IQVIA (United States)

Severe hypoglycemic events (SHEs) impose substantial clinical and economic burden on people with type 1 diabetes (pwT1D), yet real-world data describing this burden remain limited in the U.S. hospital setting. This study examined T1D-related complications and direct medical costs in pwT1D hospitalized or treated in the emergency department (ED) for hypoglycemia. IQVIA's PharMetrics Plus database was used to identify adults with T1D who experienced at least 1 hypoglycemic event requiring an inpatient hospitalization or ED visit from April 2016-April 2020. The SHE date was defined as the date of the first hospital-treated SHE: a claim with a hypoglycemia diagnosis and an inpatient hospitalization or ED visit. Patients were followed up until the end of continuous enrollment or end of the study period (April 30, 2022). Prevalence of T1D-related complications were descriptively summarized, and all-cause direct medical costs were calculated as per-patient-per-year (PPPY). The study was conducted during a period of early adoption of advanced diabetes technologies, such as hybrid closed-loop systems, and only included direct medical costs, potentially underestimating total costs. Among 4627 adults with T1D and hospital-treated SHEs, mean age was 41.4years, 57.3% were male, and 93.4% had commercial insurance. Common comorbidities included hypertension (24.6%), anxiety (9.5%), and depression (9.3%). Prevalence of retinopathy, neuropathy, chronic kidney disease (any stage), coronary artery disease, and peripheral vascular disease were 38.6%, 38.6%, 17.7%, 13.2%, and 11.4%, respectively. Total all-cause direct medical costs averaged $52,849 PPPY in 2022 USD ($59,719 in 2025 USD), driven primarily by inpatient hospitalization (mean-$22,981 in 2022 USD, $25,968 in 2025 USD). Among patients with a hospitalization, mean (SD) number of hospitalizations (PPPY) were 1.5 (3.6) and the average length of stay per patient (PPPY) was 5.0 (20.7) days. High T1D-related complication rates and elevated direct medical costs highlight the complexity of pwT1D who experienced hospital-treated SHEs.

Clinical evidence is needed for performance of novel coronavirus disease (COVID-19) molecular tests in asymptomatic populations to support regulatory decisions. To support claim expansion of a direct molecular test, clinical use and performance of the Cobas® SARS-CoV-2 qualitative test for use on Cobas 5800/6800/8800 Systems ("candidate test") for detecting SARS-CoV-2 in individuals who are asymptomatic were investigated. This study leveraged real-world data from the 2020 National Football League (NFL) COVID-19 Surveillance Program during August 1, 2020-January 3, 2021. NFL players and staff from 32 clubs had nasal samples prospectively collected on a near-daily basis. Samples underwent reverse transcription polymerase chain reaction (RT-PCR) testing by a single provider across five laboratories. The study population included individuals whose samples were tested on the candidate test. A comparator algorithm was constructed based on comparator test results and clinical adjudication within the NFL program. Results from the candidate test were compared against the comparator algorithm to calculate positive and negative percent agreements (PPA and NPA). Two-sided 95% confidence intervals (CIs) for PPA and NPA were determined (Wilson score method). A total of 1776 samples were included in the final analysis. All 11 samples with positive comparator status were positive on the candidate test (PPA 100% [95%CI 74.1, 100]). Of 1765 samples with negative comparator status, 1762 were negative on the candidate test (NPA 99.8% [95%CI 99.5, 99.9]). Results were consistent when stratified by age and sex. Based on data collected during this occupational testing protocol, our study provides strong evidence supporting real-world performance of this test in an asymptomatic population. These findings, complemented by data from an existing clinical study, provided the totality-of-evidence that supported the US Food and Drug Administration clearance for the expanded claim of the candidate test for the qualitative detection of SARS-CoV-2 in the asymptomatic population.

Introduction and Objectives: Lebrikizumab received U.S. Food and Drug Administration approval on September 13, 2024, for adults and adolescents (≥12 years, ≥40 kg) with moderate-to-severe atopic dermatitis (AD). The recommended dosing regimen consists of a 500-mg loading dose (two 250-mg injections) at Week 0 and Week 2, followed by 250 mg every 2 weeks (Q2W) until Week 16 or adequate clinical response. The approved maintenance dose is lebrikizumab 250 mg every 4 weeks (Q4W). Due to prescribing information (PI) flexibility and clinician discretion, real-world evidence describing the proportion of patients who transition to lebrikizumab Q4W dosing is warranted. Methods: We assessed the proportion of patients treated with lebrikizumab who transitioned from Q2W to Q4W dosing using the IQVIA Longitudinal Access and Adjudication Data (LAAD) database. Patients who initiated lebrikizumab between September 13, 2024, and August 31, 2025 were identified; only final paid claims were included. The index date was defined as the date of the first paid lebrikizumab prescription. Patients were required to be ≥12 years old and to have pharmacy activity for ≥6 months following the index date. Data from weeks 16, 20, and 24 were assessed. If a patient receives five lebrikizumab prescriptions (28-day supply), the first, consistent opportunity to move to Q4W dosing per the label is at Week 16. However, the first opportunity to identify an Q4W dosing interval in the data would be between fills five and six, Week 16 and 20. Results: Overall, 2,948 patients were included had pharmacy activity for ≥6 months and were ≥12 years old. The mean age of the study population was 44.1 years (SD 18.9). The majority (78.6%) of patients utilizing lebrikizumab were 18–64 years. Among patients who initiated lebrikizumab, Q2W dosing, and had ≥5 lebrikizumab claims (n = 1,717) over 6 months, 72.7% had transitioned from Q2W to Q4W dosing by Week 16, 83.3% by Week 20, and 88.1% by Week 24. Of the 83.3% of patients that transitioned from Q2W to Q4W dosing by Week 20, the average time (mean) to dosing transition (Q2W to Q4W) was 13.3 weeks. Conclusion: By Week 20, 83.3% of patients receiving lebrikizumab transitioned to Q4W maintenance dosing, a proxy for adequate clinical response. This analysis was restricted to patients with consistent lebrikizumab fills and is subject to the inherent limitations of claims administrative data. Additional research will further elucidate broader lebrikizumab treatment patterns. Funding sources: this study was funded by Eli Lilly and Company.

This age-based sub-group analysis was conducted within the investigator-initiated PRECISE trial, developed by academic leadership with funding and participation from HeartFlow Inc. The overall trial protocol and interpretation of results were reviewed and approved by the steering committee independently of the sponsor. Trial conduct followed the study protocol and was overseen by an independent data and safety monitoring board and the PRECISE steering committee. Operations were managed jointly by HeartFlow Inc. and the Duke Clinical Research Institute. Outcome assessments, including data and safety monitoring, event adjudication, and core lab functions, were performed independently of the sponsor. Academic authors drafted and revised the manuscript with input from HeartFlow Inc., which assisted in study conduct and data collection but did not influence outcome assessments or interpretation. The sponsor reviewed but did not prepare or approve the manuscript. The decision to publish was made independently by the lead authors and the steering committee. M.D. Kelsey: Advisory board for Bayer; Consultant/Speaker for Heartflow Inc. S. Vemulapalli: National Institutes of Health, Food and Drug Administration, American College of Cardiology, Cytokinetics, Edwards Lifesciences, Abbott Vascular; Consulting/Advisory: Astra Zeneca, Boehringer-Ingelheim, Cytokinetics, Edwards Lifesciences, Medtronic, Total CME, Ikon, Veralox Therapeutics. D.B. Mark: grant support from HeartFlow Inc. during the conduct of this study; grant support from Merck and Novo Nordisk outside the submitted work; grants or research support from NIH/NHLBI and American Heart Association; consulting fees from CeleCor, Novartis, and Boehringer Ingelheim outside the submitted work; honoraria from Elsevier outside the submitted work. C. Rogers: Employee and shareholder of HeartFlow. S. Mullen: Employee & shareholder of HeartFlow. W. Huey: Employee & shareholder of HeartFlow. A. Caune: Employee & shareholder of HeartFlow. J.A. Leipsic: Dr. Leipsic provides institutional CT core laboratory support to Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific but takes no personal compensation and is a consultant to HeartFlow and Circle CVI. R.A. Byrne: Professor Robert A. Byrne does not accept direct or personal payments from the medical device or pharmaceutical industry, reports research funding to the institution from Abbott Vascular, Biosensors, Boston Scientific, and Translumina without impact on personal remuneration. N. Ng: Employee & stock options in HeartFlow. J.E. Udelson: Dr. Udelson has received personal fees from scPharmaceuticals, Merck, Alleviant, Reprieve CV, and Cardurion. P.S. Douglas: Dr. Douglas reports relevant research support to her institution from HeartFlow and as a consultant for Cleerly. M.G. Nanna: Dr. Nanna reports consulting for Heartflow, Merck, and Novo Nordisk as well as research support from the American College of Cardiology Foundation supported by the George F. and Ann Harris Bellows Foundation, the Patient-Centered Outcomes Research Institute (PCORI), the Yale Claude D. Pepper Older Americans Independence Center (P30AG021342), and the National Institute on Aging (K76AG088428). E. Vemmou, K. Chiswell, R.M. Clare, E. Yow, K. Pier declare no conflicts of interest. Table S1: Cardiac Catheterization Rates Among Those with Positive and Negative Testing Stratified By Population Definition, Age, and Testing Strategy. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Patients with moderate-to-severe atopic dermatitis (AD) who discontinue dupilumab need additional therapeutic options. Lebrikizumab's distinct mechanism of action may provide that alternative treatment. We evaluated efficacy and safety of lebrikizumab in adults and adolescents with moderate-to-severe AD previously treated with dupilumab. In the open-label ADapt trial, patients who discontinued dupilumab due to inadequate response, adverse events (AEs)/intolerance, or other reasons received lebrikizumab 250-mg every 2weeks (Q2W) following 500-mg loading dose at baseline/week2, through week16, with optional topical therapy. From weeks16-24, responders (≥ 75% improvement in Eczema Area and Severity Index [EASI75] or Investigator's Global Assessment score 0/1 with ≥ 2-point improvement from baseline) received lebrikizumab every 4weeks; inadequate responders continued lebrikizumab Q2W. The primary endpoint was EASI75 at week16 in the intent-to-treat population; EASI75 was also analyzed by reason for dupilumab discontinuation. Secondary and exploratory efficacy endpoints were assessed throughout. Among the 86 patients enrolled, primary reasons for stopping dupilumab were inadequate response (n = 48, 55.8%), AEs/intolerance (n = 14, 16.3%), and other reasons (n = 24, 27.9%). Fifty-nine patients (68.6%) completed week16; 52 patients (60.5%) completed week24. At weeks16 and 24, respectively, response rates were 57.4% (35/61) and 60.0% (33/55) for EASI75; 53.2% (25/47) and 61.5% (24/39) for Pruritus Numeric Rating Scale ≥ 4-point improvement; and 83.0% (44/53) and 83.0% (39/47) for Dermatology Life Quality Index ≥ 4-point improvement. Most treatment-emergent AEs were mild/moderate. Serious AEs and discontinuations due to AEs were reported by 2 (2.3%) and 5 (5.8%) patients, respectively. Of the 10 patients who discontinued dupilumab due to eye-related events, facial dermatitis, or inflammatory arthritis, none reported similar events with lebrikizumab. Results suggest that lebrikizumab provides meaningful improvements in skin clearance, itch, and quality of life in dupilumab-experienced patients with moderate-to-severe AD, with a safety profile consistent with other lebrikizumab phase3 trials. ClinicalTrials.gov identifier, NCT05369403.

Miscarriage is a common pregnancy complication that is difficult to study. Using information on 580,000 US pregnancies from a menstrual- and pregnancy-tracking app, we demonstrate that mobile device data can detect miscarriage and replicate patterns of miscarriage risk found in high-quality Norwegian administrative data and in US clinical cohorts. App data may greatly expand research on miscarriage, including the contributions of "upstream" social, economic, and environmental factors that have eluded study.