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Budget Impact of Faricimab in Neovascular Age-Related Macular Degeneration in the Netherlands: A Systematic Review and Meta-Analysis of Injection Count

Ophthalmol Ther. 2026 Jan 16. doi: 10.1007/s40123-025-01301-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Frequent anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of neovascular age-related macular degeneration (nAMD) burden patients and healthcare systems. Faricimab may reduce this burden, but robust data are lacking. This study aimed to systematically quantify the injection frequency reduction with faricimab compared to anti-VEGF agents and estimate Dutch budget impact.

METHODS: A systematic review of studies on patients with nAMD switching to faricimab was conducted in PubMed. A hybrid approach using artificial intelligence (NotebookLM) and manual verification was employed for data extraction and risk of bias assessment. A random-effects meta-analysis determined the pooled mean difference in annual injections. A budget impact analysis estimated direct medical costs (drug and administration costs) over a 1-year time horizon using Dutch data.

RESULTS: A meta-analysis of 19 real-world studies (2231 patients) was conducted. Patients switched to faricimab for persistent fluid or to extend treatment intervals, resulting in a significant mean reduction of 2.65 injections in the first year (from 9.70 to 7.05; 95% confidence interval – 3.36 to – 1.93). The base-case analysis projected annual savings of approximately €79 million, corresponding to 96,235 fewer injections nationwide. Scenario analyses showed that substantial savings (€16 to €75 million) can be achieved when using faricimab in second- and third-line settings, although replacing first-line bevacizumab would increase costs.

CONCLUSIONS: Switching patients to faricimab reduced the injection frequency by two to three injections in the first year. Although evidence certainty was limited by statistical heterogeneity, the reduction was consistent across studies. Although replacing first-line bevacizumab increases costs, substantial savings are achievable in later lines. Strategic positioning of faricimab in the second-line yields significantly higher savings compared to third-line use, and could significantly lower the clinical, patient, and economic burden of nAMD care in the Netherlands. These findings provide quantified, real-world evidence to inform Dutch clinical practice and healthcare policy.

PMID:41543675 | DOI:10.1007/s40123-025-01301-0

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The role of multimodality imaging in selection, response assessment, and follow-up of patients receiving 177Lutetium-PSMA-therapy

Insights Imaging. 2026 Jan 16;17(1):13. doi: 10.1186/s13244-025-02151-x.

ABSTRACT

Prostate cancer is the most commonly diagnosed cancer among men in 112 countries, accounting for approximately 15% of all cancer cases. Whilst the 5-year survival rate for localised disease exceeds 90%, there is a significant drop to 50% if metastases are present. Following the VISION and TheraP trials, 177Lu-PSMA-therapy was approved for treatment of metastatic castrate resistant prostate cancer by the FDA and EMA 2022. Patient selection for 177Lu-PSMA-therapy is now relatively well defined, guided by PSMA-PET/CT criteria established in pivotal trials. Nevertheless, clinical consensus on appropriate criteria is still evolving, and additional imaging modalities such as 18F-FDG PET, post-therapy SPECT/CT, or emerging techniques such as whole-body diffusion-weighted MRI may serve as valuable adjuncts to identify PSMA-negative or treatment-resistant disease that may not be apparent on PSMA-PET/CT alone. This review examines the current evidence on imaging biomarkers and complementary diagnostic techniques used for patient selection, treatment monitoring, and response assessment in [¹⁷⁷Lu]Lu-PSMA-617 therapy for metastatic castrate resistant prostate cancer. Baseline imaging biomarkers on PSMA-PET/CT, such as mean standardised uptake value (SUVmean), PSMA-avid total tumour volume, and inter-lesional PSMA heterogeneity, have shown promise in predicting treatment response and assessing outcomes. Additionally, statistical prognostic models have been developed to predict treatment efficacy, though further validation is required. Imaging plays a crucial role and should be considered alongside blood biomarkers, clinic-demographic history, and circulating tumour markers to improve patient selection for 177Lu-PSMA-therapy. CRITICAL RELEVANCE STATEMENT: PSMA-PET/CT is the established imaging modality for patient selection for ¹⁷⁷Lu-PSMA-therapy, while ¹⁸F-FDG PET, post-therapy SPECT/CT, and emerging techniques such as whole-body diffusion-weighted MRI can be adjunctive for patient selection, response assessment and long-term monitoring. KEY POINTS: PSMA-PET/CT is the mainstay for patient selection for ¹⁷⁷Lu-PSMA-therapy. 18F-FDG PET, SPECT/CT or whole-body diffusion-weighted MRI could be used as adjuncts. Interim and longitudinal PSMA-PET/CT offer sensitive detection of progression, quantitative biomarkers for response assessment, and standardised frameworks. Advances in AI, radiomics, and standardisation frameworks may refine prognostication, enable personalised dosimetry, and integrate imaging biomarkers into clinical practice, though further validation is required.

PMID:41543663 | DOI:10.1186/s13244-025-02151-x

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Forming bootstrap confidence intervals and examining bootstrap distributions of standardized coefficients in structural equation modelling: A simplified workflow using the R package semboottools

Behav Res Methods. 2026 Jan 16;58(2):38. doi: 10.3758/s13428-025-02911-z.

ABSTRACT

Standardized coefficients – including factor loadings, correlations, and indirect effects – are fundamental to interpreting structural equation modeling (SEM) results in psychology. However, they often exhibit skewed sampling distributions in finite samples, which are not captured by conventional symmetric confidence intervals (CIs). Methods such as bootstrap CI that do not impose symmetry are more appropriate for these coefficients. Despite its popularity, the widely used R package lavaan (version 0.6-19 or earlier) provides limited bootstrap support for standardized coefficients. Specifically, its function standardizedSolution() uses the delta method for CIs and lacks bootstrap p values. It provides a flexible and powerful function, bootstrapLavaan(), for bootstrapping, and it can be used to form bootstrap CIs for the standardized coefficients. However, this function requires a certain level of R coding skills. Moreover, no built-in functions are available to inspect bootstrap distributions, which are recommended for assessing the stability of the bootstrap estimates. To address these limitations, we developed the semboottools R package, which provides a simple workflow in SEM to form bootstrap confidence intervals for unstandardized and standardized estimates of model and user-defined parameters. It allows researchers to generate percentile or bias-corrected bootstrap CIs, standard errors, asymmetric p values, compare the bootstrap CIs with other CI methods (e.g., delta method), and visualize the distributions of bootstrap estimates – with minimal coding effort. We believe the tool can facilitate researchers in easily forming bootstrap CIs, comparing different CI methods to assess the need for bootstrapping, and examining the distribution of bootstrap estimates to assess their stability.

PMID:41543658 | DOI:10.3758/s13428-025-02911-z

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5 T vs 3 T Non-contrast enhanced MRA: enhanced vessel delineation and lipid suppression in lower limbs

MAGMA. 2026 Jan 16. doi: 10.1007/s10334-025-01319-2. Online ahead of print.

ABSTRACT

OBJECTIVE: This study compared image quality and lipid suppression efficacy between 5 and 3 T MR systems for lower-extremity non-contrast enhanced magnetic resonance angiography (NCE-MRA) using an optimized 2D time-of-flight (TOF) sequence with spatially separated lipid pre-saturation (SLIP).

MATERIALS AND METHODS: Ten healthy volunteers underwent 2D TOF examination on lower limbs at both field strengths. The SLIP technique was evaluated across field strengths and compared with conventional CHESS to assess lipid suppression efficiency. Subjective scoring was used to assess vessel visualization and image quality, while quantitative analysis of vessel-to-muscle contrast ratios was performed. Statistical significance was determined using paired t-tests. Three patients with Peripheral Arterial Occlusive Disease (PAOD) were evaluated at 5 T and compared to computed tomography angiography (CTA) as the reference standard.

RESULTS: The implementation of SLIP underscores the capability of increased field strength for more effective implementation of chemical shift-based lipid suppression technique. 5 T NCE MRA demonstrated higher Likert scores of radiologists’ subjective evaluations of vessel delineation (5 T vs 3 T: 3.73 vs. 3.47, P < 0.001) and image quality (3.58 vs 3.27, P = 0.002) than 3 T. Vessel-to-background ratio (VBR) (14.87 ± 3.80 vs 10.07 ± 2.64, P < 0.001) and vessel contrast-to-background ratio (VCBR) were higher at 5 T (0.84 ± 0.11 vs 0.77 ± 0.12, P < 0 .001), indicating enhanced vessel delineation than 3 T.

CONCLUSION: 5 T NCE-MRA outperforms 3 T in visualizing lower limb vasculature, with enhanced lipid suppression and reduced in-plane saturation artifacts, offering a non-invasive alternative for peripheral vascular assessment.

PMID:41543643 | DOI:10.1007/s10334-025-01319-2

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Integrating multiomics data using a correlation based graph attention network for subtype classification in lower grade glioma

Discov Oncol. 2026 Jan 16. doi: 10.1007/s12672-026-04428-z. Online ahead of print.

ABSTRACT

Accurate classification of cancer subtypes is crucial for personalised therapies and targeted interventions. In this study, we propose BioGAT-LGG, a deep learning framework that integrates multi-omics data, including mRNA, miRNA, and DNA methylation, using a correlation-based Graph Attention Network version 2 (GATv2) for biomarker discovery and Lower-Grade Glioma (LGG) subtype classification. Unlike existing methodologies that rely on external biological priors, such as protein-protein interaction networks or reference graphs, BioGAT-LGG constructs gene-driven correlation graphs, enabling the model to learn biologically meaningful molecular interactions. To improve feature interpretability and reduce dimensionality, LASSO regression is performed during model training. The model achieved 98.03% accuracy, with precision (98.12%), recall (97.74%), and F1-score (97.87%) in a stratified 10-fold cross-validation. Extensive analysis and enrichment of known cancer-related pathways, including PI3K-Akt signalling, Small Cell Lung Cancer, and Transcriptional Misregulation in Cancer, identified the biomarkers hsa-mir-3936, MTCO1P40, and CCND2, which were subsequently validated. These results indicate that BioGAT-LGG effectively captures biologically validated mechanisms and can enable clinically significant subtype classification and biomarker-guided decision-making. This framework thus lays a scalable foundation for multi-omics integration in oncology, which can be further adopted in other tumour types.

PMID:41543639 | DOI:10.1007/s12672-026-04428-z

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Concurrent inguinal hernia repair during robotic radical prostatectomy: a systematic review and meta-analysis

Hernia. 2026 Jan 16;30(1):64. doi: 10.1007/s10029-025-03568-5.

ABSTRACT

PURPOSE: Inguinal hernias are commonly encountered during robotic-assisted radical prostatectomy (RARP), either preoperatively or intraoperatively. Performing concurrent inguinal hernia repair (IHR) at the time of RARP may prevent the morbidity, cost, and inconvenience associated with a second operation. This systematic review and meta-analysis aimed to evaluate the safety and efficacy of concurrent IHR during RARP compared with RARP alone.

METHODS: This study followed PRISMA guidelines and was prospectively registered with PROSPERO (CRD42025646245). Comprehensive searches of PubMed, EMBASE, and Cochrane CENTRAL were conducted to identify studies comparing outcomes of RARP with and without concurrent IHR. Primary outcomes included operative time, length of hospital stay, blood loss, and postoperative complications. A proportional meta-analysis was performed using a random-effects model, and heterogeneity was assessed using the I² statistic.

RESULTS: Twenty studies comprising 1,402 patients who underwent concurrent IHR and 20,405 patients who underwent RARP alone were included. Concurrent IHR was associated with a statistically significant increase in operative time (mean difference 30.45 min; 95% CI 13.71-77.38) but showed no significant differences in postoperative complications, blood loss, or hospital stay. The pooled hernia recurrence rate was low (mean 1.9%), and Clavien-Dindo I-III complication rates were comparable between groups.

CONCLUSION: Concurrent IHR during RARP may be feasible, with perioperative outcomes broadly comparable to RARP alone. Concurrent repair may be considered in selected patients and experienced centres however given study heterogeneity and the predominance of retrospective evidence, these findings should be interpreted cautiously.

TRIAL REGISTRATION: The trial was prospectively registered on PROSPERO on 03/02/2025 under ID: CRD42025646245.

PMID:41543617 | DOI:10.1007/s10029-025-03568-5

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Bodies under stress-a psychological parallel mediation model between daily LGBTQ + heterosexism and eating disorder risk

Eat Weight Disord. 2026 Jan 16. doi: 10.1007/s40519-026-01817-9. Online ahead of print.

ABSTRACT

PURPOSE: LGBTQ + people have shown health disparities compared to heterosexual and cisgender people in eating disorders. How these disparities are determined, however, is an understudied area. Through the use of a psychological mediation framework, this study aims to explore how daily heterosexist experiences related to one’s LGBTQ + identity may determine eating disorder risk.

METHODS: 376 LGBTQ + people from Italy responded to self-report questionnaires regarding daily heterosexist experiences, eating behaviors and associated factors in an online anonymous survey. Descriptive, bivariate and mediation analyses were conducted using the “PROCESS” macro, including distress scores for heterosexist experiences, emotion dysregulation, self-esteem, shame, and eating disorder risk, controlling for body-mass index, age and socioeconomic status.

RESULTS: Statistically significant positive associations were found between distress related to heterosexist experiences, emotion dysregulation, shame and eating disorder risk. Mediation analyses found that the direct effect of heterosexist experiences on eating disorder risk was nonsignificant. The indirect effects of heterosexist experiences on eating disorder risk through emotion dysregulation (B = 0.041, β = 0.304, BootSE = 0.017, 95% CI [0.006, 0.078]) and low self-esteem (B = 0.092, β = 0.089, BootSE = 0.023, 95% CI [0.049, 0.145]) were significant. The indirect effect through shame was nonsignificant.

CONCLUSIONS: Heterosexist experiences seem to have significant indirect effects on eating disorder risk through emotion dysregulation and low self-esteem. Policies for reducing harassment, discrimination and violence related to sexual orientation and gender identity in institutional, organizational and social contexts may help prevent negative health outcomes in LGBT + people. Clinical contexts may benefit from considering the effects of minority stress.

LEVEL OF EVIDENCE: Level 3-Observational cross-sectional study.

PMID:41543611 | DOI:10.1007/s40519-026-01817-9

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Diabetes risk reduction diet and the risk of oral and pharyngeal cancer

Eur J Nutr. 2026 Jan 16;65(1):32. doi: 10.1007/s00394-025-03888-3.

NO ABSTRACT

PMID:41543610 | DOI:10.1007/s00394-025-03888-3

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Biopolymeric Zein Protein Nanoparticles for Oral Vildagliptin Delivery: Fabrication, Statistical Optimization, and In Vivo Pharmacokinetics and Pharmacodynamics Insights

AAPS PharmSciTech. 2026 Jan 15;27(1):74. doi: 10.1208/s12249-025-03300-7.

ABSTRACT

Vildagliptin (VLD) is a powerful oral hypoglycemic agent used in the management of type II diabetes. The goal of the current research was to develop VLD-loaded zein protein-based nanoparticles (VLD-ZP NPs) for enhancing their oral hypoglycemic effect, achieving a sustained release profile, and addressing the issues associated with rapid metabolism and side effects. A 23 full factorial design was utilized to assess the influence of independent formulation variables on the observed responses. The independent variables considered were VLD-to-zein weight ratio (X1), ethanol-to-water volume ratio (X2), and stirring time (X3). The dependent responses evaluated were particle size (Ps), zeta potential (Zp), entrapment efficiency (EE), and percent of drug release after 2H (Q2H) and 8H (Q8H). The optimized VLD-ZP NPs formula (F04), with a desirability value of 0.94, exhibited a small Ps (149.64 ± 1.4nm), low Q2H (23.97 ± 2.1%), high Zp (- 37.67 ± 1.8mV), high EE (68.67 ± 2.3%), and sustained Q8H release (62.57 ± 2.4%). Further investigations of F04 confirmed sustained drug release, spherical vesicle morphology through TEM, and effective entrapment via DSC and X-ray diffraction. In vivo pharmacokinetic studies revealed that Cmax and AUC0-12H of F04 were enhanced by 1.25-fold and 1.8-fold compared to the marketed VLD product. Also, t1/2 and MRT were extended by 1.84-fold and 1.56-fold, respectively. These findings indicated improved oral bioavailability and prolonged residence time of VLD. Additionally, the in vivo pharmacodynamic study revealed that F04 provided markedly superior and sustained hypoglycemic effects over the marketed VLD product, with higher Rmax, longer TR½, and a 2.8-fold increase in AUC(0-24H).

PMID:41540169 | DOI:10.1208/s12249-025-03300-7

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Effectiveness and Safety of Biqi Capsules in 2,267 Patients with Rheumatoid Arthritis: A Real-World Clinical Study

Chin J Integr Med. 2026 Jan 15. doi: 10.1007/s11655-026-4137-5. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the effectiveness and safety of Biqi Capsules in the treatment of rheumatoid arthritis (RA).

METHODS: This multicenter, prospective cohort study was conducted across more than 100 centers in China. Data on RA patients were collected from the CERTAIN database between January 2019 and March 2024. Patients were categorized into an exposed group and a control group. The control group was treated with conventional Western medicine, and the exposed group was combined with Biqi Capsules (0.3 g/capsule, 4 capsules per dose, orally, 2-3 times/d) on the basis of conventional treatment. Propensity score matching (PSM) was applied to balance baseline characteristics. The main outcomes was the Disease Activity Score-28 (DAS28-ESR), and secondary outcomes included Health Assessment Questionnaire (HAQ), Visual Analogue Scale (VAS) for pain, tender joint count (TJC), swollen joint count (SJC), Patient Global Assessment (PGA), and Evaluator Global Assessment (EGA) scores, as well as erythrocyte sedimentation rate (ESR), and other laboratory test results as safety indicators.

RESULTS: A total of 2,267 patient records were analyzed, with 711 in the exposed group and 1,556 in the control group. After PSM, 710 patients were included in each group, with comparable baseline demographic characteristics (P>0.05). Following matching, pre-treatment HAQ and TJC were similar between groups (P>0.05), while significant differences were observed in DAS28-ESR, EGA, PGA, VAS, SJC, TJC, and ESR (P<0.01). Post-treatment analysis showed that all indices improved significantly in both groups (P<0.01). Furthermore, post-treatment levels of EGA, PGA, VAS, SJC, and TJC were statistically significant between the two groups (P<0.01). The reduction in DAS28-ESR was significantly greater in the exposed group than in the control group (P<0.01). Statistically greater improvements were also found in EGA, PGA, SJC, TJC, and ESR, indicating superior clinical improvement in the exposed group (P<0.01). The incidence of abnormal γ-glutamyl transferase and creatinine levels were higher in the control group than in the exposed group (P<0.01 or P<0.05), while no significant differences were observed in other safety indicators between the two groups (P>0.05).

CONCLUSION: Biqi Capsules combined with conventional treatment of Western medicine effectively reduce RA disease activity, lower inflammation levels, relieve clinical symptoms, and do not increase the incidence of adverse events. (Registration No. NCT05219214).

PMID:41540164 | DOI:10.1007/s11655-026-4137-5