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Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies.
No full textOBJECTIVE: To assess the longer-term effect of bimekizumab up to 1 year on patient-reported symptoms, health-related quality of life (HRQOL), and work productivity in patients with active PsA who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR).
METHODS: BE OPTIMAL (ClinicalTrials.gov: NCT03895203; bDMARD-naïve patients) and BE COMPLETE (NCT03896581; TNFi-IR patients) are phase III studies of subcutaneous bimekizumab 160 mg every 4 weeks. Both studies were double-blind and placebo-controlled to 16 weeks. Patients who completed week 52 of BE OPTIMAL or week 16 of BE COMPLETE were eligible for the open-label extension, BE VITAL (NCT04009499), during which all patients received bimekizumab. Patient-reported pain, fatigue, physical function, HRQOL, and work productivity are reported to week 52 or 40 (52/40) using individual study data for bimekizumab and placebo treatment arms.
RESULTS: Bimekizumab-randomized patients demonstrated sustained mean improvements from baseline in patient-reported outcomes to week 52/40, including pain (visual analog scale [0-100 mm]: bDMARD-naïve -30.5; TNFi-IR -31.8), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue scale [0-52]: bDMARD-naïve 5.3; TNFi-IR 6.0), physical function (Health Assessment Questionnaire-Disability Index [0-3]: bDMARD-naïve -0.34; TNFi-IR -0.39), and HRQOL (36-item Short Form Health Survey, physical component summary: bDMARD-naïve 8.1; TNFi-IR 8.4); placebo patients who switched to bimekizumab at week 16 demonstrated comparable levels of improvement from week 16 to week 52/40. Improvements in overall work impairment were sustained among bimekizumab-randomized patients to week 52. Similar trends were observed for absenteeism, presenteeism, and activity impairment.
CONCLUSION: Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms, HRQOL, and work productivity up to 1 year in bDMARD-naïve and TNFi-IR patients with active PsA
APMAT analysis reveals the association between CD8 T cell receptors, cognate antigen, and T cell phenotype and persistence.
No full textElucidating the relationships between a class I peptide antigen, a CD8 T cell receptor (TCR) specific to that antigen, and the T cell phenotype that emerges following antigen stimulation, remains a mostly unsolved problem, largely due to the lack of large data sets that can be mined to resolve such relationships. Here, we describe Antigen-TCR Pairing and Multiomic Analysis of T-cells (APMAT), an integrated experimental-computational framework designed for the high-throughput capture and analysis of CD8 T cells, with paired antigen, TCR sequence, and single-cell transcriptome. Starting with 951 putative antigens representing a comprehensive survey of the SARS-CoV-2 viral proteome, we utilize APMAT for the capture and single cell analysis of CD8 T cells from 62 HLA A*02:01 COVID-19 participants. We leverage this comprehensive dataset to integrate with peptide antigen properties, TCR CDR3 sequences, and T cell phenotypes to show that distinct physicochemical features of the antigen-TCR pairs strongly associate with both T cell phenotype and T cell persistence. This analysis suggests that CD8 T cell phenotype following antigen stimulation is at least partially deterministic, rather than the result of stochastic biological properties
Head and Neck Cancer Research Training Program Associated with Academic Success for Trainees.
No full textThis study is to analyze academic success metrics of otolaryngology cancer research laboratory trainees. This is a retrospective analysis of trainee academic outcomes from 2000 to 2020. We examined careers of 99 trainees of the senior author\u27s cancer research laboratory, including undergraduates, medical students, otolaryngology residents/fellows, and NIH T32 postdocs. We compared medical school matriculation rates, otolaryngology and head and neck surgery (OHNS) residency match rates, fellowship match rates, publication rates, and academic positions with publicly available data from the American Association of Medical Colleges (AAMC), National Resident Matching Program (NRMP), and others. Nine undergraduates achieved a 100% medical school matriculation rate compared with the AAMC rate of 43.4%. Of 22/53 medical students who applied to OHNS residency, students achieved a 100% match rate, compared with the NRMP match rate of 82.1%. Of 33 medical students who completed training, 45.4% became academicians, compared with 44.9% in an NIH R25E program cohort, which is notable. Interestingly, medical student trainees overall had more publications compared with incoming OHNS residents. Our residents achieved a 100% fellowship match rate compared with 79.0% average match rate across OHNS fellowship programs. Twelve of 25 (48%) residents earned advanced degrees (10 MS, 2 PhD), 11 of which were directly related to oncology. This was statistically significant compared to incoming otolaryngology residents via the NRMP data. Sixty percent (3/5) of surgical fellows entered academics. We observed multiple benefits from participation in our research laboratory at all levels of academic cancer training, specifically medical school and otolaryngology residency matriculation and academic faculty placement of former trainees
Practical management of adverse events in patients receiving tarlatamab, a delta-like ligand 3-targeted bispecific T-cell engager immunotherapy, for previously treated small cell lung cancer.
No full textTarlatamab is a bispecific T-cell engager immunotherapy targeting delta-like ligand 3 (DLL3) and the cluster of differentiation 3 (CD3) molecule. In the phase 2 DeLLphi-301 trial of tarlatamab for patients with previously treated small cell lung cancer, tarlatamab 10 mg every 2 weeks achieved durable responses and encouraging survival outcomes. Analyses of updated safety data from the DeLLphi-301 trial demonstrated that the most common treatment-emergent adverse events were cytokine release syndrome (53%), pyrexia (38%), decreased appetite (36%), dysgeusia (32%), and an emia (30%). Cytokine release syndrome was mostly grade 1 or 2 in severity, occurred primarily after the first or second tarlatamab dose, and was managed with supportive care, which included the administration of antipyretics (e.g., acetaminophen), intravenous hydration, and/or glucocorticoids. Other treatment-emergent adverse effects of interest included neutropenia (16%) and immune effector cell-associated neurotoxicity syndrome and associated neurologic events (10%). Given that tarlatamab is the first T-cell engager approved for the treatment of small cell lung cancer, raising awareness with regard to the monitoring and management of tarlatamab-associated adverse events is essential. Here, the authors describe the timing, occurrence, and duration of these adverse events and review the management and risk-mitigation strategies used by clinical investigators during the DeLLphi-301 trial
Providing Skilled Mentorship for a Newly Forming Research and Evidence-Based Practice (EBP) & Education Council
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Risk Management and Good Governance Support Organizational Value.
No full textAs healthcare faces mounting financial challenges and an uncertain flow of resources, proactive risk officers are working to implement effective operating policies to handle those challenges and uncertainties. Clear governance structures that are fully integrated into the organization\u27s strategic planning process can provide the framework for effective risk management. At Providence, a large not-for-profit health system, enterprise risk management practices serve to identify, assess, and manage the risks that can affect the entire organization. Armed with a complete view of risks (both taken and those avoided), system executives, core leaders, and board members work together to protect value and advance the corporate mission
Natural Language Processing in Gastroenterology: Current Applications and Future Directions.
No full textNatural language processing (NLP), a branch of artificial intelligence, has rapidly gained importance in health care for converting unstructured clinical data into structured formats, enhancing decision-making, research, and patient care. Gastroenterology generates vast amounts of clinical data, including clinical notes, pathology reports, and endoscopy findings, much of which remains underutilized due to its unstructured nature. This article explores the key applications of NLP in gastroenterology, such as automating clinical documentation, diagnostic assistance, patient engagement, and research literature analysis. The article also highlights future directions for NLP in gastroenterology, particularly its role in precision medicine and multimodal data integration
