Comparative Safety of Ustekinumab and Vedolizumab in Older Patients with Inflammatory Bowel Disease: A Bicentric Cohort Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Data Collection
2.3. Outcomes Measures
2.4. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Safety Outcome
4. Discussion
5. Conclusions
Author Contributions
Funding
Data Availability Statement
Conflicts of Interest
Abbreviations
References
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Vedolizumab | Ustekinumab | Anti-TNF | |||
---|---|---|---|---|---|
n = 22 | n = 30 | n = 63 | p | ||
Gender n (%) | Male | 11 (50) | 9 (30) | 35 (56) | 0.068 |
Female | 11 (50) | 21 (70) | 28 (44) | ||
Median age at diagnosis | 42 | 50 | 60 | 0.004 | |
Median duration of disease, year | 23 | 15 | 5 | 0.0002 | |
Median duration of follow-up | 1 | 1 | 1 | 0.447 | |
Perineal disease, n (%) | 7 (32) | 4 (13) | 11 (19) | 0.247 | |
Missing | 5 | ||||
Smoking status, n (%) | 0.366 | ||||
Never Smoked | 12 (55) | 18 (60) | 27 (44) | ||
Former Smoker | 8 (36) | 11 (37) | 33 (53) | ||
Current smoker | 2 (9) | 1 (3) | 2 (3) | ||
Unknown | 1 | ||||
History of surgery, n (%) | 0.364 | ||||
Yes | 5 (50) | 14 (74) | 10 (56) | ||
None | |||||
Missing | 12 | 11 | 45 | ||
Previous treatment, n (%) | |||||
Anti-TNF | - | ||||
Yes | 17 (81) | 27 (96) | 4 (7) | ||
Missing | 1 | 2 | 3 | ||
Vedolizumab | Yes | 8 (27) | 0 | - | |
Missing | 3 | ||||
Ustekinumab | 2 (9) | 0 | - | ||
Missing | 3 | ||||
Corticosteroids | Yes | 18 (86) | 30 (100) | 15 (88) | 0.114 |
Missing | 1 | 46 | |||
Immunosuppressant n (%) | Yes | 14 (67) | 20 (67) | 30 (51) | 0.245 |
Missing | 1 | 4 | |||
Concomitant treatment, n (%) | |||||
Corticosteroids | 4 (18) | 9 | 33 (57) | 0.002 | |
Missing | 5 | ||||
Immunosupressant | Yes | 5 (23) | 10 (33) | 16 (28) | 0.701 |
Missing | 6 | ||||
Comorbidities n (med) | 10 (1,.5) | 17 (1) | 16 (1.,5) | 0.996 |
Vedolizumab | Anti-TNF | |||
---|---|---|---|---|
n = 31 | n = 35 | p | ||
Gender, n (%) | Male | 21 (68) | 20 (57) | 0.376 |
Female | 10 (32) | 15 (43) | ||
Median age at diagnosis | 58 | 57 | 0.899 | |
Median duration of disease | 6 | 4.5 | 0.371 | |
Median duration of follow up | 1 | 1 | 0.040 | |
Smoking status, n (%) | ||||
Never Smoked | 17 (55) | 8 (23) | 0.022 | |
Former Smoker | 12 (39) | 25 (71) | ||
Current smoker | 2 (6) | 2 (6) | ||
History of surgery, n (%) | 0.219 | |||
Yes | 0 | 1 (9) | ||
None | 16 (100) | 10 (91) | ||
Missing | 15 | 24 | ||
Previous treatment, n (%) | ||||
Anti-TNF | <0.0001 | |||
Yes | 24 (77) | 4 (12) | ||
Missing | 0 | 2 | ||
Vedolizumab | Yes | 0 | - | |
Missing | 2 | |||
Ustekinumab | Yes | 0 | 0 | - |
Missing | 0 | 2 | ||
Corticosteroids | Yes | 28 (90) | 8 (89) | 0.900 |
Missing | 0 | 26 | ||
Immunosuppressant n (%) | Yes | 20 (64) | 19 (61) | 0.793 |
Missing | 0 | 4 | ||
Concomitant treatment, n (%) | ||||
Corticosteroids | Yes | 13 (42) | 20 (61) | 0.135 |
Missing | 0 | 2 | ||
Immunosuppressant | Yes | 7 (23) | 9 (27) | 0.665 |
Missing | 0 | 2 | ||
Comorbidities, n (med) | 16 (2) | 8 (2) | 0.959 |
Vedolizumab | Ustekinumab | Anti-TNF | ||
---|---|---|---|---|
n = 21 | n = 27 | n = 54 | ||
Number of AE per year of follow up (CD) | p * | |||
Vedolizumab vs. Ustekinumab | 0.23 | 1.03 | 0.258 | |
Vedolizumab vs. Anti-TNF | 0.23 | 1.02 | 0.274 | |
Ustekinumab vs. Anti-TNF | 1.03 | 1.02 | 0.360 | |
Vedolizumab | Anti-TNF | |||
n = 31 | n = 33 | |||
Number of AE per year of follow up (UC) | p * | |||
0.37 | 0.27 | 0.876 |
Vedolizumab | Ustekinumab | ||
---|---|---|---|
n = 21 | n = 27 | ||
Adverse event per year of follow-up, n (%) | p | ||
Total | 4 (19) | 10 (37) | 0.1737 |
Dermatological | 1 | 2 | |
Infectious | 3 | 7 | |
Allergic | 0 | 1 | |
Rheumatological | 0 | 0 | |
Neoplasia | 0 | 0 | |
Dermatological + Infectious | 0 | 0 | |
Vedolizumab | Anti TNF | ||
n = 21 | n = 54 | ||
Adverse event per year of follow-up, n (%) | p | ||
Total | 4 (19) | 14 (26) | 0.5312 |
Dermatological | 1 | 3 | |
Infectious | 3 | 4 | |
Allergic | 0 | 0 | |
Rheumatological | 0 | 4 | |
Neoplasia | 0 | 2 | |
Dermatological + Infectious | 0 | 1 | |
Ustekinumab | Anti TNF | ||
n = 27 | n = 54 | ||
Adverse event per year of follow-up, n (%) | p | ||
Total | 10 (37) | 14 (26) | 0.3019 |
Dermatological | 2 | 3 | |
Infectious | 7 | 4 | |
Allergic | 1 | 0 | |
Rheumatological | 0 | 4 | |
Neoplasia | 0 | 2 | |
Dermatological + Infectious | 0 | 1 |
Vedolizumab | Anti-TNF | ||
---|---|---|---|
n = 31 (48%) | n = 33 (52%) | ||
Adverse event per year of follow-up, n (%) | p | ||
Total | 7 (23) | 7 (21) | 0.895 |
Dermatological | 1 | 0 | |
Rheumatological | 0 | 2 | |
Infectious | 3 | 3 | |
Other adverse event | 2 | 2 | |
Dermatological + Infectious | 1 | 0 |
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Burgevin, A.; Caron, B.; Sasson, A.; Luc, A.; Netter, P.; Baumann, C.; Ananthakrishnan, A.N.; Peyrin-Biroulet, L. Comparative Safety of Ustekinumab and Vedolizumab in Older Patients with Inflammatory Bowel Disease: A Bicentric Cohort Study. J. Clin. Med. 2022, 11, 6967. https://doi.org/10.3390/jcm11236967
Burgevin A, Caron B, Sasson A, Luc A, Netter P, Baumann C, Ananthakrishnan AN, Peyrin-Biroulet L. Comparative Safety of Ustekinumab and Vedolizumab in Older Patients with Inflammatory Bowel Disease: A Bicentric Cohort Study. Journal of Clinical Medicine. 2022; 11(23):6967. https://doi.org/10.3390/jcm11236967
Chicago/Turabian StyleBurgevin, Alice, Bénédicte Caron, Alexa Sasson, Amandine Luc, Patrick Netter, Cédric Baumann, Ashwin N. Ananthakrishnan, and Laurent Peyrin-Biroulet. 2022. "Comparative Safety of Ustekinumab and Vedolizumab in Older Patients with Inflammatory Bowel Disease: A Bicentric Cohort Study" Journal of Clinical Medicine 11, no. 23: 6967. https://doi.org/10.3390/jcm11236967