medical institutionsc | National public hospital | 54 (14.8) |
University hospital | 116 (31.8) | |
Other hospitals | 124 (34.0) | |
Clinic | 97 (26.6) | |
Travel time to hospital (one way), min | < 30 | 181 (49.6) |
30–60 | 131 (35.9) | |
≥ 60 | 53 (14.5) | |
Burden of hospital visits | Feeling | 55 (15.1) |
Somewhat feeling | 158 (43.3) | |
Not feeling much | 122 (33.4) | |
Not feeling | 30 (8.2) | |
Employment status | Employed | 267 (73.2) |
Permanent employees | 157 (58.8) | |
Temporary and atypical employees | 31 (11.6) | |
Self-employment, freelance | 20 (7.5) | |
Part-time | 59 (22.1) | |
Unemployed | 98 (26.8) | |
Homemaker | 42 (42.9) | |
Student | 16 (16.3) | |
Leave of absence, unemployment, or retirement due to UC | 28 (28.6) | |
Leave of absence, unemployment, or retirement not related to UC | 12 (12.2) | |
Questions concerning employment (n = 267) | ||
Working hours | Full-time (about 40 hr/wk) | 181 (67.8) |
For a short time | 86 (32.2) | |
Working overtime (No. of days worked overtime/wk) | 0 | 163 (61.0) |
1–2 | 57 (21.3) | |
≥ 3 | 47 (17.6) | |
Option to telework | Yes | 82 (30.7) |
No | 185 (69.3) | |
Option to flexible work hours | Yes | 68 (25.5) |
No | 199 (74.5) | |
Business trip with stay | Almost none | 253 (94.8) |
At least once a month | 14 (5.2) | |
Taking leave for medical treatment | Easy to take | 140 (52.4) |
Somewhat easy to take | 87 (32.6) | |
Somewhat difficult to take | 24 (9.0) | |
Difficult to take | 16 (6.0) | |
Do your superiors and colleagues know your UC? | Yes | 151 (56.6) |
Only some | 84 (31.5) | |
Not informed | 28 (10.5) | |
Don’t have superiors or colleagues | 4 (1.5) |
Independent variables | Total (n=365) |
Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events within 1 yr | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 243 | –0.003 (0.008) | 0.004 (0.008) | 0.005 (0.009) | –0.015 (0.010) | 0.000 (0.009) | 0.003 (0.009) |
Age (vs. < 40 yr) | 40–59 | 187 | –0.005 (0.008) | 0.001 (0.008) | 0.010 (0.009) | 0.019 (0.009)a | –0.029 (0.009)b | 0.014 (0.009) |
≥ 60 | 29 | –0.013 (0.015) | –0.008 (0.015) | 0.038 (0.017)a | 0.019 (0.018) | –0.040 (0.017)a | 0.018 (0.016) | |
Disease duration (vs. < 1 yr) | 1–5 | 157 | 0.009 (0.018) | 0.019 (0.018) | –0.002 (0.021) | 0.020 (0.021) | 0.002 (0.021) | –0.037 (0.019) |
≥ 6 | 191 | 0.012 (0.018) | 0.015 (0.018) | 0.002 (0.021) | 0.009 (0.021) | 0.007 (0.021) | –0.036 (0.019) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 75 | –0.004 (0.012) | –0.009 (0.011) | 0.008 (0.013) | –0.001 (0.014) | 0.006 (0.013) | 0.011 (0.012) |
Pancolitis | 204 | –0.016 (0.011) | 0.003 (0.010) | 0.016 (0.012) | –0.013 (0.012) | 0.019 (0.012) | 0.019 (0.011) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 242 | 0.004 (0.010) | 0.009 (0.010) | –0.017 (0.011) | 0.008 (0.012) | 0.012 (0.011) | –0.001 (0.010) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 196 | 0.000 (0.009) | –0.003 (0.008) | –0.005 (0.010) | –0.013 (0.010) | 0.000 (0.010) | 0.017 (0.009) |
Medical institutions (vs. other than clinic) | Clinic | 97 | –0.008 (0.009) | 0.018 (0.009)a | 0.008 (0.010) | –0.001 (0.010) | –0.012 (0.010) | –0.004 (0.009) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 122 | 0.016 (0.015) | 0.014 (0.014) | –0.002 (0.017) | 0.015 (0.017) | 0.009 (0.016) | –0.013 (0.015) |
Somewhat feeling | 158 | 0.026 (0.014) | 0.021 (0.014) | –0.004 (0.016) | 0.013 (0.017) | 0.013 (0.016) | –0.003 (0.015) | |
Feeling | 55 | 0.017 (0.016) | 0.027 (0.016) | –0.003 (0.018) | –0.001 (0.019) | 0.005 (0.018) | –0.003 (0.017) | |
Employment status (vs. employed) | Unemployed | 98 | –0.006 (0.009) | –0.008 (0.008) | 0.015 (0.010) | 0.001 (0.010) | 0.003 (0.010) | 0.009 (0.009) |
Stool frequency score during most severe symptoms (vs. same as usual or 1–4 stools more than usual) | ≥ 5 stools more than usual | 327 | 0.005 (0.014) | 0.001 (0.014) | –0.007 (0.016) | 0.018 (0.017) | 0.029 (0.016) | –0.031 (0.015)a |
Rectal bleeding score during most severe symptoms (vs. no blood and streaks blood with stool less than half the time) | Obvious blood with stool most of the time | 106 | –0.004 (0.012) | –0.005 (0.012) | –0.006 (0.014) | –0.009 (0.014) | 0.008 (0.014) | –0.005 (0.013) |
Mostly blood | 199 | –0.009 (0.012) | –0.003 (0.012) | 0.001 (0.013) | –0.019 (0.014) | –0.013 (0.013) | 0.010 (0.013) | |
Degree of abdominal pain during most severe symptoms (vs. none or mild) | Moderate | 131 | –0.018 (0.011) | –0.004 (0.011) | 0.012 (0.012) | –0.007 (0.013) | 0.005 (0.012) | 0.020 (0.011) |
Severe | 158 | –0.015 (0.011) | –0.012 (0.011) | 0.010 (0.013) | –0.005 (0.013) | 0.003 (0.013) | 0.001 (0.012) | |
Number of days with bowel urgency during most severe symptoms (vs. 0–2 day) | 3 | 317 | 0.014 (0.013) | –0.010 (0.013) | –0.009 (0.009) | –0.002 (0.015) | 0.005 (0.015) | –0.003 (0.014) |
Coefficient of determination | 0.041 | 0.042 | 0.037 | 0.054 | 0.094 | 0.072 |
Independent variable | Total (n=365) |
Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events within 1 yr | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 243 | –0.006 (0.008) | 0.003 (0.008) | 0.008 (0.009) | –0.016 (0.009) | 0.001 (0.009) | 0.005 (0.009) |
Age (vs. < 40 yr) | 40–59 | 187 | –0.003 (0.008) | 0.002 (0.008) | 0.007 (0.009) | 0.019 (0.009)a | –0.028 (0.009)b | 0.013 (0.009) |
≥ 60 | 29 | –0.008 (0.015) | –0.005 (0.015) | 0.031 (0.017) | 0.023 (0.017) | –0.037 (0.017)a | 0.015 (0.016) | |
Disease duration (vs. < 1 yr) | 1–5 | 157 | 0.009 (0.018) | 0.015 (0.018) | 0.002 (0.021) | 0.026 (0.021) | 0.002 (0.021) | –0.037 (0.019) |
≥ 6 | 191 | 0.009 (0.018) | 0.008 (0.018) | 0.007 (0.021) | 0.012 (0.021) | 0.008 (0.021) | –0.038 (0.020) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 75 | –0.003 (0.012) | –0.009 (0.011) | 0.007 (0.013) | 0.001 (0.013) | 0.007 (0.013) | 0.008 (0.013) |
Pancolitis | 204 | –0.015 (0.011) | 0.002 (0.010) | 0.013 (0.012) | –0.011 (0.012) | 0.019 (0.012) | 0.015 (0.011) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 242 | 0.002 (0.010) | 0.008 (0.009) | –0.016 (0.011) | 0.004 (0.011) | 0.011 (0.011) | 0.000 (0.010) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 196 | 0.000 (0.009) | –0.001 (0.008) | –0.004 (0.010) | –0.011 (0.010) | 0.000 (0.010) | 0.018 (0.009) |
Medical institutions (vs. other than clinic) | Clinic | 97 | –0.007 (0.009) | 0.021 (0.009)a | 0.008 (0.010) | –0.001 (0.010) | –0.015 (0.010) | –0.001 (0.009) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 122 | 0.015 (0.015) | 0.015 (0.014) | –0.003 (0.016) | 0.013 (0.017) | 0.008 (0.016) | –0.013 (0.016) |
Somewhat feeling | 158 | 0.026 (0.014) | 0.025 (0.014) | –0.005 (0.016) | 0.011 (0.017) | 0.010 (0.016) | –0.003 (0.015) | |
Feeling | 55 | 0.017 (0.017) | 0.032 (0.016)a | –0.006 (0.019) | –0.004 (0.019) | 0.003 (0.019) | –0.001 (0.018) | |
Employment status (vs. employed) | Unemployed | 98 | –0.005 (0.009) | –0.009 (0.008) | 0.016 (0.010) | 0.004 (0.010) | 0.003 (0.010) | 0.008 (0.009) |
Current stool frequency score (vs. same as usual) | ≥ 1 stool more than usual | 225 | 0.008 (0.008) | 0.002 (0.008) | 0.010 (0.009) | 0.030 (0.010)b | –0.001 (0.009) | –0.004 (0.009) |
Current rectal bleeding score (vs. no blood) | Blood present | 56 | 0.005 (0.011) | 0.008 (0.011) | –0.013 (0.013) | 0.012 (0.013) | –0.019 (0.013) | 0.003 (0.012) |
Degree of current abdominal pain (vs. none) | Yes | 114 | –0.005 (0.009) | –0.018 (0.009)a | 0.005 (0.010) | 0.007 (0.010) | 0.014 (0.010) | –0.014 (0.010) |
Number of days with current bowel urgency (vs. 0 days) | ≥ 1 | 107 | –0.009 (0.010) | –0.004 (0.010) | 0.000 (0.011) | –0.028 (0.011)a | 0.008 (0.011) | 0.005 (0.011) |
Coefficient of determination | 0.033 | 0.050 | 0.037 | 0.081 | 0.083 | 0.044 |
Independent variable | Total (n=267) |
Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events within 1 yr | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 166 | –0.013 (0.011) | 0.015 (0.011) | 0.010 (0.012) | –0.008 (0.012) | –0.016 (0.013) | 0.001 (0.011) |
Age (vs. < 40 yr) | 40–59 | 142 | 0.000 (0.010) | 0.005 (0.010) | 0.009 (0.011) | 0.022 (0.012) | –0.031 (0.012)b | 0.019 (0.011) |
≥ 60 | 22 | –0.020 (0.019) | –0.011 (0.019) | 0.043 (0.021)a | 0.024 (0.022) | –0.034 (0.022) | 0.007 (0.020) | |
Disease duration (vs. < 1 yr) | 1–5 | 113 | 0.024 (0.023) | 0.027 (0.024) | –0.015 (0.026) | 0.034 (0.027) | 0.026 (0.027) | –0.051 (0.025)a |
≥ 6 | 143 | 0.015 (0.023) | 0.015 (0.024) | 0.003 (0.027) | 0.011 (0.027) | 0.025 (0.028) | –0.037 (0.025) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 51 | 0.008 (0.014) | 0.006 (0.015) | –0.003 (0.016) | 0.020 (0.017) | 0.007 (0.017) | 0.003 (0.015) |
Pancolitis | 147 | 0.004 (0.013) | 0.009 (0.014) | 0.003 (0.015) | –0.011 (0.015) | 0.032 (0.016)a | 0.016 (0.014) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 170 | 0.016 (0.012) | 0.016 (0.012) | –0.033 (0.013)a | 0.011 (0.014) | 0.026 (0.014) | –0.007 (0.013) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 144 | 0.017 (0.011) | –0.001 (0.011) | –0.010 (0.012) | –0.011 (0.012) | 0.003 (0.013) | 0.019 (0.012) |
Medical institutions (vs. other than clinic) | Clinic | 67 | 0.001 (0.011) | 0.026 (0.011)a | 0.000 (0.012) | 0.004 (0.013) | –0.007 (0.013) | –0.004 (0.012) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 91 | 0.027 (0.017) | 0.022 (0.018) | –0.009 (0.019) | 0.015 (0.020) | 0.009 (0.020) | –0.010 (0.018) |
Somewhat feeling | 114 | 0.027 (0.016) | 0.026 (0.017) | 0.004 (0.019) | 0.021 (0.019) | 0.014 (0.020) | 0.000 (0.018) | |
Feeling | 38 | 0.032 (0.019) | 0.023 (0.020) | 0.000 (0.022) | 0.002 (0.022) | 0.014 (0.023) | –0.001 (0.020) | |
Stool frequency score during most severe symptoms (vs. same as usual and 1–4 stools more than usual) | ≥ 5 stools more than usual | 238 | 0.008 (0.017) | 0.000 (0.017) | –0.020 (0.019) | 0.014 (0.020) | 0.027 (0.020) | –0.041 (0.018)a |
Rectal blooding score during most severe symptoms (vs. no blood and streaks blood with stool less than half the time) | Obvious blood with stool most of the time | 75 | –0.009 (0.014) | –0.006 (0.014) | –0.007 (0.016) | 0.002 (0.016) | 0.003 (0.017) | –0.007 (0.015) |
Mostly blood | 146 | –0.013 (0.014) | –0.005 (0.014) | 0.012 (0.016) | –0.018 (0.016) | –0.013 (0.016) | 0.010 (0.015) | |
Degree of abdominal pain during the most severe symptoms (vs. none or mild) | Moderate | 97 | –0.028 (0.012)a | –0.003 (0.012) | 0.018 (0.014) | –0.006 (0.014) | 0.012 (0.014) | 0.014 (0.013) |
Severe | 107 | –0.024 (0.013) | –0.018 (0.013) | 0.020 (0.015) | –0.006 (0.015) | 0.000 (0.015) | 0.001 (0.014) | |
No. of days with bowel urgency during most severe symptoms (vs. 0–2 day) | 3 | 230 | 0.020 (0.015) | 0.005 (0.016) | –0.019 (0.017) | 0.008 (0.018) | –0.006 (0.018) | –0.001 (0.016) |
Employment status (vs. permanent employees) | Temporary and atypical employees | 31 | 0.019 (0.015) | –0.011 (0.016) | –0.001 (0.017) | –0.008 (0.018) | –0.015 (0.018) | 0.016 (0.016) |
Self-employment and freelance | 20 | –0.010 (0.021) | –0.001 (0.022) | 0.005 (0.024) | –0.017 (0.025) | 0.013 (0.025) | –0.002 (0.023) | |
Part-time | 59 | 0.007 (0.016) | –0.013 (0.017) | 0.001 (0.019) | 0.032 (0.019) | 0.032 (0.020) | –0.010 (0.018) | |
Working hours (vs. full-time) | For a short time | 86 | –0.017 (0.014) | 0.003 (0.015) | 0.013 (0.016) | –0.033 (0.017)a | 0.005 (0.017) | 0.006 (0.016) |
Working overtime (vs. 0 day) | 1–2 | 57 | –0.009 (0.012) | –0.004 (0.013) | –0.012 (0.014) | 0.004 (0.014) | –0.003 (0.014) | –0.014 (0.013) |
≥ 3 | 47 | –0.021 (0.013) | 0.017 (0.014) | 0.010 (0.015) | 0.004 (0.016) | –0.013 (0.016) | 0.006 (0.014) | |
Option to telework (vs. yes) | No | 185 | 0.012 (0.012) | –0.013 (0.012) | –0.001 (0.014) | 0.008 (0.014) | –0.007 (0.014) | –0.004 (0.013) |
Option to flexible work hours (vs. yes) | No | 199 | 0.013 (0.013) | 0.009 (0.013) | –0.026 (0.014) | –0.019 (0.015) | –0.001 (0.015) | 0.003 (0.014) |
Business trips with stay (vs. almost none) | At least once a month | 14 | 0.009 (0.021) | 0.026 (0.022) | –0.029 (0.024) | –0.010 (0.024) | 0.028 (0.025) | –0.037 (0.022) |
Taking leave for medical treatment (vs. easy to take) | Somewhat easy | 87 | 0.016 (0.010) | –0.010 (0.011) | –0.015 (0.012) | 0.006 (0.012) | 0.010 (0.012) | –0.017 (0.011) |
Somewhat difficult | 24 | 0.021 (0.017) | 0.030 (0.017) | –0.034 (0.019) | 0.018 (0.019) | –0.007 (0.020) | –0.031 (0.018) | |
Difficult | 16 | –0.011 (0.020) | –0.006 (0.020) | 0.008 (0.022) | –0.018 (0.023) | 0.001 (0.023) | –0.017 (0.021) | |
Only some | 84 | 0.004 (0.010) | –0.009 (0.011) | 0.008 (0.012) | –0.014 (0.012) | 0.010 (0.012) | 0.013 (0.011) | |
Do your superiors and colleagues know your UC? (vs. yes) | Not informed | 28 | 0.009 (0.016) | 0.018 (0.016) | –0.015 (0.018) | –0.009 (0.018) | –0.003 (0.019) | –0.009 (0.017) |
Don’t have superiors or colleagues | 4 | –0.010 (0.038) | 0.024 (0.039) | –0.035 (0.043) | 0.045 (0.044) | –0.034 (0.045) | –0.007 (0.040) | |
Coefficient of determination | 0.145 | 0.108 | 0.131 | 0.130 | 0.159 | 0.128 |
Independent variable | Total (n=98) |
Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 77 | –0.006 (0.021) | 0.014 (0.018) | –0.028 (0.024) | –0.021 (0.026) | 0.022 (0.022) | 0.000 (0.022) |
Age (vs. < 40 yr) | 40–59 | 45 | 0.003 (0.020) | –0.003 (0.016) | –0.011 (0.022) | 0.028 (0.024) | –0.013 (0.020) | –0.018 (0.020) |
≥ 60 | 7 | –0.022 (0.032) | 0.012 (0.027) | 0.021 (0.037) | 0.013 (0.039) | –0.068 (0.034)a | 0.021 (0.034) | |
Disease duration (vs. < 1 yr) | 1–5 | 44 | 0.004 (0.036) | –0.003 (0.030) | –0.007 (0.041) | 0.052 (0.044) | –0.034 (0.037) | –0.022 (0.038) |
≥ 6 | 48 | 0.033 (0.037) | 0.010 (0.030) | –0.013 (0.042) | 0.059 (0.044) | –0.034 (0.038) | –0.035 (0.038) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 24 | –0.014 (0.027) | –0.042 (0.022) | 0.037 (0.031) | –0.046 (0.033) | 0.022 (0.028) | 0.032 (0.028) |
Pancolitis | 57 | –0.036 (0.024) | 0.002 (0.020) | 0.042 (0.027) | –0.013 (0.029) | 0.009 (0.025) | 0.031 (0.025) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 72 | –0.017 (0.020) | 0.003 (0.017) | 0.008 (0.023) | 0.002 (0.025) | –0.011 (0.021) | 0.005 (0.021) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 52 | –0.044 (0.019)a | 0.013 (0.015) | –0.006 (0.021) | –0.026 (0.023) | –0.001 (0.019) | 0.014 (0.019) |
Medical institutions (vs. other than clinic) | Clinic | 30 | –0.003 (0.019) | –0.005 (0.015) | 0.019 (0.021) | –0.001 (0.023) | –0.030 (0.019) | 0.002 (0.019) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 31 | –0.044 (0.037) | 0.032 (0.030) | 0.026 (0.042) | 0.011 (0.044) | 0.016 (0.038) | –0.029 (0.038) |
Somewhat feeling | 44 | –0.018 (0.036) | 0.047 (0.033) | 0.001 (0.042) | –0.036 (0.044) | 0.018 (0.038) | 0.000 (0.038) | |
Feeling | 17 | –0.037 (0.040) | 0.052 (0.023) | 0.030 (0.030) | –0.040 (0.048) | –0.021 (0.041) | 0.043 (0.041) | |
Stool frequency score during most severe symptoms (vs. same as usual and 1–4 stools more than usual) | ≥ 5 stools more than usual | 89 | 0.014 (0.031) | 0.008 (0.025) | 0.031 (0.035) | –0.004 (0.037) | 0.029 (0.032) | 0.016 (0.032) |
Rectal blooding score during most severe symptoms (vs. no blood and streaks blood with stool less than half the time) | Obvious blood with stool most of the time | 31 | 0.013 (0.030) | 0.032 (0.024) | –0.018 (0.034) | –0.002 (0.036) | –0.013 (0.031) | –0.026 (0.031) |
Mostly blood | 53 | 0.006 (0.027) | 0.021 (0.023) | –0.04 (0.031) | –0.005 (0.033) | –0.031 (0.028) | –0.008 (0.028) | |
Degree of abdominal pain during the most severe symptoms (vs. none or mild) | Moderate | 34 | 0.000 (0.029) | –0.028 (0.024) | 0.011 (0.033) | –0.027 (0.035) | –0.004 (0.030) | 0.043 (0.030) |
Severe | 51 | –0.021 (0.029) | –0.024 (0.024) | 0.012 (0.034) | –0.033 (0.036) | 0.023 (0.030) | 0.007 (0.031) | |
No. of days with bowel urgency during most severe symptoms (vs. 0–2 day) | 3 | 87 | –0.013 (0.030) | –0.037 (0.024) | 0.000 (0.034) | –0.040 (0.036) | 0.016 (0.031) | 0.007 (0.031) |
Employment status (vs. homemaker) | Student | 16 | 0.036 (0.028) | 0.040 (0.023) | –0.042 (0.031) | 0.021 (0.033) | –0.009 (0.028) | –0.030 (0.029) |
Leave of absence, unemployment, or retirement due to UC | 28 | 0.007 (0.020) | 0.011 (0.017) | –0.008 (0.023) | 0.047 (0.025) | –0.006 (0.021) | –0.031 (0.021) | |
Leave of absence, unemployment, or retirement not related to UC | 12 | 0.010 (0.026) | 0.006 (0.022) | 0.030 (0.030) | –0.058 (0.032) | –0.028 (0.027) | 0.075 (0.027)b | |
Coefficient of determination | 0.230 | 0.225 | 0.172 | 0.247 | 0.233 | 0.297 |
Treatment attribute | Level |
---|---|
Location of administration | Administered at a hospital or clinic |
Can be administered at home | |
Route/frequency of administration | Intravenous infusion over 30 min to 2 hr every 8 wk |
Subcutaneous injection every 2 wk | |
Subcutaneous injection every 4 wk | |
Subcutaneous injection every 8–12 wk | |
Daily oral administration | |
Time to symptom improvement (speed of onset of action) | 1 wk |
2 wk | |
4 wk | |
Proportion of patients with sustained improvement in symptoms at 1 yr (maintenance-sustainability) | 60 of 100 patients |
70 of 100 patients | |
80 of 100 patients | |
Risk of serious adverse events within 1 yr | 5 of 100 patients |
10 of 100 patients | |
15 of 100 patients | |
Novelty of the drug: time since launch and amount of long-term use data | Launched within 1 yr and with limited long-term use data |
Launched more than 1 yr ago and with much long-term use data |
Characteristic | Total (n=365) | |
---|---|---|
Sex | Female | 243 (66.6) |
Age (yr) | Mean ± SD | 42.9 ± 11.8 |
< 40 | 149 (40.8) | |
40–59 | 187 (51.2) | |
≥ 60 | 29 (7.9) | |
Age at diagnosis (yr) | Mean ± SD | 33.8 ± 12.2 |
< 40 | 246 (67.4) | |
40–59 | 110 (30.1) | |
≥ 60 | 9 (2.5) | |
Disease duration (yr) | Mean ± SD | 9.2 ± 8.8 |
<1 | 17 (4.7) | |
1–5 | 157 (43.0) | |
≥6 | 191 (52.3) | |
Extent of disease | Pancolitis | 204 (55.9) |
Left-sided colitis | 75 (20.5) | |
Proctitis | 73 (20.0) | |
Unknown | 13 (3.6) | |
Disease status (most severe symptoms/current symptoms |
||
Stool frequency score | 0 (Same as usual/no change) | 3 (0.8)/140 (38.4) |
1 (1–2 stools more than usual) | 10 (2.7)/122 (33.4) | |
2 (3–4 stools more than usual) | 25 (6.8)/63 (17.3) | |
3 (≥ 5 stools more than usual) | 327 (89.6)/40 (11.0) | |
Rectal bleeding score | 0 (No blood seen) | 14 (3.8)/309 (84.7) |
1 (Streaks of blood with stool less than half the time) | 46 (12.6)/37 (10.1) | |
2 (Obvious blood with stool most of the time) | 106 (29.0)/17 (4.7) | |
3 (Mostly blood) | 199 (54.5)/2 (0.5) | |
Abdominal pain | None | 26 (7.1)/251 (68.8) |
Mild | 50 (13.7)/89 (24.4) | |
Moderate | 131 (35.9)/23 (6.3) | |
Severe | 158 (43.3)/2 (0.5) | |
Bowel urgency (No. of days in the past 3 days) | 0 | 13 (3.6)/258 (70.7) |
1 | 19 (5.2)/51 (14.0) | |
2 | 16 (4.4)/20 (5.5) | |
3 | 317 (86.8)/36 (9.9) | |
Prior treatment (n = 150) |
Topical agents (5-ASA/steroid) | 284 (77.8) |
Steroids (oral/injection) | 242 (66.3) | |
Thiopurines | 135 (37.0) | |
Advanced therapies | 169 (46.3) | |
Anti-TNFα antibodies | 159 (43.6) | |
α4β7 integrin inhibitor | 56 (15.3) | |
Anti-IL-12/IL-23 antibody | 41 (11.2) | |
JAK inhibitors | 63 (17.3) | |
Calcineurin inhibitors | 43 (11.8) | |
Route of administration of prior biologics |
Intravenous infusion | 114 (76.0) |
Subcutaneous injection (hospital) | 70 (46.7) | |
Subcutaneous injection (self-administration) | 49 (32.7) | |
Medical institutions |
National public hospital | 54 (14.8) |
University hospital | 116 (31.8) | |
Other hospitals | 124 (34.0) | |
Clinic | 97 (26.6) | |
Travel time to hospital (one way), min | < 30 | 181 (49.6) |
30–60 | 131 (35.9) | |
≥ 60 | 53 (14.5) | |
Burden of hospital visits | Feeling | 55 (15.1) |
Somewhat feeling | 158 (43.3) | |
Not feeling much | 122 (33.4) | |
Not feeling | 30 (8.2) | |
Employment status | Employed | 267 (73.2) |
Permanent employees | 157 (58.8) | |
Temporary and atypical employees | 31 (11.6) | |
Self-employment, freelance | 20 (7.5) | |
Part-time | 59 (22.1) | |
Unemployed | 98 (26.8) | |
Homemaker | 42 (42.9) | |
Student | 16 (16.3) | |
Leave of absence, unemployment, or retirement due to UC | 28 (28.6) | |
Leave of absence, unemployment, or retirement not related to UC | 12 (12.2) | |
Questions concerning employment (n = 267) | ||
Working hours | Full-time (about 40 hr/wk) | 181 (67.8) |
For a short time | 86 (32.2) | |
Working overtime (No. of days worked overtime/wk) | 0 | 163 (61.0) |
1–2 | 57 (21.3) | |
≥ 3 | 47 (17.6) | |
Option to telework | Yes | 82 (30.7) |
No | 185 (69.3) | |
Option to flexible work hours | Yes | 68 (25.5) |
No | 199 (74.5) | |
Business trip with stay | Almost none | 253 (94.8) |
At least once a month | 14 (5.2) | |
Taking leave for medical treatment | Easy to take | 140 (52.4) |
Somewhat easy to take | 87 (32.6) | |
Somewhat difficult to take | 24 (9.0) | |
Difficult to take | 16 (6.0) | |
Do your superiors and colleagues know your UC? | Yes | 151 (56.6) |
Only some | 84 (31.5) | |
Not informed | 28 (10.5) | |
Don’t have superiors or colleagues | 4 (1.5) |
Independent variables | Total (n=365) | Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events within 1 yr | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 243 | –0.003 (0.008) | 0.004 (0.008) | 0.005 (0.009) | –0.015 (0.010) | 0.000 (0.009) | 0.003 (0.009) |
Age (vs. < 40 yr) | 40–59 | 187 | –0.005 (0.008) | 0.001 (0.008) | 0.010 (0.009) | 0.019 (0.009) |
–0.029 (0.009) |
0.014 (0.009) |
≥ 60 | 29 | –0.013 (0.015) | –0.008 (0.015) | 0.038 (0.017) |
0.019 (0.018) | –0.040 (0.017) |
0.018 (0.016) | |
Disease duration (vs. < 1 yr) | 1–5 | 157 | 0.009 (0.018) | 0.019 (0.018) | –0.002 (0.021) | 0.020 (0.021) | 0.002 (0.021) | –0.037 (0.019) |
≥ 6 | 191 | 0.012 (0.018) | 0.015 (0.018) | 0.002 (0.021) | 0.009 (0.021) | 0.007 (0.021) | –0.036 (0.019) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 75 | –0.004 (0.012) | –0.009 (0.011) | 0.008 (0.013) | –0.001 (0.014) | 0.006 (0.013) | 0.011 (0.012) |
Pancolitis | 204 | –0.016 (0.011) | 0.003 (0.010) | 0.016 (0.012) | –0.013 (0.012) | 0.019 (0.012) | 0.019 (0.011) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 242 | 0.004 (0.010) | 0.009 (0.010) | –0.017 (0.011) | 0.008 (0.012) | 0.012 (0.011) | –0.001 (0.010) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 196 | 0.000 (0.009) | –0.003 (0.008) | –0.005 (0.010) | –0.013 (0.010) | 0.000 (0.010) | 0.017 (0.009) |
Medical institutions (vs. other than clinic) | Clinic | 97 | –0.008 (0.009) | 0.018 (0.009) |
0.008 (0.010) | –0.001 (0.010) | –0.012 (0.010) | –0.004 (0.009) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 122 | 0.016 (0.015) | 0.014 (0.014) | –0.002 (0.017) | 0.015 (0.017) | 0.009 (0.016) | –0.013 (0.015) |
Somewhat feeling | 158 | 0.026 (0.014) | 0.021 (0.014) | –0.004 (0.016) | 0.013 (0.017) | 0.013 (0.016) | –0.003 (0.015) | |
Feeling | 55 | 0.017 (0.016) | 0.027 (0.016) | –0.003 (0.018) | –0.001 (0.019) | 0.005 (0.018) | –0.003 (0.017) | |
Employment status (vs. employed) | Unemployed | 98 | –0.006 (0.009) | –0.008 (0.008) | 0.015 (0.010) | 0.001 (0.010) | 0.003 (0.010) | 0.009 (0.009) |
Stool frequency score during most severe symptoms (vs. same as usual or 1–4 stools more than usual) | ≥ 5 stools more than usual | 327 | 0.005 (0.014) | 0.001 (0.014) | –0.007 (0.016) | 0.018 (0.017) | 0.029 (0.016) | –0.031 (0.015) |
Rectal bleeding score during most severe symptoms (vs. no blood and streaks blood with stool less than half the time) | Obvious blood with stool most of the time | 106 | –0.004 (0.012) | –0.005 (0.012) | –0.006 (0.014) | –0.009 (0.014) | 0.008 (0.014) | –0.005 (0.013) |
Mostly blood | 199 | –0.009 (0.012) | –0.003 (0.012) | 0.001 (0.013) | –0.019 (0.014) | –0.013 (0.013) | 0.010 (0.013) | |
Degree of abdominal pain during most severe symptoms (vs. none or mild) | Moderate | 131 | –0.018 (0.011) | –0.004 (0.011) | 0.012 (0.012) | –0.007 (0.013) | 0.005 (0.012) | 0.020 (0.011) |
Severe | 158 | –0.015 (0.011) | –0.012 (0.011) | 0.010 (0.013) | –0.005 (0.013) | 0.003 (0.013) | 0.001 (0.012) | |
Number of days with bowel urgency during most severe symptoms (vs. 0–2 day) | 3 | 317 | 0.014 (0.013) | –0.010 (0.013) | –0.009 (0.009) | –0.002 (0.015) | 0.005 (0.015) | –0.003 (0.014) |
Coefficient of determination | 0.041 | 0.042 | 0.037 | 0.054 | 0.094 | 0.072 |
Independent variable | Total (n=365) | Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events within 1 yr | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 243 | –0.006 (0.008) | 0.003 (0.008) | 0.008 (0.009) | –0.016 (0.009) | 0.001 (0.009) | 0.005 (0.009) |
Age (vs. < 40 yr) | 40–59 | 187 | –0.003 (0.008) | 0.002 (0.008) | 0.007 (0.009) | 0.019 (0.009) |
–0.028 (0.009) |
0.013 (0.009) |
≥ 60 | 29 | –0.008 (0.015) | –0.005 (0.015) | 0.031 (0.017) | 0.023 (0.017) | –0.037 (0.017) |
0.015 (0.016) | |
Disease duration (vs. < 1 yr) | 1–5 | 157 | 0.009 (0.018) | 0.015 (0.018) | 0.002 (0.021) | 0.026 (0.021) | 0.002 (0.021) | –0.037 (0.019) |
≥ 6 | 191 | 0.009 (0.018) | 0.008 (0.018) | 0.007 (0.021) | 0.012 (0.021) | 0.008 (0.021) | –0.038 (0.020) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 75 | –0.003 (0.012) | –0.009 (0.011) | 0.007 (0.013) | 0.001 (0.013) | 0.007 (0.013) | 0.008 (0.013) |
Pancolitis | 204 | –0.015 (0.011) | 0.002 (0.010) | 0.013 (0.012) | –0.011 (0.012) | 0.019 (0.012) | 0.015 (0.011) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 242 | 0.002 (0.010) | 0.008 (0.009) | –0.016 (0.011) | 0.004 (0.011) | 0.011 (0.011) | 0.000 (0.010) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 196 | 0.000 (0.009) | –0.001 (0.008) | –0.004 (0.010) | –0.011 (0.010) | 0.000 (0.010) | 0.018 (0.009) |
Medical institutions (vs. other than clinic) | Clinic | 97 | –0.007 (0.009) | 0.021 (0.009) |
0.008 (0.010) | –0.001 (0.010) | –0.015 (0.010) | –0.001 (0.009) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 122 | 0.015 (0.015) | 0.015 (0.014) | –0.003 (0.016) | 0.013 (0.017) | 0.008 (0.016) | –0.013 (0.016) |
Somewhat feeling | 158 | 0.026 (0.014) | 0.025 (0.014) | –0.005 (0.016) | 0.011 (0.017) | 0.010 (0.016) | –0.003 (0.015) | |
Feeling | 55 | 0.017 (0.017) | 0.032 (0.016) |
–0.006 (0.019) | –0.004 (0.019) | 0.003 (0.019) | –0.001 (0.018) | |
Employment status (vs. employed) | Unemployed | 98 | –0.005 (0.009) | –0.009 (0.008) | 0.016 (0.010) | 0.004 (0.010) | 0.003 (0.010) | 0.008 (0.009) |
Current stool frequency score (vs. same as usual) | ≥ 1 stool more than usual | 225 | 0.008 (0.008) | 0.002 (0.008) | 0.010 (0.009) | 0.030 (0.010) |
–0.001 (0.009) | –0.004 (0.009) |
Current rectal bleeding score (vs. no blood) | Blood present | 56 | 0.005 (0.011) | 0.008 (0.011) | –0.013 (0.013) | 0.012 (0.013) | –0.019 (0.013) | 0.003 (0.012) |
Degree of current abdominal pain (vs. none) | Yes | 114 | –0.005 (0.009) | –0.018 (0.009) |
0.005 (0.010) | 0.007 (0.010) | 0.014 (0.010) | –0.014 (0.010) |
Number of days with current bowel urgency (vs. 0 days) | ≥ 1 | 107 | –0.009 (0.010) | –0.004 (0.010) | 0.000 (0.011) | –0.028 (0.011) |
0.008 (0.011) | 0.005 (0.011) |
Coefficient of determination | 0.033 | 0.050 | 0.037 | 0.081 | 0.083 | 0.044 |
Independent variable | Total (n=267) | Mild symptom scenario |
Severe symptom scenario |
|||||
---|---|---|---|---|---|---|---|---|
Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events within 1 yr | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 166 | –0.013 (0.011) | 0.015 (0.011) | 0.010 (0.012) | –0.008 (0.012) | –0.016 (0.013) | 0.001 (0.011) |
Age (vs. < 40 yr) | 40–59 | 142 | 0.000 (0.010) | 0.005 (0.010) | 0.009 (0.011) | 0.022 (0.012) | –0.031 (0.012) |
0.019 (0.011) |
≥ 60 | 22 | –0.020 (0.019) | –0.011 (0.019) | 0.043 (0.021) |
0.024 (0.022) | –0.034 (0.022) | 0.007 (0.020) | |
Disease duration (vs. < 1 yr) | 1–5 | 113 | 0.024 (0.023) | 0.027 (0.024) | –0.015 (0.026) | 0.034 (0.027) | 0.026 (0.027) | –0.051 (0.025) |
≥ 6 | 143 | 0.015 (0.023) | 0.015 (0.024) | 0.003 (0.027) | 0.011 (0.027) | 0.025 (0.028) | –0.037 (0.025) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 51 | 0.008 (0.014) | 0.006 (0.015) | –0.003 (0.016) | 0.020 (0.017) | 0.007 (0.017) | 0.003 (0.015) |
Pancolitis | 147 | 0.004 (0.013) | 0.009 (0.014) | 0.003 (0.015) | –0.011 (0.015) | 0.032 (0.016) |
0.016 (0.014) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 170 | 0.016 (0.012) | 0.016 (0.012) | –0.033 (0.013) |
0.011 (0.014) | 0.026 (0.014) | –0.007 (0.013) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 144 | 0.017 (0.011) | –0.001 (0.011) | –0.010 (0.012) | –0.011 (0.012) | 0.003 (0.013) | 0.019 (0.012) |
Medical institutions (vs. other than clinic) | Clinic | 67 | 0.001 (0.011) | 0.026 (0.011) |
0.000 (0.012) | 0.004 (0.013) | –0.007 (0.013) | –0.004 (0.012) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 91 | 0.027 (0.017) | 0.022 (0.018) | –0.009 (0.019) | 0.015 (0.020) | 0.009 (0.020) | –0.010 (0.018) |
Somewhat feeling | 114 | 0.027 (0.016) | 0.026 (0.017) | 0.004 (0.019) | 0.021 (0.019) | 0.014 (0.020) | 0.000 (0.018) | |
Feeling | 38 | 0.032 (0.019) | 0.023 (0.020) | 0.000 (0.022) | 0.002 (0.022) | 0.014 (0.023) | –0.001 (0.020) | |
Stool frequency score during most severe symptoms (vs. same as usual and 1–4 stools more than usual) | ≥ 5 stools more than usual | 238 | 0.008 (0.017) | 0.000 (0.017) | –0.020 (0.019) | 0.014 (0.020) | 0.027 (0.020) | –0.041 (0.018) |
Rectal blooding score during most severe symptoms (vs. no blood and streaks blood with stool less than half the time) | Obvious blood with stool most of the time | 75 | –0.009 (0.014) | –0.006 (0.014) | –0.007 (0.016) | 0.002 (0.016) | 0.003 (0.017) | –0.007 (0.015) |
Mostly blood | 146 | –0.013 (0.014) | –0.005 (0.014) | 0.012 (0.016) | –0.018 (0.016) | –0.013 (0.016) | 0.010 (0.015) | |
Degree of abdominal pain during the most severe symptoms (vs. none or mild) | Moderate | 97 | –0.028 (0.012) |
–0.003 (0.012) | 0.018 (0.014) | –0.006 (0.014) | 0.012 (0.014) | 0.014 (0.013) |
Severe | 107 | –0.024 (0.013) | –0.018 (0.013) | 0.020 (0.015) | –0.006 (0.015) | 0.000 (0.015) | 0.001 (0.014) | |
No. of days with bowel urgency during most severe symptoms (vs. 0–2 day) | 3 | 230 | 0.020 (0.015) | 0.005 (0.016) | –0.019 (0.017) | 0.008 (0.018) | –0.006 (0.018) | –0.001 (0.016) |
Employment status (vs. permanent employees) | Temporary and atypical employees | 31 | 0.019 (0.015) | –0.011 (0.016) | –0.001 (0.017) | –0.008 (0.018) | –0.015 (0.018) | 0.016 (0.016) |
Self-employment and freelance | 20 | –0.010 (0.021) | –0.001 (0.022) | 0.005 (0.024) | –0.017 (0.025) | 0.013 (0.025) | –0.002 (0.023) | |
Part-time | 59 | 0.007 (0.016) | –0.013 (0.017) | 0.001 (0.019) | 0.032 (0.019) | 0.032 (0.020) | –0.010 (0.018) | |
Working hours (vs. full-time) | For a short time | 86 | –0.017 (0.014) | 0.003 (0.015) | 0.013 (0.016) | –0.033 (0.017) |
0.005 (0.017) | 0.006 (0.016) |
Working overtime (vs. 0 day) | 1–2 | 57 | –0.009 (0.012) | –0.004 (0.013) | –0.012 (0.014) | 0.004 (0.014) | –0.003 (0.014) | –0.014 (0.013) |
≥ 3 | 47 | –0.021 (0.013) | 0.017 (0.014) | 0.010 (0.015) | 0.004 (0.016) | –0.013 (0.016) | 0.006 (0.014) | |
Option to telework (vs. yes) | No | 185 | 0.012 (0.012) | –0.013 (0.012) | –0.001 (0.014) | 0.008 (0.014) | –0.007 (0.014) | –0.004 (0.013) |
Option to flexible work hours (vs. yes) | No | 199 | 0.013 (0.013) | 0.009 (0.013) | –0.026 (0.014) | –0.019 (0.015) | –0.001 (0.015) | 0.003 (0.014) |
Business trips with stay (vs. almost none) | At least once a month | 14 | 0.009 (0.021) | 0.026 (0.022) | –0.029 (0.024) | –0.010 (0.024) | 0.028 (0.025) | –0.037 (0.022) |
Taking leave for medical treatment (vs. easy to take) | Somewhat easy | 87 | 0.016 (0.010) | –0.010 (0.011) | –0.015 (0.012) | 0.006 (0.012) | 0.010 (0.012) | –0.017 (0.011) |
Somewhat difficult | 24 | 0.021 (0.017) | 0.030 (0.017) | –0.034 (0.019) | 0.018 (0.019) | –0.007 (0.020) | –0.031 (0.018) | |
Difficult | 16 | –0.011 (0.020) | –0.006 (0.020) | 0.008 (0.022) | –0.018 (0.023) | 0.001 (0.023) | –0.017 (0.021) | |
Only some | 84 | 0.004 (0.010) | –0.009 (0.011) | 0.008 (0.012) | –0.014 (0.012) | 0.010 (0.012) | 0.013 (0.011) | |
Do your superiors and colleagues know your UC? (vs. yes) | Not informed | 28 | 0.009 (0.016) | 0.018 (0.016) | –0.015 (0.018) | –0.009 (0.018) | –0.003 (0.019) | –0.009 (0.017) |
Don’t have superiors or colleagues | 4 | –0.010 (0.038) | 0.024 (0.039) | –0.035 (0.043) | 0.045 (0.044) | –0.034 (0.045) | –0.007 (0.040) | |
Coefficient of determination | 0.145 | 0.108 | 0.131 | 0.130 | 0.159 | 0.128 |
Independent variable | Total (n=98) | Mild symptom scenario |
Severe symptom scenario |
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Route/frequency of administration | Maintenance-sustainability | Risk of serious adverse events | Route/frequency of administration | Speed of onset of action | Risk of serious adverse events within 1 yr | |||
Sex (vs. male) | Female | 77 | –0.006 (0.021) | 0.014 (0.018) | –0.028 (0.024) | –0.021 (0.026) | 0.022 (0.022) | 0.000 (0.022) |
Age (vs. < 40 yr) | 40–59 | 45 | 0.003 (0.020) | –0.003 (0.016) | –0.011 (0.022) | 0.028 (0.024) | –0.013 (0.020) | –0.018 (0.020) |
≥ 60 | 7 | –0.022 (0.032) | 0.012 (0.027) | 0.021 (0.037) | 0.013 (0.039) | –0.068 (0.034) |
0.021 (0.034) | |
Disease duration (vs. < 1 yr) | 1–5 | 44 | 0.004 (0.036) | –0.003 (0.030) | –0.007 (0.041) | 0.052 (0.044) | –0.034 (0.037) | –0.022 (0.038) |
≥ 6 | 48 | 0.033 (0.037) | 0.010 (0.030) | –0.013 (0.042) | 0.059 (0.044) | –0.034 (0.038) | –0.035 (0.038) | |
Extent of disease (vs. proctitis) | Left-sided colitis | 24 | –0.014 (0.027) | –0.042 (0.022) | 0.037 (0.031) | –0.046 (0.033) | 0.022 (0.028) | 0.032 (0.028) |
Pancolitis | 57 | –0.036 (0.024) | 0.002 (0.020) | 0.042 (0.027) | –0.013 (0.029) | 0.009 (0.025) | 0.031 (0.025) | |
Prior treatment of steroids (oral/injection) (vs. no) | Yes | 72 | –0.017 (0.020) | 0.003 (0.017) | 0.008 (0.023) | 0.002 (0.025) | –0.011 (0.021) | 0.005 (0.021) |
Prior treatment of advanced therapy (vs. use) | Advanced therapy-naive | 52 | –0.044 (0.019) |
0.013 (0.015) | –0.006 (0.021) | –0.026 (0.023) | –0.001 (0.019) | 0.014 (0.019) |
Medical institutions (vs. other than clinic) | Clinic | 30 | –0.003 (0.019) | –0.005 (0.015) | 0.019 (0.021) | –0.001 (0.023) | –0.030 (0.019) | 0.002 (0.019) |
Burden of hospital visits (vs. not feeling burden) | Not feeling much | 31 | –0.044 (0.037) | 0.032 (0.030) | 0.026 (0.042) | 0.011 (0.044) | 0.016 (0.038) | –0.029 (0.038) |
Somewhat feeling | 44 | –0.018 (0.036) | 0.047 (0.033) | 0.001 (0.042) | –0.036 (0.044) | 0.018 (0.038) | 0.000 (0.038) | |
Feeling | 17 | –0.037 (0.040) | 0.052 (0.023) | 0.030 (0.030) | –0.040 (0.048) | –0.021 (0.041) | 0.043 (0.041) | |
Stool frequency score during most severe symptoms (vs. same as usual and 1–4 stools more than usual) | ≥ 5 stools more than usual | 89 | 0.014 (0.031) | 0.008 (0.025) | 0.031 (0.035) | –0.004 (0.037) | 0.029 (0.032) | 0.016 (0.032) |
Rectal blooding score during most severe symptoms (vs. no blood and streaks blood with stool less than half the time) | Obvious blood with stool most of the time | 31 | 0.013 (0.030) | 0.032 (0.024) | –0.018 (0.034) | –0.002 (0.036) | –0.013 (0.031) | –0.026 (0.031) |
Mostly blood | 53 | 0.006 (0.027) | 0.021 (0.023) | –0.04 (0.031) | –0.005 (0.033) | –0.031 (0.028) | –0.008 (0.028) | |
Degree of abdominal pain during the most severe symptoms (vs. none or mild) | Moderate | 34 | 0.000 (0.029) | –0.028 (0.024) | 0.011 (0.033) | –0.027 (0.035) | –0.004 (0.030) | 0.043 (0.030) |
Severe | 51 | –0.021 (0.029) | –0.024 (0.024) | 0.012 (0.034) | –0.033 (0.036) | 0.023 (0.030) | 0.007 (0.031) | |
No. of days with bowel urgency during most severe symptoms (vs. 0–2 day) | 3 | 87 | –0.013 (0.030) | –0.037 (0.024) | 0.000 (0.034) | –0.040 (0.036) | 0.016 (0.031) | 0.007 (0.031) |
Employment status (vs. homemaker) | Student | 16 | 0.036 (0.028) | 0.040 (0.023) | –0.042 (0.031) | 0.021 (0.033) | –0.009 (0.028) | –0.030 (0.029) |
Leave of absence, unemployment, or retirement due to UC | 28 | 0.007 (0.020) | 0.011 (0.017) | –0.008 (0.023) | 0.047 (0.025) | –0.006 (0.021) | –0.031 (0.021) | |
Leave of absence, unemployment, or retirement not related to UC | 12 | 0.010 (0.026) | 0.006 (0.022) | 0.030 (0.030) | –0.058 (0.032) | –0.028 (0.027) | 0.075 (0.027) |
|
Coefficient of determination | 0.230 | 0.225 | 0.172 | 0.247 | 0.233 | 0.297 |
Values are number (%) unless otherwise indicated. Symptoms in the last 3 days. Includes currently used medications for UC. Multiple answers. SD, standard deviation; 5-ASA, 5-aminosalicylic acid; TNF, tumor necrosis factor; IL, interleukin; JAK, Janus kinase; UC, ulcerative colitis.
Values are regression coefficients (standard error) for the entire population (n=365).
Values are regression coefficients (standard error) for the entire population (n=365).
Values are regression coefficients (SE) for the employed population (n=267). SE, standard error; UC, ulcerative colitis
Values are regression coefficients (SE) for the unemployed population (n=98). SE, standard error; UC, ulcerative colitis.