Comparative Effectiveness and Safety of Anti–Tumor Necrosis Factor Agents in Biologic-Naive Patients With Crohn’s Disease

Inhibitors of tumor necrosis factor (anti-TNF agents) are the most effective therapy for Crohn’s disease (CD). We evaluated the real-world comparative effectiveness and safety of different anti-TNF agents (infliximab, adalimumab, and certolizumab pegol) in biologic-naïve patients with CD in a retrospective, propensity-matched cohort study using a national administrative claims database (Optum Labs Data Warehouse)

Risk of Malignancy with Vedolizumab Versus Tumor Necrosis Factor-α Antagonists in Patients with Inflammatory Bowel Diseases

Background and aimsWe conducted a retrospective cohort study comparing the risk of malignancy between patients treated with vedolizumab vs. tumor necrosis factor-α (TNFα) antagonists in patients with inflammatory bowel diseases (IBD).MethodsUsing an administrative claims database, we identified patients with IBD without prior malignancy who were new users of either vedolizumab or TNFα antagonists between 2014-2018, with no prior exposure to either biologic or in preceding 1 y and had insurance coverage for at least 1 y after treatment initiation. We estimated incidence rate of malignancy (solid organ, hematological or skin cancers) in patients treated with vedolizumab and TNFα antagonists, and compared risk using Cox proportional hazard analysis.ResultsWe included 4807 patients treated with TNFα antagonists (age, 41 ± 15 y, 60% with Crohn's disease [CD]) of whom 65 developed malignancy over 7214 person-year [PY] follow-up (incidence rate [IR], 9.0 per 1000-PY), and 759 patients treated with vedolizumab (age, 46 ± 16y, 42% CD) of whom 11 developed malignancy over 950-PY follow-up (IR, 11.6). No difference was observed in the incidence of malignancy between vedolizumab versus TNFα antagonists (incidence rate ratio, 1.28; 95% CI, 0.61-2.45). After adjusting for age, sex, race, comorbidity burden, disease phenotype and concomitant use of immunomodulators, no difference was observed in time to incident malignancy between vedolizumab versus TNFα antagonists (HR, 1.15; 95% CI, 0.61-2.19). Similar results were observed on stratified analysis by age and concomitant immunomodulators, and after excluding non-melanoma skin cancers.ConclusionsIn an observational study of patients with IBD, no differences were observed in the risk of incident malignancy in patients treated with vedolizumab versus TNFα antagonists

Predictors of Return Visits Among Insured Emergency Department Mental Health and Substance Abuse Patients, 2005-2013

Introduction: Our goal was to describe the pattern and identify risk factors of early-return ED visits or inpatient admissions following an index mental health and substance abuse (MHSA)-related ED visit in the United States. Methods: We performed a retrospective cohort study using Optum Labs Data Warehouse, a nationally representative database containing administrative claims data on privately insured and Medicare Advantage enrollees. Authors identified patients presenting to an ED with a primary diagnosis of MHSA between 2005 and 2013 who were discharged home. Study inclusion required continuous insurance enrollment for the 12 months preceding and the 31 days following the index ED visit. During the study period we included only the first ED visit for each patient. Results: A total of 49,672 (14.2%) had a return visit to the ED or had a hospitalization within 30 days following discharge. Mean time to the next ED visit or inpatient admission was 11.7 days. An increased age (age 65+ vs. age <18 years; OR 1.65, 95% CI [1.57 to 1.74]), chronic medical comorbidities (Hwang comorbidity 5+ vs 0; OR 1.31, 95% CI [1.27 to 1.35]), prior ED and inpatient utilization (4+ visits vs 0 visits; OR 5.59, 95% CI [5.41 to 5.78]) were associated with return visits within 30 days following discharge. Conclusion: In an analysis of nearly 350,000 ED visits for MHSA, 14.2 % of patients returned to the ED or hospital within 30 days. This study identified a number of factors associated with return visits for acute care

Predictors of Return Visits Among Insured Emergency Department Mental Health and Substance Abuse Patients, 2005–2013

Introduction: Our goal was to describe the pattern and identify risk factors of early-return ED visits or inpatient admissions following an index mental health and substance abuse (MHSA)-related ED visit in the United States. Methods: We performed a retrospective cohort study using Optum Labs Data Warehouse, a nationally representative database containing administrative claims data on privately insured and Medicare Advantage enrollees. Authors identified patients presenting to an ED with a primary diagnosis of MHSA between 2005 and 2013 who were discharged home. Study inclusion required continuous insurance enrollment for the 12 months preceding and the 31 days following the index ED visit. During the study period we included only the first ED visit for each patient. Results: A total of 49,672 (14.2%) had a return visit to the ED or had a hospitalization within 30 days following discharge. Mean time to the next ED visit or inpatient admission was 11.7 days. An increased age (age 65+ vs. age <18 years; OR 1.65, 95% CI [1.57 to 1.74]), chronic medical comorbidities (Hwang comorbidity 5+ vs 0; OR 1.31, 95% CI [1.27 to 1.35]), prior ED and inpatient utilization (4+ visits vs 0 visits; OR 5.59, 95% CI [5.41 to 5.78]) were associated with return visits within 30 days following discharge. Conclusion: In an analysis of nearly 350,000 ED visits for MHSA, 14.2 % of patients returned to the ED or hospital within 30 days. This study identified a number of factors associated with return visits for acute care

Comparative Risk of Serious Infections With Tumor Necrosis Factor α Antagonists vs Vedolizumab in Patients With Inflammatory Bowel Diseases

Background and aimsWe conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-a (TNFa) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD).MethodsUsing an administrative claims database, we identified patients with IBD who were new-users of either TNFa antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFa antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates.ResultsWe included 4881 patients treated with TNFa antagonists (age, 41 ± 15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFa antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD.ConclusionsIn an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFa antagonists, in patients with UC, but not in patients with CD

Frailty and Risk of Serious Infections in Biologic-treated Patients With Inflammatory Bowel Diseases

BackgroundIdentifying biologic-treated patients with inflammatory bowel diseases (IBDs) at higher risk of serious infections is a priority. We conducted a retrospective cohort study evaluating frailty and risk of serious infections in biologic-treated patients with IBD.MethodsUsing an administrative claims database, we identified biologic-treated patients with IBD between 2014 and 2018 with follow-up 1 year before and after treatment initiation. Using a validated claims-based hospital frailty risk scoring system, patients were classified as frail and nonfrail. We compared the risk of serious infections (infections requiring hospitalization) between frail and nonfrail patients using Cox proportional hazard analysis adjusting for age, comorbidities, disease characteristics, health care utilization, use of corticosteroids, immunomodulators, and opiates.ResultsWe included 5987 biologic-treated patients with IBD (4881 on TNFα antagonists, 1106 on vedolizumab), of whom 2350 (39.3%) were classified as frail; over 7115 person-years of follow-up was included, and 520 patients developed serious infection. Frailty was not associated with increased risk of serious infection (adjusted hazard ratio [aHR], 1.12; 95% CI, 0.93-1.36), whereas advanced age (older than 60 years), high comorbidity burden, corticosteroid use, opiate use, and prior serious infection were associated with increased risk of serious infection. On stratified analysis, frailty was associated with increased risk of serious infections in vedolizumab-treated patients (aHR, 1.69; 95% CI, 1.03-2.79) but not in TNFα antagonist-treated patients (aHR, 1.03; 95% CI, 0.83-1.27).ConclusionsIn biologic-treated patients with IBD, frailty assessed using a claims-based frailty index was not independently associated with increased risk of serious infections. Future studies evaluating objective and biological measures of frailty are warranted to risk-stratify older patients with IBD

Epidemiology of cardiogenic shock and cardiac arrest complicating non‐ST‐segment elevation myocardial infarction: 18‐year US study

Abstract Aims This study aims to evaluate the impact of the combination of cardiogenic shock (CS) and cardiac arrest (CA) complicating non‐ST‐segment elevation myocardial infarction (NSTEMI). Methods and results Adult (>18 years) NSTEMI admissions using the National Inpatient Sample database (2000 to 2017) were stratified by the presence of CA and/or CS. Outcomes of interest included in‐hospital mortality, early coronary angiography, hospitalization costs, and length of stay. Of the 7 302 447 hospitalizations due to NSTEMI, 147 795 (2.0%) had CS only, 155 522 (2.1%) had CA only, and 41 360 (0.6%) had both CS and CA. Compared with 2000, the adjusted odds ratios (ORs) and 95% confidence interval (CIs) for CS, CA, and both CS and CA in 2017 were 3.75 (3.58–3.92), 1.46 (1.42–1.50), and 4.52 (4.16–4.87), respectively (all P < 0.001). The CS + CA (61.2%) cohort had higher multiorgan failure than CS (42.3%) and CA only (32.0%) cohorts, P < 0.001. The CA only cohort had lower rates of overall (52% vs. 59–60%) and early (17% vs. 18–27%) angiography compared with the other groups (all P < 0.001). CS + CA admissions had higher in‐hospital mortality compared with those with CS alone (aOR 4.12 [95% CI 4.00–4.24]), CA alone (aOR 1.69 [95% CI 1.65–1.74]), or without CS/CA (aOR 22.66 [95% CI 22.06–23.27]). The presence of CS, either alone or with CA, was associated with higher hospitalization costs and longer hospital length of stay. Conclusions The combination of CS and CA is associated with higher rates of acute non‐cardiac organ failure and in‐hospital mortality in NSTEMI admissions as compared with those with either CS or CA alone