Risk of post‐operative surgical site infections after vedolizumab vs anti‐tumour necrosis factor therapy: a propensity score matching analysis in inflammatory bowel disease

Park, K. T.; Sceats, Lindsay A.; Dehghan, Melody; Trickey, Amber W.; Wren, Anava A.; Wong, Jessie J.; Bensen, Rachel; Limketkai, Berkeley N.; Keyashian, Kian; Kin, Cindy

doi:10.1111/apt.14842

Cited by 24 publications

(11 citation statements)

References 47 publications

(99 reference statements)

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“…The Humedica/Optum database includes electronic health records (EHR) from medical groups, integrated delivery networks, and hospital systems and linked outpatient, inpatient, and pharmaceutical claims and laboratory data from privately insured patients across the United States (US). EHR data are available for approximately 30 4 million individuals across 38 states in the US and claims data are available for 12-14 million patients annually across all 50 states [13,14].…”

Section: Databases and Study Designmentioning

confidence: 99%

Impact of Cardio-Renal-Metabolic Comorbidities on Cardiovascular Outcomes and Mortality in Type 2 Diabetes Mellitus

et al. 2019

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Background: We evaluated the incremental contribution of chronic kidney disease (CKD) to the risk of major adverse cardiovascular (CV) events (MACE), heart failure (HF), and all-cause mortality (ACM) in type 2 diabetes mellitus (T2DM) patients and its importance relative to the presence of other cardio-renal-metabolic (CaReMe) comorbidities. Methods: Patients (≥40 years) were identified at the time of T2DM diagnosis from US (Humedica/Optum) and UK (Clinical Practice Research Datalink) databases. Patients were monitored post-diagnosis for modified MACE (myocardial infarction, stroke, ACM), HF, and ACM. Adjusted hazard ratios were obtained using Cox proportional-hazards regression to evaluate the relative risk of modified MACE, HF, and ACM due to CKD. Patients were stratified by the presence or absence of atherosclerotic CV disease (ASCVD) and age. Results: Between 2011 and 2015, of 227,224 patients identified with incident T2DM, 40,063 (17.64%) had CKD. Regardless of prior ASCVD, CKD was associated with higher risk of modified MACE, HF, and ACM; this excess hazard was more pronounced in older patients with prior ASCVD. In time-to-event analyses in the overall cohort, patients with T2DM + CKD or T2DM + CKD + hypertension + hyperlipidemia had increased risks for modified MACE, HF, and ACM versus patients with T2DM and no CaReMe comorbidities. Patients with CKD had higher risks for and shorter times to modified MACE, HF, and ACM than those without CKD. Conclusion: In T2DM patients, CKD presence was associated with higher risk of modified MACE, HF, and ACM. This may have risk-stratification implications for T2DM patients based on background CKD and highlights the potential importance of novel renoprotective strategies.

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Section: Databases and Study Designmentioning

confidence: 99%

Impact of Cardio-Renal-Metabolic Comorbidities on Cardiovascular Outcomes and Mortality in Type 2 Diabetes Mellitus

et al. 2019

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“…The authors found that anemia and preoperative steroid administration were dominant factors in multivariate analysis for increasing the complications. A study conducted by Park et al [37] showed the same results -no complication risk increased with previous vedolizumab, using a similar methodology. The authors investigated two groups; vedolizumab and anti-TNFα groups.…”

Section: Evidence Of Perioperative Consequences Of Vedolizumabmentioning

confidence: 59%

Perioperative Use of Vedolizumab in Crohn’s Disease Patients and Surgical Outcomes

Alfawaz

2021

JPRI

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Despite advancement in managing Crohn’s disease (CD), a considerable proportion of cases still need surgical intervention, which is an essential means in therapy algorithms. Other drugs of the biologics are recently available, while most CD cases having operations have previously received a drug of this class. This class of agents has a direct association with higher postoperative complication rates, which raises a lot of controversies. In this review summarize the essential data concerning the vedolizumab effect on CD’s postoperative results. The previous data did not demonstrate a cause-effect absolute connection between the increased postoperative morbidities and vedolizumab. Many routing factors unquestionably affect CD’s postoperative outcomes and complications, like malnutrition, unsuitable abdominal settings, and steroids’ previous use. Using vedolizumab perioperatively seems safe. Nevertheless, a definitive relationship from the available data is controversial. Personalized, multidisciplinary evaluations and decisions should be made for each case independently, adjusting the surgical plan regarding the involved risk factors.

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“…Preoperative steroid use and anemia were significant factors for increased complications in multivariate analysis. Park et al, 46 with the same methodology, demonstrated similar results, with no increased risk for complications in patients treated with VDZ. No differences in SSI between the two groups (12% with anti-TNFs and 14.9% with VDZ) was observed.…”

Section: Vedolizumabmentioning

confidence: 70%

“…As seen in this review, despite the initial alarm study from the Mayo Clinic, 14 which described a possible increase in complications with previous use of VDZ, most studies published more recently described opposite results, positioning VDZ as a safe therapy in the perioperative period. 45,46 It is also important to state that a study from Germany demonstrated that a reduction in classical monocytes (M2 macrophages) in systemic circulation is noted with the inhibition of the integrin α4-β7, caused by VDZ, what could impact wound healing. 56 Therefore, owing to this important basic science concept, added to the fact that no prospective studies with 19 impaired nutritional status, 11 and an unfavorable abdominal environment.…”

Section: Discussionmentioning

confidence: 99%

Biologics and surgical outcomes in Crohn’s disease: is there a direct relationship?

Quaresma

Yamamoto

Kotze

2020

Therap Adv Gastroenterol

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Despite significant advances in medical therapy in the management of Crohn’s disease (CD), surgery is still required in a significant proportion of patients and constitutes an important tool in treatment algorithms. Recently, more options of biological agents have been made available, and most patients with CD undergoing surgical procedures have been previously exposed to this class of drugs. There is controversy in the literature as to whether anti-tumor necrosis factor (TNF) agents, anti-integrins, or anti-interleukins (ILs) have a direct relationship with increased postoperative complications. In this narrative review, the authors summarize the most important data regarding the effect of biologics on postoperative outcomes in CD. Most studies (with different designs) are based on the experience with anti-TNF agents, mostly with infliximab. Some studies outlined the relationship between vedolizumab and postoperative complications, and there is a lack of data with ustekinumab in this scenario. Most studies are retrospective, but few prospective data are available. A cause–effect (proof of concept) direct relationship between biologics and an increase in postoperative morbidity has not been demonstrated to date. Several confounding factors such as previous use of steroids, malnutrition, and unfavorable abdominal conditions have a definitely effect on postoperative complications in CD. Biologics seem safe to be used in the perioperative period, but available data are still controversial. Multidisciplinary individualized decisions should be made on a case-to-case basis, adapting the surgical strategy according to risk factors involved.

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Risk of post‐operative surgical site infections after vedolizumab vs anti‐tumour necrosis factor therapy: a propensity score matching analysis in inflammatory bowel disease

Abstract: In the largest, risk-adjusted cohort analysis to date, perioperative exposure to VDZ therapy was not associated with a significantly higher risk of developing an SSI compared to TNFi therapy.

Cited by 24 publications

References 47 publications

Impact of Cardio-Renal-Metabolic Comorbidities on Cardiovascular Outcomes and Mortality in Type 2 Diabetes Mellitus

Impact of Cardio-Renal-Metabolic Comorbidities on Cardiovascular Outcomes and Mortality in Type 2 Diabetes Mellitus

Perioperative Use of Vedolizumab in Crohn’s Disease Patients and Surgical Outcomes

Biologics and surgical outcomes in Crohn’s disease: is there a direct relationship?

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