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Population Pharmacokinetics of Orvacabtagene Autoleucel, an Autologous BCMA-Directed Chimeric Antigen Receptor T-Cell Product, in Patients with Relapsed/Refractory Multiple Myeloma.
Clin Cancer Res
January 2025
Bristol-Myers Squibb (United States), Summit, New Jersey, United States.
Purpose: Orvacabtagene autoleucel (orva-cel; JCARH125), a CAR T-cell therapy targeting B-cell maturation antigen (BCMA), was evaluated in relapsed/refractory multiple myeloma (RRMM) patients in the EVOLVE phase 1/2 study (NCT03430011). We applied a modified piecewise model to characterize orva-cel transgene kinetics and assessed the impact of various covariates on its pharmacokinetics (PK).
Experimental Design: The population PK analysis included 159 patients from the EVOLVE study.
Effectiveness of Additional or Standalone Corticosteroid Injections Compared to Physical Therapist Interventions in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Phys Ther
January 2025
IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Importance: Rotator cuff tendinopathy represents the most prevalent cause of shoulder pain, the third most common musculoskeletal disorder after low back pain and knee pain.
Objective: The objective of this study was to determine the effectiveness of corticosteroid injection(s), alone or in combination with anesthetic injection or any other physical therapist interventions, compared to physical therapist interventions alone in adults with rotator cuff tendinopathy.
Design: This study was a systematic review and meta-analysis of randomized controlled trials.
Mindfulness Training vs Recovery Support for Opioid Use, Craving, and Anxiety During Buprenorphine Treatment: A Randomized Clinical Trial.
JAMA Netw Open
January 2025
Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.
Importance: During buprenorphine treatment for opioid use disorder (OUD), risk factors for opioid relapse or treatment dropout include comorbid substance use disorder, anxiety, or residual opioid craving. There is a need for a well-powered trial to evaluate virtually delivered groups, including both mindfulness and evidence-based approaches, to address these comorbidities during buprenorphine treatment.
Objective: To compare the effects of the Mindful Recovery Opioid Use Disorder Care Continuum (M-ROCC) vs active control among adults receiving buprenorphine for OUD.
Use of Albumin-Adjusted Calcium Measurements in Clinical Practice.
JAMA Netw Open
January 2025
Division of Endocrinology and Metabolism, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
Importance: Using albumin-adjusted calcium is commonly recommended for for measuring calcium, but with little empirical evidence to support the practice.
Objective: To assess the correlation between total calcium measurements (with or without adjustment) vs the ionized calcium level as a reference standard.
Design, Setting, And Participants: This was a population-based cross-sectional study in the province of Alberta, Canada, including adults tested for serum total calcium and ionized calcium simultaneously between January 1, 2013, and October 31, 2019.
Travel Time as an Indicator of Poor Access to Care in Surgical Emergencies.
JAMA Netw Open
January 2025
Department of Surgery, University of Washington, Seattle.
Importance: Timely access to care is a key metric for health care systems and is particularly important in conditions that acutely worsen with delays in care, including surgical emergencies. However, the association between travel time to emergency care and risk for complex presentation is poorly understood.
Objective: To evaluate the impact of travel time on disease complexity at presentation among people with emergency general surgery conditions and to evaluate whether travel time was associated with clinical outcomes and measures of increased health resource utilization.
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