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Purpose: We investigated time trends in validation performance characteristics for six sources of death data available within the Healthcare Integrated Research Database (HIRD) over 8 years. Methods: We conducted a secondary analysis of a cohort of advanced cancer patients with linked National Death Index (NDI) data identified in the HIRD between 2010 and 2018. We calculated sensitivity, specificity, positive predictive value, and negative predictive value for six sources of death status data and an algorithm combining data from available sources using NDI data as the reference standard. Measures were calculated for each year of the study including all members in the cohort for at least 1 day in that year. Results: We identified 27 396 deaths from any source among 40 692 cohort members. Between 2010 and 2018, the sensitivity of the Death Master File (DMF) decreased from 0.77 (95% CI = 0.76, 0.79) to 0.12 (95% CI = 0.11, 0.14). In contrast, the sensitivity of online obituary data increased from 0.43 (95% CI = 0.41, 0.45) in 2012 to 0.71 (95% CI = 0.68, 0.73) in 2018. The sensitivity of the composite algorithm remained above 0.83 throughout the study period. PPV was observed to be high from 2010 to 2016 and decrease thereafter for all sources. Specificity and NPV remained at high levels throughout the study. Conclusions: We observed that the sensitivity of mortality data sources compared with the NDI could change substantially between 2010 and 2018. Other validation characteristics were less variable. Combining multiple sources of mortality data may be necessary to achieve adequate performance particularly for multiyear studies. [ABSTRACT FROM AUTHOR]

Introduction & Objectives There are limited data on peri-partum use of atopic dermatitis (AD) therapies, including for dupilumab, the first AD biologic drug approved by the United States (US) Food and Drug Administration. We characterized AD medication (systemic therapy or phototherapy) use among pregnant individuals. Materials & Methods Individuals from two US-based commercial health insurance claims databases, the Optum Research Database and the Healthcare Integrated Research Database, were eligible for inclusion if they met the following criteria: 1) start of pregnancy (i.e. estimated date of last menstrual period [LMP]) 01 April 2017 – 31 October 2023; 2) ≥ one AD diagnosis code; 3) continuous health plan enrollment for ≥6 months prior to and including LMP (baseline period); 4) age 18–49 years at LMP; and 5) an additional indicator for AD beginning from up to one year prior to LMP through end of pregnancy: receipt of systemic or topical AD therapy; use of phototherapy; or receipt of a second AD diagnosis. We included the first qualifying pregnancy per person. AD medication use during pregnancy was assessed beginning at LMP minus 5x the therapy half-life (e.g. LMP – 10 weeks for dupilumab) through the end of pregnancy (earlier of a pregnancy outcome [e.g. miscarriage, live birth] or 42 weeks after LMP). We describe characteristics and medication use among those: 1) exposed to dupilumab (dupilumab cohort), 2) exposed to phototherapy or systemic AD therapy other than dupilumab (other systemic therapy cohort), and 3) not exposed to systemic AD therapy or phototherapy (unexposed cohort), which were hierarchically defined based on therapy use any time during pregnancy. Results We identified 19,643 pregnant individuals with AD. Of these, 419 (2%) were included in the dupilumab cohort, 2,639 (13%) in the other systemic therapy cohort, and 6,807 (35%) in the unexposed cohort, yielding 9,865 individuals; the remaining 9,778 were excluded due to having a single AD diagnosis. While the majority (56-61%) in all cohorts were age 25-34 years at LMP, more individuals in the dupilumab cohort were age 18-24 years (23%) compared to those in the other systemic therapy (14%) or unexposed cohorts (12%). Among the dupilumab cohort, 90% used dupilumab in the baseline period prior to pregnancy; 30% had exposure to other systemic therapy prior to pregnancy. Very few individuals (<1%) had baseline exposure to dupilumab prior to pregnancy in either the other systemic therapy or the unexposed cohorts. More individuals in the other systemic therapy cohort had exposure to other systemic therapy (50%) prior to pregnancy than in the unexposed cohort (15%); in both cohorts, oral or parenteral corticosteroids accounted for >97% of other systemic therapies used. Dupilumab use among pregnant individuals increased over time, from 28 pregnancies in 2018 to 108 in 2022 (+286%); use of other systemic therapy increased slightly (<23%) over this time. Among the dupilumab cohort, use of any systemic AD therapy or phototherapy became less common over the course of pregnancy (>98%, 45%, and 21% in the first, second and third trimesters, respectively), which is aligned with the findings of general AD pregnant populations in the literature. Conclusion Among individuals with AD, a minority used systemic AD therapy or phototherapy prior to and during pregnancy. However, use of dupilumab is observed to have grown in this population. Ongoing studies are analyzing safety outcomes of dupilumab use during pregnancy. [ABSTRACT FROM AUTHOR]

Background: Trastuzumab is an antihuman epidermal growth factor receptor 2 monoclonal antibody used to treat breast and other cancers. Trastuzumab biosimilars were approved in the United States beginning in 2017. Utilization information on these biosimilars is limited., Objective: To examine utilization patterns and characteristics of patients treated with trastuzumab (biosimilars and reference) and other human epidermal growth factor receptor 2 products., Methods: We evaluated health care claims data from the Biologics and Biosimilars Collective Intelligence Consortium distributed research network, representing a large, geographically diverse US population of commercially insured individuals. We queried 4 distributed research network health plan partners to capture product usage data and patient information from October 1, 2016, to October 31, 2022. Patients were required to be continuously enrolled in their health plan for at least 365 days before their first observed trastuzumab utilization date in this study period. Data were aggregated across data partners., Results: More than 16 million eligible health plan members representing more than 31 million person-years of data were evaluated. We identified 5,984 incident treatment episodes; 3,878 (64.8%) episodes were with the reference trastuzumab. The mean ages were consistent across trastuzumab products (60.2 to 65.1 years) and at least 80% of the episodes were among female patients. The mean comorbidity index score was 1.2 (SD = 1.9) among users of the reference vs the biosimilars (range 1.2-2.5). Other clinical characteristics (eg, diabetes, hypertension) were comparable across products. The proportion of total incident episodes of the reference trastuzumab decreased substantially over time (96% in 2016 vs 28% in 2021) as utilization of the biosimilars increased (eg, use of trastuzumab-anns increased from 2% [2019] to 36% [2021]). Similar utilization trends were seen among patients with and without metastatic breast cancer., Conclusions: Trastuzumab biosimilars utilization has grown since their introduction to the US market. Exploration of these biosimilars' comparative effectiveness and safety to their reference product is warranted.