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Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial.
No full textPsoriatic arthritis (PsA) is a progressive, multidomain and interleukin-17 (IL-17)-linked disease that results in substantial quality-of-life deficits. Thereby, we conducted a phase 2 randomized, double-blind, placebo (PBO)-controlled trial of sonelokimab (SLK), a nanobody that binds with a similarly high affinity to IL-17A and IL-17F, inhibiting all dimers. Overall, 207 patients with active PsA were randomized to SLK 120-mg or 60-mg every 4 weeks (Q4W; both with induction (WI)), or to 60-mg Q4W with no induction, PBO or adalimumab (reference arm). The primary endpoint of American College of Rheumatology (ACR) 50 at week 12 was met for SLK 60-mg and 120-mg WI (60-mg WI = 46.3% (19/41; odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.3-9.9; P \u3c 0.05); 120-mg WI = 46.5% (20/43; OR = 4.0; 95% CI = 1.4-11.3; P \u3c 0.01) versus PBO = 20.0% (8/40)). SLK resulted in significant benefits across the key secondary endpoints of ACR20 (60-mg WI = 78.0% (32/41; P \u3c 0.001) and 120-mg WI = 72.1% (31/43; P = 0.002) versus PBO = 37.5% (15/40)) and Psoriasis Area and Severity Index (PASI) 90 at week 12 (60-mg WI = 76.9% (20/26; P \u3c 0.001) and 120-mg WI = 59.3% (16/27; P = 0.003) versus PBO = 15.4% (4/26)). Robust responses were observed among patients randomized to SLK at week 24 for the high-threshold composite endpoints of ACR70 + PASI 100 (exploratory) and minimal disease activity (secondary), achieved by up to 48% (13/27; 120-mg WI) and 61% (25/41; 60-mg WI), respectively. SLK was well-tolerated; the most common treatment-emergent adverse events were nasopharyngitis (60 mg = 6.1%; 120 mg = 5.2%), upper respiratory tract infection (60 mg = 6.1%; 120 mg = 4.1%), injection-site erythema (60 mg = 3.7%; 120 mg = 3.1%) and headache (60 mg = 2.4%; 120 mg = 4.1%). Four cases of mild to moderate oral candidiasis occurred (60 mg = 2.4%; 120 mg = 2.1%). Overall, SLK delivered substantial improvements in the signs and symptoms of PsA across various outcomes and domains. ClinicalTrials.gov registration: NCT05640245
Using Chlorhexidine-Coated Dialysis Catheter Caps to Reduce Central Venous Dialysis Catheter Infection Rates: A Quality Improvement Project.
No full textBACKGROUND: Many patients with end-stage kidney disease begin dialysis therapy with central venous dialysis catheters, significantly increasing the risk of dialysis catheter-related bloodstream infection. Bloodstream infections are among the most severe harm events affecting patients receiving dialysis.
LOCAL PROBLEM: In 2023, the dialysis catheter-related central line [catheter]-associated bloodstream infection (CLABSI) rate at an acute care medical center in southern California was thrice the national benchmark. This quality improvement project aimed to decrease this rate by adding chlorhexidine-coated dialysis catheter caps to standard care.
METHODS: Using the Knowledge to Action model, the medical center made a dialysis catheter-related CLABSI reduction practice change. Preimplementation and postimplementation monthly aggregate data were collected for dialysis catheter-related CLABSIs, central venous dialysis catheter days, and dialysis catheter-related infection rates. One-on-one dialysis staff simulation training and process compliance audits ensured intervention fidelity. The intervention was replacement of nonchlorhexidine dialysis catheter caps with chlorhexidine-coated dialysis catheter caps for patients with central venous dialysis catheters.
RESULTS: An 8-week preimplementation period included 119 patients, 561 dialysis therapies, 934 central dialysis catheter days, and 2 dialysis catheter-related CLABSIs (2.14 infections per 1000 catheter days). An 8-week postimplementation period included 128 patients, 583 dialysis therapies, 897 central dialysis catheter days, and 0 dialysis catheter-related CLABSIs; no dialysis catheter-related CLABSIs occurred during postimplementation sustainability assessment (24 weeks total).
CONCLUSIONS: Use of chlorhexidine-coated dialysis catheter caps led to clinically significant results among patients receiving dialysis with central catheters at an acute care medical center
Telehealth in Radiation Oncology: Time to Refine, Not Just Expand.
No full textThe COVID-19 pandemic accelerated the adoption of telehealth in radiation oncology, transforming on-treatment management visits (OTVs) into virtual encounters and expanding access, particularly in rural settings. A Medicare-based analysis by Patel et al. found that telehealth OTVs were associated with higher rates of ED visits, hospitalizations, and Medicare spending, raising concerns about unintended consequences of widespread telehealth use without adequate safeguards. While telehealth offers convenience and broader access, it may also compromise real-time clinical assessment and symptom management. These findings underscore the need for a risk-stratified, evidence-informed approach to telehealth policy in radiation oncology, one that prioritizes refinement and appropriate integration rather than unchecked expansion
Early implementation study of a co-caring and virtual nursing model.
No full textBACKGROUND: The Co-Caring Nursing Model, incorporating virtual registered nurses (vRNs) into team-based nursing, aims to address challenges due to nursing shortages, increasing patient acuity, and professional burnout.
PURPOSE: To evaluate the early impact of the Co-Caring Nursing Model on patient experience, safety (as measured by rates of catheter-associated urinary tract infections and central line-associated bloodstream infections), cost of care, and employee experience.
METHODS: This study used a difference in difference approach, analyzing electronic medical records from August 2023 to August 2024. Employee experience with the model and burnout in the workplace were assessed via a survey administered 6 months post implementation.
DISCUSSION: Length of stay increased modestly for intervention units; no significant changes in readmissions, patient experience, or safety metrics were observed. Employee feedback revealed varied experiences: vRNs favored the model, while bedside registered nurses (bRNs) reported more challenges.
CONCLUSION: The model does not adversely affect patient safety or costs but presents challenges in bRN workload and adaptation. Effective change management is crucial for successful implementation
Therapeutic Considerations in Preventing Chronic Kidney Disease.
No full textChronic kidney disease (CKD) affects 35.5 million US adults, but most patients are unaware of their diagnosis. Screening for CKD at-risk individuals is required, as symptoms do not appear until advanced stages. The combination of urine albumin-to-creatinine ratio and estimated glomerular filtration rate permits the classification of CKD stages and the determination of risk of CKD progression and cardiovascular disease, which is the most common cause of death in CKD. Cardiovascular-kidney-metabolic syndrome highlights the complex interplay between the heart, kidney, and metabolic disorders, such as diabetes and dysfunctional obesity, which promotes chronic inflammation, leading to injury in these organs and systems. New guideline-directed medical therapies consisting of sodium-glucose cotransporter 2 inhibitors, glucose-like peptide-1 receptor agonists, and nonsteroidal mineralocorticoid receptor antagonists, in addition to standard-of-care therapies including angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, have revolutionized CKD management, which may be best facilitated through a multidisciplinary care approach
Multidomain therapy for Alzheimer\u27s disease: a scoping review of cognitive decline trials.
No full textImpact of Complications on DRG Assignment for Adult Spinal Deformity Surgery Using the ISSG-AO Classification System.
No full textSTUDY DESIGN: Retrospective cohort.
OBJECTIVE: The ISSG-AO Spinal Deformity Complication Classification System (SDCCS) predicts Diagnosis Related Group (DRG) coding and cost.
BACKGROUND: Inconsistent definitions of complications contribute to variation in reported surgical complication rates. Incorrect complication reporting can lead to over or under DRG reimbursement. The ISSG-AO SDCCS provides improved complication reporting reproducibility and may help predict complication costs.
METHODS: ASD patients were grouped into: DRG without complication or comorbidity (CC) or Major CC (MCC) (DRGs 455 & 458), with CC (DRGs 454 & 457), and with MCC (DRGs 453 & 456). Complications were graded by intervention severity per ISSG-AO system: grade 0 (none), 1 (mild-e.g., med change), 2 (moderate-e.g., ICU), 3 (severe-e.g., reoperation). Cost were based on Medicare inpatient prospective payment system (IPSS, Medicare Allowable rate). A multinomial logistic model identified key predictors of DRG assignment by complication grades.
RESULTS: Of the 675 patients, 14% were in DRGs without CC/MCC, 71% in DRGs with CC, and 15% were DRGs with MCC. Patients with complications requiring intervention mostly fell into the higher DRG categories (97%). Patients who received an intervention are approximately 6.75 (2.01-22.75, P\u3c .0021) times more likely to be classified under DRG with CC and 15.72 (95% CI, 4.23-58.45, P\u3c .0001) times more likely to be classified with DRG with MCC compared to those who did not receive an intervention. Each unit increase in Edmonton Frailty Score raises the odds of being in DRG with MCC by 1.24 (95% CI 1.04-1.48, P 0.017). Similar trends were seen for OR time and LOS. Reimbursement showed incremental increase from 56K to $70K across DRG categories.
CONCLUSIONS: Patients with elevated ISSG-AO scores are more likely to be categorized into higher DRGs, experience extended lengths of stay and generate greater healthcare expenditures. The ISSG-AO SDCCS predicts DRG thereby helping standardize complication reporting
Design and validation of a clinical whole genome sequencing-based assay for patient screening in a large healthcare system.
No full textINTRODUCTION: Population genetic screening is rapidly emerging as a key methodology in the clinical laboratory for detecting actionable genomic conditions in asymptomatic patients. While current clinical methods are largely focused on targeted gene panels, the increasing efficiency of next-generation sequencing (NGS) platforms permits the use of whole genome sequencing (WGS) for routine clinical applications. The key advantage of WGS is that the complete genome produced by a single sequencing event can form the basis for a patient\u27s genomic health care record for reanalysis throughout a patient\u27s lifetime.
METHODS: We developed a scalable clinical WGS-based lab developed procedure (LDP) for heritable disease gene testing and pharmacogenomics (PGx). We performed extensive validation across a range of blood, saliva, and reference specimens.
RESULTS: The clinical deliverable for the WGS LDP was 78 genes associated with actionable genomic conditions and 4 PGx genes. The validation cohort consisted of samples from 188 study participants that were orthogonally sequenced at commercial reference laboratories and additional reference materials. The WGS LDP demonstrated excellent sensitivity, specificity, and accuracy.
CONCLUSION: The deployed LDP was then used to sequence over 2,000 patients as part of a broader clinical implementation study ( Geno4ME ). Our findings support WGS as a viable method for broad clinical screening
Industrialization drives convergent microbial and physiological shifts in the human metaorganism.
No full textUnderstanding how host lifestyle and industrialization shape the human gut microbiome and intestinal physiology requires multimodal analyses across diverse global host contexts. Here, we generate multivariate data from the Global Microbiome Conservancy cohort, including gut microbiome, IgA-sequencing, host genotyping, diet, lifestyle and fecal biomarker profiles, to investigate host-microbiome interactions across gradients of industrialization and geography. We show that industrialization is associated with homogenized microbial compositions, reduced microbial diversity, and lower community stability, independent of host confounders. We further show that industrialization is linked to elevated markers of gut stress, increased IgA secretion, and altered patterns of IgA-bacteria interactions. Finally, we show that microbiome-based disease predictors trained on industrialized populations lose accuracy in less industrialized cohorts, highlighting limited cross-population transferability. Together, our results suggest profound restructuring of host-microbiome interactions due to industrialized lifestyles, and emphasize the need for inclusive, globally representative data to improve translational microbiome applications across diverse human populations