Expert Opinion on Biological Therapy最新文献_第2页

The role of antibody therapies in treating relapsed chronic lymphocytic leukemia: a review. 抗体疗法在治疗复发慢性淋巴细胞白血病中的作用。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-10 DOI: 10.1080/14712598.2024.2413365

Magdalena Witkowska, Agata Majchrzak, Paweł Robak, Anna Wolska-Washer, Tadeusz Robak

{"title":"The role of antibody therapies in treating relapsed chronic lymphocytic leukemia: a review.","authors":"Magdalena Witkowska, Agata Majchrzak, Paweł Robak, Anna Wolska-Washer, Tadeusz Robak","doi":"10.1080/14712598.2024.2413365","DOIUrl":"10.1080/14712598.2024.2413365","url":null,"abstract":"Introduction: Chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adult patients. The landscape of CLL therapy has changed in the last decades with the introduction of antibody-based therapies and novel targeted agents resulting in improved outcomes.Areas covered: This article describes the use of monoclonal antibodies, bispecific antibodies and antibody-drug conjugates in the treatment of relapsed and refractory CLL. The mechanism of action and clinical applications and safety of antibody-based therapies, both as monotherapy and in combination with other drugs, are discussed. A literature search was performed using PubMed, Web of Science, and Google Scholar for articles published in English. Additional relevant publications were obtained by reviewing the references from the chosen articles.Expert opinion: Antibody-based therapeutic strategies have drastically changed the treatment of CLL, as they have introduced the concept of boosting immune responses against tumor cells. While immunotherapy is generally effective, some treatment failure can occur due to antigen loss, mutation, or down-regulation, and this remains the main obstacle to cure. The development of novel antibody therapies, including their combinations with targeted drugs and bispecific antibodies, might help to reduce toxicity and improve efficacy.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371386","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

Dynamics of biological markets with multiple biosimilar competitors in the United States. 美国存在多个生物仿制药竞争者的生物市场动态。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-09 DOI: 10.1080/14712598.2024.2412648

Morgane C Mouslim, Mariana P Socal, Antonio J Trujillo

{"title":"Dynamics of biological markets with multiple biosimilar competitors in the United States.","authors":"Morgane C Mouslim, Mariana P Socal, Antonio J Trujillo","doi":"10.1080/14712598.2024.2412648","DOIUrl":"https://doi.org/10.1080/14712598.2024.2412648","url":null,"abstract":"Background: The dynamics of biological markets with multiple biosimilar competitors in the United States are poorly understood. Moreover, due to confidentiality issues, the relationship between originator biologic net prices, rebates, and biosimilar entry is largely unexplored.Research design and methods: We conducted a review of the Food Drug Administration (FDA) purple book and manufacturer websites to identify all originator biologics with multiple competitors and their characteristics. We leveraged a novel data source to examine originator biologic net prices and rebates over time and used descriptive statistics and interrupted time-series analyses to assess their relationship with biosimilar entry.Results: By December 2022, only five originator biologics had three or more available biosimilar competitors. Mean time between biosimilar approval and biosimilar launch was 9 months (SD = 7.04 months). By third biosimilar competitor, entry net prices for originator biologics had decreased by 9.34% to 50.93%, while rebates had increased by 25.35% to 89.71%.Conclusions: Very few originator biologics have multiple available biosimilar competitors. Barrier to biosimilar availability seems to be at the approval level as the time between approval and launch is relatively short. However, originator biologics respond quickly to biosimilar competition, mainly through an increase in rebates.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142389160","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

Correction. 更正。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-09 DOI: 10.1080/14712598.2024.2415245

引用次数: 0

Perispinal etanercept stroke trial design: PESTO and beyond. 围皮层依那西普中风试验设计：PESTO 及其他

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-23 DOI: 10.1080/14712598.2024.2390636

Edward Tobinick, Danielle Ucci, Kirsten Bermudo, Samantha Asseraf

{"title":"Perispinal etanercept stroke trial design: PESTO and beyond.","authors":"Edward Tobinick, Danielle Ucci, Kirsten Bermudo, Samantha Asseraf","doi":"10.1080/14712598.2024.2390636","DOIUrl":"10.1080/14712598.2024.2390636","url":null,"abstract":"Introduction: Perispinal etanercept (PSE) is an innovative treatment designed to improve stroke recovery by addressing chronic post-stroke neuroinflammation. Basic science evidence, randomized clinical trial (RCT) evidence and 14 years of favorable clinical experience support the use of PSE to treat chronic stroke. This article provides guidance for the design of future PSE RCTs in accordance with current FDA recommendations.Areas covered: Scientific background and essential elements of PSE RCT design.Expert opinion: Intimate familiarity with PSE, its novel method of drug delivery, and the characteristics of ideal enriched study populations are necessary for those designing future PSE stroke trials. The design elements needed to enable a PSE RCT to generate valid results include a suitable research question; a homogeneous study population selected using a prospective enrichment strategy; a primary outcome measure responsive to the neurological improvements that result from PSE; trialists with expertise in perispinal delivery; optimal etanercept dosing; and steps taken to minimize the number of placebo responders. RCTs failing to incorporate these elements, such as the PESTO trial, are incapable of reaching reliable conclusions regarding PSE efficacy. SF-36 has not been validated in PSE trials and is unsuitable for use as a primary outcome measure in PSE RCTs.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035597","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

Developing combination therapies with biologics in triple-negative breast cancer. 针对三阴性乳腺癌开发生物制剂联合疗法。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-10-03 DOI: 10.1080/14712598.2024.2408756

Gilda Gaudio, Enzo Martino, Gloria Pellizzari, Matteo Cavallone, Grazia Castellano, Abeid Omar, Lika Katselashvili, Dario Trapani, Giuseppe Curigliano

{"title":"Developing combination therapies with biologics in triple-negative breast cancer.","authors":"Gilda Gaudio, Enzo Martino, Gloria Pellizzari, Matteo Cavallone, Grazia Castellano, Abeid Omar, Lika Katselashvili, Dario Trapani, Giuseppe Curigliano","doi":"10.1080/14712598.2024.2408756","DOIUrl":"10.1080/14712598.2024.2408756","url":null,"abstract":"Introduction: Novel compounds have entered the triple-negative breast cancer (TNBC) treatment algorithm, namely immune checkpoints inhibitors (ICIs), PARP inhibitors and antibody-drug conjugates (ADCs). The optimization of treatment efficacy can be enhanced with the use of combination treatments, and the incorporation of novel compounds. In this review, we discuss the combination treatments under development for the treatment of TNBC.Areas covered: The development of new drugs occurring in recent years has boosted the research for novel combinations to target TNBC heterogeneity and improve outcomes. ICIs, ADCs, tyrosine kinase inhibitors (TKIs), and PARP inhibitors have emerged as leading players in this new landscape, while other compounds like novel intracellular pathways inhibitors or cancer vaccines are drawing more and more interest. The future of TNBC is outlined in combination approaches, and based on new cancer targets, including many chemotherapy-free treatments.Expert opinion: A large number of TNBC therapies have either proved clinically ineffective or weighted by unacceptable safety profiles. Others, however, have provided promising results and are currently in late-stage clinical trials, while a few have actually changed clinical practice in recent years. As novel, more and more selective drugs come up, combination strategies focusing the concept of synergy are fully warranted for the future.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364935","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

Targeted and combination immunotherapies using biologics for gastric cancer: the state-of-the-art. 使用生物制剂治疗胃癌的靶向和联合免疫疗法：最新进展。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-10-04 DOI: 10.1080/14712598.2024.2401622

Jane E Rogers, Qiong Gan, Rebecca E Waters, Ashley A Horak, Jaffer A Ajani

{"title":"Targeted and combination immunotherapies using biologics for gastric cancer: the state-of-the-art.","authors":"Jane E Rogers, Qiong Gan, Rebecca E Waters, Ashley A Horak, Jaffer A Ajani","doi":"10.1080/14712598.2024.2401622","DOIUrl":"10.1080/14712598.2024.2401622","url":null,"abstract":"Introduction: Gastric adenocarcinoma (GAC) remains a prevalent cancer worldwide and its incidence is increasing in South America. The heterogenous nature of GAC makes advances in management challenging.Areas covered: Despite challenges, recent therapeutic targets are individualizing treatment. For localized disease with microsatellite-instability-high/deficient mismatch repair, immunotherapy is now an adopted practice. In the advanced unresectable setting, those harboring human epidermal growth factor receptor-2 (HER2) expression continue to be a separate entity.Expert opinion: Future targets are developing. Among these include claudin 18.2 (CLDN18.2), fibroblast growth factor receptor 2b (FGFR2b), and trophoblast cell surface antigen-2 (TROP-2). FDA approval of zolbetuximab's, an anti-CLDN 18.2 monoclonal antibody, is expected soon. Additionally, bemarituzumab, ananti-FGFR2b monoclonal antibody, has shown improvements in combination with chemotherapy in those with HER2 negative GAC with FGFR2 overexpression. This combination is now being investigated in a phase 3 trial. Lastly, TROP-2 has emerged as an exciting solid tumor target and study is expected in GAC. All three of these therapeutic targets have seen an abundance of drug development in recent years, and we anticipate newer targeted agents driving therapeutic decisions in GAC in the coming years.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307395","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

The frontier of neoadjuvant therapy in non-small cell lung cancer beyond PD-(L)1 agents. 超越 PD-(L)1 药物的非小细胞肺癌新辅助疗法前沿。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1080/14712598.2024.2408292

Marco Sposito, Serena Eccher, Ilaria Scaglione, Alice Avancini, Antonio Rossi, Sara Pilotto, Lorenzo Belluomini

{"title":"The frontier of neoadjuvant therapy in non-small cell lung cancer beyond PD-(L)1 agents.","authors":"Marco Sposito, Serena Eccher, Ilaria Scaglione, Alice Avancini, Antonio Rossi, Sara Pilotto, Lorenzo Belluomini","doi":"10.1080/14712598.2024.2408292","DOIUrl":"10.1080/14712598.2024.2408292","url":null,"abstract":"Introduction: While surgical resection is the cornerstone of treatment for resectable lung cancer, neoadjuvant/adjuvant chemotherapy has shown limited improvement in survival rates over the past decades. With the success of immune checkpoint inhibitors (ICIs) in advanced NSCLC, there is growing interest in their application in earlier stages of the disease. Recent approvals for neoadjuvant/adjuvant ICIs in stage II-IIIA NSCLC highlight this shift in treatment paradigms.Areas covered: In this review, we aim to explore available data regarding alternative agents beyond the PD-(L)1 inhibitors, such as monoclonal antibodies against CTLA4, LAG3, TIGIT, antiangiogenic drugs, and novel therapies (antibody drug conjugates, bispecific antibodies) in neoadjuvant/perioperative regimens.Expert opinion: Novel agents and combinations (with or without ICI or/and chemotherapy), guided by molecular profiling and immune phenotyping, showed promise in improving surgical and survival outcomes. Crucial is, also in early setting, to identifying biomarkers predictive of treatment efficacy in order to personalize neoadjuvant/perioperative treatment strategies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282522","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

Physicians' and patients' perception of biosimilars and factors affecting biosimilar prescribing in selected Asian countries: a survey study. 选定亚洲国家医生和患者对生物仿制药的看法以及影响生物仿制药处方的因素：一项调查研究。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-17 DOI: 10.1080/14712598.2024.2400523

Supat Thongpooswan, Anupam Das, Pravin Patil, Mark Latymer, Lyndon Llamado, James Wee

{"title":"Physicians' and patients' perception of biosimilars and factors affecting biosimilar prescribing in selected Asian countries: a survey study.","authors":"Supat Thongpooswan, Anupam Das, Pravin Patil, Mark Latymer, Lyndon Llamado, James Wee","doi":"10.1080/14712598.2024.2400523","DOIUrl":"10.1080/14712598.2024.2400523","url":null,"abstract":"Background: This study evaluated physicians' and patients' beliefs about biosimilars in Hong Kong, India, Pakistan, Singapore, Taiwan, and Thailand.Research design and methods: An online survey administered to physicians (dermatologists, n = 119; gastroenterologists, n = 148; rheumatologists, n = 161) between 22 October 2021 and 7 January 2022, and patients (n = 90) with rheumatic or inflammatory bowel disease between 25 October 2021 and 12 April 2022.Results: Most (68%) physicians reported having a strong knowledge about biosimilars, yet 49% indicated that biosimilars are readily available to them. Physicians cited potential cost savings (81%) as the main benefit of biosimilars, and cost/coverage support (36%), patient support (25%), and increasing biosimilar awareness/education (24%) as main strategies for improving usage. Few (21%) patients reported having a strong knowledge about biosimilars. Patients cited offering alternatives in case of drug shortages (77%) as the main benefit of biosimilars, and cost/coverage support (53%), increasing awareness of product profile (22%), and providing biosimilars with a good efficacy profile/effective product (19%) as main strategies for improving usage.Conclusion: Programs focused on cost/coverage support, patient support, and biosimilar awareness could improve acceptance of biosimilars for chronic immune-mediated inflammatory diseases in Asian countries, thereby increasing patient access to essential biologic therapies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132252","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

Monoclonal antibodies against pediatric ulcerative colitis: a review of clinical progress. 针对小儿溃疡性结肠炎的单克隆抗体：临床进展回顾。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-20 DOI: 10.1080/14712598.2024.2404076

Debora Curci, Marianna Lucafò, Giuliana Decorti, Gabriele Stocco

{"title":"Monoclonal antibodies against pediatric ulcerative colitis: a review of clinical progress.","authors":"Debora Curci, Marianna Lucafò, Giuliana Decorti, Gabriele Stocco","doi":"10.1080/14712598.2024.2404076","DOIUrl":"10.1080/14712598.2024.2404076","url":null,"abstract":"Introduction: In children, ulcerative colitis (UC) is often more severe and extensive than in adults and hospitalization for acute exacerbations occurs in around a quarter of subjects. There is a need for effective drugs, which could avoid or reduce the use of corticosteroids which, especially in children, are burdened by a number of severe side effects. The introduction in therapy of monoclonal antibodies has completely changed the therapeutic scenario and the prognosis of the disease.Areas covered: In this review, the use of the monoclonal antibodies directed against tumor necrosis factor (TNF)α or other inflammatory targets for the treatment of pediatric UC will be discussed. A search of the literature was done using the keywords 'pediatric,' 'ulcerative colitis,' 'inflammatory bowel disease,' 'monoclonal antibodies;' 'infliximab,' 'adalimumab,' 'golimumab,' vedolizumab,\" 'ustekinumab' and 'risankizumab.'Expert opinion: The use of monoclonal antibodies has greatly increased in recent years in pediatric UC, both in patients who did not respond to conventional therapies, and, more often, as initial therapy. Thanks to therapeutic drug monitoring and to the availability of biologics with different targets, therapy has become more targeted and personalized, with a significant improvement in response, in quality of life, and with a good safety profile.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282521","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

Unmet needs in cervical cancer - can biological therapies plug the gap? 宫颈癌方面尚未满足的需求--生物疗法能否填补空白？

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1080/14712598.2024.2408754

Michelle Greenman, Yifan Emily Chang, Blair McNamara, Levent Mutlu, Alessandro D Santin

{"title":"Unmet needs in cervical cancer - can biological therapies plug the gap?","authors":"Michelle Greenman, Yifan Emily Chang, Blair McNamara, Levent Mutlu, Alessandro D Santin","doi":"10.1080/14712598.2024.2408754","DOIUrl":"10.1080/14712598.2024.2408754","url":null,"abstract":"Introduction: Cervical cancer remains one of the most common gynecologic malignancies worldwide. A disproportionate burden of cases occurs in developing countries due to inadequate screening and treatment. Even among patients adequately treated, in the presence of locally advanced or recurrent disease, outcomes tend to be poor. The introduction of biologic therapy into treatment has increased overall survival; however, a considerable opportunity still exists to improve current standards in treatment. Biologics have shown antitumor activity in multiple tumor types and are actively being pursued for the management of cervical cancer.Areas covered: In this article, we will discuss the historical evolution of biologic therapy in cervical cancer including use of angiogenesis inhibitors, immune checkpoint inhibitors, antibody-drug conjugates, and vaccines. We will review how these therapies have been integrated into current treatment recommendations and discuss ongoing investigations intended to improve clinical outcomes. We also postulate on persistent gaps in care.Expert opinion: Biologic therapies have had a tremendous impact on our current approach to managing cervical cancer. We anticipate that significant more research and development will be committed to the continued investigation of biologics in cervical cancer in an effort to improve a historically difficult to treat malignancy.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282523","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