Gastrointestinal Perforations Associated With JAK Inhibitors: A Disproportionality Analysis of the FDA Adverse Event Reporting System.

Background: Gastrointestinal perforations have been reported in a small number of rheumatoid arthritis (RA) patients treated with Janus kinase (JAK) inhibitors in clinical trials. However, large-scale postmarketing data repositories are needed to further investigate this potentially rare but serious adverse event.

Methods: A retrospective, pharmacovigilance study of the FDA adverse event reporting system (July 2014 to September 2023) assessing the reporting of gastrointestinal perforations following JAK inhibitors compared to biological disease-modifying antirheumatic drugs (bDMARDs) in RA patients.

A comparison between lipid-based vs. glycemic-based insulin sensitivity indices for the association with abnormal ECG findings and 20-year mortality among older adults.

Background: A direct comparison between glycemic-based and lipid-based insulin sensitivity indices (ISIs) for ECG findings and all-cause and cardiovascular mortality is lacking.

Methods: 963 community-dwelling older adults, examined as part of the third phase of the Glucose intolerance, Obesity, and Hypertension study between 1999 and 2008, were followed until December 2016 and December 2019 for cardiovascular and all-cause mortality, respectively. Eleven different ISIs were calculated and evaluated against ECG findings, all-cause, and cardiovascular mortality with multivariable regression models.

Predictors and implications of renal injury after CD19 chimeric antigen receptor T-cell therapy.

Chimeric Antigen Receptor (CAR) T cells targeting CD19 induce durable remissions in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), but many patients experience treatmentrelated toxicity. Cytokine release syndrome and immune effector cell-associated neurologic syndrome are extensively characterized. However, limited data exist on the burden, predictors, and implications of acute kidney injury (AKI) after CAR T cell therapy.

Adverse cardiovascular events in rheumatoid arthritis patients treated with JAK inhibitors: An analysis of postmarketing spontaneous safety reports.

Objectives: The ORAL Surveillance trial, a postmarketing safety clinical trial, found an increased risk of adverse cardiovascular events and venous thromboembolism (VTE) in patients treated with Janus Kinase (JAK) inhibitors compared to tumor necrosis factor (TNF) inhibitors. However, additional studies yielded mixed results and data on other JAK inhibitors are limited.

Methods: A retrospective, pharmacovigilance study using the FDA adverse event reporting system (FAERS) to assess reporting of adverse cardiovascular events following treatment with JAK inhibitors in rheumatoid arthritis (RA) patients between January 2015 and June 2023.

The Perfect Circle Technique Shows Poor Inter-rater Reliability in Measuring Anterior Glenoid Bone Loss on Magnetic Resonance Imaging.

Purpose: To evaluate the reliability of the perfect circle methodology for measurement of glenoid bone loss in patients with anterior glenohumeral instability.

Methods: We performed a chart review of retrospectively collected patients who underwent isolated arthroscopic anterior labral repair between January 1 and June 30, 2021, using our institution's electronic medical records. The inclusion criteria included isolated anterior shoulder instability with anterior labral repair and corroborated tears on magnetic resonance imaging.

The Perfect-Circle Technique Demonstrates Poor Inter-Rater Reliability in Measuring Posterior Glenoid Bone Loss on Magnetic Resonance Imaging.

Purpose: To evaluate the reliability of the "perfect-circle" methodology for measurement of glenoid bone loss with magnetic resonance imaging (MRI) in patients with posterior glenohumeral instability.

Methods: A prospective chart review was performed on patients who underwent isolated arthroscopic posterior labral repairs in our institution's electronic medical records between January 1, 2021, and June 30, 2021. Inclusion criteria included isolated posterior shoulder instability with posterior labral repair and corroborated tears on MRI.

The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data.

Background: Heart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population.

Risk Factors for Glenoid Bone Loss in the Setting of Posterior Glenohumeral Instability.

Background: Posterior instability has been reported to account for up to 24% of cases of shoulder instability in certain active populations. However, there is a paucity of data available regarding the risk factors associated with posterior glenoid bone loss.

Purpose: To characterize the epidemiology of, and risk factors associated with, glenoid bone loss within a cohort of patients who underwent primary arthroscopic shoulder stabilization for isolated posterior-type glenohumeral instability.

Baseline renal function and the risk of cancer among apparently healthy middle-aged adults.

Background: The association between mildly impaired renal function with all-site and site-specific cancer risk is not established. We aim to explore this association among apparently healthy adults.

Methods: We followed 25,073 men and women, aged 40-79 years, free of cancer or cardiovascular disease at baseline who were screened annually in preventive healthcare settings.

Mild renal impairment is associated with increased cardiovascular events and all-cause mortality following cancer diagnosis.

Background: The association between mildly decreased renal function and cardiovascular (CV) outcomes in cancer patients remains unestablished.

Aims: We sought to explore this association in asymptomatic self-referred healthy adults.

Method: We followed 25, 274 adults, aged 40-79 years, who were screened in preventive healthcare settings.

Adolescent Hypertension Is Associated With Stroke in Young Adulthood: A Nationwide Cohort of 1.9 Million Adolescents.

Background: Adult hypertension is a well-established risk factor for stroke in young adults (aged <55 years), and the effects are even more deleterious than at an older age. However, data are limited regarding the association between adolescent hypertension and the risk of stroke in young adulthood.

Methods: A nationwide, retrospective cohort study of adolescents (aged 16-19 years) who were medically evaluated before compulsory military service in Israel during 1985 to 2013.

Sex specific serum uric acid levels are associated with ischemic changes on ECG and with 20-year all-cause mortality among older adults.

Background: Uric acid is an emerging biomarker for cardiovascular morbidity and mortality, but its association with all-cause mortality and ECG findings remains unestablished, specifically among older adults. We aimed to evaluate the association between serum uric acid (SUA) with incidental findings of ECG abnormalities and with long-term all-cause mortality.

Methods: We conducted a prospective cohort study of 851 community dwelling men and women, who were examined between 1999 and 2008, and followed over 20 years until December 2019 for all-cause mortality.

Polypharmacy is differentially associated with 20-year mortality among community-dwelling elderly women and men: The Israel Glucose Intolerance, Obesity and Hypertension cohort study.

Background: Elderly individuals are characterized by multimorbidity and high medication intake, entailing risks for adverse events. We examined the overall and sex-specific association of polypharmacy (≥5 drugs concurrently) with 20-year mortality among community-dwelling older adults.

Methods: Survivors of the longitudinal Israel Study of Glucose Intolerance, Obesity, and Hypertension underwent extensive evaluation during 1999-2004, and were followed-up for all-cause mortality until 2019.

The real-world safety profile of sodium-glucose co-transporter-2 inhibitors among older adults (≥ 75 years): a retrospective, pharmacovigilance study.

Background: As indications for sodium-glucose co-transporter-2 inhibitors (SGLT2i) are expanding, a growing number of older adults have become candidates for treatment. We studied the safety profile of SGLT2i among older adults.

Methods: A retrospective, pharmacovigilance study of the FDA's global database of safety reports.

Progressive multifocal leukoencephalopathy in patients treated with chimeric antigen receptor T cells.

Using 2 global postmarketing surveillance databases, Goldman and colleagues report that progressive multifocal leukoencephalopathy (PML), a viral disease associated with profound immunosuppression, occurs in approximately 0.9 cases per 1000 recipients of CD19-directed CAR T-cell therapy. The risk of PML appears higher with CAR T-cell therapy than other cancer therapies, but its precise role cannot be distinguished from antecedent therapies that these patients receive.

Hyperglycaemic disorders associated with PCSK9 inhibitors: a real-world, pharmacovigilance study.

Aims: While genetic and biological studies indicated a potential association between proprotein-convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and hyperglycaemia, real-world data are limited. Therefore, we sought to investigate this association using the FDA adverse event reporting system (FAERS).

Methods And Results: The FAERS database (2015-2020) was retrospectively queried to characterize reporting of hyperglycaemic adverse events (AEs) with PCSK9i.

Adverse Cardiovascular and Pulmonary Events Associated With Chimeric Antigen Receptor T-Cell Therapy.

Background: Pivotal trials of chimeric antigen receptor T-cell (CAR-T) have identified common toxicities but may have been underpowered to detect cardiovascular and pulmonary adverse events (CPAEs).

Objectives: This study sought to investigate CPAEs associated with commercial CD19-directed CAR-T therapy.

Methods: In this retrospective, pharmacovigilance study, the authors used the Food and Drug Administration adverse event reporting system to identify CPAEs associated with axicabtagene-ciloleucel and tisagenlecleucel.