Expert Opinion on Biological Therapy最新文献

Safety and effectiveness of efgartigimod for intravenous infusion in patients with generalized myasthenia gravis: an interim analysis of Japanese post-marketing surveillance. 静脉输注艾夫加替莫德治疗广泛性重症肌无力的安全性和有效性：日本上市后监测的中期分析

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-08 DOI: 10.1080/14712598.2025.2490063

Hirofumi Teranishi, Koichi Tsuda, Rumiko Kanzaki, Tomoyo Hayashi, Daisuke Harada

{"title":"Safety and effectiveness of efgartigimod for intravenous infusion in patients with generalized myasthenia gravis: an interim analysis of Japanese post-marketing surveillance.","authors":"Hirofumi Teranishi, Koichi Tsuda, Rumiko Kanzaki, Tomoyo Hayashi, Daisuke Harada","doi":"10.1080/14712598.2025.2490063","DOIUrl":"https://doi.org/10.1080/14712598.2025.2490063","url":null,"abstract":"Background: Efgartigimod for intravenous infusion (efgartigimod-IV) is approved in Japan for generalized myasthenia gravis (gMG). Post-marketing surveillance was mandated by regulatory authorities to assess the safety and effectiveness of efgartigimod in patients with gMG.Research design and methods: Patients with gMG who received efgartigimod-IV between May 2022 and September 2023 were registered. The interim analysis data cutoff point was June 2024 and included patients whose institutions agreed to publication.Results: The safety analysis set consisted of 373 patients: 53.35% (n = 199) anti-acetylcholine receptor antibody positive, 14.21% (n = 53) anti-muscle-specific receptor kinase antibody positive, and 31.64% (n = 118) double-seronegative. Adverse drug reaction and serious adverse drug reaction were reported in 21.45% (80/373) and 4.29% (16/373) of patients, respectively. Although six deaths were reported, none of them were related to efgartigimod. The effectiveness analysis set consisted of 246 patients. After three weeks from the first administration, mean score of MG-Activities of Daily Living decreased from 7.5 to 4.4: -3.1 points improvement (standard deviation: 2.95, p < 0.001). No remarkable differences were observed in the response to efgartigimod between the subgroups of patient baseline characteristics, e.g. autoantibody profiles.Conclusions: In real-world settings, efgartigimod-IV was well tolerated and effective in patients with gMG.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810853","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

Biological therapies in thrombocytopenia and primary antiphospholipid syndrome: where are we now? 血小板减少症和原发性抗磷脂综合征的生物治疗：我们现在在哪里？

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-06 DOI: 10.1080/14712598.2025.2484844

Massimo Radin, Alice Barinotti, David Galarza, Irene Cecchi, Sofia Camerlo, Antonella Vaccarino, Dario Roccatello, Alessandro Morotti, Savino Sciascia

引用次数: 0

Perspectives on the use of biological therapies for the treatment of asthma in low-middle income countries. 对中低收入国家使用生物疗法治疗哮喘的看法。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-04 DOI: 10.1080/14712598.2025.2490064

Betül Özdel Öztürk, Sevim Bavbek

引用次数: 0

Ivonescimab in non-small cell lung cancer: harmonizing immunotherapy and anti-angiogenesis. 依维单抗在非小细胞肺癌中的应用：协调免疫治疗和抗血管生成。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-02 DOI: 10.1080/14712598.2025.2487512

Yan Zhang, Xinyu Liu, Shengxiang Ren

{"title":"Ivonescimab in non-small cell lung cancer: harmonizing immunotherapy and anti-angiogenesis.","authors":"Yan Zhang, Xinyu Liu, Shengxiang Ren","doi":"10.1080/14712598.2025.2487512","DOIUrl":"10.1080/14712598.2025.2487512","url":null,"abstract":"Introduction: Immunotherapy combined with anti-angiogenesis has become a useful strategy in cancer treatment. Ivonescimab, the first-approved bispecific antibody targeting both immune checkpoint inhibition and anti-angiogenesis, represents a breakthrough over the conventional dual-drug combination approach. The emerging clinical evidence demonstrates promising efficacy and manageable safety profile of ivonescimab in the treatment of non-small cell lung cancer (NSCLC), suggesting its potential role as a cornerstone in the next generation of cancer immunotherapy.Areas covered: This review presents the pharmacological characteristics of ivonescimab, revisits relevant clinical trials and key data, and provides an in-depth analysis. Additionally, the potential of ivonescimab in NSCLC treatment is discussed, along with its clinical prospects.Expert opinion: The available clinical data demonstrate that simultaneously targeting both immune checkpoint inhibition and angiogenesis pathways through a single bispecific antibody represents a significant therapeutic advancement in NSCLC treatment. Ivonescimab's innovative dual-targeting mechanism, supported by promising efficacy data from the HARMONi trials and its manageable safety profile, appears to be fundamental to its potential to challenge current standards of care. As the first approved bispecific antibody with this unique mechanism of action, ivonescimab may not only transform current treatment paradigms but also pioneer a new direction in cancer immunotherapy.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-7"},"PeriodicalIF":3.6,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751769","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

Perceptions of patients with inflammatory bowel diseases on switching from reference product adalimumab to biosimilar adalimumab-atto. 炎症性肠病患者从参考产品阿达木单抗转向生物仿制药阿达木单抗-atto的认知

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-02 DOI: 10.1080/14712598.2025.2488222

Catherine Pham, Deana Bitar, Fang Niu, Kim Ngoc Le, Rita Lai-Han Hui, Thomas Delate

{"title":"Perceptions of patients with inflammatory bowel diseases on switching from reference product adalimumab to biosimilar adalimumab-atto.","authors":"Catherine Pham, Deana Bitar, Fang Niu, Kim Ngoc Le, Rita Lai-Han Hui, Thomas Delate","doi":"10.1080/14712598.2025.2488222","DOIUrl":"10.1080/14712598.2025.2488222","url":null,"abstract":"Background: There may be patient concerns with switching to a biosimilar product. The purpose of this study was to describe the perspectives of patients with inflammatory bowel disease (IBD) after switching from reference product (RP) adalimumab to adalimumab-atto.Research design and methods: This was a telephonic survey of US patients with IBD conducted in June-July 2023 among adult, English-speaking patients who were switched to biosimilar adalimumab-atto from RP adalimumab within the previous 100 days, and were receiving adalimumab-atto at the time of the survey. Consented participants were queried on adalimumab-atto safety and effectiveness, cost, product preference, and education received for the switch. Descriptive statistics were used to depict responses.Results: Of the 250 patients contacted, 154 participants completed the survey. Respondents (77.9%) reported no concerns with loss of disease control, potential side effects (67.9%), or cost (89.5%) after switching. About 28.7% reported a preference for adalimumab-atto, while 39.3% reported no preference between products. About 43.7% reported being satisfied/very satisfied with the education they received, while 65.1% stated they did not feel they knew enough about adalimumab-atto.Conclusions: There was widespread satisfaction with adalimumab-atto after switching from RP adalimumab. Nevertheless, participants reported limited knowledge of adalimumab-atto, suggesting a need for enhanced education on biosimilars.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-4"},"PeriodicalIF":3.6,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751774","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

Psoriasis and cancer: the role of inflammation, immunosuppression, and cancer treatment. 银屑病与癌症的作用：炎症、免疫抑制和癌症治疗。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-04 DOI: 10.1080/14712598.2025.2471093

Manfredo Bruni, Fabio Lobefaro, Cristina Pellegrini, Mirco Mastrangelo, Giulio Gualdi, Maria Esposito, Paolo Antonetti, Paolo De Sanctis, Paolo Amerio, Maria Concetta Fargnoli

{"title":"Psoriasis and cancer: the role of inflammation, immunosuppression, and cancer treatment.","authors":"Manfredo Bruni, Fabio Lobefaro, Cristina Pellegrini, Mirco Mastrangelo, Giulio Gualdi, Maria Esposito, Paolo Antonetti, Paolo De Sanctis, Paolo Amerio, Maria Concetta Fargnoli","doi":"10.1080/14712598.2025.2471093","DOIUrl":"10.1080/14712598.2025.2471093","url":null,"abstract":"Introduction: The relationship between psoriasis, immunomodulatory therapies, and the risk of malignancies is complex and still debated. The scarcity of evidence in this field makes clinicians hesitate to prescribe biological therapies for 'difficult-to-treat' patients.Areas covered: Based on a comprehensive MEDLINE/PUBMED search of articles published up to November 2024, this review synthesizes the current evidence on the association between psoriasis and cancer. This review specifically addresses four key aspects: the overall cancer risk in psoriatic patients, the potential role of cytokines involved in psoriasis pathogenesis in tumor development, the association between biological therapies and the incidence of new malignancies in this population, and the risk of cancer recurrence or progression in patients with a history of malignancy who are treated with biologics.Expert opinion: Biological therapies do not significantly elevate malignancy risk compared to non-biological treatments or the general population. Evidence is also reassuring for patients with prior malignancy, showing no tumor progression or recurrence. These findings support the timely use of biological treatments in 'difficult-to-treat' patients. Regular cancer screenings and risk-factor minimization should always be recommended for psoriatic patients undergoing immunomodulatory therapies. Multidisciplinary management involving oncologists is suggested, particularly for patients with active and advanced oncological disease.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"395-411"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540680","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

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

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