Drugs最新文献_第9页

Current Drug Treatment for Acute and Recurrent Pericarditis. 急性和复发性心包炎的药物治疗现状。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-03-22 DOI: 10.1007/s40265-025-02169-x

Aldo Bonaventura, Davide Santagata, Alessandra Vecchié, Antonio Abbate

{"title":"Current Drug Treatment for Acute and Recurrent Pericarditis.","authors":"Aldo Bonaventura, Davide Santagata, Alessandra Vecchié, Antonio Abbate","doi":"10.1007/s40265-025-02169-x","DOIUrl":"10.1007/s40265-025-02169-x","url":null,"abstract":"Pericarditis is the most frequent pericardial disease and presents with a relatively benign course when treated according to guideline-directed therapies at first presentation. Recurrence is the most frequent complication and may occur more frequently after a first episode, in patients with autoimmune etiology, in patients who received glucocorticoids, or after rapid (i.e., within 1 month) tapering of anti-inflammatory drugs. The therapeutic armamentarium for pericarditis includes high-dose nonsteroidal anti-inflammatory drugs (NSAIDs) that are tapered rapidly once symptoms are controlled. Colchicine is necessary to both relieve symptoms and reduce the rate of recurrences and is continued for at least 3-6 months. Low- to moderate-dose glucocorticoids are reserved for patients with a first recurrence for which NSAIDs and colchicine failed and/or who have an autoimmune disorder, with a slow tapering. Interleukin-1 blockers-anakinra, rilonacept, and goflikicept-are used as a third-line option in patients who cannot come off glucocorticoids or as second-line therapy after NSAIDs and colchicine in patients with contraindications to glucocorticoids or in those with high-risk features (i.e., multiple episodes, markedly elevated inflammatory markers, or extensive abnormalities at pericardial imaging) in whom treatment with glucocorticoids is unlikely to succeed.","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"643-658"},"PeriodicalIF":13.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12031812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Tailored Biosimilar Approach: Expectations and Requirements. 量身定制的生物仿制药方法：期望和要求。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-04-01 DOI: 10.1007/s40265-025-02168-y

Elena Guillen, Sean Barry, Nils Jost, Niklas Ekman, Verena Knippel, Johanna Kuhlmann-Gottke, Julia Maier, Martina Weise, Andrea Laslop, René Anour, Ger van Zandbergen, Nadine Kirsch-Stefan

{"title":"The Tailored Biosimilar Approach: Expectations and Requirements.","authors":"Elena Guillen, Sean Barry, Nils Jost, Niklas Ekman, Verena Knippel, Johanna Kuhlmann-Gottke, Julia Maier, Martina Weise, Andrea Laslop, René Anour, Ger van Zandbergen, Nadine Kirsch-Stefan","doi":"10.1007/s40265-025-02168-y","DOIUrl":"10.1007/s40265-025-02168-y","url":null,"abstract":"Regulatory approval of biosimilar medicines currently requires a combination of physicochemical and functional testing, pharmacokinetic data, and clinical efficacy studies (CES). In this article, we discuss the tailored biosimilar approach, which represents an evolution in regulatory thinking by moving away from the default requirement for CES in biosimilar approval. We explore how physicochemical and functional data can be predictive for clinical performance and address the limitations of CES for regulatory decision-making. We argue that, in most cases, the combination of a robust package of physicochemical and functional testing, with appropriately designed pharmacokinetic studies provides sufficient evidence to establish biosimilarity. Additionally, we provide our perspective on the requirements, expectations, and exceptions for future biosimilar approvals, outlining specific scenarios where additional clinical evidence may be necessary. These include cases where the mechanism of action is unknown or poorly characterized, when product heterogeneity cannot be adequately characterized, or where relevant safety or immunogenicity concerns arise with the reference product or biosimilar candidate. Finally, we aim to clarify the remaining concerns surrounding the tailored biosimilar approach, providing insights into the potential to streamline biosimilar development and regulatory approval.","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"601-608"},"PeriodicalIF":13.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12031863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Correction: From Prospective Evaluation to Practice: Model-Informed Dose Optimization in Oncology. 更正：从前瞻性评估到实践：肿瘤中基于模型的剂量优化。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-03-20 DOI: 10.1007/s40265-025-02174-0

Bram C Agema, Birgit C P Koch, Ron H J Mathijssen, Stijn L W Koolen

引用次数: 0

Zanidatamab: First Approval. Zanidatamab：首次批准。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-03-20 DOI: 10.1007/s40265-025-02163-3

Susan J Keam

引用次数: 0

Cosibelimab: First Approval. Cosibelimab：首次批准。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-04-01 DOI: 10.1007/s40265-025-02164-2

Arnold Lee

引用次数: 0

Iparomlimab and Tuvonralimab: First Approval. Iparomlimab和Tuvonralimab：首次批准。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-04-01 DOI: 10.1007/s40265-025-02160-6

Susan J Keam

引用次数: 0

Classic Psychedelics for the Treatment of Depression: Potential Benefits and Challenges. 经典迷幻药治疗抑郁症：潜在的好处和挑战。

IF 13 1区医学

Drugs Pub Date : 2025-05-01 Epub Date: 2025-03-24 DOI: 10.1007/s40265-025-02172-2

Sharmin Ghaznavi, Sarah G Richter

引用次数: 0

From Prospective Evaluation to Practice: Model-Informed Dose Optimization in Oncology. 从前瞻性评估到实践：肿瘤中基于模型的剂量优化。

IF 13 1区医学

Drugs Pub Date : 2025-04-01 Epub Date: 2025-02-12 DOI: 10.1007/s40265-025-02152-6

Bram C Agema, Birgit C P Koch, Ron H J Mathijssen, Stijn L W Koolen

{"title":"From Prospective Evaluation to Practice: Model-Informed Dose Optimization in Oncology.","authors":"Bram C Agema, Birgit C P Koch, Ron H J Mathijssen, Stijn L W Koolen","doi":"10.1007/s40265-025-02152-6","DOIUrl":"10.1007/s40265-025-02152-6","url":null,"abstract":"One dose does not fit all, especially in oncolytic drugs, where side effects and therapy failures highlight the need for personalized dosing approaches. In recent years, the quest to apply model-informed precision dosing to oncology drugs has gained significant momentum, reflecting its potential to revolutionize patient care by tailoring treatments to individual pharmacokinetic profiles. Despite this progress, model-informed precision dosing has not (yet) become widely integrated into routine clinical care. We aimed to explain model-informed precision dosing from a clinical viewpoint while addressing all prospective model-informed precision dosing implementation and validation studies in the field of oncology. We identified 16 different drugs for which prospective model-informed precision dosing validation/implementation has been performed. Although these studies are mostly focused on attaining adequate drug exposures and reducing inter-individual variability, improved clinical outcomes after performing model-informed precision dosing were shown for busulfan, and high-dose methotrexate. Toxicities were significantly reduced for busulfan and cyclophosphamide treatment. In contrast, for carboplatin, for which model-informed precision dosing has been used in the Calvert formula, no prospective validation on outcomes was deemed necessary as the therapeutic window had been extensively validated. Model-informed precision dosing has shown to be of added value in oncology and is expected to significantly change dosing regimens in the future.","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"487-503"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11946950/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Olezarsen: First Approval. Olezarsen：第一次批准。

IF 13 1区医学

Drugs Pub Date : 2025-04-01 Epub Date: 2025-03-13 DOI: 10.1007/s40265-025-02166-0

Yahiya Y Syed

引用次数: 0

Update on the Treatment of Chronic Spontaneous Urticaria. 慢性自发性荨麻疹治疗进展。

IF 13 1区医学

Drugs Pub Date : 2025-04-01 Epub Date: 2025-03-12 DOI: 10.1007/s40265-025-02170-4

Pavel Kolkhir, Jie Shen Fok, Emek Kocatürk, Philip H Li, Tiia-Linda Okas, Joao Marcelino, Martin Metz

{"title":"Update on the Treatment of Chronic Spontaneous Urticaria.","authors":"Pavel Kolkhir, Jie Shen Fok, Emek Kocatürk, Philip H Li, Tiia-Linda Okas, Joao Marcelino, Martin Metz","doi":"10.1007/s40265-025-02170-4","DOIUrl":"10.1007/s40265-025-02170-4","url":null,"abstract":"Chronic spontaneous urticaria (CSU) is a mast cell-mediated skin disease that presents with wheals, angioedema, or both for more than 6 weeks. Less than 10% of patients have complete control of their CSU (the main goal of CSU treatment) with second generation H1-antihistamines, the first-line treatment. About 70% of patients with antihistamine-refractory CSU do not reach complete control with omalizumab, the second-line treatment. Novel therapies are especially needed for patients with mast cell-activating immunoglobulin (Ig)G autoantibodies (autoimmune CSU) associated with nonresponse or late response to omalizumab. Furthermore, there is a lack of disease-modifying treatments that induce long-term CSU remission after drug withdrawal. Several emerging treatments can address these unmet needs including Bruton tyrosine kinase inhibitors, e.g., remibrutinib and rilzabrutinib; anti-KIT monoclonal antibodies, e.g., barzolvolimab; and anti-cytokine therapies, e.g., dupilumab. In clinical trials, 30-31%, 28-32%, and 38-51% of patients with CSU showed complete response to treatment with dupilumab (phase 3, week 24), remibrutinib (phase 3, week 24), and barzolvolimab (phase 2, week 12), respectively. The most common adverse events were injection site reactions for dupilumab (12%), respiratory tract infections (11%), headache (6%), and petechiae (4%) for remibrutinib and changes in hair color (14%), neutropenia / decreased neutrophil count (9%) and skin hypopigmentation (1%) for barzolvolimab. This review provides an update on the current state of development of treatments for CSU.","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"475-486"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11946961/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0