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A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy.
No full textBACKGROUND: IgA nephropathy, the most common primary glomerulopathy worldwide, is a kidney disorder of B-cell origin characterized by mesangial accumulation of IgA-containing immune complexes. In at least 50% of patients, IgA nephropathy leads to kidney failure or death within 10 to 20 years after diagnosis. Atacicept is a native human transmembrane activator and calcium-modulator and cyclophilin-ligand interactor (TACI)-Fc fusion protein that inhibits two key immunoregulatory cytokines - B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) - that are thought to be central to the pathophysiology of IgA nephropathy.
METHODS: In this ongoing, phase 3, multicenter, double-blind, randomized, placebo-controlled trial, we assigned patients with IgA nephropathy in a 1:1 ratio to receive atacicept at a dose of 150 mg once weekly, administered subcutaneously by patients at home, or matching placebo. The primary end point was the percentage change from baseline in the 24-hour urinary protein-to-creatinine ratio at week 36. Safety was also evaluated.
RESULTS: A total of 203 patients were included in the prespecified interim analysis: 106 patients in the atacicept group and 97 in the placebo group. At week 36, the percentage reduction from baseline in the urinary protein-to-creatinine ratio was 45.7% in the atacicept group and 6.8% in the placebo group, with a geometric mean between-group difference of 41.8 percentage points (95% confidence interval, 28.9 to 52.3; P\u3c 0.001). Adverse events were observed in 59.3% of the patients in the atacicept group and in 50.0% in the placebo group; most were mild or moderate in severity.
CONCLUSIONS: In this prespecified interim analysis, treatment with atacicept resulted in a significantly greater reduction in proteinuria than placebo at week 36 in patients with IgA nephropathy. (Funded by Vera Therapeutics; ORIGIN 3 ClinicalTrials.gov number, NCT04716231.)
The sedentary business of telemedicine: A review of ergonomic interventions for physicians working from home and recommendations to reduce work-related musculoskeletal disorders.
No full textPrevious investigations of work-related musculoskeletal disorders (WMSDs) and proper ergonomics in physicians have largely focused on interventionalists and surgeons, given the nature of their jobs. However, with the societal shift toward increased desk work and the widespread adoption of telemedicine, it is essential to examine the ergonomic challenges associated with remote care. Understanding and addressing these factors is critical to prevent musculoskeletal (MSK) strain among physicians and to ensure they can continue delivering high-quality patient care in the long run. Therefore, the goal of this review is to summarize recent interventions targeting ergonomic workspace improvements to mitigate WMSD in physicians practicing telemedicine. A database search was conducted in August 2024 using PubMed, Embase, CINAHL, and Scopus. Studies published in the last 15 years were included if they examined adults in interventional designs measuring musculoskeletal outcomes or sitting time. A total of 47 studies met the inclusion criteria, exploring various ergonomic interventions including: ergonomic training, active workstations, exercise programs, standing desks, backrests, ergonomic chairs, forearm supports, head-alignment devices, and biofeedback devices. Most studies had a positive impact on WMSD. This review highlights the importance of integrating movement, posture optimization, and personalized workspace adjustments to alleviate MSK discomfort and enhance workplace health for physicians
Association of EEG Response to Hypertonic Saline and Neurologic Outcomes in Pediatric Acute Brain Injury.
No full textBACKGROUND: Electroencephalography (EEG) is a critical tool for neuromonitoring and neuroprognostication in children with acute brain injury. Quantitative EEG (qEEG), particularly the alpha-delta ratio (ADR), can detect worsening cerebral ischemia in adults, but it is unknown whether it can identify more subtle and transient changes in cerebral blood flow, such as those induced by hypertonic saline (HTS), in children with acute brain injury. We aimed to determine whether we could identify a cohort of patients with an ADR response to HTS and to evaluate the association between an ADR response and neurologic outcomes in critically ill children with acute brain injury.
METHODS: We conducted a retrospective cohort study of patients admitted to a pediatric intensive care unit with acute brain injury who received HTS during EEG monitoring from 2018 to 2023. The ADR was calculated before and after HTS administration. An ADR response was defined as a \u3e 20% increase from baseline to within 30 min of receiving HTS in either hemisphere. The primary outcome was survival with favorable neurologic outcome, defined as a Functional Status Scale score change \u3c 3 from prehospital baseline to discharge. Secondary outcome was survival to hospital discharge.
RESULTS: Among 87 patients (median age 10 years [interquartile range 3.6-14.5], 46% female), 28% (24 of 87) had an ADR response to HTS. ADR responders were older (12.9 vs. 8.0 years; p = 0.004) and more likely to have continuous, normal-voltage EEG backgrounds (67% vs. 40%; p = 0.006). Patients with an ADR response had four times increased odds of favorable outcome and survival (odds ratio [OR] 4.0 [95% confidence interval (CI) 1.3-12.7] and OR 3.9 [95% CI 1.0-10.7], respectively).
CONCLUSIONS: An ADR increase \u3e 20% following HTS was associated with increased odds of survival with favorable neurologic outcome and survival to hospital discharge in critically ill pediatric patients with acute brain injury. qEEG response to HTS may serve as a real-time, noninvasive biomarker of cerebral perfusion responsiveness
Editorial. Introducing the VPS Reporting Guideline as a framework to improve evidence in hydrocephalus care
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