Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama, Japan
© Copyright 2022. 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
The authors received no financial support for the research, authorship, and/or publication of this article.
Conflict of Interest
No potential conflict of interest relevant to this article was reported.
Data Availability Statement
Not applicable.
Author Contribution
Conceptualization, data curation: Otake H, Matsumoto S. Formal analysis: Matsumoto S. Investigation, methodology, project administration: Otake H, Matsumoto S. Supervision: Mashima H. Writing - original draft: Otake H, Matsumoto S. Writing - review & editing: Otake H, Matsumoto S, Mashima H. Approval of final manuscript: all authors.
Characteristics | Total (n = 82) | IFX (n = 43) | ADA (n = 39) | P-value | |
---|---|---|---|---|---|
Male sex | 58 (70.7) | 32 (74.4) | 26 (66.7) | 0.475 | |
Age at onset (yr) | 25 ± 10 (6–58) | 24 ± 10 (10–55) | 26 ± 11 (6–58) | 0.587 | |
Age at start of biologics (yr) | 32 ± 13 (15–66) | 32 ± 12 (16–63) | 32 ± 15 (15–66) | 0.993 | |
Duration of disease (yr) | 7.1 ± 8.3 (0.0–36.3) | 7.8 ± 8.7 (0.2–36.3) | 6.4 ± 8.1 (0.0–29.6) | 0.470 | |
Disease location | 0.424 | ||||
Ileum (L1) | 18 (22.0) | 11 (25.6) | 7 (17.9) | ||
Colon (L2) | 16 (19.5) | 6 (14.0) | 10 (25.6) | ||
Ileum and colon (L3) | 48 (58.5) | 26 (60.5) | 22 (56.4) | ||
Upper GI tract inflammation | 18 (22.0) | 9 (20.9) | 9 (23.1) | 1.000 | |
Disease phenotype | 0.105 | ||||
Non-structuring, non-penetrating (B1) | 44 (53.7) | 20 (46.5) | 24 (61.5) | ||
Stricturing (B2) | 24 (29.3) | 12 (27.9) | 12 (30.8) | ||
Penetrating (B3) | 14 (17.1) | 11 (25.6) | 3 (7.7) | ||
Extraintestinal manifestations | 14 (17.1) | 4 (9.3) | 10 (25.6) | 0.077 | |
Anal fistula | 25 (30.5) | 17 (39.5) | 8 (20.5) | 0.092 | |
Prior ileocolonic resection | 14 (17.1) | 9 (20.9) | 5 (12.8) | 0.389 | |
Current smoking | 19 (23.2) | 11 (25.6) | 8 (20.5) | 0.612 | |
Prior treatment | |||||
Immunomodulators | 35 (42.7) | 25 (58.1) | 10 (25.6) | 0.004 | |
Corticosteroid | 57 (69.5) | 27 (62.8) | 30 (76.9) | 0.230 | |
Concomitant treatment | |||||
Mesalazine | 78 (95.1) | 40 (93.0) | 38 (97.4) | 0.617 | |
Immunomodulators | 26 (31.7) | 20 (46.5) | 6 (15.4) | 0.004 | |
Corticosteroid | 41 (50.0) | 22 (51.2) | 19 (48.7) | 1.000 | |
Enteral nutrition | 58 (70.7) | 30 (69.8) | 28 (71.8) | 1.000 | |
Clinical examination | |||||
Hemoglobin (g/dL) | 12.0 ± 1.8 (7.4–16.5) | 11.9 ± 1.7 (8.4–14.6) | 12.2 ± 1.9 (7.4–16.5) | 0.424 | |
Leukocyte count (109/L) | 7.4 ± 2.5 (1.9–14.6) | 7.3 ± 2.7 (3.0–14.6) | 7.7 ± 2.4 (2.8–13.9) | 0.811 | |
Platelet count (109/L) | 386 ± 108 (171–719) | 408 ± 124 (171–719) | 362 ± 837 (177–603) | 0.055 | |
Albumin (g/dL) | 3.5 ± 0.6 (2.2–4.9) | 3.5 ± 0.6 (2.2–4.6) | 3.6 ± 0.5 (2.6–4.7) | 0.260 | |
C-reactive protein (mg/L) | 20.2 ± 25.9 (0.2–142.1) | 21.4 ± 32.0 (0.2–142.1) | 19.0 ± 17.7 (0.4–51.3) | 0.681 | |
CDAI | 206 ± 110 (0–585) | 231 ± 101 (30–585) | 177 ± 115 (0–456) | 0.027 |
Characteristics | LOR (n = 31) | Non-LOR (n = 47) | P-value | |
---|---|---|---|---|
Male sex | 20 (64.5) | 35 (74.5) | 0.448 | |
Age at onset (yr) | 22 ± 8 | 26 ± 12 | 0.139 | |
Age at start of biologics (yr) | 30 ± 12 | 33 ± 14 | 0.237 | |
Kind of biologics, IFX/ADA | 19/12 | 22/25 | 0.251 | |
Duration of disease (yr) | 7.1 ± 8.7 | 7.0 ± 8.4 | 0.963 | |
Disease location | 0.021 | |||
Ileum (L1) | 3 (9.7) | 15 (31.9) | ||
Colon (L2) | 4 (12.9) | 10 (21.3) | ||
Ileum and colon (L3) | 24 (77.4) | 22 (46.8) | ||
Upper GI tract inflammation | 12 (38.7) | 6 (12.8) | 0.013 | |
Disease phenotype | 0.465 | |||
Non-structuring, non-penetrating (B1) | 14 (45.2) | 28 (59.6) | ||
Stricturing (B2) | 11 (35.5) | 12 (25.5) | ||
Penetrating (B3) | 6 (19.3) | 7 (14.9) | ||
Extraintestinal manifestations | 7 (22.6) | 7 (14.9) | 0.546 | |
Anal fistula | 12 (38.7) | 13 (27.7) | 0.331 | |
Prior ileocolonic resection | 5 (16.1) | 7 (14.9) | 1.000 | |
Current smoking | 8 (25.8) | 11 (23.4) | 1.000 | |
Prior treatment | ||||
Immunomodulators | 17 (54.8) | 16 (34.0) | 0.242 | |
Corticosteroid | 24 (77.4) | 32 (68.1) | 0.446 | |
Concomitant treatment | ||||
Mesalazine | 28 (90.3) | 46 (97.9) | 0.295 | |
Immunomodulators | 11 (35.5) | 14 (29.8) | 0.627 | |
Corticosteroid | 18 (58.1) | 22 (46.8) | 0.363 | |
Enteral nutrition | 25 (80.6) | 31 (66.0) | 0.203 | |
Clinical examination | ||||
CRP at start of biologics (mg/L) | 17.6 ± 16.7 | 21.8 ± 31.0 | 0.500 | |
CRP at 12–14 wk (mg/L) | 8.0 ± 13.9 | 5.1 ± 14.9 | 0.385 | |
ALB at start of biologics (g/dL) | 3.6 ± 0.6 | 3.6 ± 0.6 | 0.875 | |
ALB at 12–14 wk (g/dL) | 4.0 ± 0.6 | 4.2 ± 0.5 | 0.065 | |
CRP/ALB ratio at 12–14 wk | 2.5 ± 4.9 | 1.3 ± 3.8 | 0.260 | |
CRP/ALB ratio ≥ 0.18 | 27 (87.1) | 21 (44.7) | < 0.001 | |
CDAI at start of biologics | 227 ± 97 | 187 ± 114 | 0.114 |
Predictive factors | HR (95% CI) | P-value |
---|---|---|
Duration of disease | 0.96 (0.91–1.01) | 0.083 |
Disease location | ||
L2 vs. L1 | 1.02 (0.23–4.49) | 0.973 |
L3 vs. L1 | 0.64 (0.11–3.46) | 0.606 |
Upper GI tract inflammation (yes vs. no) | 3.00 (1.26–7.13) | 0.013 |
Disease phenotype | ||
B2 vs. B1 | 1.83 (0.74–4.55) | 0.193 |
B3 vs. B1 | 1.18 (0.37–3.73) | 0.781 |
Anal fistula (yes vs. no) | 1.64 (0.69–3.88) | 0.261 |
Prior ileocolonic resection (yes vs. no) | 1.65 (0.49–5.66) | 0.419 |
CRP/ALB ratio (≥ 0.18 vs. < 0.18) | 5.86 (1.56–22.0) | 0.009 |
Values are presented as number (%) or mean±standard deviation (range). IFX, infliximab; ADA, adalimumab; GI, gastrointestinal; CDAI, Crohn’s Disease Activity Index.
Data are presented as number (%) or mean±standard deviation. LOR, loss of response; IFX, infliximab; ADA, adalimumab; GI, gastrointestinal; CRP, C-reactive protein; ALB, albumin; CDAI, Crohn’s Disease Activity Index.
LOR, loss of response; HR, hazard ratio; CI, confidence interval; GI, gastrointestinal; CRP, C-reactive protein; ALB, albumin.