Early Ustekinumab Use Improves Clinical Outcomes in Biologic-Naive Crohn’s Disease Patients: A Retrospective Multicenter Cohort Study in Taiwan
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients and Data Collection
2.2. Clinical Outcome Evaluation
2.3. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Clinical Outcomes at Six Months
3.3. Clinical Outcomes at One Year
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Overall | Early-UST | Control (n = 36) | p-Value | |
---|---|---|---|---|
(n = 60) | (n = 24) | |||
Baseline Characteristics | ||||
Age at biologics initiation (years) | 40.53 ± 17.53 | 36.63 ± 12.73 | 43.14 ± 19.85 | 0.127 |
Gender, male (%) | 45 (75.0) | 16 (66.7) | 29 (80.6) | 0.224 |
Smoker (%) | 11 (18.3) | 3 (12.5) | 8 (22.2) | 0.34 |
BMI | 21.67 ± 4.90 | 22.21 ± 4.40 | 21.31 ± 5.23 | 0.487 |
Time from diagnosis to UST initiation (weeks) | 193.77 ± 326.73 | 13.19 ± 7.51 | 314.16 ± 377.69 | <0.001 * |
CDAI score | 284.53 ± 74.21 | 266.81 ± 86.72 | 296.34 ± 63.10 | 0.16 |
HBI score | 6.50 ± 2.83 | 6.42 ± 2.92 | 6.49 ± 2.87 | 0.913 |
Previous intestinal resection (%) | 14 (23.3) | 4 (16.7) | 10 (27.8) | 0.319 |
Montreal classification (%) | ||||
L1, ileal | 25 (41.7) | 11 (45.8) | 14 (38.9) | 0.830 |
L2, colonic | 6 (10.0) | 1 (4.2) | 5 (13.9) | 0.387 |
L3, ileocolonic | 29 (48.3) | 12 (50.0) | 17 (47.2) | 0.792 |
L4, isolated upper disease | 0 | 0 | 0 | - |
B1, non-stricturing, non-penetrating | 39 (65.0) | 14 (58.3) | 25 (69.4) | 0.418 |
B2, stricturing | 13 (21.7) | 8 (33.3) | 5 (13.9) | 0.110 |
B3, penetrating | 8 (13.3) | 2 (8.3) | 6 (16.7) | 0.457 |
P, perianal disease | 11 (18.3) | 3 (12.5) | 8 (22.2) | 0.500 |
Concomitant IBD medication (%) | ||||
Steroid | 43 (71.7) | 18 (75.0) | 25 (69.4) | 0.640 |
Immunosuppressant | 24 (40.0) | 7 (29.2) | 17 (47.2) | 0.162 |
5-ASA | 34 (56.7) | 14 (58.3) | 20 (55.6) | 0.832 |
Lab data | ||||
Hemoglobin (g/dL) | 12.52 ± 2.39 | 13.05 ± 1.69 | 12.17 ± 2.72 | 0.128 |
Albumin (g/dL) | 4.01 ± 0.68 | 4.18 ± 0.37 | 3.93 ± 0.80 | 0.747 |
CRP (mg/L) | 14.29 ± 31.78 | 11.67 ± 19.16 | 16.03 ± 38.12 | 0.562 |
EIM | 8 (13.3) | 3 (12.5) | 5 (13.9) | 1.000 |
6 Month | 1 Year | |||||||
---|---|---|---|---|---|---|---|---|
Overall (%) | Early-UST (%) | Control (%) | p-Value | Overall (%) | Early-UST (%) | Control (%) | p-Value | |
(n = 60) | (n = 24) | (n = 36) | (n = 46) | (n = 17) | (n = 29) | |||
CDAI score | 96.66 ± 72.41 | 73.03 ± 65.90 | 112.42 ± 73.12 | 0.038 * | 72.01 ± 68.99 | 39.94 ± 43.13 | 91.48 ± 74.92 | 0.005 * |
HBI score | 2.22 ± 2.08 | 1.46 ± 1.69 | 2.72 ± 2.17 | 0.020 * | 1.37 ± 1.55 | 0.88 ± 1.27 | 1.66 ± 1.65 | 0.104 |
Concomitant IBD medication (%) | ||||||||
Steroid | 9 (15.0) | 3 (12.5) | 6 (16.7) | 0.729 | 10 (21.7) | 3 (17.6) | 7 (24.1) | 0.723 |
Immunosuppressant | 7 (11.7) | 2 (8.3) | 5 (13.9) | 0.691 | 10 (21.7) | 2 (11.8) | 8 (27.6) | 0.282 |
Clinical remission | 45 (75.0) | 22 (91.7) | 23 (63.9) | 0.017 * | 36 (78.3) | 16 (94.1) | 21 (72.4) | 0.124 |
Steroid-free remission | 37 (61.7) | 19 (79.2) | 18 (50.0) | 0.031 * | 28 (60.9) | 13 (76.5) | 15 (51.7) | 0.205 |
Lab data | ||||||||
Hemoglobin | 13.04 ± 2.28 | 13.51 ± 1.84 | 12.72 ± 2.52 | 0.272 | 13.30 ± 2.30 | 13.51 ± 1.84 | 12.98 ± 2.68 | 0.507 |
Albumin | 4.28 ± 0.51 | 4.39 ± 0.28 | 4.20 ± 0.26 | 0.841 | 4.28 ± 0.52 | 4.39 ± 0.23 | 4.22 ± 0.62 | 0.788 |
CRP | 7.55 ± 14.43 | 3.52 ± 5.58 | 10.04 ± 17.46 | 0.585 | 7.41 ± 25.56 | 1.37 ± 1.21 | 11.35 ± 32.49 | 0.136 |
BMI | 22.84 ± 4.89 | 23.08 ± 5.67 | 22.68 ± 4.34 | 0.790 | 22.44 ± 4.01 | 23.58 ± 6.19 | 22.42 ± 5.17 | 0.870 |
Adverse event (%) | ||||||||
Malignancy | 0 | 0 | 0 | - | 0 | 0 | 0 | - |
Opportunistic infection | 3 (5.0) | 1 (4.2) | 2 (5.6) | 1.000 | 6 (13.0) | 2 (11.8) | 4 (13.8) | 1.000 |
CD-related ED visits (%) | 4 (6.7) | 0 | 4 (11.1) | 0.121 | 4 (8.7) | 1 (5.9) | 3 (10.3) | 0.619 |
CD-related hospitalization (%) | 4 (6.7) | 1 (4.2) | 3 (8.3) | 0.632 | 5 (10.9) | 2 (11.8) | 3 (10.3) | 1.000 |
Dose escalation | 5 (8.3) | 2 (8.3) | 3 (8.3) | 1.000 | 9 (19.6) | 3 (17.6) | 6 (20.7) | 1.000 |
EIM (%) | 2 (3.3) | 0 | 2 (5.6) | 0.512 | 3 (6.5) | 2 (11.8) | 1 (3.4) | 0.547 |
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Chang, Y.-C.; Chuang, C.-H.; Huang, T.-Y.; Chung, C.-S.; Kuo, C.-J.; Pan, Y.-B.; Le, P.-H. Early Ustekinumab Use Improves Clinical Outcomes in Biologic-Naive Crohn’s Disease Patients: A Retrospective Multicenter Cohort Study in Taiwan. Biomedicines 2025, 13, 391. https://doi.org/10.3390/biomedicines13020391
Chang Y-C, Chuang C-H, Huang T-Y, Chung C-S, Kuo C-J, Pan Y-B, Le P-H. Early Ustekinumab Use Improves Clinical Outcomes in Biologic-Naive Crohn’s Disease Patients: A Retrospective Multicenter Cohort Study in Taiwan. Biomedicines. 2025; 13(2):391. https://doi.org/10.3390/biomedicines13020391
Chicago/Turabian StyleChang, Yen-Cheng, Chiao-Hsiung Chuang, Tien-Yu Huang, Chen-Shuan Chung, Chia-Jung Kuo, Yu-Bin Pan, and Puo-Hsien Le. 2025. "Early Ustekinumab Use Improves Clinical Outcomes in Biologic-Naive Crohn’s Disease Patients: A Retrospective Multicenter Cohort Study in Taiwan" Biomedicines 13, no. 2: 391. https://doi.org/10.3390/biomedicines13020391
APA StyleChang, Y.-C., Chuang, C.-H., Huang, T.-Y., Chung, C.-S., Kuo, C.-J., Pan, Y.-B., & Le, P.-H. (2025). Early Ustekinumab Use Improves Clinical Outcomes in Biologic-Naive Crohn’s Disease Patients: A Retrospective Multicenter Cohort Study in Taiwan. Biomedicines, 13(2), 391. https://doi.org/10.3390/biomedicines13020391