Advances in Therapy最新文献

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Guideline-Recommended Disease-Modifying Therapies for Patients with Cardiorenal Disease: A Call-to-Action Narrative Review. 指南推荐的心血管疾病患者的疾病改善疗法:一项呼吁行动的叙事回顾。
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-28 DOI: 10.1007/s12325-025-03228-1
Christoph Wanner, Ming-Hui Zhao, Alpesh N Amin, Luca De Nicola, Andrew J Sauer, Alaster M Allum, Unai Aranda, You-Seon Nam, Javed Butler
{"title":"Guideline-Recommended Disease-Modifying Therapies for Patients with Cardiorenal Disease: A Call-to-Action Narrative Review.","authors":"Christoph Wanner, Ming-Hui Zhao, Alpesh N Amin, Luca De Nicola, Andrew J Sauer, Alaster M Allum, Unai Aranda, You-Seon Nam, Javed Butler","doi":"10.1007/s12325-025-03228-1","DOIUrl":"https://doi.org/10.1007/s12325-025-03228-1","url":null,"abstract":"<p><p>Substantial gaps exist between recommendations for guideline-directed medical therapy (GDMT) for chronic kidney disease (CKD) and its use in real-world clinical practice. This includes suboptimal dosing of renin-angiotensin system inhibitors (RASi), low uptake of sodium-glucose co-transporter 2 inhibitors (SGLT2i) for CKD, and low uptake and/or transient use of potassium binders to manage RASi-induced hyperkalemia. Suboptimal RASi therapy deprives patients of the full cardiorenal benefits associated with RASi, and increases the risk of cardiorenal adverse events and mortality. Hyperkalemia can be managed and optimal RASi dosing can be continued by using novel potassium binders, such as sodium zirconium cyclosilicate or patiromer. Similarly, low uptake of SGLT2i might be associated with the concern of an accelerated decline in estimated glomerular filtration rate and, therefore, disease progression when initiating SGLT2i. Numerous clinical trials have demonstrated that adding SGLT2i to RASi therapy can improve clinical outcomes and prolong patient survival in CKD. The recently published Kidney Disease: Improving Global Outcomes (KDIGO) 2024 clinical practice guideline for the evaluation and management of CKD extends the recommendation of SGLT2i to individuals with CKD without diabetes, reinforces the cardiorenal benefits of optimized RASi, recommends the addition of newer drug classes in suitable patients with CKD, and notes the use of novel potassium binders to manage hyperkalemia and enable optimal use of GDMT. In doing so, the guideline targets achievement of the \"quadruple aim\" of GDMT in CKD, i.e., enabling optimal use of RASi and SGLT2i in most patients, along with nonsteroidal mineralocorticoid receptor antagonists, and glucagon-like peptide-1 receptor agonists in diabetic kidney disease. This manuscript constitutes a call to action to raise awareness of the growing clinical and economic burdens of CKD and to promote a united approach to the early detection and optimal treatment of CKD through stricter adherence to GDMT.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144155490","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}
引用次数: 0
Driving Best Practices Throughout the Treatment Journey for Patients with NSCLC with Actionable Alterations: A Podcast Discussion. 通过可操作的改变推动NSCLC患者整个治疗过程中的最佳实践:播客讨论。
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-22 DOI: 10.1007/s12325-025-03195-7
Christine M Bestvina, Chul Kim, Nathalie Daaboul
{"title":"Driving Best Practices Throughout the Treatment Journey for Patients with NSCLC with Actionable Alterations: A Podcast Discussion.","authors":"Christine M Bestvina, Chul Kim, Nathalie Daaboul","doi":"10.1007/s12325-025-03195-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03195-7","url":null,"abstract":"<p><p>Non-small cell lung cancer (NSCLC) treatment has been revolutionized by the advent of targeted therapies for tumors harboring specific actionable alterations. Targeted agents are now approved for use in patients with advanced NSCLC with various drivers including ALK rearrangements, BRAF V600E mutations, EGFR mutations, ERBB2 mutations, KRAS G12C mutations, MET exon 14 skipping alterations, NTRK fusions, RET rearrangements, and ROS1 rearrangements. Importantly, the availability of these agents has raised the clinical question of how to optimally sequence their use alongside chemotherapy and/or immunotherapy strategies, which are indicated for broader populations. Key considerations include (i) evidence for better outcomes when first-line treatment is initiated following availability of molecular profiling data; (ii) the decreasing proportion of patients able to receive therapy in each successive treatment line; (iii) the efficacy of targeted agents demonstrated in either single-arm trials or head-to-head comparisons with chemotherapy and/or immunotherapy, as compared with evidence for poor or modest efficacy of immunotherapy in patients with tumors with actionable drivers; (iv) real-world data showing better outcomes of patients with tumors with actionable alterations who received targeted therapies compared with those who did not; (v) the generally favorable safety profile of targeted therapies, as well as the potential for increased toxicity when immunotherapy precedes certain targeted agents; and (vi) patient-centric factors including the greater ease of administration of oral targeted therapies over intravenous chemotherapy or immunotherapy strategies. In line with these considerations, guidelines typically recommend most targeted agents approved for first-line use as initial therapy over chemotherapy and/or immunotherapy. In this podcast, the authors discuss the current therapeutic landscape of NSCLC with actionable alterations and provide their perspectives on treatment algorithms, and how to optimally sequence therapies for patients with tumors harboring actionable alterations, using patient cases to illustrate key principles.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118543","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}
引用次数: 0
Real-World Utilization of Biologic and Targeted Synthetic Disease-Modifying Anti-rheumatic Drugs in Psoriatic Arthritis and Axial Spondyloarthritis: Insights from Sweden and Germany. 银屑病关节炎和轴性脊柱炎的生物和靶向合成疾病修饰抗风湿药物的实际应用:来自瑞典和德国的见解
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-22 DOI: 10.1007/s12325-025-03216-5
Helena Roque, Alexander Rieem Dun, Alexandra Cooper, Scarlette Kienzle, Sarah Welby, Thomas Wilke, Jie Song, Christoph Abé
{"title":"Real-World Utilization of Biologic and Targeted Synthetic Disease-Modifying Anti-rheumatic Drugs in Psoriatic Arthritis and Axial Spondyloarthritis: Insights from Sweden and Germany.","authors":"Helena Roque, Alexander Rieem Dun, Alexandra Cooper, Scarlette Kienzle, Sarah Welby, Thomas Wilke, Jie Song, Christoph Abé","doi":"10.1007/s12325-025-03216-5","DOIUrl":"https://doi.org/10.1007/s12325-025-03216-5","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world data on patient characteristics and dosing patterns for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are limited. This study assessed characteristics and dosing patterns in patients initiating a biologic or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD).</p><p><strong>Methods: </strong>This cohort study included adult patients with PsA and axSpA newly initiating b/tsDMARDs, identified in the Swedish National Registers (2017-2021) and a German insurance claims database (2018-2021) from two regions (Saxony and Thuringia). Patient characteristics and dosing patterns were analyzed descriptively.</p><p><strong>Results: </strong>Overall, 9414 (Sweden) and 2045 (Germany) patients with PsA and 7763 (Sweden) and 1756 (Germany) patients with axSpA were included. Patients with PsA were generally older and more often female than the patients with axSpA. Swedish patients were generally younger with fewer co-diagnoses than German patients. The most common co-diagnoses were psoriasis, hypertension, and joint pain. Most patients were b/tsDMARD-naïve and had prior nonsteroidal anti-inflammatory drug or corticosteroid use. Anti-tumor necrosis factor agents were most commonly used (Sweden: PsA 71.22%, axSpA 86.42%; Germany: PsA 41.66%, axSpA 79.67%). Secukinumab was the most frequently prescribed treatment with recommended dose escalation, followed by ixekizumab and guselkumab. For secukinumab, German patients typically received higher maintenance doses (300 mg vs 150 mg/month) than those in Sweden, especially in those without psoriasis. For ixekizumab, while all patients in Sweden received an 80 mg/month maintenance dose, some patients in Germany received a 160 mg/month maintenance dose. For guselkumab, some patients in Germany received higher-than-recommended maintenance doses; this pattern was not observed in Sweden.</p><p><strong>Conclusion: </strong>Differences between patient characteristics and dosing patterns were observed between patients with PsA and axSpA in Sweden and Germany. Treatment variations may reflect high prevalences of co-diagnoses, like psoriasis, or unmet therapeutic needs. This work serves as a first step towards future research for personalized treatment approaches to optimize treatment outcomes.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118519","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}
引用次数: 0
Patient Number and Treatment Patterns in Cytomegalovirus Viremia and Disease Following Solid Organ and Hematopoietic Stem Cell Transplantation in Germany: Results of a Delphi Consensus Study. 德国实体器官和造血干细胞移植后巨细胞病毒血症和疾病的患者数量和治疗模式:德尔菲共识研究的结果。
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-22 DOI: 10.1007/s12325-025-03210-x
Daniel Teschner, Jana Knop, Christian Piehl, Tino Schubert, Oliver Witzke
{"title":"Patient Number and Treatment Patterns in Cytomegalovirus Viremia and Disease Following Solid Organ and Hematopoietic Stem Cell Transplantation in Germany: Results of a Delphi Consensus Study.","authors":"Daniel Teschner, Jana Knop, Christian Piehl, Tino Schubert, Oliver Witzke","doi":"10.1007/s12325-025-03210-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03210-x","url":null,"abstract":"<p><strong>Introduction: </strong>Management of cytomegalovirus (CMV) viremia/disease in transplant recipients may be complicated by toxicities and resistance to conventional antivirals, adding to the overall healthcare burden. Despite advances in analyzing real-world data in current years, little is known about refractory and resistant CMV. This study therefore aimed to characterize treatment patterns and patient numbers with special focus on refractory and resistant CMV.</p><p><strong>Methods: </strong>Two classical three-round Delphi consensus panels with German clinical experts in CMV following solid organ transplantations (SOT) and hematopoietic stem cell transplantations (HSCT) were held between October and December 2021 using online questionnaires. Consensus was defined as agreement of 75% of participants.</p><p><strong>Results: </strong>Following SOT, experts agreed that on average 65% of SOT patients are not affected by CMV at all, while 35% of patients experience CMV viremia or disease. Of SOT patients treated with antiviral therapies, experts agreed that 90% respond to their first-line treatment and 10% do not. For HSCT, experts agreed that 62% of patients experience no CMV, while 38% of patients are diagnosed with either CMV viremia or CMV disease. It was further estimated that 23% HSCT patients receiving antiviral treatment do not respond to their first-line CMV treatment. Experts reached consensus on the reasons for non-response, suggesting that among non-responders, 55% were intolerant, while 45% of non-responders were refractory/resistant to first-line treatment.</p><p><strong>Conclusion: </strong>Based on the current incidence of transplantations in Germany, experts estimated that 103 SOT and 225 HSCT patients need second-line CMV treatment annually.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118514","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}
引用次数: 0
Real-World Insights on Satisfaction and Experience with Acthar Gel via SelfJect (RISE™): A Cross-Sectional Patient Survey. 通过SelfJect (RISE™)对Acthar凝胶满意度和体验的真实世界见解:一项横断面患者调查。
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-22 DOI: 10.1007/s12325-025-03232-5
Jas Bindra, Ishveen Chopra, Kyle Hayes, John Niewoehner, Mary Panaccio, Sheila Elliott, Bobby Trawick, George J Wan
{"title":"Real-World Insights on Satisfaction and Experience with Acthar Gel via SelfJect (RISE™): A Cross-Sectional Patient Survey.","authors":"Jas Bindra, Ishveen Chopra, Kyle Hayes, John Niewoehner, Mary Panaccio, Sheila Elliott, Bobby Trawick, George J Wan","doi":"10.1007/s12325-025-03232-5","DOIUrl":"https://doi.org/10.1007/s12325-025-03232-5","url":null,"abstract":"<p><strong>Introduction: </strong>Acthar<sup>®</sup> Gel Single-Dose Pre-filled SelfJect™ Injector (\"Acthar Gel via SelfJect\") is approved by the US Food and Drug Administration for appropriate patients with chronic and acute inflammatory and autoimmune conditions. It has fewer steps than a multi-dose vial. This survey assessed patients' perceptions of their experience with this device, including their satisfaction, confidence, convenience, and ease of use, as well as persistence and compliance.</p><p><strong>Methods: </strong>Real-World Insights on Patient Satisfaction and Experience with Acthar Gel via SelfJect (RISE™) gathered responses via a non-interventional, observational, cross-sectional online survey with a pre-specified protocol (November 2024-January 2025). Eligible participants were aged ≥18 years, had a diagnosis of an indication of Acthar Gel based on the prescribing information, and had used Acthar Gel via SelfJect for ≥6 self-injections during the survey.</p><p><strong>Results: </strong>Fifty-four participants completed the survey (mean age 55.4 years, 76% women). Thirty-three percent (18/54) had chronic or recurring ocular inflammatory disease, and 26% (14/54) had rheumatoid arthritis. Thirty-nine percent (21/54) reported dexterity or visual problems, and 39% (21/54) had prior experience with Acthar Gel multi-dose vial. On average, administering Acthar Gel via SelfJect took 3.4 min. Overall, 91% (49/54) of participants reported that they were satisfied or very satisfied with Acthar Gel via SelfJect; 89% (48/54) felt very or extremely confident injecting with Acthar Gel via SelfJect; and 91% (49/54) found it to be convenient or very convenient. Seventy-six percent (41/54) felt that it was very or extremely easy to self-inject with this device. Eighty-seven percent (47/54) perceived that they were likely or very likely to maintain persistence and compliance with this device.</p><p><strong>Conclusions: </strong>Survey participants reported a favorable experience with Acthar Gel via SelfJect, with a high level of satisfaction, confidence, convenience, and ease of use. Participants reported perceptions of anticipated positive persistence and compliance with this device, which may correlate with the possibility of improved continuity of care.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118516","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}
引用次数: 0
Shared Decision-Making for Restoring Trust in the Management of Atherosclerotic Cardiovascular Disease in the Post-pandemic Era. 大流行后时代动脉粥样硬化性心血管疾病管理中重建信任的共同决策
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-22 DOI: 10.1007/s12325-025-03182-y
Warren J Wexelman, Nicole Ciffone, Nishant P Shah
{"title":"Shared Decision-Making for Restoring Trust in the Management of Atherosclerotic Cardiovascular Disease in the Post-pandemic Era.","authors":"Warren J Wexelman, Nicole Ciffone, Nishant P Shah","doi":"10.1007/s12325-025-03182-y","DOIUrl":"https://doi.org/10.1007/s12325-025-03182-y","url":null,"abstract":"<p><p>Real-world data indicate that the management of low-density lipoprotein cholesterol (LDL-C) is suboptimal in clinical practice and that many patients fail to reach guideline-recommended LDL-C goals. This may be due in part to physician inertia with regard to prescribing appropriate lipid-lowering therapies or poor adherence to such therapies in real-world practice. Shared decision-making is a collaborative process in which patients and healthcare professionals work together to develop treatment plans and management strategies that consider an individual's values and preferences, as well as clinical evidence. In this commentary, two preventive cardiologists and a nurse practitioner working in US practice discuss their real-world experiences of shared decision-making as well as key benefits such as helping to tackle the negative impacts of medical misinformation to restore patients' trust in healthcare professionals. Other potential benefits of shared decision-making include increased adherence to therapy and greater trust between patients and healthcare professionals. Finally, the authors discuss proposed solutions for potential barriers to the implementation of shared decision-making, including the support of a multidisciplinary team, the provision of learning materials from trustworthy sources, and tailoring of discussions to the individual patient.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118521","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}
引用次数: 0
Reality of Patient-Reported Symptoms in 200 Patients with Eosinophilic Granulomatosis with Polyangiitis: A Cross-Sectional Survey (The KUNPU Study). 200例嗜酸性肉芽肿病合并多血管炎患者报告症状的现况:一项横断面调查(昆普研究)。
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-20 DOI: 10.1007/s12325-025-03197-5
Koichi Amano, Keita Ono, Kazuya Sumi, Hitomi Uchimura, Hayato Oka, Naoyuki Makita, Masami Taniguchi
{"title":"Reality of Patient-Reported Symptoms in 200 Patients with Eosinophilic Granulomatosis with Polyangiitis: A Cross-Sectional Survey (The KUNPU Study).","authors":"Koichi Amano, Keita Ono, Kazuya Sumi, Hitomi Uchimura, Hayato Oka, Naoyuki Makita, Masami Taniguchi","doi":"10.1007/s12325-025-03197-5","DOIUrl":"https://doi.org/10.1007/s12325-025-03197-5","url":null,"abstract":"<p><strong>Introduction: </strong>Eosinophilic granulomatosis with polyangiitis (EGPA) is a type of antineutrophil cytoplasmic antibody-associated vasculitis characterized by inflammation of small- and medium-sized vessels, causing symptoms in multiple organs. The symptoms and daily life problems reported by patients with EGPA themselves are largely unknown. We conducted a cross-sectional survey to investigate the reality of EGPA-related symptoms in patients with EGPA.</p><p><strong>Methods: </strong>Specialists and specialized facilities with experience in treating patients with EGPA cooperated in the survey; specialists from 28 facilities across Japan participated. Patients diagnosed with EGPA by their physician and treated for ≥ 1 year who agreed to answer the online questions were enrolled and completed the survey between March and June 2024. Patients answered questions about their general symptoms, asthma symptoms, and quality of life.</p><p><strong>Results: </strong>We analyzed valid responses from 200 patients (61.0% female/38.5% male/0.5% prefer not to answer) with EGPA. The mean age was 57.9 years and 34.5% were ≥ 65 years old. Patients were treated at rheumatology departments (48.0%), respiratory/allergy departments (48.0%), and other departments (4.0%). Basic treatments included oral glucocorticoids (63.0%) and anti-interleukin-5/receptor α biologics (61.0%). Symptoms in > 50.0% of patients (past month) were pain/numbness (73.5%), fatigue/malaise (68.0%), asthmatic symptoms (56.0%), nasal/paranasal symptoms (55.0%), and joint/muscle pain (54.5%). Pain/numbness was considered the most painful symptom (29.5%). Nearly all patients experienced symptoms affecting two or more organs/systems. Patients reported that EGPA symptoms had detrimental impacts on physical and mental health; 67.0% of patients thought they were not understood by others because their disease is invisible, and symptoms frequently affected their daily life (61.5%), work (53.0%), sleep (49.5%), and social life (36.5%).</p><p><strong>Conclusion: </strong>This is the largest survey of patients with EGPA. We have revealed the reality of patients' perceptions of EGPA-related symptoms. These results are expected to contribute to improvement in patient-centered EGPA management.</p><p><strong>Trial registration: </strong>jRCT1050230186.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109357","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}
引用次数: 0
Effectiveness and Safety of Tezepelumab in a Diverse Population of US Patients with Severe Asthma: Initial Results of the PASSAGE Study. Tezepelumab在美国不同人群重度哮喘患者中的有效性和安全性:PASSAGE研究的初步结果
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-19 DOI: 10.1007/s12325-025-03231-6
Njira L Lugogo, Praveen Akuthota, Kaharu Sumino, Sameer K Mathur, Autumn F Burnette, Andrew W Lindsley, Jean-Pierre Llanos, Claudio Marchese, Christopher S Ambrose, Benjamin Emmanuel
{"title":"Effectiveness and Safety of Tezepelumab in a Diverse Population of US Patients with Severe Asthma: Initial Results of the PASSAGE Study.","authors":"Njira L Lugogo, Praveen Akuthota, Kaharu Sumino, Sameer K Mathur, Autumn F Burnette, Andrew W Lindsley, Jean-Pierre Llanos, Claudio Marchese, Christopher S Ambrose, Benjamin Emmanuel","doi":"10.1007/s12325-025-03231-6","DOIUrl":"https://doi.org/10.1007/s12325-025-03231-6","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical trials for severe uncontrolled asthma (SUA) often underrepresent or exclude key patient populations. The phase 4 PASSAGE study assesses the effectiveness and safety of tezepelumab in a diverse, real-world US population of patients with SUA.</p><p><strong>Methods: </strong>PASSAGE is an ongoing, multicenter, single-arm, open-label study of patients (≥ 12 years) with SUA. The study enrolled participants across asthma phenotypes, based on blood eosinophil counts (BECs) (≥/< 300 cells/µL) and perennial aeroallergen sensitization, and underrepresented subgroups (Black/African Americans, adolescents, participants with comorbid mild to moderate chronic obstructive pulmonary disease (COPD) and smokers [≥ 10 pack-years]). Participants receive tezepelumab 210 mg subcutaneously every 4 weeks for 52 weeks. This interim analysis assessed annualized asthma exacerbation rates (AAERs) in the 12-month baseline period (before starting tezepelumab) and the treatment period, and changes from baseline to week 24 in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV<sub>1</sub>), Asthma Control Questionnaire-6 (ACQ-6) score and health-related quality of life (HRQoL) outcomes.</p><p><strong>Results: </strong>Of 208 participants in this analysis, 41% had BEC ≥ 300 cells/µL, 56% had confirmed allergy, 17% were Black/African American, 5% were adolescents, 13% had comorbid COPD, and 23% were smokers. The AAER decreased by 76% (95% CI (confidence interval): 69, 81) from baseline to the treatment period; comparable reductions were observed across asthma phenotypes and underrepresented subgroups. The least squares mean change from baseline to week 24 in pre-BD FEV<sub>1</sub> was 0.11 L (95% CI: 0.06, 0.17) overall and 0.19 L (95% CI: 0.12, 0.25) among participants with baseline pre-BD FEV<sub>1</sub> ≤ 80% predicted. Clinically meaningful improvements from baseline to week 24 were observed for ACQ-6 score and HRQoL outcomes. No new safety signals were identified.</p><p><strong>Conclusion: </strong>The PASSAGE study of US patients with SUA treated with tezepelumab demonstrates substantial reductions in AAERs across asthma phenotypes and underrepresented subgroups, with clinically meaningful improvements in lung function, asthma control and HRQoL.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05329194.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144092501","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}
引用次数: 0
Advances in Clinical Cardiology 2024: A Summary of Key Clinical Trials. 临床心脏病学进展2024:关键临床试验综述
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-19 DOI: 10.1007/s12325-025-03220-9
Patrick Savage, Michael Campbell, Meadhbh Hogg, Daniel McElhatton, Ian Menown
{"title":"Advances in Clinical Cardiology 2024: A Summary of Key Clinical Trials.","authors":"Patrick Savage, Michael Campbell, Meadhbh Hogg, Daniel McElhatton, Ian Menown","doi":"10.1007/s12325-025-03220-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03220-9","url":null,"abstract":"<p><strong>Introduction: </strong>In 2024, numerous key clinical trials in the field of clinical cardiology have been published or presented at major international conferences. This review seeks to collate and summarise these trials and reflect on their clinical context.</p><p><strong>Methods: </strong>The authors evaluated all clinical trials presented at major cardiology conferences during 2024 with a focus on clinical trials which would influence and/or change current clinical practice. We reviewed clinical trials presented at all major international conferences including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials considered to have highest impact and/or broad relevance across the field of clinical cardiology, with a high likelihood to change or impact upon clinical practice were included.</p><p><strong>Results: </strong>Over 90 key cardiology clinical trials were identified across the spectrum of clinical cardiology. Important updates in percutaneous coronary intervention were reviewed including new ESC guidance and several key trials in the field of coronary physiology (FAVOR III), drug-coated balloons (REGCAGE-FREE, AGENT-IDE), shock, and acute coronary syndromes (SENIOR-RITA, DanGer-Shock). Structural trials included major updates in transcatheter aortic valve replacement (TAVR) from EARLY-TAVR, TAVR-UNLOAD and NOTION 3, as well as seminal trials in tricuspid (TRISCEND II) and mitral intervention (MATTERHORN). Key updates in preventative cardiology included new data in lipoprotein (a) pharmacotherapy, low-density lipoprotein (LDL) cholesterol reduction and hypertension management (BPROAD, BedMed, KRAKEN), as well as several key trials in heart failure (SUMMIT, FINEARTS) hypertrophic cardiomyopathy (SEQUOIA-HCM) and cardiac amyloid (HELIOS-B).</p><p><strong>Conclusion: </strong>The review presents a concise summary of the key clinical cardiology trials published or presented during the past year and should be of interest to clinicians and researchers in the field of cardiology.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144092457","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}
引用次数: 0
Glycaemic and Weight Control in People Aged 65 or Younger Newly Diagnosed with Type 2 Diabetes in Spain: Insights from the PRIORITY-T2D Study. 西班牙65岁及以下新诊断为2型糖尿病患者的血糖和体重控制:来自PRIORITY-T2D研究的见解
IF 3.4 3区 医学
Advances in Therapy Pub Date : 2025-05-19 DOI: 10.1007/s12325-025-03230-7
Emilio Ortega, Jennifer Redondo-Antón, Silvia Díaz-Cerezo, Miriam Rubio-de Santos, Irene Romera
{"title":"Glycaemic and Weight Control in People Aged 65 or Younger Newly Diagnosed with Type 2 Diabetes in Spain: Insights from the PRIORITY-T2D Study.","authors":"Emilio Ortega, Jennifer Redondo-Antón, Silvia Díaz-Cerezo, Miriam Rubio-de Santos, Irene Romera","doi":"10.1007/s12325-025-03230-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03230-7","url":null,"abstract":"<p><strong>Introduction: </strong>The objective of this study was to determine the number of people within glycated haemoglobin (HbA1c) targets and achieving weight-loss goals during the first 5 years after type 2 diabetes (T2D) diagnosis and to explore the relationship between early weight loss and glycaemic control in routine care in Spain.</p><p><strong>Methods: </strong>This was an observational retrospective study using IQVIA's electronic medical record database, including adults aged ≤ 65 years newly diagnosed with T2D. Variables included baseline sociodemographic/clinical characteristics, yearly HbA1c and weight data, and treatment patterns. Descriptive statistics and regression analyses were used.</p><p><strong>Results: </strong>A total of 8973 people with T2D were included (mean age 53 years; mean baseline HbA1c 7.7%; obesity at diagnosis: 64%). During the first 5 years post-T2D diagnosis, 46-63% of the population did not have HbA1c < 6.5%, and > 60%, and > 80% of subjects did not achieve ≥ 5% and ≥ 10% weight loss, respectively. Early weight loss goal achievement (1st year after diagnosis) and weight loss magnitude were associated with a higher percentage of people with HbA1c < 6.5%.</p><p><strong>Conclusions: </strong>Many individuals with T2D did not have HbA1c < 6.5% in the first 5 years after diagnosis and did not achieve ≥ 5% or ≥ 10% weight loss. Early weight loss after T2D diagnosis was associated with higher likelihood of achieving early glycaemic control.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144092503","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}
引用次数: 0
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