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Relationship of radiographic progression status to low disease activity in patients with psoriatic arthritis receiving secukinumab treatment for two years.
No full textOBJECTIVE: To examine relationships between radiographic progression and achievement of low disease activity (LDA) or remission at week 104 in patients with psoriatic arthritis (PsA) receiving secukinumab.
METHODS: This post hoc analysis included data from patients with active PsA enrolled in the phase 3 FUTURE 5 study (NCT02404350). Patients were pooled by treatment received at week 104 (secukinumab 300 mg with loading dose [LD], secukinumab 150 mg with LD, or secukinumab 150 mg without LD) and grouped by radiographic progression status. Radiographic progression was defined as change from baseline to week 104 in van der Heijde modified Total Sharp Score \u3e0.5. Efficacy was assessed by achievement of minimal disease activity (MDA), very low disease activity (VLDA), and Disease Activity Index for Psoriatic Arthritis (DAPSA) LDA or remission. Demographics and clinical characteristics associated with radiographic progression at week 104 were identified by logistic regression analyses.
RESULTS: Of the 541 patients included in this analysis, 457 (84.5%) were radiographic nonprogressors and 84 (15.5%) were radiographic progressors. Higher proportions of nonprogressors achieved MDA, VLDA, and DAPSA LDA and remission at week 104 than progressors. Radiographic progression at week 104 was associated with older age and higher baseline high-sensitivity C-reactive protein level, whereas nonprogression was associated with 300 mg secukinumab (vs 150 mg secukinumab without LD), no prior exposure to tumour necrosis factor inhibitors, and lower body mass index.
CONCLUSION: Patients without radiographic progression through 2 years of secukinumab treatment had greater achievement of LDA states at week 104 than patients with radiographic progression.
TRIAL REGISTRATION: ClinicalTrials.gov; NCT02404350
ZUMA-8: a phase 1 study of brexucabtagene autoleucel in patients with relapsed/refractory chronic lymphocytic leukemia.
No full textZUMA-8 evaluated the safety of brexucabtagene autoleucel (brexu-cel), a CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapy, for patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Patients with ≥2 prior lines of therapy (including a Bruton tyrosine kinase inhibitor) underwent leukapheresis, optional bridging therapy, and conditioning chemotherapy (fludarabine/cyclophosphamide) before infusion of 1 × 106 (cohort 1) or 2 × 106 (cohort 2) anti-CD19 CAR T cells per kg. Patients in cohort 3 (low tumor burden), and cohort 4A (postibrutinib) received 1 × 106 cells per kg. Fifteen patients, median age of 63 years (range, 52-79), were treated in cohorts 1 (n = 6), 2 (n = 3), 3 (n = 3), and 4A (n = 3). Median follow-up was 24.3 months. One dose-limiting toxicity was observed in cohort 3 (grade 4 cytokine release syndrome). Grade ≥3 neurologic events occurred in 3 patients (20%). Seven of 15 patients responded (overall response rate, 47%; complete response [CR], 7%), including all 3 patients in cohort 3 (1 with CR). CAR T-cell expansion occurred in 4 patients (27%), with an apparent weak inverse correlation with absolute lymphocyte count before apheresis. Brexu-cel had no new safety signals in R/R CLL. CAR T-cell expansion and responses occurred in patients with low tumor burden. This trial was registered at www.clinicaltrials.gov as #NCT03624036
Ectopic adipose tissue in subsistence populations with minimal coronary disease, large left atria, and very low rates of atrial fibrillation.
No full textBACKGROUND: Greater deposits of epicardial adipose tissue are associated with atrial fibrillation and coronary disease, but have not been studied in subsistence populations.
METHODS: We performed CT imaging to measure coronary artery and thoracic aortic calcium (CAC, TAC), epicardial fat thickness (EFT), liver density, and left atrial (LA) anteroposterior diameter and, using a deep learning-enabled software program, epicardial and thoracic fat volume (EFV, TFV), in two remote Amerindian subsistence populations with minimal coronary artery calcification and virtually no atrial fibrillation. We compared 893 adult Tsimane (mean age 58.3±10.5 y, 51.6% male), 440 Moseten (55.9±10.4 y, 53.6% male) to 955 U.S. (56.8±10.8 y, 51.6% male) subjects.
RESULTS: Tsimane and Moseten had 43%-52% lower EFT, EFV, TFV, and 48-92% less CAC and TAC, respectively than the U.S. cohort. Mean liver measurements were 14-22% denser and LA diameters 10-14% larger (≈ 40% larger by volume). For EFV, Tsimane, Moseten, and U.S. cohorts averaged 54.2±25.6, 60.3±35.1, and 106±53.5 cc, respectively (p\u3c 0.05 for all comparisons). EFV remained significantly smaller after adjustment for age, BMI, and other characteristics. For all CT metrics, the more acculturated Moseten measures were intermediate between Tsimane and the U.S. cohort.
CONCLUSIONS: Tsimane mean EFV was the lowest of any population ever reported in the literature, achieving a new population standard. The low levels of EFV in the Tsimane and Moseten add to the body of evidence linking ectopic fat and atherosclerosis and further confirm (in the negative) the association, and likely causative role, of epicardial fat and atrial fibrillation
Nurses\u27 Perspectives on Caring for Critically Ill Children During a Measles Outbreak: A Case Report.
No full textINTRODUCTION: Measles is a highly contagious respiratory illness spread through droplets. Signs range from mild to severe, and some patients need hospitalization. Vaccines to prevent measles have been accessible since the late 1960s, and the disease was declared eliminated in the United States in 2000.
CLINICAL FINDINGS: A measles outbreak in 2025 provided an opportunity to examine the perspectives of 3 pediatric intensive care unit nurses who cared for critically ill children with measles. Interviews revealed strengths and stressors they encountered during their care of these patients.
OUTCOMES: The nurses demonstrated resilience and adaptation while managing an infectious disease outbreak. They used organizational support, teamwork, and lessons learned from the COVID-19 pandemic to navigate the complexities of patient care. Strengths included enhanced preparedness, responsiveness facilitated by organizational leaders, and infection prevention measures. Stressors included media impact, community trust issues, and communication barriers. Despite these challenges, the nurses were committed to overcoming misinformation, building trust, and effectively communicating with families to ensure comprehensive disease prevention education.
CONCLUSION: Recommendations for health care institutions include enhancing media literacy, addressing vaccine hesitancy, and promoting disaster preparedness to equip nurses for future challenges
Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction.
No full textBackground: Systemic inflammation contributes to the pathophysiology of heart failure (HF). Inflammation in heart failure with mildly reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF) has been linked to cardiovascular-kidney-metabolic conditions, whereas inflammation in heart failure and reduced ejection fraction (HFrEF) is thought to develop secondary to cardiac stress and circulatory derangements.
Objectives: This study aims to characterize the prevalence and correlates of systemic inflammation across the spectrum of HF.
Methods: Patients with HF participating in 3 large outcome trials (SELECT, SOUL, and FLOW) were examined to identify the prevalence of systemic inflammation, defined as elevated high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L. Clinical characteristics associated with elevated hsCRP were examined by HF subtype and across the HF spectrum.
Results: Across the 3 trials, 3,204 patients had HFpEF, 1,246 had HFmrEF, and 1,018 had HFrEF. Elevated hsCRP was observed in 2,335 patients (52.5%) with HFpEF/HFmrEF and 503 patients (49.4%) with HFrEF. Compared with patients with lower hsCRP levels, those with higher hsCRP levels were more likely to be female and have obesity, diabetes, lower estimated glomerular filtration rate, higher albuminuria, and chronic obstructive pulmonary disease, without meaningful differences by HF subtype. hsCRP level was unrelated to ejection fraction (R2 \u3c 0.001; P = 0.73) but increased linearly with the number of comorbidities for all HF subtypes (R2 = 0.94; P \u3c 0.001).
Conclusions: Systemic inflammation is present in one-half of patients with HF, and is associated with excess body fat, chronic kidney disease, albuminuria, and diabetes, and increases with comorbidity burden. These relationships are not specific to HFpEF/HFmrEF but are also common to HFrEF (Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity [SELECT]; NCT03574597; A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease [FLOW]; NCT03819153; A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes [SOUL]; NCT03914326)
Antineutrophil Cytoplasmic Antibody Negative Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) Presenting as Acute Decompensated Heart Failure.
No full textBACKGROUND: Eosinophilic granulomatosis with polyangiitis (EGPA) is a chronic inflammatory condition with eosinophilic infiltration of the respiratory system, heart, peripheral nerves, integumentary system, and gastrointestinal tract.
CASE SUMMARY: A man in his mid-60s presented with a 3-month history of progressive dyspnea. He was found to have a large pleural effusion. Over the subsequent 3 months, dyspnea returned, and echocardiography demonstrated left ventricular hypokinesis with an ejection fraction of 40%. He was later admitted for altered mental status and found to have an elevated total eosinophil count with negative antineutrophil cytotoxic antibodies. Repeat echocardiography revealed ventricular thrombi and ejection fraction of 20%. Endomyocardial biopsy revealed eosinophilic infiltration, necrosis, and fibrosis. He was treated with oral prednisone and intravenous cyclophosphamide for 6 months and maintained on oral azathioprine and prednisone.
DISCUSSION: Antineutrophil cytotoxic antibody-negative EGPA is associated with a cardiac-predominant presentation, which is effectively treated with induction and maintenance immunosuppression.
TAKE-HOME MESSAGE: Cardiac involvement should be further evaluated on recognition of EGPA
Evaluating the Longitudinal Impact of Mental Health First Aid Training on Student Pharmacist Perceptions.
No full textOBJECTIVE: To assess the longitudinal impact of Mental Health First Aid (MHFA) training on student pharmacists\u27 perceptions of stigma, comfort, confidence, and willingness to intervene with someone experiencing a mental health issue over time.
METHODS: Students in a PharmD program completed MHFA training as a curricular requirement and were surveyed to gather perceptions 6 months after the training. Survey data were analyzed in combination with 2 separate surveys conducted immediately before and after the training during a previous project. Surveys included multiple validated tools for evaluating students\u27 perceptions of mental health stigma as well as comfort, confidence, and willingness to intervene with someone experiencing mental health challenges. A 1-way repeated-measures analysis of variance and t tests with the Bonferroni correction were used to analyze results.
RESULTS: MHFA training was completed by 235 students, and the 6-month post-training survey was completed by 147. A significant change in scores was observed in students\u27 ability to identify mental health concerns, recognize suicide warning signs, and provide resources for mental health and suicide prevention counseling. A significant improvement in stigma was limited over time; willingness to work with a colleague who disclosed a mental illness and to tell friends about their own mental illness improved immediately after training but not at 6 months post-training.
CONCLUSION: MHFA had mixed longitudinal results in decreasing stigma,but did impact both professional and personal views on mental health. MHFA training was most impactful in increasing student confidence in assisting individuals experiencing mental health concerns and in suicide prevention
Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial.
No full textCoronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention (PCI) is often performed as an alternative to CABG in patients at high surgical risk. However, in patients with HFrEF and limited myocardial reserve, PCI may result in haemodynamic instability, increasing risk and precluding optimal revascularisation. Mechanical circulatory support (MCS) during high-risk PCI may enhance haemodynamic stability during the procedure and enable complete revascularisation. We thus performed the PROTECT IV trial to determine whether PCI with routine use of the Impella CP microaxial flow pump improves early and late outcomes in patients with HFrEF and complex CAD compared with PCI with or without use of an intra-aortic balloon pump (IABP). PROTECT IV is a prospective, multicentre, randomised, parallel-controlled, open-label, superiority trial with an adaptive design. Patients with complex CAD and left ventricular ejection fraction ≤40% (n=1,252) deemed at excessive surgical risk for bypass grafting by the Heart Team will be randomised in a 1:1 ratio to PCI with Impella CP versus PCI with or without an IABP. The primary endpoint is the composite of all-cause death, stroke, myocardial infarction, unplanned clinically driven revascularisation, durable left ventricular assist device implant or heart transplant, or other hospitalisation for cardiovascular causes at 3-year follow-up, with at least 1-year follow-up in all patients. Prespecified substudies will evaluate the impact of MCS on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment. The PROTECT IV trial will determine whether routine MCS with Impella CP during high-risk PCI improves the prognosis of patients with complex CAD and HFrEF
Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis.
No full textBACKGROUND: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated 2-year efficacy in non-radiographic axial spondyloarthritis (nr-axSpA) and radiographic axSpA (r-axSpA) phase III studies.
OBJECTIVE: Assess the impact of BKZ on peripheral manifestations to week 104 of those studies.
METHODS: BE MOBILE 1 (nr-axSpA) and 2 (r-axSpA) each comprised a 16-week double-blind, placebo-controlled period, then all received BKZ 160 mg every 4 weeks for 36 weeks. Patients not meeting withdrawal criteria could enter a combined open-label extension. We report change in enthesitis (Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)) in patients with baseline MASES\u3e0, peripheral arthritis (swollen joint count (SJC)/Disease Activity Index for Psoriatic Arthritis (DAPSA)) in patients with baseline SJC\u3e0 and proportions achieving DAPSA disease states to week 104. Resolution of enthesitis (MASES=0)/arthritis (SJC=0) is reported to week 104 for those with baseline enthesitis/arthritis. We also report associations between peripheral manifestation resolution (MASES=0/SJC=0) and week 104 clinical outcomes in those with baseline enthesitis/arthritis.
RESULTS: At baseline, 186/254 (73.2%) and 88/254 (34.6%) patients with nr-axSpA had enthesitis (MASES\u3e0) and arthritis (SJC\u3e0), respectively, compared with 199/332 (59.9%) and 66/332 (19.9%) patients with r-axSpA. Pooled BKZ/placebo-randomised patients with enthesitis (nr-axSpA/r-axSpA) showed average MASES improvement from 4.8/4.3 (baseline) to 1.6/1.3 (week 52) and 1.6/1.0 (week 104). Pooled BKZ/placebo-randomised patients with arthritis showed average SJC improvement from 4.0/4.5 (baseline) to 1.2/0.7 (week 52) and 0.9/0.6 (week 104). Over 60% of patients achieved DAPSA low disease activity/remission by week 52. Over 40%/60% patients achieved resolution of enthesitis (MASES=0)/arthritis (SJC=0) at week 104; enthesitis resolution was associated with larger improvements in week 104 clinical outcomes for patients with r-axSpA.
CONCLUSION: BKZ resulted in sustained improvements in peripheral manifestations to 2 years across the full disease spectrum of axSpA
Characterization of sarcoidosis at a combined rheumatology-pulmonary clinic.
No full textOBJECTIVE: The treatment landscape for sarcoidosis remains poorly defined, as there is no standardized approach to management. This study aims to characterize a cohort of sarcoidosis patients in a combined rheumatology-pulmonary clinic with regard to organ involvement and medications used. To our knowledge, this will be the first published manuscript to detail such a population, providing critical insight to inform and improve the care of patients with sarcoidosis in the multidisciplinary setting.
METHODS: This study was a retrospective chart review of sarcoidosis patients seen at the collaborative rheumatology-pulmonology clinic at Oregon Health & Science University during the first 5 years following the clinic\u27s inception (October 2018 to October 2023). Using ICD-10 diagnostic codes, 219 patient charts were identified. Of these, 37 were excluded for not meeting inclusion criteria, resulting in 182 charts eligible for data analysis. We used Excel spreadsheets to analyze our data.
RESULTS: 119 (65.3%) of patients in our data base had multi-organ involvement of sarcoidosis. Treatment patterns differed between patients with multi-organ sarcoidosis and those with single-organ or isolated lung/lymph node involvement. Notable differences (in prescribing) were observed among patients with cardiac and neurologic manifestations. Additionally, patients with cardiac involvement demonstrated distinct demographic characteristics, including differences in age and SRY carrier status, when compared to the broader cohort.
CONCLUSION: Our data highlights the complexity and heterogeneity of sarcoidosis seen in a combined rheumatology-pulmonary clinic. Further research is required to prospectively evaluate various pharmacologic treatment in these patients