Advances in Therapy最新文献

{"title":"The Role of Omics Techniques in Diabetic Wound Healing: Recent Insights into the Application of Single-Cell RNA Sequencing, Bulk RNA Sequencing, Spatial Transcriptomics, and Proteomics.","authors":"Eleftheria-Angeliki Valsami, Guangyu Chu, Ming Guan, Jessica Gilman, Georgios Theocharidis, Aristidis Veves","doi":"10.1007/s12325-025-03212-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03212-9","url":null,"abstract":"<p><p>Diabetic foot ulcers (DFUs) are a devastating complication of diabetes mellitus (DM) that affect millions of people worldwide every year. They have a long-term impact on patients' quality of life and pose a significant challenge for both patients and clinicians, alongside negative economic implications on affected individuals. The current therapeutic approaches are costly and, in many cases, ineffective, highlighting the urgent need to develop novel, affordable, more efficient, and personalized treatments. Recent advances in high-throughput omics technologies, including proteomics, bulk RNA sequencing (bulk RNA-seq), single-cell RNA sequencing (scRNA-seq), and spatial transcriptomics in both preclinical animal and human clinical studies, have enhanced our understanding of the molecular function and mechanisms of DFUs, thereby offering potential for targeted therapies. Additionally, these technologies provide valuable insights behind the mechanism of action of novel wound dressings and treatments. In this review, we outline the latest application of omics technologies in DFU preclinical animal and human clinical research on diabetic wound healing, and spotlight recent findings.A graphical abstract is available with this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085641","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":"A Comprehensive Review and Meta-analysis on the Treatment of Acute Gastroenteritis in Children with a Bacillus clausii Preparation (Enterogermina^®).","authors":"Martin C Michel, Paolo Pellegrino","doi":"10.1007/s12325-025-03221-8","DOIUrl":"https://doi.org/10.1007/s12325-025-03221-8","url":null,"abstract":"<p><p>Several probiotics have become guideline-recommended treatments for acute gastroenteritis in children, but no recommendation was made for Bacillus clausii preparations on the basis of too limited data. As available B. clausii preparations differ in regard to strain composition and pharmaceutical quality, we focused on the most frequently investigated preparation that is available under the brand name Enterogermina^®, which includes a combination of the O/C, SIN, N/R, and T strains. We performed a systematic review and meta-analysis including several newer studies. We identified 11 randomized and three non-randomized controlled trials. A meta-analysis was performed for the three most often reported parameters in the randomized trials, i.e., duration of diarrhea, number of stools, and duration of hospital stay. Risk of bias was assessed using the Centre for Reviews and Dissemination criteria. Risk of bias of the randomized trials was classified as fair to good. The duration of diarrhea was reduced by 0.6 Hedge's g, the number of stools by 0.34 Hedge's g, and the duration of hospital stay by 0.27 Hedge's g (p < 0.05 for all three parameters). Several other parameters also appeared improved. Adverse events were absent or similarly present in the B. clausii and control groups. We conclude that the B. clausii preparation analyzed here is an effective and well-tolerated treatment of acute gastroenteritis in children. However, more high-quality randomized controlled trials are needed, particularly in comparison to other probiotics.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085640","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":"Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial.","authors":"Guillermo Garcia-Manero, Valeria Santini, Amer M Zeidan, Rami S Komrokji, Veronika Pozharskaya, Shelonitda Rose, Karen Keeperman, Yinzhi Lai, Sameer Kalsekar, Barkha Aggarwal, Dimana Miteva, David Valcárcel, Pierre Fenaux, Jake Shortt, Matteo Giovanni Della Porta, Uwe Platzbecker","doi":"10.1007/s12325-025-03208-5","DOIUrl":"https://doi.org/10.1007/s12325-025-03208-5","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy of erythropoiesis-stimulating agents (ESAs) for transfusion-dependent (TD) anemia in lower-risk myelodysplastic syndromes (LR-MDS) is limited. Luspatercept achieved significantly greater rates of red blood cell (RBC) transfusion independence (TI) versus epoetin alfa (an ESA) in the phase 3 COMMANDS trial. This analysis assessed long-term RBC-TI, cumulative response, and safety with luspatercept in COMMANDS.</p><p><strong>Methods: </strong>Eligible patients aged ≥ 18 years, with ESA-naive, RBC TD LR-MDS were randomized 1:1 to receive luspatercept (1.0 mg/kg, titration to 1.75 mg/kg permitted) or epoetin alfa (450 IU/kg, titration to 1050 IU/kg). Disease assessment was carried out at week 24 (day 169) and every 24 weeks thereafter. Treatment continued until disease progression, lack of clinical benefit, unacceptable toxicity, or consent withdrawal.</p><p><strong>Results: </strong>At data cutoff (September 22, 2023; median follow-up: luspatercept 21.4 months, epoetin alfa 20.3 months), a greater proportion of patients treated with luspatercept (n = 182) versus epoetin alfa (n = 181) achieved a longest single RBC-TI period ≥ 1 year (44.5% vs. 27.6%; P = 0.0003) and ≥ 1.5 years (30.2% vs. 13.8%; P < 0.0001). Higher rates of RBC-TI ≥ 1.5 years with luspatercept over epoetin alfa were consistent across all prespecified subgroups, including patients with ring sideroblast-negative status and low baseline serum erythropoietin. Longer cumulative RBC-TI response [sum of all durations of RBC-TI for ≥ 12 weeks; week 1 to end of treatment (95% CI)] was observed with luspatercept [154.7 weeks (118.4-NR)] versus epoetin alfa [91.1 weeks (73.1-123.9)]. Rates of treatment-emergent adverse events, including asthenia and hypertension, generally decreased over time in both arms. Progression rates to high-risk MDS and acute myeloid leukemia were similarly low (< 5%) in both treatment arms.</p><p><strong>Conclusions: </strong>These data demonstrated sustained, durable clinical benefit across subgroups and support luspatercept as the treatment of choice for anemia in patients with LR-MDS who are TD and ESA-naive.</p><p><strong>Trial registration number: </strong>NCT03682536.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075359","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":"Elevating the Patient Voice: Understanding Treatment Preferences in Patients with Advanced Prostate Cancer.","authors":"Elizabeth R Kessler, Elizabeth Wulff-Burchfield, Jennifer Phillips, Wesley Peters, Tracy McGowan, Pankaj Aggarwal","doi":"10.1007/s12325-025-03214-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03214-7","url":null,"abstract":"<p><strong>Introduction: </strong>With multiple oral medications currently available for patients with prostate cancer, there is a need to understand how patients' preferences and experiences are impacted by several factors including pill burden and dosing frequency. This study aimed to understand medication preferences from patients with advanced prostate cancer (APC).</p><p><strong>Methods: </strong>We conducted a cross-sectional, online survey of patients with APC living in the USA.</p><p><strong>Results: </strong>The survey was completed by 100 patients with a median age of 65 years (range 35-79). Most patients were White (53%) with 31% Black and 15% Hispanic. Nearly half (48%) reported taking more than five pills per day and 50% reported taking more than three prescription medications per day. Nearly two-thirds (63%) reported difficulty remembering to take pills multiple times per day and 91% said they would choose a one-pill-once-daily option over a multi-pill regimen. Twenty-two (22%) patients had difficulty swallowing pills or were unsure. Of these 22, 21 (95%) considered it important that a pill can be dispersed in water or applesauce. Most patients (81%) had undergone chemotherapy previously and 80% reported taking oral medications for prostate cancer. Eighty-nine (89%) patients said they would prefer an oral treatment option compared to intravenous chemotherapy.</p><p><strong>Conclusion: </strong>Most patients prefer a one-pill-once-daily regimen. Most patients prefer the option of an oral treatment regimen over intravenous chemotherapy. When discussing treatment options, providers should consider the individual patient's preferences and engage in shared decision-making.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959014","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":"Understanding Epidemiology of Physical Activity and Sedentary Behaviour Among Adults in Haryana: Insights from the ICMR-INDIAB Study [ICMR-INDIAB-19].","authors":"Madhur Verma, Sanjay Kalra, Mohan Deepa, Ulagamadesan Venkatesan, Nikita Sharma, Rajendra Pradeepa, Kirti Chauhan, Omna Singh, Nirmal Elangovan, Sameer Aggarwal, Rakesh Kakkar, R S Dhaliwal, Tanvir Kaur, Viswanathan Mohan, Ranjit Mohan Anjana","doi":"10.1007/s12325-025-03200-z","DOIUrl":"https://doi.org/10.1007/s12325-025-03200-z","url":null,"abstract":"<p><strong>Introduction: </strong>Physical inactivity contributes to non-communicable disease (NCD) health burden, making it essential to study and address this issue at a population level. The present research aims to explore the patterns of physical activity (PA) in Haryana through a subgroup analysis of the national Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study.</p><p><strong>Methods: </strong>This study was conducted between December 2018 and July 2019 in Haryana and included 3918 adult participants. Physical activity was assessed using the validated MDRF Physical Activity Questionnaire (MPAQ), which has domain-wise assessments of PA. Weighted prevalence was estimated using state-specific sampling weights, and associations between PA, anthropometric and biochemical profiles were assessed using bivariate analysis done using Student's unpaired t tests, one-way analysis of variance (ANOVA), or chi-square tests. Factors describing the likelihood of being active were ascertained using a multivariable nominal regression analysis.</p><p><strong>Results: </strong>About 73% of the study participants were physically inactive, and only 27% were moderately to vigorously active. The time spent in different PA domains varied significantly across sociodemographic variables, including sex, education, region, occupation, and socioeconomic status. Participants from the middle socioeconomic class spent more time in work-related PA, compared to low and upper-class participants who spent more time in general and transport-related PA. There were significant statistical differences between active and non-active groups concerning their mean blood glucose levels, body mass index, waist circumference and systolic blood pressure, but the differences in the lipid profile were non-significant. However, regression analysis showed higher odds of being physically active among younger participants, men, residents in rural areas, and those having fewer years of education.</p><p><strong>Conclusion: </strong>We highlight the alarmingly high prevalence of physical inactivity across different segments of society in Haryana with significant sociodemographic disparities. Considering the increasing prevalence of NCDs, it is high time to prioritise health promotion measures and inculcate more physical activity amongst the population to achieve health-related sustainable development goals.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143962835","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":"Comparative Efficacy of Ciltacabtagene Autoleucel Versus Standard-of-Care Treatments for Patients with Previously Treated Relapsed or Refractory Multiple Myeloma: A Matching-Adjusted Indirect Comparison.","authors":"Noemi Puig, Joris Diels, Suzy van Sanden, João Mendes, Heather Burnett, Allie Cichewicz, Seina Lee, Teresa Hernando, Jordan M Schecter, Nikoletta Lendvai, Nitin Patel, José María Sanchez-Pina, Serena Rocchi, Roberto Mina, Paolo Corradini, Michele Cavo, Jesús San Miguel, Leyla Shune, Abdullah M Khan, Surbhi Sidana, Xavier Leleu, Salomon Manier, Brea Lipe, Katja Weisel, Joaquin Martinez-Lopez","doi":"10.1007/s12325-025-03205-8","DOIUrl":"https://doi.org/10.1007/s12325-025-03205-8","url":null,"abstract":"<p><strong>Introduction: </strong>Matching adjusted indirect comparisons (MAICs) were performed to compare the efficacy of cilta-cel versus elotuzumab + pomalidomide + dexamethasone (EloPd), isatuximab + carfilzomib + dexamethasone (IsaKd), isatuximab + pomalidomide + dexamethasone (IsaPd), and selinexor + bortezomib + dexamethasone (SVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy and are lenalidomide-refractory.</p><p><strong>Methods: </strong>Unanchored MAICs were performed using individual patient-level data (IPD) for all apheresed patients randomized to the cilta-cel arm of CARTITUDE-4 (n = 208) and published arm-level data for EloPd from ELOQUENT-3 (n = 60), IsaKd from IKEMA (lenalidomide-refractory subgroup, n = 57), IsaPd from ICARIA-MM (n = 154), and SVd from BOSTON (lenalidomide-refractory subgroup, n = 53). Eligibility criteria from each comparator trial were applied to the cilta-cel arm IPD, and further imbalances in patient characteristics were adjusted by weighting the cilta-cel patient data to match the reported baseline characteristics of the comparator trials. Comparative efficacy was estimated for overall response rate, very good partial response or better (≥ VGPR) rate, complete response or better (≥ CR) rate, progression-free survival (PFS), and overall survival (OS).</p><p><strong>Results: </strong>After adjustment, cilta-cel patients were significantly more likely to achieve an overall response versus EloPd, IsaPd, and SVd, and were significantly more likely to achieve ≥ VGPR and ≥ CR versus all comparators. Cilta-cel patients also had significant reductions in the risk of disease progression or death (PFS) versus all comparators: 64% versus EloPd, 49% versus IsaKd, 69% versus IsaPd, and 62% versus SVd. Similarly, cilta-cel patients had significant improvements in OS for all feasible comparisons: 52% versus EloPd, 58% versus IsaPd, and 60% versus SVd.</p><p><strong>Conclusion: </strong>Cilta-cel patients demonstrated clinically meaningful benefits over EloPd, IsaKd, IsaPd, and SVd for response and survival outcomes, highlighting its superiority over alternative treatment options for patients with RRMM who have received at least one prior therapy and are refractory to lenalidomide.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959516","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":"How do Japanese Patients with Chronic Heart Failure View Their Disease, Self-care, and Support?","authors":"Shoko Nagata, Kosuke Shiki, Nobutaka Yagi, Naoki Sato","doi":"10.1007/s12325-025-03203-w","DOIUrl":"https://doi.org/10.1007/s12325-025-03203-w","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic heart failure (HF) is a progressive disease with increasing prevalence in Japan. Adherence to lifestyle modifications is important to prevent disease progression and to improve outcomes. An accumulation of insufficient self-care behaviors is an independent risk factor of hospitalization for HF and/or cardiac death; however, there is a lack of self-care awareness in patients with chronic HF. This study aims to increase the understanding of self-care behavior of people living with chronic HF in Japan.</p><p><strong>Methods: </strong>This non-interventional, cross-sectional study used an explanatory sequential design in mixed methods research with a quantitative and consecutive qualitative phase. In the quantitative research phase, an anonymous online survey questionnaire was distributed to 262 people and completed by 162 participants. In the qualitative phase, 15 participants who had completed the quantitative phase were selected using stratified random sampling from the survey participants and took part in a semi-structured interview. Endpoints included participant demographics and HF characteristics, physical and emotional burdens associated with HF, knowledge of disease, self-care, and treatment support in daily life.</p><p><strong>Results: </strong>In the quantitative study, 61.5% of participants were male, and 68.9% were ≥ 60 years old. In the qualitative study, 80.0% were male and 46.7% were ≥ 70 years old. Participants experienced physical and emotional burden due to their HF symptoms with > 60% finding brisk walking, and > 40% finding going up stairs to the second floor, burdensome or very burdensome, and approximately 70% experiencing some emotional burden. In general, participants trusted their physicians' instructions around self-care and had a high level of self-care adherence. Participants would like more information regarding HF treatment (68.0%), diet and nutrition (57.3%), and daily lifestyle tips to reduce HF burden (57.3%).</p><p><strong>Conclusion: </strong>This study highlights the importance of patient education, and the need for multidisciplinary support for patients with chronic HF.</p><p><strong>Trial registration: </strong>UMIN000047055, March 1, 2022 and UMIN000049065, September 29, 2022.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143951858","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 Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank.","authors":"Sean Khozin, Nancy A Dreyer, Dominic Galante, Raymond Liu, Peter Neumann, Nathan Nussbaum, Joyce O'Shaughnessy, Debra Patt, Mothaffar Rimawi, Hope Rugo, Sara M Tolaney, Marisa Weiss, Adam Brufsky","doi":"10.1007/s12325-025-03201-y","DOIUrl":"https://doi.org/10.1007/s12325-025-03201-y","url":null,"abstract":"<p><p>Complementing randomized controlled trials, real-world evidence (RWE) from observational analyses can extend clinical insights in oncology. While healthcare stakeholders have published rigorous RWE frameworks and resources, a multidisciplinary think tank was established to further advance acceptance and use of RWE in treatment decision-making, with the focus on breast cancer (while recognizing relevance in oncology more broadly). Members discussed perceptions of RWE from a clinical perspective, across domains of data, methodology, and mindset, and \"calls-to-action\" for stakeholders. Agreement was reached on a primary \"call-to-action,\" to develop clinically-relevant, patient-informed, real-world endpoints, and secondary \"calls-to-action\": establish a multidisciplinary consensus forum; publish examples of unique RWE value; build upon existing frameworks and resources; and tailor an approach for exhibiting utility to guideline bodies.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965233","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":"Anlotinib Plus Docetaxel is Promising in Advanced NSCLC Progressing on First-Line Immunotherapy: A Pooled Analysis of Two Randomized Trials.","authors":"Xingxiang Pu, Jiawei Shou, Zemin Xiao, Jun Chen, Maoliang Xiao, Qunyi Guo, Zhongxia Ma, Wei Hong, Qianzhi Wang, Yonghui Wang, Jia Li, Chuangzhou Rao, Jie Weng, Liqin Lu, Lin Wu, Yong Fang","doi":"10.1007/s12325-025-03170-2","DOIUrl":"https://doi.org/10.1007/s12325-025-03170-2","url":null,"abstract":"<p><strong>Introduction: </strong>Therapeutic options for patients with advanced non-small cell lung cancer (NSCLC) after progression on immune checkpoint inhibitors (ICIs) remain a significant challenge. This analysis compared outcomes of anlotinib plus docetaxel versus docetaxel alone in this population using the pooled data from two prospective randomized trials (ALTER-L016; ALTER-L018).</p><p><strong>Methods: </strong>Adult patients with EGFR/ALK/ROS1 wild-type advanced NSCLC progressing on first-line ICIs were eligible. Patients were randomly assigned to anlotinib plus docetaxel or docetaxel alone. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.</p><p><strong>Results: </strong>Seventy-one patients were included in this pooled analysis (L016, n = 39; L018, n = 32), of whom, 40 received anlotinib plus docetaxel and 31 received docetaxel. The median follow-up of all patients was 27.0 months. The median PFS was longer with anlotinib plus docetaxel than with docetaxel alone (5.4 months [95% CI 5.0-9.3] vs. 2.3 months [95% CI 1.4-2.9]; hazard ratio [HR], 0.34; 95% CI 0.18-0.63; P < 0.001). Both ORR (25.0% vs. 12.9%) and DCR (82.5% vs. 45.2%) were higher in the anlotinib plus docetaxel group than in the docetaxel group. Median OS was 16.2 months (95% CI 8.3-21.3) with anlotinib plus docetaxel versus 13.7 months (95% CI 4.6-22.3) with docetaxel (HR = 0.82; 95% CI 0.47-1.44; P = 0.488). Subsequent ICI therapy was associated with a longer OS. Grade 3 treatment-related adverse events occurred in 32.5% of patients receiving anlotinib plus docetaxel and 6.5% of patients receiving docetaxel.</p><p><strong>Conclusion: </strong>Anlotinib plus docetaxel improved PFS but not OS versus docetaxel in patients with advanced NSCLC progressing on ICIs. Larger standardized phase 3 trials are needed to verify these findings.</p><p><strong>Trial registration: </strong>ALTER-L016 (ClinicalTrials.gov identifier, NCT03726736). ALTER-L018 (ClinicalTrials.gov identifier, NCT03624309).</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958661","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":"Evaluation of Real-World Treatment Patterns and Healthcare Resource Utilization in Patients with Chronic Refractory Gout in the United States.","authors":"Nana Kragh, Andrew Worsfold, Abiola Oladapo, Emily Gao, Sakshi Sethi, Elyse Swallow","doi":"10.1007/s12325-025-03189-5","DOIUrl":"https://doi.org/10.1007/s12325-025-03189-5","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic refractory gout (CRG) is characterized by frequent flares and failure to achieve and/or maintain serum urate levels < 6.0 mg/dL with conventional urate-lowering therapies. This study evaluated the clinical profile, treatment patterns, and healthcare resource utilization (HRU) of patients with CRG in the United States (US) to provide updated information on treatment strategies and burdens.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed data for patients with CRG (≥ 3 flares within 18 months or a pegloticase prescription following gout diagnosis) between June 2011 and May 2020 in the IQVIA PharMetrics^® Plus database linked with IQVIA Ambulatory Electronic Medical Records-US. Demographic, clinical, and disease characteristics, gout-related medications, and HRU were described for patients with serum urate levels ≥ 6.0 mg/dL at baseline and in the subset with elevated levels (≥ 2 measurements ≥ 6.0 mg/dL) during the 12-month follow-up period.</p><p><strong>Results: </strong>Among 969 patients with CRG, 157 had elevated serum urate levels ≥ 6.0 mg/dL during follow-up. All patients had a high comorbidity burden. Most patients in the overall population (57.5%) and in the subset with elevated serum urate during follow-up (73.2%) did not have evidence of achieving serum urate level < 6.0 mg/dL at any point during follow-up, despite use of gout-related medications including allopurinol. Patients in the overall population and the elevated serum urate subset had high use of steroids (77.0% and 79.6%, respectively) and nonsteroid anti-inflammatory drugs (59.3% and 59.9%) to manage gout flares. Additionally, patients had high rates of gout-related HRU, including inpatient admissions [5.7% (overall) and 6.4% (subset)], emergency room visits (12.7% and 15.3%), and outpatient visits (96.8% and 100%).</p><p><strong>Conclusion: </strong>Despite the use of urate-lowering medications, patients with CRG had elevated serum urate levels and high HRU, underscoring the need for better treatment and management strategies for CRG to prevent gout flares and minimize long-term damage.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144059000","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}