Home Infliximab Infusions Are Associated With Suboptimal Outcomes Without Cost Savings in Inflammatory Bowel Diseases.

INTRODUCTION: Biologic agents including infliximab are effective but costly therapies in the management of inflammatory bowel disease (IBD). Home infliximab infusions are increasingly payer-mandated to minimize infusion-related costs. This study aimed to compare biologic medication use, health outcomes, and overall cost of care for adult and pediatric patients with IBD receiving home vs office- vs hospital-based infliximab infusions. METHODS: Longitudinal patient data were obtained from the Optum Clinformatics Data Mart. The analysis considered all patients with IBD who received infliximab from 2003 to 2016. Primary outcomes included nonadherence (≥2 infliximab infusions over 10 weeks apart in 1 year) and discontinuation of infliximab. Secondary outcomes included outpatient corticosteroid use, follow-up visits, emergency room visits, hospitalizations, surgeries, and cost outcomes (out-of-pocket costs and annual overall cost of care). RESULTS: There were 27,396 patients with IBD (1,839 pediatric patients). Overall, 5.7% of patients used home infliximab infusions. These patients were more likely to be nonadherent compared with both office-based (22.2% vs 19.8%; P = .044) and hospital-based infusions (22.2% vs 21.2%; P < .001). They were also more likely to discontinue infliximab compared with office-based (44.7% vs 33.7%; P < .001) or hospital-based (44.7% vs 33.4%; P < .001) infusions. On Kaplan-Meier analysis, the probabilities of remaining on infliximab by day 200 of therapy were 64.4%, 74.2%, and 79.3% for home-, hospital-, and office-based infusions, respectively (P < .001). Home infliximab patients had the highest corticosteroid use (cumulative corticosteroid days after IBD diagnosis: home based, 238.2; office based, 189.7; and hospital based, 208.5; P < .001) and the fewest follow-up visits. Home infusions did not decrease overall annual care costs compared with office infusions ($49,149 vs $43,466, P < .001). DISCUSSION: In this analysis, home infliximab infusions for patients with IBD were associated with suboptimal outcomes including higher rates of nonadherence and discontinuation of infliximab. Home infusions did not result in significant cost savings compared with office infusions.

Use of Biological Medications Does Not Increase Postoperative Complications Among Patients With Ulcerative Colitis Undergoing Colectomy: A Retrospective Cohort Analysis of Privately Insured Patients.

BACKGROUND: Existing studies on the effects of biological medications on surgical complications among patients with ulcerative colitis have mixed results. Because biologicals may hinder response to infections and wound healing, preoperative exposure may increase postoperative complications. OBJECTIVE: The purpose of this study was to evaluate associations between biological exposure within 6 months preceding colectomy or proctocolectomy and postoperative complications among patients with ulcerative colitis. DESIGN: This was a retrospective cohort study with multivariate regression analysis after coarsened exact matching. SETTINGS: A large commercial insurance claims database (2003-2016) was used. PATIENTS: A total of 1794 patients with ulcerative colitis underwent total abdominal colectomy with end ileostomy, total proctocolectomy with end ileostomy, or total proctocolectomy with IPAA. Twenty-two percent were exposed to biologicals in the 6 months preceding surgery. MAIN OUTCOMES MEASURES: Healthcare use (length of stay, unplanned reoperation/procedure, emergency department visit, or readmission) and complications (infectious, hernia or wound disruption, thromboembolic, or cardiopulmonary) within 30 postoperative days were measured. RESULTS: Exposure to biological medications was associated with shorter surgical hospitalization (7 vs 8 d; p <0.001) but otherwise was not associated with differences in healthcare use or postoperative complications. PATIENTS: who underwent total proctocolectomy with IPAA had higher odds of infectious complications compared with those who underwent total abdominal colectomy with end ileostomy (adjusted OR = 2.2 (95% CI, 1.5-3.0); p < 0.001) but had lower odds of cardiopulmonary complications (adjusted OR = 0.4 (95% CI, 0.3-0.6); p < 0.001). LIMITATIONS: Analysis of private insurance database claims data may not represent uninsured or government-insured patients and may be limited by coding accuracy. Matched cohorts differed in age and Charlson Comorbidity Index, which could be influential even after multivariate adjustments. CONCLUSIONS: Biological exposure among patients with ulcerative colitis is not associated with higher odds of postoperative complications or healthcare resource use. These data, in combination with clinical judgment and patient preferences, may aid in complex decision-making regarding operative timing, operation type, and perioperative medication management. See Video Abstract at http://links.lww.com/DCR/B370. EL USO DE MEDICAMENTOS BIOLÓGICOS NO AUMENTA LAS COMPLICACIONES POSTOPERATORIAS ENTRE PACIENTES CON COLITIS ULCERATIVA SOMETIDOS A UNA COLECTOMÍA: UN ANÁLISIS DE COHORTE RETROSPECTIVO DE PACIENTES CON SEGURO PRIVADO: Estudios existentes sobre los efectos de medicamentos biológicos, en complicaciones quirúrgicas, en pacientes con colitis ulcerativa, presentan resultados mixtos. Debido a que los productos biológicos pueden retrasar la respuesta a las infecciones y curación de heridas, su exposición preoperatoria pueden aumentar las complicaciones postoperatorias.Evaluar las asociaciones entre la exposición biológica dentro de los seis meses anteriores a la colectomía o proctocolectomía y las complicaciones postoperatorias entre los pacientes con colitis ulcerativa.Estudio de cohorte retrospectivo con análisis de regresión multivariante después de una coincidencia exacta aproximada.Una gran base de datos de reclamaciones de seguros comerciales (2003-2016).Un total de 1.794 pacientes con colitis ulcerativa, se sometieron a colectomía abdominal total con ileostomía terminal, proctocolectomía total con ileostomía terminal o proctocolectomía total con anastomosis anal y bolsa ileal. 22% estuvieron expuestos a productos biológicos, seis meses antes de la cirugía.Utilización de la atención médica (duración de la estadía, reoperación o procedimiento no planificado, visita al servicio de urgencias o reingreso) y complicaciones (infecciosas, hernias o dehiscencias de heridas, tromboembólicas o cardiopulmonares) dentro de los 30 días postoperatorios.La exposición a medicamentos biológicos se asoció con una hospitalización quirúrgica más corta (7 frente a 8 días, p <0,001), pero por lo demás, no se asoció con diferencias en la utilización de la atención médica o complicaciones postoperatorias. Los pacientes que se sometieron a proctocolectomía total con anastomosis anal y bolsa ileal, tuvieron mayores probabilidades de complicaciones infecciosas, en comparación con aquellos que se sometieron a colectomía abdominal total con ileostomía final (aOR 2.2, IC 95% [1.5-3.0], p <0.001) pero tuvieron menores probabilidades de complicaciones cardiopulmonares (aOR 0.4, IC 95% [0.3-0.6], p <0.001).El análisis de los datos de reclamaciones, de la base de datos de los seguros privados, puede no representar a pacientes no asegurados o asegurados por el gobierno, y puede estar limitado por la precisión de la codificación. Las cohortes emparejadas diferían en la edad y el índice de comorbilidad de Charlson, lo que podría influir incluso después de ajustes multivariados.La exposición biológica entre los pacientes con colitis ulcerativa, no se asocia con mayores probabilidades de complicaciones postoperatorias, o a la utilización de recursos sanitarios. Estos datos, en combinación con el juicio clínico y las preferencias del paciente, pueden ayudar en la toma de decisiones complejas con respecto al momento quirúrgico, el tipo de operación y el manejo de la medicación perioperatoria. Consulte Video Resumen en http://links.lww.com/DCR/B370. (Traducción-Dr Fidel Ruiz Healy).

Nationwide Trends in Acute and Chronic Pancreatitis Among Privately Insured Children and Non-Elderly Adults in the United States, 2007-2014.

BACKGROUND & AIMS: Epidemiologic analyses of acute pancreatitis (AP) and chronic pancreatitis (CP) provide insight into causes and strategies for prevention and affect allocation of resources to its study and treatment. We sought to determine current and accurate incidences of AP and CP, along with the prevalence of CP, in children and adults in the United States. METHODS: We collected data from the Truven MarketScan Research Databases of commercial inpatient and outpatient insurance claims in the United States from 2007 through 2014 (patients 0-64 years old). We calculated the incidences of AP and CP and prevalence of CP based on International Classification of Diseases, 9th Revision diagnosis codes. Children were defined as 18 years or younger and adults as 19 to 64 years old. RESULTS: The incidence of pediatric AP was stable from 2007 through 2014, remaining at 12.3/100,000 persons in 2014. Meanwhile, the incidence for adult AP decreased from 123.7/100,000 persons in 2007 to 111.2/100,000 persons in 2014. The incidence of CP decreased over time in children (2.2/100,000 persons in 2007 to 1.9/100,000 persons in 2014) and adults (31.7/100,000 persons in 2007 to 24.7/100,000 persons in 2014). The prevalences of pediatric and adult CP were 5.8/100,000 persons and 91.9/100,000 persons, respectively, in 2014. Incidences of AP and CP increased with age. We found little change in incidence during the first decade of life but linear increases starting in the second decade. CONCLUSIONS: We performed a comprehensive epidemiologic analysis of privately insured, non-elderly adults and children with AP and CP in the United States. Changes in gallstone formation, smoking, and alcohol consumption, along with advances in pancreatitis management, may be responsible for the stabilization and even decrease in the incidences of AP and CP.

Temporal Analysis of Inflammatory Bowel Disease and Pancreatitis Co-Occurrence in Children and Adults in the United States.

INTRODUCTION: Pancreatitis in inflammatory bowel disease has been attributed to peripancreatic intestinal disease and/or drug-induced pancreatic toxicity. We used large cohort analyses to define inflammatory bowel disease and pancreatitis temporal co-occurrence with a detailed descriptive analysis to gain greater insight into the pathophysiological relationship between these 2 diseases. METHODS: Truven Health MarketScan private insurance claims from 141,017,841 patients (younger than 65 years) and 7,457,709 patients from 4 academic hospitals were analyzed. We calculated the prevalence of Crohn's disease or ulcerative colitis (UC) with acute pancreatitis or chronic pancreatitis (CP) and performed temporal and descriptive analyses. RESULTS: Of 516,724 patients with inflammatory bowel disease, 12,109 individuals (2.3%) had pancreatitis. Acute pancreatitis (AP) was 2-6x more prevalent than CP. In adults, AP occurred equally among Crohn's disease and UC (1.8%-2.2% vs 1.6%-2.1%, respectively), whereas in children, AP was more frequent in UC (2.3%-3.4% vs 1.5%-1.8%, respectively). The highest proportion of pancreatitis (21.7%-44.7%) was at/near the time of inflammatory bowel disease diagnosis. Of them, 22.1%-39.3% were on steroids during pancreatitis. Individuals with CP or recurrent pancreatitis hospitalizations had increased risk of a future inflammatory bowel disease diagnosis (odds ratio = 1.52 or 1.72, respectively). DISCUSSION: Pancreatitis in inflammatory bowel disease may not simply be a drug adverse event but may also involve local and/or systemic processes that negatively affect the pancreas. Our analysis of pancreatitis before, during, and after inflammatory bowel disease diagnosis suggests a bidirectional pathophysiologic relationship between inflammatory bowel disease and pancreatitis, with potentially more complexity than previously appreciated.

Worse outcomes and higher costs of care in fibrostenotic Crohn's disease: a real-world propensity-matched analysis in the USA.

BACKGROUND: Patients with Crohn's disease (CD) may develop fibrostenotic strictures. No currently available therapies prevent or treat fibrostenotic CD (FCD), making this a critical unmet need. AIM: To compare health outcomes and resource utilisation between CD patients with and without fibrostenotic disease. METHODS: Patients aged ≥18 years with FCD and non-FCD between 30 October 2015 and 30 September 2018 were identified in the Truven MarketScan Commercial Claims and Encounters Database. We conducted 1:3 nearest neighbour propensity score matching on age, sex, malnutrition, payer type, anti-tumour necrosis factor use, and Charlson Comorbidity Index score. Primary outcomes up to 1 year from the index claim were ≥1 hospitalisation, ≥1 procedure, ≥1 surgery, and steroid dependency (>100 day supply). Associations between FCD diagnosis and outcomes were estimated with a multivariable logistic regression model. This study was exempt from institutional review board approval. RESULTS: Propensity score matching yielded 11 022 patients. Compared with non-FCD, patients with FCD had increased likelihood of hospitalisations (17.1% vs 52.4%; p<0.001), endoscopic procedures (4.4% vs 8.6%; p<0.001), IBD-related surgeries (4.7% vs 9.1%; p<0.001), steroid dependency (10.0% vs 15.7%; p<0.001), and greater mean annual costs per patient ($47 575 vs $77 609; p<0.001). FCD was a significant risk factor for ≥1 hospitalisation (adjusted OR (aOR), 6.1), ≥1 procedure (aOR, 2.1), ≥1 surgery (aOR, 2.0), and steroid dependency (aOR, 1.7). CONCLUSIONS: FCD was associated with higher risk for hospitalisation, procedures, abdominal surgery, and steroid dependency. Patients with FCD had a greater mean annual cost per patient. FCD represents an ongoing unmet medical need.

The impact of Medicaid expansion on trauma-related emergency department utilization: A national evaluation of policy implications.

BACKGROUND: The impact of the 2014 Affordable Care Act (ACA) upon national trauma-related emergency department (ED) utilization is unknown. We assessed ACA-related changes in ED use and payer mix, hypothesizing that post-ACA ED visits would decline and Medicaid coverage would increase disproportionately in regions of widespread policy adoption. METHODS: We queried the National Emergency Department Sample (NEDS) for those with a primary trauma diagnosis, aged 18 to 64. Comparing pre-ACA (2012) to post-ACA (10/2014 to 09/2015), primary outcomes were change in ED visits and payer status; secondary outcomes were change in costs, discharge disposition and inpatient length of stay. Univariate and multivariate analyses were performed, including difference-in-differences analyses. We compared changes in ED trauma visits by payer in the West (91% in a Medicaid expansion state) versus the South (12%). RESULTS: Among 21.2 million trauma-related ED visits, there was a 13.3% decrease post-ACA. Overall, there was a 7.2% decrease in uninsured ED visits (25.5% vs. 18.3%, p < 0.001) and a 6.6% increase in Medicaid coverage (17.6% vs. 24.2%, p < 0.001). Trauma patients had 40% increased odds of having Medicaid post-ACA (vs. pre-ACA: aOR 1.40, p < 0.001). Patients in the West had 31% greater odds of having Medicaid (vs. South: aOR 1.31, p < 0.001). The post-ACA increase in Medicaid was greater in the West (vs. South: aOR 1.60, p < 0.001). Post-ACA, inpatients were more likely to have Medicaid (vs. ED discharge: aOR 1.20, p < 0.001) and there was a 25% increase in inpatient discharge to rehabilitation (aOR 1.24, p < 0.001). CONCLUSION: Post-ACA, there was a significant increase in insured trauma patients and a decrease in injury-related ED visits, possibly resulting from access to other outpatient services. Ensuring sustainability of expanded coverage will benefit injured patients and trauma systems. LEVEL OF EVIDENCE: Economic, level III.

Comparative Incidence of Inflammatory Bowel Disease in Different Age Groups in the United States.

BACKGROUND: Data on the incidence of inflammatory bowel disease (IBD) by age group are available in countries outside of the United States or localized populations within the United States. We aimed to estimate the incidence rates (IRs) of IBD by age group using a US multiregional data set. METHODS: We used the Optum Research Database to identify incident IBD patients with a disease-free interval of 1.5 years between 2005 and 2015. Overall and age-specific IRs were calculated for 4 different age groups: pediatric (0-17 years), young adult (18-25 years), adult (26-59 years), elderly (>60 years). Time trends of incidence were evaluated in each age group. Perianal phenotype (in Crohn's disease [CD]) was also compared. RESULTS: The mean IR for the cohort (n = 60,247) from 2005 to 2015 was 37.5/100,000. The IR was highest in adult and elderly cohorts (36.4 and 36.7/100,000 respectively). In the adult and elderly groups, the IR for UC was higher than that for CD, whereas the opposite was true in the pediatric and young adult groups. The IR increased over the 10-year study period for all age groups (time trends P < 0.001). The elderly group had less perianal disease than the adult group (20.8 vs 22.3%, respectively; P < 0.05). CONCLUSIONS: In one of the most comprehensive evaluations of the incidence of IBD in the United States, we found an incidence rate similar to those of other national populations. We also confirmed differences of specific IBD phenotypes based on age groups, with lower rates of perianal disease in the elderly.

Association of Opioid Prescriptions From Dental Clinicians for US Adolescents and Young Adults With Subsequent Opioid Use and Abuse.

Importance: Through prescription writing, dental clinicians are a potential source of initial opioid exposure and subsequent abuse for adolescents and young adults. Objective: To examine the association between index dental opioid prescriptions from dental clinicians for opioid-naive adolescents and young adults in 2015 and new persistent use and subsequent diagnoses of abuse in this population. Design, Setting, and Participants: This retrospective cohort study examined outpatient opioid prescriptions for patients aged 16 to 25 years in the Optum Research Database in 2015. Prescriptions were linked by National Provider Identifier number to a clinician category. Exposures: Individuals were included in the index dental opioid (opioid-exposed) cohort if they filled an opioid prescription from a dental clinician in 2015, had continuous health plan coverage and no record of opioid prescriptions for 12 months before receiving the prescription, and had 12 months of health plan coverage after receiving the prescription. Two age- and sex-matched opioid-nonexposed control individuals were selected for each opioid-exposed individual and were assigned a corresponding phantom prescription date. Main Outcomes and Measures: Receipt of an opioid prescription within 90 to 365 days, a health care encounter diagnosis associated with opioid abuse within 365 days, and all-cause mortality within 365 days of the index opioid or phantom prescription date. Results: Among 754 002 individuals with continuous enrollment in 2015, 97 462 patients (12.9%) received 1 or more opioid prescriptions, of whom 29 791 (30.6%) received prescriptions supplied by a dental clinician. The opioid-exposed cohort included 14 888 participants (7882 women [52.9%], 11 273 white [75.7%], with mean [SD] age, 21.8 [2.4] years), and the randomly selected opioid-nonexposed cohort included 29 776 participants (15 764 women [52.9%], 20 078 [67.4%] white, with mean [SD] age, 21.8 [2.4] years). Among the 14 888 individuals in the index dental opioid cohort, 1021 (6.9%) received another opioid prescription 90 to 365 days later compared with 30 of 29 776 (0.1%) opioid-nonexposed controls (adjusted absolute risk difference, 6.8%; 95% CI, 6.3%-7.2%), and 866 opioid-exposed individuals (5.8%) experienced 1 or more subsequent health care encounters with an opioid abuse-related diagnosis compared with 115 opioid-nonexposed controls (0.4%) (adjusted absolute risk difference, 5.3%; 95% CI, 5.0%-5.7%). There was only 1 death in each cohort. Conclusions and Relevance: The findings suggest that a substantial proportion of adolescents and young adults are exposed to opioids through dental clinicians. Use of these prescriptions may be associated with an increased risk of subsequent opioid use and abuse.

Procalcitonin as a Predictive Marker for Bacteremia in Children With a Central Line and Fever.

OBJECTIVES: Unnecessary use of antibiotics is an increasing problem. In this study, we sought to determine the diagnostic accuracy of procalcitonin in predicting bacteremia in children with a central line and fever, and we sought to determine optimal cutoff values to maximize sensitivity and specificity. This is the largest study to date in which procalcitonin is examined as a predictive marker of bacteremia in pediatric patients with a central line and fever. METHODS: We conducted a retrospective cohort study of children aged 0 to 23 years with a central line and fever of 38°C who had procalcitonin and blood cultures drawn before initiation of antibiotics and had no other identified bacterial infection. Patients were also prospectively monitored via a custom-built electronic medical record dashboard for eligibility. RESULTS: There were 523 patients and >2500 procalcitonin values reviewed for eligibility. Of these, 169 (47%) patients and 335 blood cultures with procalcitonin were included. There were 94 (28%) positive bacterial blood cultures and 241 (72%) negative bacterial blood cultures. In bacteremic cultures, the mean procalcitonin level was 9.96 ± 15.96 ng/mL, and the median procalcitonin level was 4.85 ng/mL (interquartile range 18.5). In nonbacteremic cultures, the mean procalcitonin level was 1.23 ± 10.37 ng/mL, and the median procalcitonin level was 0.3 ng/mL (interquartile range 0.7). A receiver operating characteristic analysis indicated a procalcitonin level of ≥0.6 ng/mL as the best cutoff point that produced a sensitivity of 85.6% and a specificity of 65.7% (area under the curve 0.85). CONCLUSIONS: Procalcitonin is a sensitive biomarker in predicting bacteremia in children with a central line and fever.

Depression and Health Care Use in Patients With Inflammatory Bowel Disease.

BACKGROUND: Depression frequently co-occurs in patients with inflammatory bowel disease [IBD] and is a driver in health care costs and use. AIM: This study examined the associations between depression and total health care costs, emergency department [ED] visits, computed tomography [CT] during ED/inpatient visits, and IBD-related surgery among IBD patients. METHODS: Our sample included 331772 IBD patients from a national administrative claims database [Truven Health MarketScan® Database]. Gamma and Poisson regression analyses assessed differences related to depression, controlling for key variables. RESULTS: Approximately 16% of the IBD cohort was classified as having depression. Depression was associated with a $17,706 (95% confidence interval [CI] [$16,892, 18,521]) increase in mean annual IBD-related health care costs and an increased incidence of ED visits (adjusted incidence rate ratio [aIRR] of 1.5; 95% CI [1.5, 1.6]). Among patients who had one or more ED/inpatient visits, depression was associated with an increased probability of receiving repeated CT [one to four scans, adjusted odds ratio [aOR] of 1.6; 95% CI [1.5, 1.7]; five or more scans, aOR of 4.6; 95% CI [2.9, 7.3]) and increased odds of undergoing an IBD-related surgery (aOR of 1.2; 95% CI [1.1, 1.2]). Secondary analysis with a paediatric subsample revealed that approximately 12% of this cohort was classified as having depression, and depression was associated with increased costs and incidence rates of ED visits and CT, but not of IBD-related surgery. CONCLUSIONS: Quantifiable differences in health care costs and patterns of use exist among patients with IBD and depression. Integration of mental health services within IBD care may improve overall health outcomes and costs of care.

Starting Young: Trends in Opioid Therapy Among US Adolescents and Young Adults With Inflammatory Bowel Disease in the Truven MarketScan Database Between 2007 and 2015.

Background: Opioids are commonly prescribed for relief in inflammatory bowel disease (IBD). Emerging evidence suggests that adolescents and young adults are a vulnerable population at particular risk of becoming chronic opioid users and experiencing adverse effects. Objectives: This study evaluates trends in the prevalence and persistence of chronic opioid therapy in adolescents and young adults with IBD in the United States. Method: A longitudinal retrospective cohort analysis was conducted with the Truven MarketScan Database from 2007 to 2015. Study subjects were 15-29 years old with ≥2 IBD diagnoses (Crohn's: 555/K50; ulcerative colitis: 556/K51). Opioid therapy was identified with prescription claims within the Truven therapeutic class 60: opioid agonists. Persistence of opioid use was evaluated by survival analysis for patients who remained in the database for at least 3 years following index chronic opioid therapy use. Results: In a cohort containing 93,668 patients, 18.2% received chronic opioid therapy. The annual prevalence of chronic opioid therapy increased from 9.3% in 2007 to 10.8% in 2015 (P < 0.01), peaking at 12.2% in 2011. Opioid prescriptions per patient per year were stable (approximately 5). Post hoc Poisson regression analyses demonstrated that the number of opioid pills dispensed per year increased with age and was higher among males. Among the 2503 patients receiving chronic opioid therapy and followed longitudinally, 30.5% were maintained on chronic opioid therapy for 2 years, and 5.3% for all 4 years. Conclusion: Sustained chronic opioid use in adolescents and young adults with IBD is increasingly common, underscoring the need for screening and intervention for this vulnerable population.