Advances in Therapy最新文献

{"title":"Comparative Effectiveness of Mepolizumab Versus Dupilumab in Medicare Fee-for-Service Beneficiaries with Asthma: A Real-World Cohort Study.","authors":"Guillaume Germain, Emmeline Burrows, Jacob Klimek, Patrick Gravelle, François Laliberté, Arijita Deb","doi":"10.1007/s12325-026-03825-8","DOIUrl":"https://doi.org/10.1007/s12325-026-03825-8","url":null,"abstract":"<p><strong>Introduction: </strong>Mepolizumab and dupilumab are biologic therapies used to manage uncontrolled asthma, though direct comparative real-world evidence between these two agents is limited. This study compared asthma-related hospitalizations and asthma exacerbations between mepolizumab and dupilumab among an older and clinically complex population of Medicare fee-for-service (FFS) beneficiaries with asthma.</p><p><strong>Methods: </strong>Data from Komodo Research Database (01/01/2018-05/31/2025) were used to identify Medicare FFS beneficiaries with asthma and a first claim for mepolizumab or dupilumab on or after January 1, 2019 (index date), as well as a subgroup of patients adherent to the index biologic for ≥ 6 months. Cohorts were balanced using overlap weighting based on a propensity score model. Rates of asthma-related hospitalizations and asthma exacerbations were evaluated while on treatment as the number of events per patient-year (PPY) and compared between weighted cohorts using rate ratios (RRs) with 95% confidence intervals (CIs). Rates of asthma-related hospitalizations were assessed for non-inferiority using a fixed-margin approach.</p><p><strong>Results: </strong>Overall, 1055 and 1218 patients were included in the mepolizumab and dupilumab cohorts, respectively (mean age 70.1 and 67.4 years). Baseline characteristics were well balanced after weighting. Mepolizumab demonstrated non-inferiority to dupilumab for asthma-related hospitalizations within the overall population (RR 0.71, 95% CI 0.46, 1.08; p = 0.113; non-inferiority margin 1.10) and superiority to dupilumab within the adherent subgroup (RR 0.54, 95% CI 0.30, 0.99; p = 0.047). Mepolizumab was also associated with significantly lower rates of asthma exacerbations than dupilumab in the overall population (RR 0.85, 95% CI 0.72, 1.00; p = 0.047) and directionally favorable rates in the adherent subgroup (RR 0.82, 95% CI 0.63, 1.05; p = 0.116).</p><p><strong>Conclusions: </strong>Among Medicare FFS beneficiaries, mepolizumab demonstrated comparable real-world effectiveness to dupilumab for asthma-related hospitalizations and was associated with significantly lower rates of asthma exacerbations, supporting mepolizumab as an effective treatment option for older, clinically complex patients with asthma.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149206512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Diabetes on Risk of Revision Following Anterior Cruciate Ligament Reconstruction: A Real-World Data Study.","authors":"Aikaterini Eleftheriadou, Matthew Anson, Zien Fozo, Shehzaad Khan, Khalid Al-Hourani, Uazman Alam","doi":"10.1007/s12325-026-03815-w","DOIUrl":"https://doi.org/10.1007/s12325-026-03815-w","url":null,"abstract":"<p><strong>Introduction: </strong>Given the increasing prevalence of diabetes mellitus (DM), understanding its impact on anterior cruciate ligament reconstruction (ACLR) revision risk is important for clinical decision-making and patient counselling. This study evaluated whether DM is associated with an increased risk of revision ACLR within 5 years of primary reconstruction.</p><p><strong>Methods: </strong>We conducted a retrospective observational cohort study using a global federated health research network (TriNetX, Cambridge, USA), including 73,951 patients who underwent primary ACLR across 53 healthcare organisations, of whom 990 had DM (type 1 and 2). Patients undergoing primary ACLR between 5 August 2005 and 4 August 2025 were included. The index event was primary ACLR, and the outcome was subsequent ACLR to the ipsilateral knee. Follow-up was extended until revision surgery or up to 5 years. Patients with DM (type 1 or type 2) were compared with patients without DM following 1:1 propensity score matching for age, sex, and BMI. Following propensity score matching, 988 patients were analysed per cohort. Kaplan-Meier survival analysis and hazard ratios (HRs) were used to assess revision risk. A further sensitivity analysis excluded patients undergoing concomitant soft tissue knee procedures, including meniscectomy, meniscal repair, meniscal transplantation, and additional ligament reconstruction procedures.</p><p><strong>Results: </strong>Of the 73,951 patients included, 990 had DM, corresponding to a prevalence of 1.3% among individuals undergoing ACLR. Following propensity score matching, revision ACLR occurred in 30 of 988 patients with DM and 38 of 988 patients without DM, with no statistically significant difference in revision risk between the cohorts (HR 0.77, 95% CI 0.47-1.26). In the sensitivity analysis excluding patients with concomitant soft tissue knee procedures, between 1 and 10 revision events occurred in each matched cohort (243 patients per cohort), and no statistically significant difference in revision risk was observed (HR 0.45, 95% CI 0.08-2.45).</p><p><strong>Conclusion: </strong>DM was not associated with an increased risk of revision ACLR within 5 years of the primary procedure. These findings were consistent in a sensitivity analysis excluding concomitant soft tissue knee procedures. The results should be interpreted in the context of the study's limitations and do not replace individualised clinical risk assessment.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149206431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety, Efficacy, and Pharmacokinetics of Agalsidase Alfa in Treatment-Naive Chinese Patients with Fabry Disease: 52-Week Phase 3, Open-Label, Single-Arm Study.","authors":"Hong Ren, Jianhua Mao, Rong Wang, Yucheng Chen, Zhengqing Qiu, Jing Peng, Yan Ouyang, Jiao Ji, Jaco Botha, Grace Chen, Nan Chen","doi":"10.1007/s12325-026-03688-z","DOIUrl":"https://doi.org/10.1007/s12325-026-03688-z","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical data on the efficacy, tolerability, and pharmacokinetics of agalsidase alfa in Chinese patients with Fabry disease are limited. We evaluated the safety, efficacy, and pharmacokinetics of agalsidase alfa in Chinese patients who are treatment-naive over 52 weeks.</p><p><strong>Methods: </strong>This was an open-label, non-randomized, single-arm, multicenter (six centers in China) phase 3 study. Patients with Fabry disease (aged 7-65 years; either sex) received agalsidase alfa 0.2 mg/kg intravenously (every other week for up to 52 weeks). The primary endpoint was the incidence of serious treatment-emergent adverse events (TEAEs). Secondary endpoints included the incidence of TEAEs, changes from baseline in estimated glomerular filtration rate (eGFR), left ventricular mass index (LVMI), left ventricular ejection fraction (LVEF), and agalsidase alfa pharmacokinetics.</p><p><strong>Results: </strong>Overall, 20 patients were enrolled (May 2022 to January 2024) and received ≥ 1 dose of agalsidase alfa. The median number of infusions was 27; median exposure duration was 12.0 months. Agalsidase alfa was generally well tolerated. Two patients (10.0%) reported one serious TEAE each (sepsis, ectopic pregnancy). All patients reported ≥ 1 TEAE, most of which were mild or moderate (98.2%); nine patients (45.0%) had ≥ 1 TEAE assessed as related to treatment. Baseline eGFR, LVMI, and LVEF were 118.8 (21.4) mL/min/1.73 m², 38.0 (11.2) g/m^2.7, and 66.8% (4.9), respectively. Renal function and cardiac structure and function remained relatively stable over 52 weeks; mean (SD) changes in eGFR, LVMI, and LVEF from baseline were 4.1 (12.5) mL/min/1.73 m², 0.56 (8.71) g/m^2.7, and 0.8% (3.3%), respectively. Agalsidase alfa exposure (area under the concentration-time curve and maximum serum concentration) was generally similar at week 0 and at week 28.</p><p><strong>Conclusions: </strong>Data from this 52-week study support the use of agalsidase alfa as a long-term treatment option for Chinese patients with Fabry disease. Safety, efficacy, and pharmacokinetic profiles were consistent with studies in other populations. Graphical Abstract available for this article.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov id: </strong>NCT04974749.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149190738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Effectiveness and Safety of Advanced Combination Treatment in Patients with Refractory Inflammatory Bowel Disease.","authors":"Enas Fouad Ahmed, Camille Conde Oribiana, Maryam A Alahmad, Nadeen Mamon Omar, Kishore Kumar Chitra Kumar, Mohammed Nabil Quraishi","doi":"10.1007/s12325-026-03828-5","DOIUrl":"https://doi.org/10.1007/s12325-026-03828-5","url":null,"abstract":"<p><strong>Introduction: </strong>Advanced combination treatment (ACT) pairs two advanced therapies with distinct mechanisms of action for inflammatory bowel disease (IBD) that has not responded to single agents. However, real-world evidence on individual regimens remains limited.</p><p><strong>Methods: </strong>We retrospectively identified all ACT courses at a tertiary centre in Abu Dhabi (June 2021 to May 2026). A course required the concurrent use of two advanced therapies with documented clinical intent, with no minimum duration. Disease activity, laboratory values, endoscopic findings and therapeutic drug monitoring were recorded prospectively in the centre's IBD registry, and every rate is reported over the whole cohort. The primary outcome was composite remission (clinical and biochemical remission together); endoscopic outcomes were reported separately.</p><p><strong>Results: </strong>A total of 16 patients (11 Crohn's disease, 5 ulcerative colitis) received 21 courses across 12 regimens; 13 (81%) were Emirati. The commonest combinations paired a selective anti-interleukin-23 agent with a Janus kinase inhibitor (10 courses) or with an anti-tumour necrosis factor agent (5). Patients had failed a median of four prior advanced therapies, and the median course duration was 218 days. Composite remission was achieved in 11 of 21 courses (52%, 95% confidence interval [CI] 30-74%; 11 of 16 patients), clinical remission in 15 of 21 (71%) and biochemical remission in 11 of 21 (52%); 14 of 21 (67%) were corticosteroid-free. Clinically timed endoscopic reassessment in 14 courses showed endoscopic remission in five. Twelve courses (57%) were discontinued, seven for treatment failure. One serious adverse event, a urinary tract infection requiring admission, occurred during combination therapy.</p><p><strong>Conclusion: </strong>ACT achieved composite remission in just over half of courses in this multi-refractory cohort, with one serious adverse event. These findings support consideration of ACT in carefully selected multi-refractory patients under close monitoring; further real-world data on individual regimens are needed to guide the choice of combination.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149190760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ibogaine for Substance Use Disorders.","authors":"Ahmed I Anwar, Abdul-Rahman A Hegazi, M Farris Sawaya, Joshua R Nelson, Audrey E Lashley, Jillian M Gatti, Kristy M Pham, Ibraheem A Hachem, Molly E McNulty, Destiny S Lewis, Kevin S Murnane, Alan D Kaye","doi":"10.1007/s12325-026-03814-x","DOIUrl":"https://doi.org/10.1007/s12325-026-03814-x","url":null,"abstract":"<p><p>Substance use disorders (SUDs) are a major global health burden, and psychedelic-assisted therapies are now gaining scientific interest, with ibogaine being considered as a candidate for anti-addictive effects across multiple substance classes. Ibogaine is a multi-target indole alkaloid acting on opioid, glutamatergic, serotonergic, and sigma systems with potential to rapidly reduce withdrawal and cravings after a single administration. Ibogaine is metabolized into noribogaine, which has a longer half-life and contributes to sustained pharmacological effects. These compounds act on multiple neurotransmitter systems including NMDA receptors, serotonin receptors, and opioid receptors, which allow it to have a broad neurobiological effect. It also has anti-addictive properties linked to neuroplasticity, dopamine modulation, and opioid receptor activity. Additionally, iboga has use in African rituals, with modern interest increasing in the twentieth century. Ibogaine now is an unregulated or semi-regulated substance with increased interest in controlled clinical development as well. Clinical evidence for ibogaine comes from observational studies and case reports, e.g., particularly in opioid use disorder. Ibogaine carries significant risks, particularly cardiotoxicity, neurological adverse effects including hallucinations, and reported fatalities. Safer derivates such as noribogaine and tabernanthalog (TBG) are being developed to retain anti-addictive efficacy and reduce toxicity. Ibogaine induces prolonged oneirogenic states involved in autobiographical memory processing, and outcomes are influenced by setting, integration therapy, and psychotherapy. Current research is largely observational, and studies are small, which highlights the need for standardized protocols and clinical trials. Overall, ibogaine represents a therapeutic candidate for SUDs, with broad anti-addictive potential. In this review, we provide an overview of ibogaine's history and pharmacology, critically examine its therapeutic potential in multiple SUDs, and discuss current limitations, emerging alternatives, and future directions.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiorenal Protective Glucose-Lowering Treatment Patterns in Type 2 Diabetes Mellitus Based on a Real-World Study: A Clinical Phenotype Cluster Analysis.","authors":"Wenjia Yang, Shuzhen Bai, Xiaoling Cai, Ming Liu, Qiuhe Ji, Yanbing Li, Bo Feng, Nanwei Tong, Han Wu, Jingya Yan, Wei Zhao, Linong Ji","doi":"10.1007/s12325-026-03826-7","DOIUrl":"https://doi.org/10.1007/s12325-026-03826-7","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiorenal protective glucose-lowering treatments (CPT), consisting of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs), are widely applied in clinical management of patients with type 2 diabetes mellitus (T2DM). This study aimed to identify distinct clinical phenotypes linked to CPT prescribing patterns and construct a multilevel correlation framework for standardized CPT clinical application.</p><p><strong>Methods: </strong>Data were extracted from the baseline dataset of an observational registry cohort study across 61 medical centers between 2023 and 2024. Based on multiple factors, clinical phenotypes of patients were identified via the Partitioning Around Medoids (PAM) clustering algorithm, CPT utilization was compared across different phenotypes.</p><p><strong>Results: </strong>A total of 9000 patients with T2DM were enrolled [median age 55 (46, 63) years, 60.8% male and 39.2% female, median diabetes duration 5.37 (0.85, 11.44) years]. Three clinically distinct phenotypes were identified: Cluster 1 [older patients with high atherosclerotic cardiovascular disease (ASCVD) risk], Cluster 2 (metabolically stable patients without cardiorenal risk), and Cluster 3 (younger patients with obesity, high metabolic risk and short diabetes duration). The CPT utilization rates of the three clusters were 49.0%, 44.1% and 51.1%, respectively (P < 0.001), with Cluster 3 having the highest rate. Cluster 2 was dominated by SGLT2is monotherapy (73.1%). Cluster 3 showed a marked preference for GLP-1RAs-based regimens (43.6% in total), whereas Cluster 1 had an intermediate proportion of GLP-1RAs-related regimens (31.5%).</p><p><strong>Conclusion: </strong>Three clinical phenotypes were identified via cluster analysis. The younger obese group with high metabolic risk had the highest CPT utilization rate and preferred GLP-1RAs, while the older group with high ASCVD risk was predominantly treated with SGLT2is alone.</p><p><strong>Trial registration: </strong>The trial was registered with https://www.chictr.org.cn/ under registration number ChiCTR230007376 on 20 July 2023.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Economic Evaluations of Hearing Interventions in Older Adults: A Systematic Review of Evidence and Methods.","authors":"Smriti Raichand, Shan Jiang, Junling Weng, Antonio Ahumada-Canale, Sabrina Lenzen, Piers Dawes, Bonny Parkinson, Yingyao Chen, Yuanyuan Gu","doi":"10.1007/s12325-026-03788-w","DOIUrl":"https://doi.org/10.1007/s12325-026-03788-w","url":null,"abstract":"<p><strong>Introduction: </strong>Age-related hearing loss is common among older adults and is associated with poorer quality of life, falls, cognitive and psychosocial consequences, and increased healthcare use. Hearing aids, cochlear implants and rehabilitation services may improve outcomes, but their economic value remains unclear. This systematic review assessed cost-effectiveness and cost-benefit evidence for hearing interventions in older adults and examined methods, assumptions and outcome measures used in the evaluations.</p><p><strong>Methods: </strong>Medline, Embase, Scopus, Web of Science and EconLit were searched from inception to August 2026 for trial- or model-based full economic evaluations of hearing interventions in adults ≥ 60 years. Eligible studies included cost-effectiveness analyses (CEAs), cost-utility analyses (CUAs), and cost-benefit analyses (CBAs). Costs were standardised to 2024 US dollars. Quality was assessed using CHEQUE for CEAs and the Drummond checklist for CBAs.</p><p><strong>Results: </strong>A total of 27 studies in 28 articles met the inclusion criteria, of which 22 studies reported CEAs, including 19 CUAs, and 6 CBAs; 1 study reported both a CUA and a CBA. CEAs generally found cochlear implants and hearing aids to be cost-effective compared with no intervention, and cochlear implants were often cost-effective compared with hearing aids in eligible populations. Post-hearing-aid counselling or rehabilitation, transcutaneous bone conduction devices and cochlear implant processor upgrades were generally cost-effective. CBAs indicated positive net monetary benefits. Health-related quality of life was most commonly measured using the Health Utilities Index Mark 3. Costs typically included device, procedure and physician-visit costs. Key drivers included utility gains, intervention costs, age at intervention and device compliance. Limitations included omission of downstream costs, limited carer and societal impacts, inconsistent preference-based outcome measurement, insufficient model validation, limited equity analysis and no evaluations in institutional and long-term care.</p><p><strong>Conclusions: </strong>Hearing interventions, particularly hearing aids and cochlear implants, appear to offer good economic value for older adults. Future evaluations should capture broader benefits, downstream costs, carer and long-term care impacts, and use transparent, standardised methods.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149163749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methotrexate in Still's Disease: An Updated Perspective on Efficacy and Safety.","authors":"Karima Daghor-Abbaci, Oya Koker","doi":"10.1007/s12325-026-03823-w","DOIUrl":"https://doi.org/10.1007/s12325-026-03823-w","url":null,"abstract":"<p><p>The EULAR/PreS and American College of Rheumatology (ACR) guidelines for Still's disease (SD) were recently published with new therapeutic management strategies to achieve therapeutic targets within a specified timeframe. The early use of interleukin (IL)-1 or IL-6 inhibitors associated with short-term corticosteroids is recommended. Methotrexate (MTX) is not recommended as initial monotherapy for the acute systemic phase and should not be considered an alternative to early cytokine-targeted therapy when biologic treatment is available. Nevertheless, observational and real-world studies retain clinical utility of MTX as a corticosteroid-sparing agent with a favorable safety profile particularly in adult patients with residual arthritis and preserved organ function. Beyond its well-known immunomodulatory effects, MTX has been hypothesized to influence IL-1-related inflammatory pathways; however, this hypothesis is extrapolated from other inflammatory diseases, and no SD-specific mechanistic study has directly demonstrated an IL-1-mediated therapeutic effect of MTX. Reported remission rates varied according to the therapeutic regimen and study definition and should therefore be interpreted cautiously. In settings where access to biologic agents is limited, MTX may also represent a pragmatic therapeutic option, although this use reflects healthcare constraints rather than evidence of equivalence to IL-1 or IL-6 inhibition. In children with SD, MTX is mainly used for residual arthritis or as a steroid-sparing agent after control of systemic inflammation. Moreover, combining MTX with biologic agents may provide additional benefit in selected patients with residual arthritis or corticosteroid dependence. This review provides an updated perspective on the efficacy and safety of MTX in SD, with particular emphasis on its complementary role within the current biologic-first therapeutic landscape.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Return of Mailed Multitarget Stool DNA Test Kits and Subsequent Colorectal Cancer Incidence in the United States: A Retrospective Cohort Study.","authors":"Rashmi Goyat, Jordan J Karlitz, Wei Wang, A Burak Ozbay, Eric Montminy, Mallik Greene","doi":"10.1007/s12325-026-03818-7","DOIUrl":"https://doi.org/10.1007/s12325-026-03818-7","url":null,"abstract":"<p><strong>Introduction: </strong>Completion of colorectal cancer (CRC) screening is essential to realizing the benefits of early detection and prevention; however, many individuals do not complete screening after a test is provided. The association between screening completion and subsequent CRC incidence remains poorly understood. We evaluated the association between multitarget stool DNA (mt-sDNA) test kit return and CRC incidence among average-risk adults.</p><p><strong>Methods: </strong>This retrospective cohort study, linking claims data from Komodo Health with Abbott laboratory data, included adults aged 45-85 years who received an mt-sDNA kit between January 1, 2017, and December 31, 2019 (based on linked laboratory and claims data). The primary outcome was incident CRC identified using claims-based diagnosis codes. Propensity score-matched (PSM) and inverse probability treatment-weighted (IPTW) analyses assessed robustness to confounding. Adjusted incidence rate ratios (IRRs) were estimated using Poisson regression and hazard ratios (HRs) using Cox proportional hazards models.</p><p><strong>Results: </strong>The cohort included 2,574,759 adults (60.5% female, 38.5% male; 68.2% White, 8.2% Black/African American, 6.5% Hispanic, 2.6% Asian/Pacific Islander, 14.4% other/unknown race), who contributed over 14 million person-years of follow-up. CRC incidence was lower among kit returners than non-returners (248.95 vs 301.89 per 100,000 person-years). In adjusted analyses, mt-sDNA kit return was associated with 55% lower CRC incidence versus non-return [IRR 0.45; 95% confidence interval (CI) 0.45-0.46; p < 0.0001], with similar findings in PSM (IRR 0.58; 95% CI 0.57-0.59) and IPTW analyses (IRR 0.28; 95% CI 0.28-0.28). Supportive time-to-event analyses demonstrated directionally consistent associations, with mt-sDNA kit return associated with improved CRC-free survival (HR 0.76; 95% CI 0.74-0.78; p < 0.0001).</p><p><strong>Conclusions: </strong>In this large retrospective cohort study, mt-sDNA screening completion was consistently associated with lower CRC incidence across unmatched, PSM, and IPTW analyses. These findings support strategies to improve stool-based CRC screening completion to maximize the population-level benefits of CRC screening programs.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149163630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perinatal Outcomes of Pleuro-Amniotic Shunting in Isolated Pleural Effusions: Systematic Review and Meta-analysis.","authors":"Enzo Lofredo Amorim, Edward Araujo Júnior, Mucio Cevulla da Silva Lourenço, Daniel Giatti de Sousa, Felipe Muniz Ferreira, Maria Fernanda Dos Santos Lobo, Henrique Provinciatto, Eduardo Moreira Nader, Antonio Braga, Roberta Granese","doi":"10.1007/s12325-026-03809-8","DOIUrl":"https://doi.org/10.1007/s12325-026-03809-8","url":null,"abstract":"<p><strong>Introduction: </strong>Pleuro-amniotic shunting has been proposed for fetal pleural effusion, although its safety and efficacy remain uncertain. Therefore, we aimed to evaluate the perinatal outcomes of the fetal therapy for isolated pleural effusion through a systematic review and single-arm meta-analysis.</p><p><strong>Methods: </strong>PubMed/MEDLINE, Embase, Scopus, and Cochrane Central were searched for studies reporting outcomes of fetuses undergoing pleuro-amniotic shunting for isolated pleural effusion. The primary outcomes were overall survival and resolution of fetal hydrops. Single-arm random-effects meta-analyses were performed to estimate pooled event rates with 95% confidence intervals (CI).</p><p><strong>Results: </strong>Ten retrospective cohort studies comprising 416 fetuses treated with pleuro-amniotic shunting were included. The pooled overall survival rate was 65.36% (95% CI 59.46-70.83; I² = 30.7%). Resolution of fetal hydrops occurred in 62.25% of cases (95% CI 54.27-69.62; I² = 0%). A total of 62 catheter displacements were recorded, corresponding to a combined prevalence of 17.13% (95% CI 13.59-21.36). Overall, there were 155 preterm births, resulting in a pooled prevalence of 69.67% (95% CI 61.24-76.95; I² = 26.9%). Preterm premature rupture of membranes (PPROM) prevalence was 17.65% (95% CI 7.78-35.28; I² = 84.5%; p < 0.001).</p><p><strong>Conclusion: </strong>Pleuro-amniotic shunting achieves overall survival in approximately two-thirds of treated fetuses and resolving fetal hydrops in most cases. However, the procedure may be associated with preterm birth and PROM, underscoring the need for multidisciplinary perinatal management. Although the evidence is limited, these findings support pleuro-amniotic shunting as a promising treatment for progressive isolated fetal pleural effusion and highlight the need for prospective studies to optimize patient selection and perinatal care.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}