BioDrugs最新文献

{"title":"Biological Therapies in Chronic Obstructive Pulmonary Disease: New Directions in Personalised Respiratory Medicine.","authors":"Benjamin Mappin-Kasirer, Ian D Pavord","doi":"10.1007/s40259-025-00744-y","DOIUrl":"https://doi.org/10.1007/s40259-025-00744-y","url":null,"abstract":"<p><p>Chronic obstructive pulmonary disease (COPD), a leading cause of global morbidity and mortality, is a complex and heterogeneous respiratory condition characterised by incompletely reversible airflow obstruction on spirometry. The aetiologies and pathological patterns of COPD are varied, which has long been viewed as a hindrance to targeted treatment. Yet inflammation is central to the diverse mechanisms of COPD pathogenesis, and type 2 inflammation has emerged as a measurable, modifiable and clinically meaningful therapeutic target in those patients in whom it is identified. The approval of first biological therapy against type 2 inflammation in COPD builds on our understanding of immunological mechanisms in airways diseases, is informed by a decade of randomised trials and makes possible a fundamental shift in our approach to this common condition. This review will (1) assess aspects of pathological inflammation in COPD, namely type 1, 2 and 3 inflammation, and the role of epithelial alarmins; (2) examine data from randomised trials on the efficacy and safety of monoclonal antibodies against inflammatory mediators in COPD; and (3) discuss future directions for biological therapies in COPD, including new patient populations, new agents and new approaches that focus on high-risk disease and open the door to prevention.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment.","authors":"Slavica Lazarević, Maja Đanić, Nebojša Pavlović","doi":"10.1007/s40259-025-00739-9","DOIUrl":"https://doi.org/10.1007/s40259-025-00739-9","url":null,"abstract":"<p><p>The interplay between inflammatory bowel disease pharmacotherapies and the gut microbiota is increasingly recognized as a pivotal factor influencing treatment efficacy and patient outcomes. This review provides a comprehensive and up-to-date synthesis of the bidirectional interactions between inflammatory bowel disease drugs and gut microbiota, emphasizing the emerging field of pharmacomicrobiomics and associated therapeutic implications. Emerging evidence reveals that microbial composition and function not only shape drug metabolism, bioavailability, and efficacy, but are themselves profoundly altered by pharmacologic interventions. In addition to traditional oral drugs and biological therapy used in inflammatory bowel disease, recent approvals of Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators as well as late-stage developmental drugs indicate that drug-microbiota interactions may increase in prominence. Understanding these intricate interactions offers significant potential: microbial signatures may help guide therapeutic decisions as companion diagnostic tools, helping clinicians predict the therapeutic outcome. Moreover, targeted manipulation of the microbiota may open entirely new avenues to complement and enhance the effectiveness of established inflammatory bowel disease therapies. By illuminating current knowledge, knowledge gaps, and future research directions, this review underscores the potential of integrating pharmacomicrobiomic insights into the next generation of personalized inflammatory bowel disease care.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145224664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria.","authors":"Yuanzhi Ju, Luxi Weng, Tiantian Lin, Xiaohui Yang, Jiasheng Song, Jingxiang Wang, Huimin Su, Pengqin Chen, Wuping Shuai, Jia-Wei Shen, Yongzhong Du, Saiping Jiang","doi":"10.1007/s40259-025-00740-2","DOIUrl":"https://doi.org/10.1007/s40259-025-00740-2","url":null,"abstract":"<p><p>Drug-resistant bacteria have become one of the greatest threats to human health in recent decades. With the large-scale abuse of antibiotics, bacteria resistant to traditional antibiotics are becoming increasingly common while clinical options for treating refractory infections are rapidly diminishing. Antimicrobial peptides (AMPs) as a promising alternative to traditional antibiotics, exhibit unique antibacterial mechanisms and potent antimicrobial activity. In recent years, numerous AMPs have been identified and validated in laboratory settings for their efficacy against the 'ESKAPE' pathogens, including Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. Although the clinical translation of AMPs is currently hindered by challenges such as stability, toxicity, and production costs, advances in biotechnology and continued research are paving the way for their development as promising alternatives for treating drug-resistant ESKAPE pathogens. This review focuses on summarizing AMPs with demonstrated efficacy against ESKAPE pathogens and explores their clinical application potential, aiming to provide insights for future AMP research and therapeutic development.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risankizumab in Patients with Psoriasis with Current or Previous Malignancy: A Multicenter, Retrospective Real-World Study.","authors":"Marco Sousa, Ana Luísa João, Martim Luz, Pedro Mendes-Bastos, Ângela Roda, Luiz Leite, Joana Valério, Ana Ferreirinha, Bárbara Leal, Maria João Paiva Lopes, Rita Pimenta, Paulo Ferreira, Tiago Torres","doi":"10.1007/s40259-025-00745-x","DOIUrl":"https://doi.org/10.1007/s40259-025-00745-x","url":null,"abstract":"","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oncolytic Virotherapy in Solid Tumors: A Current Review.","authors":"Courtney Chen, Jennifer Cillis, Supriya Deshpande, Anthony K Park, Hannah Valencia, Sang In Kim, Jianming Lu, Yoya Vashi, Annie Yang, Zhifang Zhang, Yanghee Woo, Yuman Fong, Shyambabu Chaurasiya","doi":"10.1007/s40259-025-00743-z","DOIUrl":"https://doi.org/10.1007/s40259-025-00743-z","url":null,"abstract":"<p><p>Oncolytic viruses (OVs) are naturally occurring or genetically modified viruses that selectively target cancer cells for infection, replication, and lysis. Specifically, their tumor tropism and promising antitumoral efficacy through direct oncolysis and indirect immunogenic activation make OVs a novel immunotherapeutic class of high interest. OVs find particular relevance in solid tumors that are notoriously refractory to chemoradiation, are immunologically silent, express heterogeneous antigens, and are difficult to penetrate with existing agents. Distinct OVs have been identified; many have been extensively studied and have been approved or are pending approval in humans, including adenoviruses, herpes simplex viruses, reoviruses, vaccinia viruses, and measles viruses. While each virus type is unique in size, structure, targeting, replication, and behavior, they broadly share several antitumor mechanisms-direct oncolysis, immunogenic cell death, and modification of the tumor microenvironment. Modifications to OVs build on these features, ranging from genetic manipulation to insertion of cytokines or genes of interest, such as checkpoint inhibitors, altering virulence for tumor specificity or safety, to viral targeting enhancements. Moreover, the most recent iterations of OVs are often paired as combination therapies with chemotherapy, radiation, or other immunotherapeutic agents. This review aims to provide an up-to-date, in-depth discussion of major OVs, their precise mechanisms of action, modifications for improved therapeutic outcomes, and current combination therapy approaches against solid tumors in pre-clinical and clinical settings.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis.","authors":"Silvia Susin-Calle, Elvira Munteis, Pablo Villoslada, Jose E Martinez-Rodriguez","doi":"10.1007/s40259-025-00741-1","DOIUrl":"https://doi.org/10.1007/s40259-025-00741-1","url":null,"abstract":"<p><p>Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system characterized by inflammation, demyelination, and neurodegeneration. Advances in understanding MS immunopathogenesis have led to the development of monoclonal antibodies (MABs) that target key immune pathways, providing highly selective and effective treatment options. Approved MABs, including those against CD20, CD25, CD52, and α4‑integrin, have demonstrated robust efficacy in reducing relapse rates, suppressing MRI activity, and, to some extent, slowing disability progression. Meanwhile, emerging agents aim to modulate neuroinflammation, promote remyelination, and improve safety profiles. This review summarizes the mechanisms of action, clinical efficacy, safety, and future perspectives of MAB therapies in MS, highlighting lessons from discontinued agents and opportunities for next‑generation therapeutics.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation.","authors":"Federico Yandian, Sanjeev Sethi, Fernando C Fervenza, Fernando Caravaca-Fontán","doi":"10.1007/s40259-025-00742-0","DOIUrl":"https://doi.org/10.1007/s40259-025-00742-0","url":null,"abstract":"<p><p>Anti-CD20 monoclonal antibodies are gaining clinical relevance in the nephrology community due to their demonstrated efficacy and favorable safety profiles across short-, medium-, and long-term use. Initially developed for hematologic malignancies and multiple sclerosis, B-cell depletion therapies are now being investigated across a broader spectrum of autoimmune diseases, including glomerulopathies, both with and without associated podocytopathy. Recent advances have led to the development of novel anti-CD20 agents that are being used not only as potential alternatives to corticosteroids but also as adjunctive therapies in complex clinical settings. However, their efficacy is not uniform across all conditions, whether used for induction therapy, relapse management, or as rescue treatment following first-line therapy failure. A thorough understanding of their mechanisms of action, along with the potential for resistance and therapeutic failure, is essential for advancing precision medicine in this field. This review provides a molecular and clinical overview, incorporating pharmacokinetic and pharmacodynamic insights into the most widely used and emerging anti-CD20 monoclonal antibodies in nephrology. It serves as a practical guide to understand how these agents' function, why they may fail, and what alternative strategies should be considered in cases of adverse reactions or inadequate response. Finally, it highlights their evolving role in precision therapy, both as monotherapy in podocytopathies and as part of a multi-targeted treatment approach for glomerular diseases with systemic involvement.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":""},"PeriodicalIF":6.9,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline.","authors":"Toral Shastri, Asaad Trabolsi, Artavazd Arumov, Jonathan H Schatz","doi":"10.1007/s40259-025-00735-z","DOIUrl":"10.1007/s40259-025-00735-z","url":null,"abstract":"<p><p>Since blinatumomab's approval as the first bispecific antibody (BsAb) in cancer therapy, these immunomodulatory agents have achieved substantial success in lymphoid malignancies. A decade after provisional approval in relapsed settings, blinatumomab became part of first-line induction therapy for patients with B-cell acute lymphoblastic leukemia (B-ALL). Now, six additional BsAbs have FDA approvals for the treatment of B-cell non-Hodgkin's lymphomas and multiple myeloma (MM), achieving high response rates in otherwise refractory scenarios. In lymphoma, epcoritamab, glofitamab, and mosunetuzumab show proof-of-principle for complete remission (CR) without chemotherapy or cell-based treatment. Single-agent remissions do not appear durable, but fortunately, these immunotherapies are readily combined with other treatment modalities. Therefore, their true potential to contribute to cures may be close on the horizon owing to ongoing and future trials. In MM, teclistamab, talquetamab, and elranatamab achieve impressive CR rates in the relapsed setting and similarly, are being investigated in earlier line combinations and in precursor entities such as smoldering myeloma and monoclonal gammopathy of undetermined significance (MGUS). With a unique mechanism of action and continued testing in earlier lines, BsAbs are poised to be among the winners in the race to the frontline treatment of hematologic malignancies.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"793-814"},"PeriodicalIF":6.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354547/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study.","authors":"Casper Steenholdt, Ruben Due Lorentsen, Jon Henneberg, Pernille Nørgaard Petersen, Jørn Brynskov","doi":"10.1007/s40259-025-00730-4","DOIUrl":"10.1007/s40259-025-00730-4","url":null,"abstract":"<p><strong>Background: </strong>Increasing therapeutic options for inflammatory bowel disease calls for tools to aid choice of sequencing. We investigated if pharmacokinetic (PK) and pharmacodynamic (PD) failure mechanisms prompting therapy change influenced subsequent outcomes when switching to a different biologic drug class.</p><p><strong>Methods: </strong>Retrospective single-center cohort study including patients treated first with tumor necrosis factor (TNF) inhibitors, followed by vedolizumab, and then ustekinumab. Clinical and objective disease remission were conventionally classified by validated indices. PK-PD failure was defined according to maintenance drug concentrations (PK below thresholds and PD above thresholds): infliximab 8.0 µg/mL, adalimumab 12.0 µg/mL, golimumab 1.4 µg/mL, vedolizumab 15 µg/mL. Primary treatment failure despite dose intensification was ascribed to PD. Primary endpoints were steroid-free treatment persistence and 1-year remission.</p><p><strong>Results: </strong>The study included 112 patients switching from TNF inhibitors to vedolizumab (infliximab n = 61, adalimumab n = 32, golimumab n = 16, certolizumab pegol n = 3) and 31 subsequently to ustekinumab. Treatment persistence on vedolizumab did not differ between patients discontinuing TNF inhibitors due to PK (n = 28, 31%) or PD (n = 63, 69%) (mean 989 days [95% confidence interval: 554-1424] vs. 951 [659-1242], p = 0.93). One-year steroid-free clinical and objective remission rates on VDZ were also comparable between PK-PD groups (29% vs. 35%, p = 0.63 and 35% vs. 43%, p = 0.48, respectively). Findings for UST were similar. Sensitivity analyses with exclusion of primary non-responders and multivariate analyses correcting for potential confounders supported findings.</p><p><strong>Conclusion: </strong>PK-PD failure mechanisms do not appear to influence subsequent treatment outcomes when switching to biologics with different modes of action. Sequencing may rather rely on aspects such as efficacy, safety, and costs.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"725-734"},"PeriodicalIF":6.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State-of-the-Art Review.","authors":"Samuel D Maidman, Robert S Rosenson","doi":"10.1007/s40259-025-00731-3","DOIUrl":"10.1007/s40259-025-00731-3","url":null,"abstract":"<p><p>Despite the modern era of effective and safe high-intensity statins and non-statin agents, a significant portion of patients are still unable to achieve guideline-recommended lipid goals for the prevention of atherosclerotic cardiovascular disease (ASCVD) events. Accordingly, novel strategies are needed to further mitigate residual risk for patients on the background of maximally tolerated lipid-lowering therapies. The past decade has seen an explosion of new agents leveraging ribonucleic acid (RNA)-based technology which reduce plasma lipoprotein levels. In this state-of-the-art review, we examine the ongoing clinical development of lipid-lowering RNA therapeutics. We discuss the efficacy and safety profiles of antisense oligonucleotides and small interfering RNA agents targeting low-density lipoprotein, lipoprotein(a), and triglyceride-rich lipoproteins. We also present challenges future clinical trials must answer to prove RNA therapeutics as a viable strategy for ASCVD prevention among patients with refractory hyperlipidemia.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"753-768"},"PeriodicalIF":6.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144483110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}