Association between allergic conditions and COVID-19 susceptibility and outcomes.

Background: The relationship between underlying type 2 inflammation and immune response to COVID-19 is unclear.

Objective: To assess the relationships between allergic conditions and COVID-19 susceptibility and outcomes.

Methods: In the Optum database, adult patients with and without major allergic conditions (asthma, atopic dermatitis [AD], allergic rhinitis, food allergy, anaphylaxis, or eosinophilic esophagitis) and patients with and without severe asthma/AD were identified.

Patterns of major cutaneous surgeries and reconstructions in patients with cutaneous squamous cell carcinoma in the USA.

Since use of major cutaneous surgeries/reconstructions among patients with cutaneous squamous cell carcinoma (CSCC) is not well described, we sought to quantify major cutaneous surgeries/reconstructions among patients with CSCC who were newly diagnosed and for those treated with systemic therapy, stratified by immune status. We used the Optum Clinformatics Data Mart database (2013-2020) and Kaplan-Meier estimators to assess risk of surgeries/reconstructions. 450,803 patients were identified with an incident CSCC diagnosis, including 4111 patients with CSCC who initiated systemic therapy.

Predicting Time to and Average Quality of Future Offers for Kidney Transplant Candidates Declining a Current Deceased Donor Kidney Offer: A Retrospective Cohort Study.

Background: At the time a kidney offer is made by an organ donation organization (ODO), transplant physicians must inform candidates on the and of accepting or declining the offer. Although physicians have a general idea of expected wait time to kidney transplantation by blood group in their ODO, there are no tools that provide quantitative estimates based on the allocation score used and donor/candidate characteristics. This limits the shared decision-making process at the time of kidney offer as (1) the consequences of declining an offer in terms of wait-time prolongation cannot be provided and (2) the quality of the current offer cannot be compared with that of offers that could be made to the specific candidate in the future.

Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls.

Regulators and Health Technology Assessment (HTA) bodies are increasingly familiar with, and publishing guidance on, external controls derived from real-world data (RWD) to generate real-world evidence (RWE). We recently conducted a systematic literature review (SLR) evaluating publicly available information on the use of RWD-derived external controls to contextualize outcomes from uncontrolled trials submitted to the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and/or select HTA bodies. The review identified several key operational and methodological aspects for which more detailed guidance and alignment within and between regulatory agencies and HTA bodies is necessary.

Real-world effectiveness of casirivimab and imdevimab among patients diagnosed with COVID-19 in the ambulatory setting: a retrospective cohort study using a large claims database.

Objective: To assess the real-world effectiveness of casirivimab and imdevimab (CAS+IMD) versus no COVID-19 antibody treatment among patients diagnosed with COVID-19 in the ambulatory setting, including patients diagnosed during the Delta-dominant period prior to Omicron emergence.

Design: Retrospective cohort study.

Setting: Komodo Health closed claims database.

Effectiveness of Subcutaneous Casirivimab and Imdevimab in Ambulatory Patients with COVID-19.

Introduction: Data on real-world effectiveness of subcutaneous (SC) casirivimab and imdevimab (CAS+IMD) for the treatment of coronavirus disease 2019 (COVID-19) are limited. The objective of this study was to assess the effectiveness of SC CAS+IMD versus no antibody treatment among patients with COVID-19.

Methods: This retrospective cohort study linked Komodo Health and CDR Maguire Health and Medical data.

Utility of automated data-adaptive propensity score method for confounding by indication in comparative effectiveness study in real world Medicare and registry data.

Background: Confounding by indication is a serious threat to comparative studies using real world data. We assessed the utility of automated data-adaptive analytic approach for confounding adjustment when both claims and clinical registry data are available.

Methods: We used a comparative study example of carotid artery stenting (CAS) vs.

Characterizing the Shifting Real-World Treatment Landscape by PD-L1 Testing Status and Expression Level in Advanced Non-Small Cell Lung Cancer.

Introduction: Contemporary real-world data on advanced non-small cell lung cancer (aNSCLC) treatment patterns across programmed cell death-ligand 1 (PD-L1) expression levels and testing status are limited.

Methods: A retrospective cohort was selected of adults newly diagnosed with aNSCLC between January 1, 2018, and July 31, 2021, who initiated first-line treatments, which were described by PD-L1 status and expression levels (≥ 50%, 1-49%, < 1%). Treatment received before and after PD-L1 test results were described for patients initiating first-line treatment before PD-L1 results.

REGN1908/1909 prevented cat allergen-induced early asthmatic responses in an environmental exposure unit.

Background: The dominant allergen in cat dander, Felis domesticus allergen 1 (Fel d 1), is a persistent trigger for allergic rhinitis and asthma symptoms.

Objective: We evaluated the efficacy of Fel d 1 monoclonal antibodies (REGN1908/1909) in preventing cat allergen-induced early asthmatic responses (EARs) in cat-allergic patients with mild asthma.

Methods: Patients were randomized to single-dose REGN1908/1909 600 mg (n = 29) or placebo (n = 27).

Hedgehog pathway inhibitor real-world treatment patterns in patients with basal cell carcinoma: a claims-based analysis.

To examine real-world treatment patterns for Hedgehog pathway inhibitors (HHIs) for the treatment of advanced basal cell carcinoma. HHI initiators between January 2013 and June 2019 were identified from IBM MarketScan claims data. Time to treatment discontinuation and reinitiation were estimated using Kaplan-Meier methods using a 60-day grace period.

Real-World Treatment Patterns and Outcomes Among Patients with Basal Cell Carcinoma Following First-Line Hedgehog Inhibitor Discontinuation.

Introduction: Until recently, patients discontinuing first-line (1L) hedgehog inhibitors (HHIs) for basal cell carcinoma (BCC) had few subsequent treatment options. The objective of this study was to describe the treatment journey and prognosis of patients discontinuing 1L HHI for BCC.

Methods: This was a retrospective cohort study of patients with BCC who discontinued 1L HHI treatment in The US Oncology Network between 1 January 2012 and 1 January 2019 (with follow-up until 1 May 2020).

Real-World Treatment Patterns After CD19-Directed CAR T Cell Therapy Among Patients with Diffuse Large B Cell Lymphoma.

Introduction: CD19-directed chimeric antigen receptor T cells (CAR T) are approved for treatment of adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL) following at least two lines of therapy.

Methods: This study describes real-world treatment patterns after CAR T in adults with DLBCL. It includes adults diagnosed with DLBCL in IBM MarketScan Commercial and Medicare Supplemental healthcare claims databases administered CAR T between 2017 and 2019 (index event) and at least 6 months of continuous health plan enrollment pre-index.

A novel patient-reported outcome instrument assessing the symptoms of paroxysmal nocturnal hemoglobinuria, the PNH-SQ.

Background: Patient-reported outcome measures (PROs) used to measure symptoms of patients with paroxysmal nocturnal hemoglobinuria (PNH) in trials do not measure PNH symptoms comprehensively and do not assess daily fluctuations in symptoms. Following a literature review and consultation with a PNH expert, we drafted the PNH Symptom Questionnaire (PNH-SQ) and a patient-centric conceptual model of PNH symptoms and impacts. We then interviewed 15 patients with PNH to assess comprehensiveness of symptom capture from the patient perspective and to cognitively debrief the PNH-SQ.

The Association between Factor XI Deficiency and the Risk of Bleeding, Cardiovascular, and Venous Thromboembolic Events.

The objective of this study was to assess the relationship between factor XI (FXI) deficiency and the risks of bleeding and cardiovascular (CV) events. We conducted a retrospective cohort study using data from Maccabi Healthcare Services (MHS). We identified adults with FXI deficiency (severe: <15%, partial: 15 to <50%, any deficiency: <50%) that had been tested for FXI between 2007 and 2018 and matched to patients from the general MHS population.

A Retrospective Study of COVID-19-Related Urgent Medical Visits and Hospitalizations After Outpatient COVID-19 Diagnosis in the US.

Introduction: Identifying risk factors for progression to severe COVID-19 requiring urgent medical visits and hospitalizations (UMVs) among patients initially diagnosed in the outpatient setting may help inform patient management. The objective of this study was to estimate the incidence of and risk factors for COVID-19-related UMVs after outpatient COVID-19 diagnosis or positive SARS-CoV-2 test.

Methods: Data for this retrospective cohort study were from the Optum de-identified COVID-19 Electronic Health Record database from June 1 to December 9, 2020.

A novel patient-reported outcomes instrument assessing the side effects of peanut oral immunotherapy.

Background: Patients treated with peanut oral immunotherapy (OIT) may experience adverse reactions, particularly during up-dosing.

Objective: To develop the Side Effects of Peanut Oral Immunotherapy Diary (SEPOD), an electronic questionnaire assessing the daily side effects of peanut OIT in clinical trials.

Methods: Content and design of the SEPOD were informed by empirical literature review and meetings with 3 allergy-immunology experts.

Real-world persistence with dupilumab among adults with atopic dermatitis.

Background: The real-world persistence with dupilumab therapy for atopic dermatitis (AD) is unknown.

Objective: To characterize adults with AD who initiated dupilumab and evaluate persistence with dupilumab therapy.

Methods: This retrospective cohort study used the IBM MarketScan Commercial and Medicare database.

Treatment Patterns and Health Resource Use Among Patients with Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated at a Tertiary Referral Center.

Background: Although an increasing number of treatments have become available for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), there remains little consensus on treatment sequence and its impact on health care resource use (HRU). We sought to describe treatment patterns and HRU, in a cohort of patients with metastatic GEP-NETs treated at a tertiary referral center in the U.S.

Tracking the contribution of multiple raw and treated wastewater discharges at an urban drinking water supply using near real-time monitoring of β-d-glucuronidase activity.

Past waterborne outbreaks have demonstrated that informed vulnerability assessment of drinking water supplies is paramount for the provision of safe drinking water. Although current monitoring frameworks are not designed to account for short-term peak concentrations of fecal microorganisms in source waters, the recent development of online microbial monitoring technologies is expected to fill this knowledge gap. In this study, online near real-time monitoring of β-d-glucuronidase (GLUC) activity was conducted for 1.

1.5 °C carbon budget dependent on carbon cycle uncertainty and future non-CO forcing.

Estimates of the 1.5 °C carbon budget vary widely among recent studies, emphasizing the need to better understand and quantify key sources of uncertainty. Here we quantify the impact of carbon cycle uncertainty and non-CO forcing on the 1.