1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan
2Pfizer Japan Inc., Tokyo, Japan
© Copyright 2023. 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 work was sponsored by Pfizer Japan Inc.
Conflict of Interest
Matsuoka K has served as a scientific adviser for EA Pharma; has served on advisory boards for Boehringer Ingelheim, Bristol-Meyers Squibb, and Eli Lilly; has received personal fees from AbbVie, EA Pharma, Janssen, JIMRO, Kissei Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Pfizer Inc, Takeda Pharmaceutical, and Zeria Pharmaceutical; and has received research grants from AbbVie, EA Pharma, JIMRO, Kissei Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, and Takeda Pharmaceutical. Togo K, Hoshi M, and Arai S are employees and stockholders of Pfizer Japan Inc. Yoshii N was a former employee of Pfizer Japan Inc.
Matsuoka K is an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.
Data Sharing Statement
Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual anonymized participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.
Author Contribution
Conceptualization: Matsuoka K, Togo K, Yoshii N, Arai S. Methodology: Togo K, Yoshii N, Arai S. Formal analysis: all authors. Funding acquisition: all authors. Project administration: Arai S. Visualization: all authors. Writing - original draft: all authors. Writing - review and editing: all authors. Approval of final manuscript: all authors.
Non-Author Contributions
Medical writing support, under the guidance of the authors, was provided by Helen Findlow, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Japan Inc, Tokyo, Japan in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163: 461-464). Data analytics support was provided by the Institute of Japanese Union of Scientists & Engineers and funded by Pfizer Japan Inc.
Baseline characteristic | Group 1 (CS, IM, or TNFi) | Group 2 (IM) | Group 2-1 (TAC or CyA) | Group 2-2 (6-MP or AZA) | Group 3 (TNFi) | Group 4 (IM and TNFi) | |
---|---|---|---|---|---|---|---|
Total No. | 958 | 544 | 25 | 519 | 181 | 126 | |
Female sex, No. (%) | 352 (36.7) | 201 (36.9) | 14 (56.0) | 187 (36.0) | 63 (34.8) | 37 (29.4) | |
Age (yr) | |||||||
Mean ± SD | 41.3 ± 12.8 | 42.3 ± 12.6 | 48.3 ± 12.3 | 42.0 ± 12.5 | 39.6 ± 12.3 | 40.9 ± 11.6 | |
Median (range) | 41 (18–73) | 42 (18–73) | 49 (19–72) | 42 (18–73) | 39 (18–68) | 41 (18–66) | |
Age category (yr), No (%) | |||||||
< 35 | 306 (31.9) | 156 (28.7) | 3 (12.0) | 153 (29.5) | 67 (37.0) | 36 (28.6) | |
≥ 35 | 652 (68.1) | 388 (71.3) | 22 (88.0) | 366 (70.5) | 114 (63.0) | 90 (71.4) | |
< 50 | 687 (71.7) | 372 (68.4) | 13 (52.0) | 359 (69.2) | 140 (77.3) | 95 (75.4) | |
≥ 50 | 271 (28.3) | 172 (31.6) | 12 (48.0) | 160 (30.8) | 41 (22.7) | 31 (24.6) | |
< 65 | 931 (97.2) | 527 (96.9) | 23 (92.0) | 504 (97.1) | 177 (97.8) | 124 (98.4) | |
≥ 65 to < 75 | 27 (2.8) | 17 (3.1) | 2 (8.0) | 15 (2.9) | 4 (2.2) | 2 (1.6) | |
Treatment at index date, No. (%) | |||||||
IM | 562 (58.7) | 544 (100.0) | 25 (100.0) | 519 (100.0) | 0 | 126 (100.0) | |
TNFi | 223 (23.3) | 0 | 0 | 0 | 181 (100.0) | 126 (100.0) | |
Corticosteroid | 351 (36.6) | 119 (21.9) | 6 (24.0) | 113 (21.8) | 34 (18.8) | 28 (22.2) | |
Corticosteroid dosagea | |||||||
Mean ± SD | 19.6 ± 18.1 | 19.7 ± 17.5 | 13.7 ± 13.2 | 20.1 ± 17.7 | 18.6 ± 15.0 | 16.0 ± 10.9 | |
Median (range) | 15.0 (0.5–80.0) | 16.3 (1.0–70.0) | 7.5 (2.0–30.7) | 16.3 (1.0–70.0) | 17.9 (1.0–72.5) | 15.3 (1.0–40.0) | |
Follow-up duration (yr) | |||||||
Mean ± SD | 2.5 ± 1.5 | 2.3 ± 1.3 | 2.3 ± 1.2 | 2.3 ± 1.3 | 2.3 ± 1.4 | 2.3 ± 1.2 | |
Median (range) | 2.0 (1.0–8.0) | 1.9 (1.0–7.7) | 1.8 (1.0–5.1) | 1.9 (1.0–7.7) | 1.7 (1.0–7.8) | 2.0 (1.0–5.7) |
Baseline characteristic | Group 1 (CS, IM, or TNFi) | Group 2 (IM) | Group 2-1 (TAC or CyA) | Group 2-2 (6-MP or AZA) | Group 3 (TNFi) | Group 4 (IM and TNFi) | |
---|---|---|---|---|---|---|---|
Total No. | 6,033 | 3,495 | 171 | 3,324 | 958 | 874 | |
Female sex, No. (%) | 2,594 (43.0) | 1,461 (41.8) | 107 (62.6) | 1,354 (40.7) | 470 (49.1) | 304 (34.8) | |
Age (yr) | |||||||
Mean ± SD | 47.5 ± 16.9 | 47.3 ± 16.4 | 54.4 ± 17.8 | 47.0 ± 16.2 | 46.2 ± 16.3 | 44.4 ± 15.6 | |
Median (range) | 47 (18–97) | 47 (18–97) | 57 (18–93) | 47 (18–97) | 45 (18–90) | 44 (18–92) | |
Age category (yr), No. (%) | |||||||
< 35 | 1,562 (25.9) | 872 (24.9) | 26 (15.2) | 846 (25.5) | 271 (28.3) | 265 (30.3) | |
≥ 35 | 4,471 (74.1) | 2,623 (75.1) | 145 (84.8) | 2,478 (74.5) | 687 (71.7) | 609 (69.7) | |
< 50 | 3,351 (55.5) | 1,937 (55.4) | 66 (38.6) | 1,871 (56.3) | 577 (60.2) | 553 (63.3) | |
≥ 50 | 2,682 (44.5) | 1,558 (44.6) | 105 (61.4) | 1,453 (43.7) | 381 (39.8) | 321 (36.7) | |
< 65 | 4,884 (81.0) | 2,889 (82.7) | 108 (63.2) | 2,781 (83.7) | 786 (82.0) | 762 (87.2) | |
≥ 65 | 1,149 (19.0) | 606 (17.3) | 63 (36.8) | 543 (16.3) | 172 (18.0) | 112 (12.8) | |
Treatment at index date, No. (%) | |||||||
IM | 3,727 (61.8) | 3,494 (100.0) | 171 (100.0) | 3,324 (100.0) | 0 | 874 (100.0) | |
TNFi | 1,308 (21.7) | 0 | 0 | 0 | 958 (100.0) | 874 (100.0) | |
Corticosteroid | 2,137 (35.4) | 820 (23.5) | 46 (26.9) | 774 (23.3) | 187 (19.5) | 156 (17.8) | |
Corticosteroid dosagea | |||||||
Mean ± SD | 22.9 ± 19.4 | 21.5 ± 17.2 | 10.6 ± 11.7 | 22.1 ± 17.3 | 20.9 ± 17.5 | 19.2 ± 16.3 | |
Median (range) | 20.0 (0.5–150.0) | 19.4 (0.5–133.3) | 4.5 (1.0–50.0) | 20.0 (0.5–133.3) | 20.0 (0.5–100.0) | 17.9 (0.5–86.7) | |
Follow-up duration (yr) | |||||||
Mean ± SD | 2.8 ± 1.7 | 2.5 ± 1.5 | 2.5 ± 1.5 | 2.5 ± 1.5 | 2.6 ± 1.5 | 2.6 ± 1.5 | |
Median (range) | 2.2 (1.0–9.8) | 2.0 (1.0–9.7) | 1.9 (1.0–8.7) | 2.0 (1.0–9.7) | 2.1 (1.0–8.9) | 2.2 (1.0–9.4) |
Baseline characteristic | Group 1 (CS, IM, or TNFi) | Group 2 (IM) | Group 2-1 (TAC or CyA) | Group 2-2 (6-MP or AZA) | Group 3 (TNFi) | Group 4 (IM and TNFi) | |
---|---|---|---|---|---|---|---|
Total No. | 958 | 544 | 25 | 519 | 181 | 126 | |
Female sex, No. (%) | 352 (36.7) | 201 (36.9) | 14 (56.0) | 187 (36.0) | 63 (34.8) | 37 (29.4) | |
Age (yr) | |||||||
Mean ± SD | 41.3 ± 12.8 | 42.3 ± 12.6 | 48.3 ± 12.3 | 42.0 ± 12.5 | 39.6 ± 12.3 | 40.9 ± 11.6 | |
Median (range) | 41 (18–73) | 42 (18–73) | 49 (19–72) | 42 (18–73) | 39 (18–68) | 41 (18–66) | |
Age category (yr), No (%) | |||||||
< 35 | 306 (31.9) | 156 (28.7) | 3 (12.0) | 153 (29.5) | 67 (37.0) | 36 (28.6) | |
≥ 35 | 652 (68.1) | 388 (71.3) | 22 (88.0) | 366 (70.5) | 114 (63.0) | 90 (71.4) | |
< 50 | 687 (71.7) | 372 (68.4) | 13 (52.0) | 359 (69.2) | 140 (77.3) | 95 (75.4) | |
≥ 50 | 271 (28.3) | 172 (31.6) | 12 (48.0) | 160 (30.8) | 41 (22.7) | 31 (24.6) | |
< 65 | 931 (97.2) | 527 (96.9) | 23 (92.0) | 504 (97.1) | 177 (97.8) | 124 (98.4) | |
≥ 65 to < 75 | 27 (2.8) | 17 (3.1) | 2 (8.0) | 15 (2.9) | 4 (2.2) | 2 (1.6) | |
Treatment at index date, No. (%) | |||||||
IM | 562 (58.7) | 544 (100.0) | 25 (100.0) | 519 (100.0) | 0 | 126 (100.0) | |
TNFi | 223 (23.3) | 0 | 0 | 0 | 181 (100.0) | 126 (100.0) | |
Corticosteroid | 351 (36.6) | 119 (21.9) | 6 (24.0) | 113 (21.8) | 34 (18.8) | 28 (22.2) | |
Corticosteroid dosage |
|||||||
Mean ± SD | 19.6 ± 18.1 | 19.7 ± 17.5 | 13.7 ± 13.2 | 20.1 ± 17.7 | 18.6 ± 15.0 | 16.0 ± 10.9 | |
Median (range) | 15.0 (0.5–80.0) | 16.3 (1.0–70.0) | 7.5 (2.0–30.7) | 16.3 (1.0–70.0) | 17.9 (1.0–72.5) | 15.3 (1.0–40.0) | |
Follow-up duration (yr) | |||||||
Mean ± SD | 2.5 ± 1.5 | 2.3 ± 1.3 | 2.3 ± 1.2 | 2.3 ± 1.3 | 2.3 ± 1.4 | 2.3 ± 1.2 | |
Median (range) | 2.0 (1.0–8.0) | 1.9 (1.0–7.7) | 1.8 (1.0–5.1) | 1.9 (1.0–7.7) | 1.7 (1.0–7.8) | 2.0 (1.0–5.7) |
Baseline characteristic | Group 1 (CS, IM, or TNFi) | Group 2 (IM) | Group 2-1 (TAC or CyA) | Group 2-2 (6-MP or AZA) | Group 3 (TNFi) | Group 4 (IM and TNFi) | |
---|---|---|---|---|---|---|---|
Total No. | 6,033 | 3,495 | 171 | 3,324 | 958 | 874 | |
Female sex, No. (%) | 2,594 (43.0) | 1,461 (41.8) | 107 (62.6) | 1,354 (40.7) | 470 (49.1) | 304 (34.8) | |
Age (yr) | |||||||
Mean ± SD | 47.5 ± 16.9 | 47.3 ± 16.4 | 54.4 ± 17.8 | 47.0 ± 16.2 | 46.2 ± 16.3 | 44.4 ± 15.6 | |
Median (range) | 47 (18–97) | 47 (18–97) | 57 (18–93) | 47 (18–97) | 45 (18–90) | 44 (18–92) | |
Age category (yr), No. (%) | |||||||
< 35 | 1,562 (25.9) | 872 (24.9) | 26 (15.2) | 846 (25.5) | 271 (28.3) | 265 (30.3) | |
≥ 35 | 4,471 (74.1) | 2,623 (75.1) | 145 (84.8) | 2,478 (74.5) | 687 (71.7) | 609 (69.7) | |
< 50 | 3,351 (55.5) | 1,937 (55.4) | 66 (38.6) | 1,871 (56.3) | 577 (60.2) | 553 (63.3) | |
≥ 50 | 2,682 (44.5) | 1,558 (44.6) | 105 (61.4) | 1,453 (43.7) | 381 (39.8) | 321 (36.7) | |
< 65 | 4,884 (81.0) | 2,889 (82.7) | 108 (63.2) | 2,781 (83.7) | 786 (82.0) | 762 (87.2) | |
≥ 65 | 1,149 (19.0) | 606 (17.3) | 63 (36.8) | 543 (16.3) | 172 (18.0) | 112 (12.8) | |
Treatment at index date, No. (%) | |||||||
IM | 3,727 (61.8) | 3,494 (100.0) | 171 (100.0) | 3,324 (100.0) | 0 | 874 (100.0) | |
TNFi | 1,308 (21.7) | 0 | 0 | 0 | 958 (100.0) | 874 (100.0) | |
Corticosteroid | 2,137 (35.4) | 820 (23.5) | 46 (26.9) | 774 (23.3) | 187 (19.5) | 156 (17.8) | |
Corticosteroid dosage |
|||||||
Mean ± SD | 22.9 ± 19.4 | 21.5 ± 17.2 | 10.6 ± 11.7 | 22.1 ± 17.3 | 20.9 ± 17.5 | 19.2 ± 16.3 | |
Median (range) | 20.0 (0.5–150.0) | 19.4 (0.5–133.3) | 4.5 (1.0–50.0) | 20.0 (0.5–133.3) | 20.0 (0.5–100.0) | 17.9 (0.5–86.7) | |
Follow-up duration (yr) | |||||||
Mean ± SD | 2.8 ± 1.7 | 2.5 ± 1.5 | 2.5 ± 1.5 | 2.5 ± 1.5 | 2.6 ± 1.5 | 2.6 ± 1.5 | |
Median (range) | 2.2 (1.0–9.8) | 2.0 (1.0–9.7) | 1.9 (1.0–8.7) | 2.0 (1.0–9.7) | 2.1 (1.0–8.9) | 2.2 (1.0–9.4) |
Prednisolone equivalent at index date. JMDC, Japan Medical Data Center; CS, corticosteroid; IM, immunosuppressant; TNFi, tumor necrosis factor inhibitor; TAC, tacrolimus; CyA, cyclosporine; 6-MP, 6-mercaptopurine; AZA, azathioprine; SD, standard deviation.
Prednisolone equivalent at index date. MDV, Medical Data Vision; CS, corticosteroid; IM, immunosuppressant; TNFi, tumor necrosis factor inhibitor; TAC, tacrolimus; CyA, cyclosporine; 6-MP, 6-mercaptopurine; AZA, azathioprine; SD, standard deviation.