Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Patients with Ulcerative Colitis: A Real-World Retrospective Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethical Considerations
2.2. Patients
2.3. VDZ and UST Treatment
2.4. Data Collection
2.5. Clinical Evaluation
2.6. Subgroup Analysis
2.7. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Comparisons of Effectiveness between VDZ and UST
3.3. Clinical Remission and Response Rates with VDZ and UST
3.4. Non-Relapse Rates with VDZ and UST
3.5. Effectiveness of UST in VDZ Failure
3.6. Subgroup Analysis
3.7. Safety
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Vedolizumab, n = 64 | Ustekinumab, n = 42 | p Value |
---|---|---|---|
Age (years), mean ± SD [range] | 48.0 ± 15.1 [20–81] | 45.0 ± 16.4 [19–80] | 0.08 |
Male/Female, n (%) | 35/29 (54.7/45.3) | 20/22 (47.6/52.4) | 0.48 |
Duration of disease (years), mean ± SD [range] | 10.5 ± 9.4 [0–38] | 9.0 ± 10.0 [1–37] | 0.34 |
Disease location | |||
Proctitis, n (%) | 5 (7.8) | 2 (4.8) | |
Left-sided colitis, n (%) | 19 (29.7) | 9 (21.4) | |
Extensive colitis, n (%) | 40 (62.5) | 31 (73.8) | |
CAI, mean ± SD [range] | 10.1 ± 3.2 [5–18] | 10.4 ± 3.1 [5–16] | 0.54 |
MES, mean ± SD [range] | 2.1 ± 0.8 [0–3] | 2.3 ± 0.7 [1–3] | 0.19 |
Previous medications | |||
Bio-naïve, n (%) | 39 (60.9) | 14 (33.3) | 0.005 |
Biologics | 25 (39.1) | 28 (66.7) | 0.005 |
One line, n (%) | 17 (26.6) | 19 (45.2) | |
Two lines, n (%) | 6 (9.4) | 8 (19.1) | |
Three lines, n (%) | 2 (3.1) | 1 (2.4) | |
Anti-TNF, n (%) | 25 (39.1) | 12 (28.6) | 0.27 |
Tofacitinib, n (%) | 0 | 0 | |
Vedolizumab, n (%) | 23 | ||
Ustekinumab, n (%) | 1 | ||
Co-treatments | |||
5-aminosalicylic acid, n (%) | 54 (84.4) | 36 (85.7) | 0.85 |
Steroids, n (%) | 16 (25.0) | 9 (21.4) | 0.67 |
Thiopurines, n (%) | 25 (39.1) | 13 (31.0) | 0.39 |
WBCs (/µL), mean ± SD [range] | 7200 ± 3070 [3300–21,700] | 8500 ± 3086 [2800–19,200] | 0.04 |
Hemoglobin (g/dL), mean ± SD [range] | 12.7 ± 2.2 [7.7–17.6] | 11.6 ± 2.0 [6.8–15.5] | 0.08 |
Platelets (×104/µL), mean ± SD [range] | 29.8 ± 10.5 [13.5–75.0] | 37.3 ± 14.9 [13.9–93.8] | 0.01 |
Albumin (g/dL), mean ± SD [range] | 3.9 ± 0.8 [1.3–4.8] | 3.4 ± 0.7 [1.9–4.4] | 0.02 |
CRP (mg/dL), mean ± SD [range] | 0.38 ± 4.88 [0.02–33.20] | 0.99 ± 5.15 [0.03–29.48] | 0.35 |
ESR (mm), mean ± SD [range] | 25 ± 25 [2–100] | 35 ± 29 [2–129] | 0.03 |
Vedolizumab | Ustekinumab | p Value | |
---|---|---|---|
Induction | 10.1 ± 3.2 [5–18] | 10.4 ± 3.1 [5–16] | 0.63 |
W6, W8 | 4.5 ± 3.4 [0–13] | 3.9 ± 3.1 [0–14] | 0.50 |
W22, W24 | 3.4 ± 3.0 [0–13] | 4.7 ± 3.6 [0–14] | 0.15 |
W54, W56 | 2.3 ± 2.1 [0–9] | 2.8 ± 2.3 [1–10] | 0.39 |
Bio-naïve | |||
Induction | 9.9 ± 3.0 [5–17] | 9.9 ± 2.7 [6–15] | 0.98 |
W6, W8 | 4.5 ± 3.3 [0–14] | 3.3 ± 2.4 [0–9] | 0.33 |
W22, W24 | 2.9 ± 2.8 [0–13] | 4.0 ± 2.4 [0–8] | 0.14 |
W54, W56 | 2.1 ± 2.0 [0–9] | 2.6 ± 1.0 [1–4] | 0.25 |
Bio-failure | |||
Induction | 10.0 ± 3.2 [6–17] | 10.5 ± 3.3 [5–16] | 0.58 |
W6, W8 | 4.9 ± 3.4 [0–13] | 3.7 ± 3.1 [0–13] | 0.20 |
W22, W24 | 3.4 ± 2.5 [0–9] | 4.0 ± 3.8 [0–14] | 0.96 |
W54, W56 | 1.9 ± 1.8 [0–7] | 3.1 ± 2.9 [0–10] | 0.29 |
Bio-Naïve, n = 14 | Vedolizumab Failure, n = 16 | p Value | |
---|---|---|---|
Remission, Response | |||
W8, n (%) | 10/14 (71.4), 12/14 (85.7) | 11/16 (68.8), 13/16 (81.3) | 0.87, 0.74 |
W24, n (%) | 8/13 (61.5), 11/13 (84.6) | 9/15 (60.0), 11/15 (73.3) | 0.93, 0.47 |
W56, n (%) | 8/10 (77.8), 8/10 (77.8) | 7/12 (58.3), 8/12 (66.6) | 0.27, 0.48 |
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Nomura, K.; Shibuya, T.; Odakura, R.; Haraikawa, M.; Ishino, H.; Orikasa, M.; Omori, M.; Koma, M.; Ito, K.; Maruyama, T.; et al. Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Patients with Ulcerative Colitis: A Real-World Retrospective Study. Biomedicines 2024, 12, 1991. https://doi.org/10.3390/biomedicines12091991
Nomura K, Shibuya T, Odakura R, Haraikawa M, Ishino H, Orikasa M, Omori M, Koma M, Ito K, Maruyama T, et al. Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Patients with Ulcerative Colitis: A Real-World Retrospective Study. Biomedicines. 2024; 12(9):1991. https://doi.org/10.3390/biomedicines12091991
Chicago/Turabian StyleNomura, Kei, Tomoyoshi Shibuya, Rina Odakura, Mayuko Haraikawa, Hirotaka Ishino, Masayuki Orikasa, Masashi Omori, Masao Koma, Kentaro Ito, Takafumi Maruyama, and et al. 2024. "Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Patients with Ulcerative Colitis: A Real-World Retrospective Study" Biomedicines 12, no. 9: 1991. https://doi.org/10.3390/biomedicines12091991