Intest Res > Volume 20(3); 2022 > Article |
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Funding Source
Sponsorship for this study were provided by Janssen Pharmaceutical K.K. (Tokyo, Japan) and Mitsubishi Tanabe Pharma Corporation (Osaka, Japan).
Conflict of Interest
Asano T, Tsuchiya H, Sugimoto K, Imai Y, and Yokoyama S are full-time employees of Janssen Pharmaceutical K.K. Nakamura S has received speaking fees from AbbVie GK, EA Pharma Co., Ltd., Mitsubishi Tanabe Pharma Corporation., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd, and Janssen Pharmaceutical K.K.; and has served as a consultant for Janssen Pharmaceutical K.K. Suzuki Y has received speaking fees from AbbVie GK, EA Pharma Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., ZERIA Pharmaceutical Co., Ltd, and Janssen Pharmaceutical K.K.; has served on grants/research support from AbbVie GK, EA Pharma Co., Ltd., Mitsubishi Tanabe Pharma Co., Ltd., Mochida Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., and JIMRO Co., Ltd.; and has served as a consultant for Janssen Pharmaceutical K.K. No other potential conflicts of interest relevant to this article were reported.
Author Contribution
Conceptualization: Tsuchiya H, Imai Y, Yokoyama S. Methodology: Tsuchiya H, Sugimoto K, Imai Y, Yokoyama S. Formal analysis: Nakamura S, Asano T, Tsuchiya H, Imai Y, Yokoyama S, Suzuki Y. Funding acquisition: Tsuchiya H, Imai Y, Suzuki Y. Project administration: Yokoyama S. Visualization: Asano T, Tsuchiya H, Imai Y, Yokoyama S. Writing - original draft: Asano T, Yokoyama S. Writing - review and editing: Nakamura S, Asano T, Yokoyama S, Tsuchiya H, Sugimoto K, Imai Y. Approval of final manuscript: all authors.
Others
We deeply appreciate the contribution of the physicians from the participating medical institutions and the patients who participated in this study. We also wish to thank Shinichi Yoshigoe (Immunology and Infectious Diseases & Vaccine Department, Medical Affairs Division, Janssen Pharmaceutical K.K.) and Noriko Sato (Ikuyaku, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation) for their contribution to the study design and data interpretation. We would also like to express our gratitude to Akiko Yamamoto, of Janssen Pharmaceutical K.K., who helped with the execution and management of the study.
All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
Variable | Value (n = 392) |
---|---|
Patients characteristics | |
Sex | |
Male | 200 (51.0) |
Female | 192 (49.0) |
Age (yr) | 43.2 ± 17.1 |
≥ 65 yr | 52 (13.3) |
Body weight (kg) | 57.1 ± 12.1 |
Duration of UC (yr) | 7.7 ± 7.6 |
BMI (kg/m2) | 21.2 ± 3.7 |
Smoking history | |
No | 278 (70.9) |
Yes | 74 (18.9) |
Continue to smoke | 19 (4.9) |
Disease type | |
Disease extent | |
Pancolitis | 290 (74.0) |
Left-sided colitis | 83 (21.2) |
Proctitis | 15 (3.8) |
Right-sided or segmental colitis | 2 (0.5) |
Others | 3 (0.8) |
Intractable UC | 345 (88.0) |
Steroid resistance | 98 (28.4) |
Steroid dependence | 230 (66.7) |
Others | 17 (4.9) |
Severitya | |
Mild | 37 (9.4) |
Moderate | 325 (82.9) |
Severe | 30 (7.7) |
Previous use of non-biologic treatment | |
5-ASA | 384 (98.0) |
Corticosteroids | 369 (94.1) |
AZA | 239 (61.0) |
6-MP | 44 (11.2) |
Tacrolimus | 75 (19.1) |
Previous use of biologics | |
No. of biologics | |
0 | 169 (43.1) |
1 | 169 (43.1) |
≥2 | 54 (13.8) |
Biologics type | 223 (56.9) |
IFX | 154 (69.1) |
IFX-BS | 9 (4.0) |
ADA | 112 (50.2) |
Concomitant medication during the study | |
5-ASA | 318 (84.4) |
Corticosteroids | 208 (55.2) |
Intravenous | 7 (3.4) |
Oral | 157 (75.5) |
Topical | 69 (33.2) |
AZA | 130 (34.5) |
6-MP | 21 (5.6) |
Tacrolimus | 16 (4.2) |
Antibiotics | 13 (3.5) |
a Baseline severity (mild, moderate, and severe) according to the Japanese diagnosis criteria [25].