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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: BACKGROUND:Perioperative vedolizumab (VDZ) and anti-tumour necrosis factor (TNFi) therapies are implicated in causing post-operative complications in inflammatory bowel disease (IBD). AIM:To compare the risk of surgical site infections (SSIs) between VDZ- and TNFi-treated IBD patients in propensity-matched cohorts. METHODS:The Optum Research Database was used to identify IBD patients who received VDZ or TNFi within 30 days prior to abdominal surgery between January 2015 and December 2016. The date of IBD-related abdominal surgery was defined as the index date. SSIs were determined by ICD-9/10 and CPT codes related to superficial wound infections or deep organ space infections after surgery. Propensity score 1:1 matching established comparable cohorts based on VDZ or TNFi exposure before surgery based on evidence-based risk modifiers. RESULTS:The propensity-matched sample included 186 patients who received pre-operative biologic therapy (VDZ, n = 94; TNFi, n = 92). VDZ and TNFi cohorts were similar based on age, gender, IBD type, concomitant immunomodulator exposure, chronic opioid or corticosteroid therapy, Charlson Comorbidity Index and malnutrition. VDZ patients were more likely to undergo an open bowel resection with ostomy. After propensity score matching, there was no significant difference in post-operative SSIs (TNFi 12.0% vs VDZ 14.9%, P = 0.56). Multivariable analysis indicated that malnutrition was the sole risk factor for developing SSI (OR 3.1, 95% CI 1.11-8.71) regardless of the type of biologic exposure. CONCLUSION: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.

SUBMITTER: Park KT

PROVIDER: S-EPMC6043399 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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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.

Park K T KT Sceats L L Dehghan M M Trickey A W AW Wren A A Wong J J JJ Bensen R R Limketkai B N BN Keyashian K K Kin C C

Alimentary pharmacology & therapeutics 20180607 3

<h4>Background</h4>Perioperative vedolizumab (VDZ) and anti-tumour necrosis factor (TNFi) therapies are implicated in causing post-operative complications in inflammatory bowel disease (IBD).<h4>Aim</h4>To compare the risk of surgical site infections (SSIs) between VDZ- and TNFi-treated IBD patients in propensity-matched cohorts.<h4>Methods</h4>The Optum Research Database was used to identify IBD patients who received VDZ or TNFi within 30 days prior to abdominal surgery between January 2015 and ...[more]

PMID: 29876995

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Project description:BackgroundLaparoscopic adrenalectomy (LA) is the gold standard treatment for adrenal lesions. Robot-assisted adrenalectomy (RAA) is a safe approach, associated with higher costs in absence of clear-cut benefits. Several series reported some advantages of RAA over LA in challenging cases, but definitive conclusions are lacking. We evaluated the cost effectiveness and outcomes of robotic (R-LTA) and laparoscopic (L-LTA) approach for lateral transabdominal adrenalectomy in a high-volume center.MethodsAmong 356 minimally invasive adrenalectomies (January 2012-August 2021), 286 were performed with a lateral transabdominal approach: 191 L-LTA and 95 R-LTA. The R-LTA and L-LTA patients were matched for lesion side and size, hormone secretion, and BMI with propensity score matching (PSM) analysis. Postoperative complications, operative time (OT), postoperative stay (POS), and costs were compared.ResultsPSM analysis identified 184 patients, 92 in R-LTA and 92 in L-LTA group. The two groups were well matched. The median lesion size was 4 cm in both groups (p = 0.533). Hormonal hypersecretion was detected in 55 and 54 patients of R-LTA and L-LTA group, respectively (p = 1). Median OT was significantly longer in R-LTA group (90.0 vs 65.0 min) (p < 0.001). No conversion was registered. Median POS was similar (4.0 vs 3.0 days in the R-LTA and L-LTA) (p = 0.467). No difference in postoperative complications was found (p = 1). The cost margin analysis showed a positive income for both procedures (3137 vs 3968 € for R-LTA and L-LTA). In the multiple logistic regression analysis, independent risk factors for postoperative complications were hypercortisolism (OR = 3.926, p = 0.049) and OT > 75 min (OR = 8.177, p = 0.048).ConclusionsThe postoperative outcomes of R-LTA and L-TLA were similar in our experience. Despite the higher cost, RAA appears to be cost effective and economically sustainable in a high-volume center (60 adrenalectomies/year), especially if performed in challenging cases, including patients with large (> 6 cm) and/or functioning tumors.

Project description:ImportanceObservational comparative effectiveness studies can inform the positioning of biologic therapies for older patients with inflammatory bowel disease (IBD) who are underrepresented in clinical trials.ObjectiveTo compare the effectiveness and safety of vedolizumab vs tumor necrosis factor (TNF) for older patients with IBD.Design, setting, and participantsThis active comparator, new-user design, comparative effectiveness study was conducted between January 1, 2005, and December 31, 2018, among 754 older patients (aged ≥50 years) with IBD from the Danish National Patient Register. The mean follow-up after treatment initiation took place at 32 to 40 weeks. Statistical analysis was performed from February 1 to April 27, 2022.InterventionsTreatment with vedolizumab or TNF antagonists.Main outcomes and measuresThe primary effectiveness outcome was treatment failure, defined as the composite risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with biologic therapy. Secondary effectiveness outcomes were time to each individual component of the composite effectiveness outcome. The primary safety outcome was the risk of serious infections, defined as infections requiring hospitalization. A 1:1 propensity score-matched analysis was conducted, accounting for patient-, disease-, and treatment-associated factors.ResultsThe study compared 377 older patients with IBD with incident use of vedolizumab (202 women [53.6%]; mean [SD] age, 61.2 [8.3] years; 177 [46.9%] with Crohn disease) vs 377 patients with incident use of TNF antagonists (206 women [54.6%]; mean [SD] age, 61.3 [8.1] years; 182 [48.3%] with Crohn disease). Overall, vedolizumab was associated with an increased risk of treatment failure compared with TNF antagonists (1-year risk, 45.4% vs 34.7%; adjusted hazard ratio [HR], 1.31; 95% CI, 1.02-1.69), including higher risk of IBD-related hospitalization (1-year risk, 27.8% vs 16.3%; adjusted HR, 1.48; 95% CI, 1.03-2.15) and IBD-related major abdominal surgery (1-year risk, 21.3% vs 8.0%; adjusted HR, 2.39; 95% CI, 1.45-3.94). In subgroup analysis by IBD phenotype, among patients with Crohn disease, vedolizumab was associated with a 77% higher risk of treatment failure (adjusted HR, 1.77; 95% CI, 1.21-2.58), while no difference in risk of treatment failure was seen among patients with ulcerative colitis (adjusted HR, 1.04; 95% CI, 0.75-1.43; P = .03 for interaction). There was no significant difference in the risk of serious infections, overall (1-year risk, 8.2% vs 8.7%; adjusted HR, 1.04; 95% CI, 0.58-1.85) and by IBD phenotype.Conclusions and relevanceIn this comparative effectiveness study of older patients with IBD, vedolizumab was associated with a higher risk of treatment failure compared with TNF antagonists, particularly among patients with Crohn disease, without offering a significant safety advantage.

Project description:BackgroundPrimary pulmonary lymphomas (PPLs) are rare malignancies that are frequently misdiagnosed due to their non-specific symptoms and ambiguous imaging findings. Although chemotherapy and radiation are typically the main treatment options, the role of surgery in managing PPLs remains uncertain. This study aimed to evaluate the impact of surgery on survival outcomes in patients with stage IE/IIE PPLs.MethodsWe analyzed 2,693 patients with stage IE/IIE PPLs using Cox regression and Kaplan-Meier analyses to assess overall survival (OS) and cancer-specific survival (CSS). Subgroup analyses were performed based on histological subtypes, including mucosa-associated lymphoid tissue (MALT) lymphoma, diffuse large B-cell lymphoma (DLBCL), other non-Hodgkin's lymphoma (NHL), and Hodgkin's lymphoma (HL). Additionally, we analyzed tumor stage and patient characteristics. Propensity score matching (PSM) was applied to reduce potential biases.ResultsAmong the patients, 1,013 underwent surgery, while 1,680 did not. After PSM, surgery was associated with significantly improved OS [hazard ratio (HR) =0.75, 95% confidence interval (CI): 0.66-0.86, P<0.001] and CSS (HR =0.66, 95% CI: 0.54-0.81, P<0.001). Notably, surgery significantly improved OS and CSS in patients with stage IE (OS: HR =0.62, 95% CI: 0.46-0.84, P=0.002; CSS: HR =0.57, 95% CI: 0.39-0.84, P=0.005) and stage IIE (OS: HR =0.64, 95% CI: 0.41-0.99, P=0.046; CSS: HR =0.47, 95% CI: 0.27-0.85, P=0.01) DLBCL. However, surgery did not significantly affect OS (P=0.24) or CSS (P=0.83) in patients with HL, stage IE/IIE MALT lymphoma (stage IE: OS, P=0.11; CSS, P=0.34; stage IIE: OS, P=0.40; CSS, P=0.75), or stage IE/IIE other NHL (stage IE: OS, P=0.050; CSS, P=0.46; stage IIE: OS, P=0.22; CSS, P=0.11). Additionally, sublobectomy demonstrated outcomes comparable to lobectomy/pneumonectomy in terms of OS and CSS for both stage IE (OS: HR =0.81, 95% CI: 0.63-1.06, P=0.13; CSS: HR =0.91, 95% CI: 0.58-1.43, P=0.70) and stage IIE (OS: HR =0.66, 95% CI: 0.40-1.09, P=0.10; CSS: HR =0.58, 95% CI: 0.26-1.29, P=0.18) PPLs.ConclusionsSurgery improves oncological outcomes for patients with stage IE/IIE DLBCL but does not provide survival benefits for MALT lymphoma, other NHL, or HL. Sublobectomy may be a viable surgical option when complete resection is achieved.

Dataset Information

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

Publications

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

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