Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy.

Background: Peanut allergy is a common, life-threatening food allergy in children. We evaluated whether dupilumab, which blocks the activity of interleukin (IL)-4/IL-13, enhances the efficacy of oral immunotherapy (OIT) AR101 in pediatric patients with peanut allergy.

Methods: A Phase II, multicenter, randomized, double-blind study was conducted in the USA (NCT03682770) in pediatric patients (6-≤ 17 years old) with confirmed peanut allergy.

Development of the celiac disease symptom diary version 2.1 (CDSD 2.1) patient-reported outcome measure.

Purpose: For patients with celiac disease (CeD), the only current management option is adherence to a strict gluten-free diet (GFD); however, many patients on a GFD continue to experience symptoms with a significant impact on quality of life. Potential new treatments for CeD are under development and a validated patient-reported outcome measure is required to evaluate their utility in clinical trials. The purpose of this article is to provide a history of the development of the Celiac Disease Symptom Diary (CDSD) 2.

Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial.

Background: Immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen-specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.

Primary Care Continuity, Frequency, and Regularity Associated With Medicare Savings.

Importance: Reducing Medicare expenditures is a key objective of Medicare's transition to value-based reimbursement models. Improving access to primary care is an important way to reduce expenditures, yet less is known about how visits should be organized to maximize savings.

Objective: To examine the association between Medicare savings and primary care visit patterns.

Novel Application of a Dynamic, In-room Survey Platform to Measure Surgical Team Satisfaction.

Objective: To elucidate the potential usage of continuous feedback regarding team satisfaction and correlations with operative performance and patient outcomes.

Background: Continuous, actionable assessment of teamwork quality in the operating room (OR) is challenging. This work introduces a novel, data-driven approach to prospectively and dynamically assess health care provider satisfaction with teamwork in the OR.

Distinct trajectories distinguish antigen-specific T cells in peanut-allergic individuals undergoing oral immunotherapy.

Background: Despite similar clinical symptoms, peanut-allergic (PA) individuals may respond quite differently to the same therapeutic interventions.

Objective: This study aimed to determine whether inherent qualities of cell response at baseline could influence response to peanut oral immunotherapy (PnOIT).

Methods: We first performed ex vivo T-cell profiling on peanut-reactive CD154CD137 T (pTeff) cells from 90 challenge-confirmed PA individuals.

Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials.

Background: Clinical trials (PALISADE [ARC003], ARTEMIS [ARC010]) proving efficacy and safety of peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) have used double-blind, placebo-controlled food challenges (DBPCFCs) to screen for eligibility and to evaluate efficacy. In routine clinical practice, individuals with peanut allergy do not always undergo food challenges to confirm diagnosis or determine candidacy for treatment.

Objective: To describe PTAH safety and tolerability in participants selected by clinical history and peanut sensitization parameters not undergoing DBPCFCs during trials and to compare findings with previously published data.

A High-Fidelity Model to Predict Length-of-Stay in the Neonatal Intensive Care Unit (NICU).

Having an interpretable dynamic length-of-stay (LOS) model can help hospital administrators and clinicians make better decisions and improve the quality of care. The widespread implementation of electronic medical record (EMR) systems has enabled hospitals to collect massive amounts of health data. However, how to integrate this deluge of data into healthcare operations remains unclear.

Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy.

Background: Immunotherapy is promising as an efficacious treatment for food allergy. Other food allergy treatments are also under development. However, adverse allergic events during treatment, as well as during oral food challenges, are common and reporting is not standardized.

Safety of peanut (Arachis hypogaea) allergen powder-dnfp in children and teenagers with peanut allergy: Pooled summary of phase 3 and extension trials.

Background: Peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; previously known as AR101) is a daily oral immunotherapy approved to mitigate allergic reactions after accidental peanut exposure in peanut-allergic individuals aged 4-17 years.

Objective: We sought to comprehensively summarize the PTAH safety profile for up to ∼2 years of treatment.

Methods: Safety and adverse event (AE) data from participants aged 4-17 years from 3 controlled, phase 3 and 2 open-label extension trials were pooled and assessed.

Using data from food challenges to inform management of consumers with food allergy: A systematic review with individual participant data meta-analysis.

Background: Eliciting doses (EDs) (eg, ED or ED values, which are the amounts of allergen expected to cause objective symptoms in 1% and 5% of the population with an allergy, respectively) are increasingly being used to inform allergen labeling and clinical management. These values are generated from food challenge, but the frequency of anaphylaxis in response to these low levels of allergen exposure and their reproducibility are unknown.

Objective: Our aim was to determine (1) the rate of anaphylaxis in response to low-level peanut exposure and (2) the reproducibility of reaction thresholds (and anaphylaxis) at food challenge.

Thousands Of Lives Could Be Saved In The US During The COVID-19 Pandemic If States Exchanged Ventilators.

It is thought that there are not enough mechanical ventilators in the United States for every patient who may need one during the novel coronavirus disease (COVID-19) pandemic. However, there has been no analysis that measures the potential magnitude of the problem or proposes a solution. In this article I combine the pandemic forecasting model used by the federal government with estimates of ventilator availability from the literature to assess the expected shortage under various scenarios.

Latiglutenase Treatment for Celiac Disease: Symptom and Quality of Life Improvement for Seropositive Patients on a Gluten-Free Diet.

Background: Celiac disease (CD) is a widespread autoimmune disease triggered by dietary gluten that can lead to severe gastrointestinal symptoms. Because there is no available treatment other than a lifelong gluten-free diet, many patients continue to experience chronic symptoms.

Aim: In this analysis we report on the efficacy of latiglutenase, an orally administered enzyme treatment, for improving multiple gluten-induced symptoms and consequent quality of life (QOL) due to inadvertent gluten consumption.

AR101 Oral Immunotherapy for Peanut Allergy.

Background: Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions.

Methods: In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program.

Measuring Change In Small Intestinal Histology In Patients With Celiac Disease.

Small intestinal histologic abnormalities in celiac disease include atrophy of the intestinal villi, hypertrophy of the crypts and lymphocytic infiltration of intraepithelial spaces and lamina propria. These findings are central to diagnosis and their severity and change over time are valuable to monitor disease course and response to therapy. Subjective methods to grade celiac disease histological severity include the Marsh-Oberhuber and Corazza-Villanacci systems.

A clinical pathway for heart failure reduces admissions from the ED without increasing congestion in the ED.

Background: A multidisciplinary team at a major academic medical center established an Acutely Decompensated Heart Failure Clinical Pathway (ADHFCP) program to reduce inpatient readmission rates among patients with heart failure which, among several interventions, included an immediate consultation from a cardiologist familiar with an ADHFCP patient when the patient presented at the Emergency Department (ED). This study analyzed how that program impacted utilization of services in the ED and its subsequent effect on rates of admission from the ED and on disposition times.

Methods: ADHFCP inpatient visits were retrospectively risk stratified and matched with non-program inpatient visits to create a control group.

A B-Cell Gene Signature Correlates With the Extent of Gluten-Induced Intestinal Injury in Celiac Disease.

Background & Aims: Celiac disease (CeD) provides an opportunity to study autoimmunity and the transition in immune cells as dietary gluten induces small intestinal lesions.

Methods: Seventy-three celiac disease patients on a long-term, gluten-free diet ingested a known amount of gluten daily for 6 weeks. A peripheral blood sample and intestinal biopsy specimens were taken before and 6 weeks after initiating the gluten challenge.

Cardiology Consultation in the Emergency Department Reduces Re-hospitalizations for Low-Socioeconomic Patients with Acute Decompensated Heart Failure.

Background: Re-hospitalization after discharge for acute decompensated heart failure is a common problem. Low-socioeconomic urban patients suffer high rates of re-hospitalization and often over-utilize the emergency department (ED) for their care. We hypothesized that early consultation with a cardiologist in the ED can reduce re-hospitalization and health care costs for low-socioeconomic urban patients with acute decompensated heart failure.