Despite major advances in the medical management of Crohn’s disease (CD), a significant proportion of patients will require surgery within 5 years of diagnosis. Malnutrition is an independent risk factor for adverse post-operative outcomes following gastrointestinal surgery. Data on the value of pre-operative total parenteral nutrition (TPN) in CD patients are mixed and there is a paucity of data in the biologic era. We aimed to define the role of pre-operative TPN in this population. This was a retrospective cohort study conducted at a tertiary referral center. CD patients who underwent major abdominal surgery were identified. Patients receiving pre-operative TPN were compared to controls. We compared the incidence of 30-day infectious and non-infectious post-operative complications between the two groups. A total of 144 CD patients who underwent major abdominal surgery between March 2007 and March 2017 were included. Fifty-five patients who received pre-operative TPN were compared to 89 controls. Twenty-one (14.6%) patients developed infectious complications (18.2% in TPN group vs 12.3% in non-TPN group, P = 0.34) and 23 (15.9%) developed non-infectious complications (14.5% in TPN group vs 16.9% in non-TPN group, P = 0.71). In a multivariate analysis, controlling for differences in baseline disease severity and malnutrition between groups, patients receiving pre-operative TPN for ≥60 days had significantly lower odds of developing non-infectious complications (odds ratio 0.07, 95% confidence interval: 0.01–0.80, P = 0.03). Weight loss of >10% in the past 6 months was a significant predictor of post-operative complications. In a subset of malnourished CD patients, TPN is safe and allows comparable operative outcomes to controls. Pre-operative TPN for ≥60 days reduced post-operative non-infectious complications without associated increase in infectious complications.

To investigate the behavior of pulsatile pressure zones (PPZ’s) as noted on high resolution esophageal impedance manometry (HREIM), and determine their association with dysphagia. Retrospective, single center case control design screening HREIM studies for cases (dysphagia) and controls (no dysphagia). Thoracic radiology studies were reviewed further in cases for (thoracic cardiovascular) thoracic cardiovascular (TCV) structures in esophageal proximity to compare with HREIM findings. Manometric data was collected for number, location, axial length, PPZ pressure and esophageal clearance function (impedance). Among 317 screened patients, 56% cases and 64% controls had PPZ’s. Fifty cases had an available thoracic radiology comparison. The distribution of PPZ’s in these 50 cases and 59 controls was similar (average 1.4 PPZ/patient). Controls (mean 31.2 ± SD 12 years) were a significantly younger population than cases (mean 67.3 ± SD 14.9 years) with P < 0.0001. The upright posture PPZ pressure was higher in controls (15.7 ± 10.0 mmHg) than cases (10.8 ± 9.7 mmHg). Although statistically significant (P = 0.005), it was a weak predictor using logistic regression and ROC model (AUC = 0.65). Three dysphagia patients had partial compression from external TCV on radiology (1 aberrant subclavian artery, 2 dilated left atrium). The posture (supine vs upright) with more prominent PPZ’s impaired bolus clearance in 9 additional cases by > 20%. Transmitted TCV pulsations observed in HREIM bear no significant impact on swallowing. However, in older adults with dysphagia, evidence of impaired bolus clearance on impedance should be evaluated for external TCV compression. These associations have never been explored previously in literature, and are novel.

Background: Patients with chronic immune-mediated disorders (IMIDs), including inflammatory bowel disease (IBD), are at increased risk of cardiovascular disease. While advanced therapies show cardioprotective effects in other IMIDs, their impact on major adverse cardiovascular events (MACE) in IBD remains unclear. We conducted a meta-analysis of randomized controlled trials (RCTs) and observational studies evaluating MACE risk with advanced therapies in IBD. Methods: Systematic search of PubMed, Embase and Cochrane Central identified 43 high-quality studies (36 RCTs,7 observational studies) published between 2002 and 2024. Primary analyses estimated odds ratios (OR) for MACE comparing advanced therapy to placebo, with secondary analyses stratified studies by drug class and length of follow-up. Results: Placebo-controlled RCTs showed a nonsignificant trend toward reduced MACE risk (OR: 0.60; 95% CI: 0.24?1.51), with similar findings after continuity correction for zero-event studies (OR: 0.87; 95% CI: 0.45?1.68). Class-specific trends suggested lower MACE risk with IL-12/IL-23 inhibitors (OR: 0.35; 95% CI: 0.05?2.21), JAK inhibitors (OR: 0.57; 95% CI: 0.16?2.06), and a potential increase with anti-TNF agents (OR: 3.04; 95% CI: 0.31?29.47), though none reached statistical significance. Long-term follow-up studies showed consistent findings. Observational studies suggested lower MACE risk for anti-TNF therapies (OR: 0.29; 95% CI: 0.21?0.40), but not for IL-12/IL-23 (OR: 4.41; 95% CI: 0.49?39.28) or JAK inhibitors (OR: 1.57; 95% CI: 0.86?2.84).Conclusion: Advanced therapies did not demonstrate a clear increase or decrease in cardiovascular risk in IBD. The discrepancies between RCTs and observational studies underscore the urgent need for rigorous-designed observational research with long-term follow-up to evaluate the real-world impact of advanced therapies on MACE risk.

Background: Anti–tumor necrosis factor (anti-TNF), particularly infliximab, have transformed inflammatory bowel disease (IBD) management, but their high cost imposes a significant economic burden. Infliximab biosimilars were introduced to reduce the unmet needs. Despite the approval of infliximab biosimilars, real-world evidence of cardiovascular safety and effectiveness of infliximab biosimilars is lacking among patients with IBD. In this trial emulation, we compared the effectiveness and cardiovascular safety between patients who initiated infliximab reference product (IFX-RP) and biosimilars (IFX-BP). Methods: Using the Merative Marketscan Research database (2011–2023), we conducted a retrospective cohort study to emulate the target trial where biologic-naïve adults were randomly assigned to initiate IFX-RP or IFX-BP. Primary outcomes included healthcare resource utilization (HRU), and incidence of major adverse cardiovascular events (MACE) over one year. Propensity score matching was applied to mimic the randomization. Both intention-to-treat and per-protocol effects were estimated. Results: After matching, 850 patients (425 per group) were included. HRU was comparable between IFX-RP and IFX-BP groups across outpatient visits, hospitalizations, surgeries, and emergency visit. During follow-up, MACE events were more frequent in the IFX-BP group (9 vs. 3), with an incidence rate ratio (IRR) of 3.04 (95% CI: 0.82–11.23). Although the difference was not statistically significant, consistent directional trends were observed across analyses. Sensitivity analyses supported primary results. Conclusion: Our study found comparable effectiveness between IFX-RP and IFX-BP in routine clinical care. While cardiovascular events were infrequent, the potential signal suggesting increased MACE risk associated with infliximab biosimilars warrants further investigation. Continued pharmacovigilance is essential to ensure the cardiovascular safety of biosimilars. Summary: Infliximab biosimilars, introduced to reduce the economic burden of anti-TNF therapy in IBD, demonstrated comparable real-world effectiveness to the infliximab reference product in a target trial emulation using Merative MarketScan data, while a potential signal of increased cardiovascular risk underscores the need for ongoing pharmacovigilance and further investigation. Key Messages: What is known? Infliximab biosimilars demonstrate comparable efficacy and safety to the reference product in IBD, but cardiovascular outcomes remain underexplored. What is new here? This U.S. real-world study emulating a target trial found similar effectiveness between infliximab reference and biosimilar products, with a possible trend toward increased cardiovascular risk in biosimilar users. How can this study help patient care? Findings highlight the need for continued pharmacovigilance and cardiovascular monitoring when prescribing infliximab biosimilars to optimize safety in IBD management.