Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN
Abstract Background Crohn’s disease (CD) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation that leads to progressive bowel damage. Despite advances in medical treatment for CD, many patients require surgical intervention. Most studies of surgery rates are...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | BMC Gastroenterology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12876-023-02723-5 |
| _version_ | 1797859932795568128 |
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| author | Michelle Vu Sabyasachi Ghosh Kandavadivu Umashankar Laura Weber Christina Landis Ninfa Candela Benjamin Chastek |
| author_facet | Michelle Vu Sabyasachi Ghosh Kandavadivu Umashankar Laura Weber Christina Landis Ninfa Candela Benjamin Chastek |
| author_sort | Michelle Vu |
| collection | DOAJ |
| description | Abstract Background Crohn’s disease (CD) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation that leads to progressive bowel damage. Despite advances in medical treatment for CD, many patients require surgical intervention. Most studies of surgery rates are from patients treated with anti-tumor necrosis factor alpha (anti-TNFα) treatments, with comparatively little data on the surgery rates of patients treated with vedolizumab and ustekinumab. SOJOURN aimed to estimate the hazard rate and incidence of the first CD-related surgery following initiation of treatment with vedolizumab or ustekinumab in biologic-naïve patients with CD. Methods SOJOURN was a retrospective, observational cohort study examining administrative claims data from the Optum® Research Database between July 1, 2017 and March 31, 2020. Included participants were adults with a diagnosis of CD and a claim for vedolizumab or ustekinumab (defined as the index treatment) between January 1, 2018 and December 31, 2019, with no claims for a biologic in the 6 months before initiation of this treatment. The variable follow-up started on the day after the index date and continued until whichever came first of discontinuation of the index treatment, surgery event, switching of the index treatment, initiation of combination biologic treatment, disenrollment, or March 31, 2020. The time to the first CD-related surgery on biologic treatment was estimated by Kaplan–Meier analysis. The hazard ratio and incidence rate ratio of CD-related surgery for each treatment cohort was compared using a Cox proportional hazards model and a Poisson regression model, respectively. Results Of the 1,122 included patients, 578 received vedolizumab and 544 received ustekinumab. After 1 year of the variable follow-up, 7.7% of patients receiving vedolizumab and 11.6% of patients receiving ustekinumab had undergone a CD-related surgery. Vedolizumab was associated with a 34.2% lower hazard rate of surgery (hazard ratio 0.658, 95% confidence interval [CI] 0.436–0.994, p = 0.047) and a 34.5% lower incidence of surgery (rate ratio 0.655, 95% CI 0.434–0.988, p = 0.044) than ustekinumab. Conclusions This real-world analysis of biologic-naïve patients with CD suggests that vedolizumab is associated with greater effectiveness in reducing the rate of CD-related surgery than ustekinumab. |
| first_indexed | 2024-04-09T21:37:34Z |
| format | Article |
| id | doaj.art-17035832b38c474fb1ceb8c6860deccb |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-04-09T21:37:34Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| spelling | doaj.art-17035832b38c474fb1ceb8c6860deccb2023-03-26T11:12:21ZengBMCBMC Gastroenterology1471-230X2023-03-0123111010.1186/s12876-023-02723-5Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURNMichelle Vu0Sabyasachi Ghosh1Kandavadivu Umashankar2Laura Weber3Christina Landis4Ninfa Candela5Benjamin Chastek6OptumTakeda Pharmaceuticals U.S.A., IncTakeda Pharmaceuticals U.S.A., IncOptumOptumTakeda Pharmaceuticals U.S.A., IncOptumAbstract Background Crohn’s disease (CD) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation that leads to progressive bowel damage. Despite advances in medical treatment for CD, many patients require surgical intervention. Most studies of surgery rates are from patients treated with anti-tumor necrosis factor alpha (anti-TNFα) treatments, with comparatively little data on the surgery rates of patients treated with vedolizumab and ustekinumab. SOJOURN aimed to estimate the hazard rate and incidence of the first CD-related surgery following initiation of treatment with vedolizumab or ustekinumab in biologic-naïve patients with CD. Methods SOJOURN was a retrospective, observational cohort study examining administrative claims data from the Optum® Research Database between July 1, 2017 and March 31, 2020. Included participants were adults with a diagnosis of CD and a claim for vedolizumab or ustekinumab (defined as the index treatment) between January 1, 2018 and December 31, 2019, with no claims for a biologic in the 6 months before initiation of this treatment. The variable follow-up started on the day after the index date and continued until whichever came first of discontinuation of the index treatment, surgery event, switching of the index treatment, initiation of combination biologic treatment, disenrollment, or March 31, 2020. The time to the first CD-related surgery on biologic treatment was estimated by Kaplan–Meier analysis. The hazard ratio and incidence rate ratio of CD-related surgery for each treatment cohort was compared using a Cox proportional hazards model and a Poisson regression model, respectively. Results Of the 1,122 included patients, 578 received vedolizumab and 544 received ustekinumab. After 1 year of the variable follow-up, 7.7% of patients receiving vedolizumab and 11.6% of patients receiving ustekinumab had undergone a CD-related surgery. Vedolizumab was associated with a 34.2% lower hazard rate of surgery (hazard ratio 0.658, 95% confidence interval [CI] 0.436–0.994, p = 0.047) and a 34.5% lower incidence of surgery (rate ratio 0.655, 95% CI 0.434–0.988, p = 0.044) than ustekinumab. Conclusions This real-world analysis of biologic-naïve patients with CD suggests that vedolizumab is associated with greater effectiveness in reducing the rate of CD-related surgery than ustekinumab.https://doi.org/10.1186/s12876-023-02723-5Crohn’s diseaseInflammatory bowel diseaseBiologicVedolizumabUstekinumabSurgery |
| spellingShingle | Michelle Vu Sabyasachi Ghosh Kandavadivu Umashankar Laura Weber Christina Landis Ninfa Candela Benjamin Chastek Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN BMC Gastroenterology Crohn’s disease Inflammatory bowel disease Biologic Vedolizumab Ustekinumab Surgery |
| title | Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN |
| title_full | Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN |
| title_fullStr | Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN |
| title_full_unstemmed | Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN |
| title_short | Comparison of surgery rates in biologic-naïve patients with Crohn’s disease treated with vedolizumab or ustekinumab: findings from SOJOURN |
| title_sort | comparison of surgery rates in biologic naive patients with crohn s disease treated with vedolizumab or ustekinumab findings from sojourn |
| topic | Crohn’s disease Inflammatory bowel disease Biologic Vedolizumab Ustekinumab Surgery |
| url | https://doi.org/10.1186/s12876-023-02723-5 |
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