Expert Opinion on Biological Therapy最新文献_第4页

IL23p19 therapies for moderately-to-severely active ulcerative colitis. IL23p19治疗中度至重度活动性溃疡性结肠炎。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-24 DOI: 10.1080/14712598.2025.2480258

Newaz Shubidito Ahmed, Christopher Ma

{"title":"IL23p19 therapies for moderately-to-severely active ulcerative colitis.","authors":"Newaz Shubidito Ahmed, Christopher Ma","doi":"10.1080/14712598.2025.2480258","DOIUrl":"10.1080/14712598.2025.2480258","url":null,"abstract":"Introduction: Ulcerative colitis (UC) is a chronic, relapsing and remitting, inflammatory bowel disease. Monoclonal antibodies targeting interleukin (IL)-23p19 have been developed to treat chronic inflammatory diseases mediated by aberrant IL23/Th17 responses, including psoriasis, psoriatic arthritis, and Crohn's disease. More recently, these agents have been evaluated for the treatment of moderately-to-severely active UC.Areas covered: In this review, we summarize and discuss phase 2 and pivotal phase 3 clinical trials informing the efficacy and safety of mirikizumab (AMAC, LUCENT, and SHINE), risankizumab (INSPIRE, COMMAND), and guselkumab (QUASAR, VEGA). The literature search included original research publications, secondary publications, and preliminary data from conference abstracts presented at international gastroenterology meetings from the past 5 years.Expert opinion: The approval of IL23p19 antagonists expands the armamentarium of effective and safe therapies for patients living with moderately-to-severely active UC. These agents demonstrate potent efficacy for both inducing and maintaining symptomatic and objective disease endpoints, including endoscopic, histologic, and biomarker remission. These well-tolerated agents are effective in both advanced treatment-naïve and experienced patients. Accordingly, IL23p19 antagonists have the potential to be used in a diverse population of patients with UC, and as potential platform therapies for future combinations with other targeted immunomodulatory agents.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"363-378"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624073","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

Optimizing biosimilar development: current approaches to demonstrating pharmacokinetic and analytical similarity and a proposal for a single reference approach. 优化生物类似药开发：目前证明药代动力学和分析相似性的方法，以及单一参考方法的建议。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-07 DOI: 10.1080/14712598.2025.2476030

Peter Kiely, David Murray

{"title":"Optimizing biosimilar development: current approaches to demonstrating pharmacokinetic and analytical similarity and a proposal for a single reference approach.","authors":"Peter Kiely, David Murray","doi":"10.1080/14712598.2025.2476030","DOIUrl":"10.1080/14712598.2025.2476030","url":null,"abstract":"Objectives: Many biosimilars have been approved in both the United States of America (U.S.A.) and European Union (EU). We aim to highlight how regulatory challenges and divergent requirements between both agencies exist.Methods: A comprehensive review of biosimilars approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) was conducted. We aimed to highlight similarities and differences in approaches taken by the agencies regarding the use of non-local (i.e. non -US and non-EU) reference medicinal products in biosimilar development. A search of the six most frequent classes of biosimilars authorized (cutoff date: 12 June 2024) by these agencies were identified and their public assessment reports reviewed.Results: The review highlighted that pharmacokinetic (PK) bioequivalence studies are often replicated, the current process is inefficient and not entirely necessary when critical quality attributes are considered.Conclusion: This article provides a comparative analysis of biosimilar approvals in EU and US regulatory agencies, focusing on non-local reference medicinal product (RMP) utilization and bioequivalence demonstration. The findings contribute to literature on biosimilar development and regulatory considerations, enhancing understanding of harmonization opportunities in biosimilar approval processes, potentially improving global access to high-quality, cost-effective biosimilars.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"447-454"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540674","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

A plain language summary of the pooled safety results of adalimumab-adbm from the VOLTAIRE clinical trials in people with rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis. 对阿达木单抗-adbm在类风湿关节炎、克罗恩病和慢性斑块性银屑病患者的伏尔泰临床试验的综合安全性结果进行简单的语言总结。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-11 DOI: 10.1080/14712598.2025.2476033

Stanley Cohen, Shaun Bender, Amy Shaberman, Richard Vinisko, Dottie McCabe

引用次数: 0

State of the art of the molecular hyperselection to guide treatment with anti-EGFR antibodies in RAS WT mCRC: implications for clinical practice and future perspectives. 分子超选择在RAS WT mCRC中指导抗egfr抗体治疗的最新进展：对临床实践和未来前景的影响。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-12 DOI: 10.1080/14712598.2025.2477192

Pilar García-Alfonso, Manuel Valladares-Ayerbes, Andrés J Muñoz Martín, Rocío Morales Herrero, Elisa Galvez Muñoz, Gerard Prat-Llorens

{"title":"State of the art of the molecular hyperselection to guide treatment with anti-EGFR antibodies in RAS WT mCRC: implications for clinical practice and future perspectives.","authors":"Pilar García-Alfonso, Manuel Valladares-Ayerbes, Andrés J Muñoz Martín, Rocío Morales Herrero, Elisa Galvez Muñoz, Gerard Prat-Llorens","doi":"10.1080/14712598.2025.2477192","DOIUrl":"10.1080/14712598.2025.2477192","url":null,"abstract":"Introduction: Adding monoclonal antibodies to chemotherapy drastically changed the landscape of advanced colorectal cancer. The prediction of benefit from anti-EGFR therapies is mainly based on the absence of mutations in RAS and BRAF genes, the primary tumor sidedness and microsatellite MSS/MSI status. Molecular hyperselection may optimize the outcome of patients receiving anti-EGFR while detecting additional resistance alterations, both in chemo-naïve and in chemo-refractory settings.Areas covered: Our review focuses on negative molecular hyperselection, both on tissue samples and ctDNA, and the impact of this further patient selection on response rate and survival outcomes. We searched electronic database, selecting relevant English-language publications from 2017 to 2024.Expert opinion: Negative hyperselection beyond RAS and BRAF in advanced colorectal cancer appears to be a powerful tool for predicting outcomes to anti-EGFR therapy and spare patients from unnecessary treatment. This improvement appears in both naïve and pre-treated patients. However, data come mainly from retrospective studies. Therefore, to validate and integrate these findings in the clinical practice, prospective studies should be conducted. It will be interesting to elucidate the role of ctDNA in this setting and the choice of molecular techniques, considering costs and accessibility, to guarantee its implementation in the clinic.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"413-423"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604346","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

Belimumab patient profile in Spain: evolution during the last decade and future directions. Belimumab患者概况在西班牙：演变在过去十年和未来的方向。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI: 10.1080/14712598.2025.2479018

Tarek Carlos Salman-Monte, María José Cuadrado, María Galindo, Gerard Espinosa, Enrique Morales, José María Pego-Reigosa, Lucio Pallarés, Covadonga López, Carmen San Román, Íñigo Rúa-Figueroa

{"title":"Belimumab patient profile in Spain: evolution during the last decade and future directions.","authors":"Tarek Carlos Salman-Monte, María José Cuadrado, María Galindo, Gerard Espinosa, Enrique Morales, José María Pego-Reigosa, Lucio Pallarés, Covadonga López, Carmen San Román, Íñigo Rúa-Figueroa","doi":"10.1080/14712598.2025.2479018","DOIUrl":"10.1080/14712598.2025.2479018","url":null,"abstract":"Introduction: Belimumab (BEL), an anti B-lymphocyte stimulator monoclonal antibody, is the only approved biological therapy for systemic lupus erythematosus (SLE) and lupus nephritis (LN).Areas covered: This review discusses BEL's real-world use and its positioning in clinical practice guidelines, focusing on the evolution of its application and patient profile over the last decade in Spain.Expert opinion: Initially used for refractory and non-major SLE manifestations, BEL's application has expanded. International guidelines now recommend earlier use of BEL in treatment algorithms. With its 2021 approval for LN, BEL is increasingly used for renal manifestations and as a first-line therapy. Safety data confirm its tolerability without a significant increase in severe infections. However, real-world evidence in Spain reveals discrepancies with these recommendations for both SLE and LN. The optimal patient for BEL treatment is one with mild, moderate, or severe SLE that cannot be controlled with hydroxychloroquine (HCQ), with or without glucocorticoids (GC) and immunosuppressants (IS), in patients with a disease duration of ≤2 years, no initial organ damage, GC doses ≥5 mg/day, and a high risk of severe flares. Further studies are needed to determine the optimal timing for BEL initiation to improve patient outcomes and modify the disease course.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"425-435"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143614018","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

An evaluation of odronextamab for the treatment of multiple subtypes of relapsed/refractory B-cell non-Hodgkin lymphoma. 评价odronexamab治疗复发/难治性b细胞非霍奇金淋巴瘤的多种亚型

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-24 DOI: 10.1080/14712598.2025.2479631

Elena Bayly-McCredie, Henry Miles Prince, Costas Kleanthes Yannakou, Salvatore Fiorenza

{"title":"An evaluation of odronextamab for the treatment of multiple subtypes of relapsed/refractory B-cell non-Hodgkin lymphoma.","authors":"Elena Bayly-McCredie, Henry Miles Prince, Costas Kleanthes Yannakou, Salvatore Fiorenza","doi":"10.1080/14712598.2025.2479631","DOIUrl":"10.1080/14712598.2025.2479631","url":null,"abstract":"Introduction: Patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) have a poor median survival rate when treated with traditional salvage therapies. Bispecific antibodies (BsAbs) are an emerging class of 'off-the-shelf' immunotherapies that show promising efficacy in this population. Odronextamab is a CD20×CD3 targeting bispecific antibody that is being investigated in multiple subtypes of relapsed/refractory B-NHL.Areas covered: This article describes the development of odronextamab from pre-clinical work through to ongoing clinical trials in relapsed/refractory B-NHL. The structure, safety, efficacy, and administration of odronextamab are discussed. Studies were selected for inclusion by performing a search in PubMed, EMBASE, Cochrane Library, and relevant conference abstracts from 2014 to 2024. The clinicaltrials.gov website and reference lists of the included studies were also reviewed.Expert opinion: Odronextamab has demonstrated manageable safety and promising efficacy in multiple subtypes of relapsed/refractory B-NHL. The low rates of immune effector cell-associated neurotoxicity syndrome (ICANS) and high response rates in rare aggressive subtypes of B-NHL are particularly noteworthy. High rates of severe infections remain a challenge with BsAbs, with further prophylactic efforts required to reduce the risk. Clinical trials of combination therapies with odronextamab are required to improve the utility of this BsAb across a wider range of settings and subtypes of B-NHL.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"331-343"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663030","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

Drawing on collective action theory to foster sustainable biosimilar markets - insights from co-creation workshops with UK and Belgian stakeholders. 借鉴集体行动理论，促进可持续的生物仿制药市场--从与英国和比利时利益相关者的共同创造研讨会中获得的启示。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-07 DOI: 10.1080/14712598.2025.2474604

Teresa Barcina Lacosta, Arnold G Vulto, Florian Turk, Isabelle Huys, Steven Simoens

{"title":"Drawing on collective action theory to foster sustainable biosimilar markets - insights from co-creation workshops with UK and Belgian stakeholders.","authors":"Teresa Barcina Lacosta, Arnold G Vulto, Florian Turk, Isabelle Huys, Steven Simoens","doi":"10.1080/14712598.2025.2474604","DOIUrl":"10.1080/14712598.2025.2474604","url":null,"abstract":"Background: Research has signaled the need for reformed biosimilar policy frameworks that adopt a behavioral approach, are informed by consensus-generating strategies and thus better align with the requirements of local healthcare communities.Research design and methods: Through a series of co-creation workshops, the current study explores the feasibility of applying learnings from Collective Action Theory to formulate evidence-based multistakeholder-supported policy recommendations.Results: Insights from the conducted workshops indicate that future policy frameworks would benefit from: 1) a working system of incentives and rewards aligned with stakeholder needs; 2) evaluating the cost-benefit balance for stakeholders prior to policy implementation; 3) involving multistakeholder panels in policy co-design; 4) adopting a long-term vision; 5) fostering coordination at the interface between levels of governance; 6) defining shared goals and efficient systems to monitor policy compliance; and 7) using policy outcome data to adapt current policy frameworks based on evolving needs. The incorporation of these elements to policies is expected to help prioritize long-term sustainable solutions, and balance short-term gains and long-term objectives in biosimilar markets.Conclusions: This study constitutes a first approach to developing multistakeholder-supported principles for sustainable biosimilar markets. This is a necessary step toward generating stakeholders' consensus on biosimilar policies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"437-446"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531481","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

A review of antibody-based immunotherapy clinical trials for adult acute myeloid leukemia (AML): monoclonal antibodies (mAbs) and beyond. 成人急性髓性白血病（AML）基于抗体的免疫治疗临床试验综述：单克隆抗体（mab）及其他。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI: 10.1080/14712598.2025.2479014

Kaitlyn C Dykes, Edward D Ball

{"title":"A review of antibody-based immunotherapy clinical trials for adult acute myeloid leukemia (AML): monoclonal antibodies (mAbs) and beyond.","authors":"Kaitlyn C Dykes, Edward D Ball","doi":"10.1080/14712598.2025.2479014","DOIUrl":"10.1080/14712598.2025.2479014","url":null,"abstract":"Introduction: Antibody-based immunotherapies are a class of therapeutics under active investigation in clinical trials for the treatment of acute myeloid leukemia (AML). Our review provides a comprehensive examination of trials published to date, focusing on recurrent challenges and promising aspects of antibody-based therapeutics.Areas covered: We described antibody-based immunotherapies for AML, specifically, an overview of the most prominent antigen targets in published clinical trials investigating monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, and chimeric antigen receptor therapies. Manuscripts and abstracts describing clinical trials investigating antibody-based therapies for AML published through December 2024, identified by searching Google Scholar and PubMed, were included.Expert opinion: Antibody-based immunotherapies for AML have encountered limitations, including imperfect target antigens with significant associated toxicity such as myelosuppression, in addition to challenges specific to the AML patient population. The majority of trials have targeted CD33, CD123, CD371 (CLL1/Clec12), and CD47. For successful implementation of antibody-based therapeutics in AML treatment, future directions require creative applications of antibody-based therapeutics specifically engineered to minimize limiting toxicities and tailoring of therapies for this unique patient population.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"345-362"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604344","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

Chasing optimal first-in-human (FIH) starting dose for biotherapeutics in oncology. 追求肿瘤生物治疗药物的最佳首次人体试验（FIH）起始剂量。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-19 DOI: 10.1080/14712598.2025.2477190

Céline Amara

引用次数: 0

X-linked myotubular myopathy: an untreated treatable disease. x连锁肌小管肌病：一种无法治疗的疾病。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI: 10.1080/14712598.2025.2473430

Cristina Martin, Laurent Servais

{"title":"X-linked myotubular myopathy: an untreated treatable disease.","authors":"Cristina Martin, Laurent Servais","doi":"10.1080/14712598.2025.2473430","DOIUrl":"10.1080/14712598.2025.2473430","url":null,"abstract":"Introduction: X-linked myotubular myopathy (XLMTM) is a life-threatening congenital disorder characterized by severe respiratory and motor impairment. This disease presents significant therapeutic challenges, with various strategies being explored to address its underlying pathology. Among these approaches, gene replacement therapy has demonstrated substantial functional improvements in clinical trials. However, safety issues emerged across different therapeutic approaches, highlighting the need for further research.Areas covered: This review provides a comprehensive analysis of the data gathered from natural history studies, preclinical models and clinical trials, with a particular focus on gene replacement therapy for XLMTM. The different therapeutic strategies are addressed, including their outcomes and associated safety concerns.Expert opinion: Despite the encouraging potential of gene therapy for XLMTM, the occurrence of safety challenges emphasizes the urgent need for a more comprehensive understanding of the disease's complex phenotype. Enhancing preclinical models to more accurately mimic the full spectrum of disease manifestations will be crucial for optimizing therapeutic strategies and reducing risks in future clinical applications.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"379-394"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556395","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