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Lay Summary Despite a high approval rate, there were unnecessary delays in therapy due to prior authorizations. This study identified the impact of type of IBD, FDA-labeled indication, and dose escalations on approvals.

Abstract Background The purpose of this study was to compare the long-term safety of infliximab and nonbiologic agents as Crohn's disease (CD) therapy. Methods Patients with CD were prospectively evaluated in this large, observational registry. Results Patients (n = 6273) participated in this observational registry from July 1999 through March 2012; 3440 (54.8%) received infliximab (20,971 patient-years), and 2833 (45.2%) received other treatments only (14,806 patient-years). Overall, 59,875 infliximab infusions were administered (80%, 5 mg/kg); 3006 (89.9%) patients received ≥2 infusions. Adverse events (AEs), most commonly those related to CD (eg, abdominal pain, diarrhea), and serious AEs occurred at a higher rate among infliximab-treated patients. Mortality (0.57/100 patient-years, 0.67/100 patient-years) and malignancy rates (0.69/100 patient-years, 0.71/100 patient-years) for infliximab-treated and other-treatments-only patients, respectively, were generally similar. Serious infection rates were higher for infliximab-treated (2.15/100 patient-years) than other-treatments-only patients (0.86/100 patient-years). Infliximab dose was not associated with mortality or serious infection. An increased risk of serious infection was observed with age (>52 years vs ≤30 years) when examined in infliximab-treated patients. Nonserious cerebrovascular accidents (13 events, 0.06/100 patient-years; 5 events, 0.03/100 patient-years) and pulmonary embolisms (11 events, 0.05/100 patient-years; 4 events 0.03/100 patient-years) also occurred at higher rates among infliximab-treated patients than other-treatments-only patients. Conclusions Through more than 13 years of registry experience and an overall median duration of patient follow-up >6 years, mortality was similar between the infliximab-treated and other-treatments-only groups. These final cumulative results are representative of real-world experience among infliximab-treated patients with CD and are consistent with the known risks of disease activity and tumor necrosis factor antagonist therapy.

Management of inpatients with inflammatory bowel disease (IBD) requires increasing resources. We aimed to identify factors associated with hospital readmissions among individuals with IBD. We collected data from the Healthcare Cost and Utilization Project Nationwide Readmissions Database 2013. We identified individuals with index hospitalizations for IBD. Patient-specific factors, comorbidities and hospitalization characteristics were extracted for the index hospitalization. We performed logistic regression modeling to create adjusted odds ratios (ORs) for 30-day hospital readmission. Subgroup analysis was performed based on disease type and performance of surgery. We analyzed a total of 55,942 index hospital discharges; 3037 patients (7.0%) were readmitted to the hospital within 30 days. Increasing patient age (> 65: OR: 0.45; 95% CI 0.39-0.53) was associated with a decreased risk of readmission, while a diagnosis of Crohn's disease (OR: 1.09; 95% CI 1.00-1.18) and male sex (OR: 1.16; 95% CI 1.07-1.25) were associated with an increased risk of readmission. The comorbidities of smoking (OR: 1.09; 95% CI 1.00-1.19), anxiety (OR: 1.17; 95% CI 1.01-1.36) and opioid dependence (OR: 1.40; 95% CI 1.06-1.86) were associated with an increased risk of 30-day readmission. Individual hospitalization characteristics and disease complications were significantly associated with readmission. Performance of a surgery during the index admission was associated with a decreased risk of readmission (OR: 0.57; 95% CI 0.33-0.96). Analyzing data from a US publicly available all-payer inpatient healthcare database, we identified patient and hospitalization risk factors associated with 30-day readmission. Identifying patients at high risk for readmission may allow for interventions during or after the index hospitalization to decrease this risk.

Recently, extended reality (XR) displays, including augmented reality (AR) and virtual reality (VR), have integrated eye tracking capabilities, which could enable novel ways of interacting with XR content. In natural settings, eye vergence angle (EVA) changes constantly, based on the distance of fixated objects. Here, we measured EVA for eye fixations on real and virtual target objects in three different environments: real objects in the real world (real), virtual objects in the real world (AR), and virtual objects in a virtual world (VR). In a repeated measures design with 13 participants, EVA was measured while participants fixated on targets at varying distances. As expected, the results showed a significant main effect of target depth such that increasing EVA was associated with closer targets. However, there were consistent individual differences in baseline EVA. There was also a smaller but statistically significant main effect of environment (real, AR, VR) on EVA. Importantly, EVA was stable with respect to the starting depth of previously fixated targets and invariant to the direction (convergence vs. divergence) of vergence changes. In addition, EVA proved to be a more veridical depth estimate than verbal subjective depth judgments.

Pupil size modulations have been used for decades as a window into the mind, and several pupillary features have been implicated in a variety of cognitive processes. Thus, a general challenge facing the field of pupillometry has been understanding which pupil features should be most relevant for explaining behavior in a given task domain. In the present study, a longitudinal design was employed where participants completed 8 biweekly sessions of a classic mental arithmetic task for the purposes of teasing apart the relationships between tonic/phasic pupil features (baseline, peak amplitude, peak latency) and two task-related cognitive processes including mental processing load (indexed by math question difficulty) and decision making (indexed by response times). We used multi-level modeling to account for individual variation while identifying pupil-to-behavior relationships at the single-trial and between-session levels. We show a dissociation between phasic and tonic features with peak amplitude and latency (but not baseline) driven by ongoing task-related processing, whereas baseline was driven by state-level effects that changed over a longer time period (i.e. weeks). Finally, we report a dissociation between peak amplitude and latency whereby amplitude reflected surprise and processing load, and latency reflected decision making times.

A 33-year-old man with ulcerative colitis presented with bloody diarrhea, an 8-month history of worsening fatigue and diarrhea, and a 4-month history of fevers, drenching night sweats, and unintentional weight loss.

The objective of this study was to contribute long-term safety data for infliximab and other therapies in Crohn's disease (CD). We prospectively evaluated CD patients enrolled in the large, observational Crohn's Therapy, Resource, Evaluation, and Assessment Tool registry, established to compare infliximab safety with conventional nonbiological medications in CD. A total of 6,273 patients were enrolled and evaluated on or before 23 February 2010; 3,420 received infliximab (17,712 patient-years; 89.9% received ≥ 2 infusions) and 2,853 received other-treatments-only (13,251 patient-years). Mean length of patient follow-up was 5.2 years. More infliximab- than other-treatments-only-treated patients had moderate-to-severe (30.6% vs. 10.7%) or severe-to-fulminant (2.5% vs. 0.6%) disease severity (P < 0.001). In the year before enrollment, more infliximab- than other-treatments-only-treated patients required surgical intervention (17.4% vs. 13.6%), medical hospitalization (14.2% vs. 8.8%), prednisone (47.8% vs. 31.4%), immunomodulators (52.0% vs. 32.1%), and narcotic analgesics (17.3% vs. 9.1%). Patient mortality was similar for infliximab- and other-treatments-only-treated patients (0.58 vs. 0.59/100 patient-years). In multivariate logistic regression analyses, treatment with prednisone (hazard ratio (HR) = 2.14, 95% confidence interval (CI) = 1.55, 2.95; P < 0.001) or narcotic analgesics (HR = 1.79, 95% CI = 1.29, 2.48; P < 0.001) and age (HR = 1.08, 95% CI = 1.07, 1.09; P < 0.001) were associated with increased mortality risk. Neither infliximab nor immunomodulator treatment was associated with increased mortality risk. Factors independently associated with serious infections included moderate-to-severe disease activity (HR = 2.24, 95% CI = 1.57, 3.19; P < 0.001), narcotic analgesic treatment (HR = 1.98, 95% CI = 1.44, 2.73; P < 0.001), prednisone therapy (HR = 1.57, 95% CI = 1.17, 2.10; P = 0.002), and infliximab treatment (HR = 1.43, 95% CI = 1.11, 1.84; P = 0.006). Mortality was similar between infliximab- and other-treatments-only-treated CD patients. An increased risk of serious infection with infliximab was observed, although CD severity and use of prednisone or narcotic analgesics carried higher risks.

We assessed potential associations between malignancy and antitumor necrosis factor therapy in patients with Crohn's disease (CD), as this relationship is currently poorly defined. Utilizing data from the Crohn's Therapy, Resource, Evaluation, and Assessment Tool (TREAT™) Registry, a prospective cohort study examining long-term outcomes of CD treatments in community and academic settings, influences of baseline patient/disease characteristics and medications were assessed by survival analysis and multivariate models. Standardized incidence ratios and exact 95 % confidence intervals were determined as the ratio of events observed (TREAT) vs. expected (general population of USA). As of 23 February 2010, 6,273 CD patients (infliximab during registry=3,420 (during or within 1 year before registry=3,764); other-treatments-only: 2,509), were enrolled and, on average, had been followed for 5.2/7.6 years, respectively, for all/currently active patients. Crude cancer incidences were similar between infliximab- and other-treatments-only-exposed patients. Multivariate Cox regression analysis demonstrated that baseline age (hazard ratio (HR)=1.59/10 years; P<0.001), disease duration (HR=1.64/10 years; P=0.012), and smoking (HR=1.38; P=0.045) but neither immunosuppressive therapy alone (HR=1.43; P=0.11), infliximab therapy alone (HR=0.59; P=0.16), nor their combination (HR=1.22, P=0.34) were independently associated with the risk of malignancy. When compared with the general population, no significant increase in incidence was observed in any malignancy category. In an exposure-based analysis, use of immunosuppressants alone (odds ratio=4.19) or in combination with infliximab (3.33) seemed to be associated with a numerically, but not significantly, greater risk of malignancy than did treatment with infliximab alone (1.96) relative to treatment with neither. In the TREAT Registry, age, disease duration, and smoking were independently associated with increased risk of malignancy. Although results for immunosuppressant use were equivocal, no significant association between malignancy and infliximab was observed.