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":"<p><strong>Background: </strong>This study evaluated physicians' and patients' beliefs about biosimilars in Hong Kong, India, Pakistan, Singapore, Taiwan, and Thailand.</p><p><strong>Research design and methods: </strong>An online survey administered to physicians (dermatologists, <i>n</i> = 119; gastroenterologists, <i>n</i> = 148; rheumatologists, <i>n</i> = 161) between 22 October 2021 and 7 January 2022, and patients (<i>n</i> = 90) with rheumatic or inflammatory bowel disease between 25 October 2021 and 12 April 2022.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-09-17","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}
Fran Seiwerth, Lela Bitar, Miroslav Samaržija, Marko Jakopović
{"title":"Long-term progression-free survival in non-small cell lung cancer patients: a spotlight on bevacizumab and its biosimilars","authors":"Fran Seiwerth, Lela Bitar, Miroslav Samaržija, Marko Jakopović","doi":"10.1080/14712598.2024.2405562","DOIUrl":"https://doi.org/10.1080/14712598.2024.2405562","url":null,"abstract":"In the era of immunotherapy, bevacizumab seems to be losing its place in NSCLC treatment algorithms. The aim of this work is to try to define the advantages and disadvantages of NSCLC treatment wit...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266210","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}
{"title":"Clinical experience of using biosimilars in Crohn’s disease and their effectiveness","authors":"Léa Sequier, Bénédicte Caron, Silvio Danese, Laurent Peyrin-Biroulet","doi":"10.1080/14712598.2024.2401616","DOIUrl":"https://doi.org/10.1080/14712598.2024.2401616","url":null,"abstract":"The approval of biosimilars in the management of inflammatory bowel diseases (IBDs) has offered an answer to a growing concern about healthcare costs, and availability of treatments. Several studie...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183434","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}
{"title":"Considerations for the use of biological therapies in elderly patients with rheumatoid arthritis","authors":"Noor Nooh, May N Lwin, Christopher Edwards","doi":"10.1080/14712598.2024.2404521","DOIUrl":"https://doi.org/10.1080/14712598.2024.2404521","url":null,"abstract":"Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that primarily affects middle-aged individuals but is increasingly prevalent among the elderly due to longer life expectancies...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183435","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}
{"title":"Mosunetuzumab for the treatment of follicular lymphoma.","authors":"Caterina Labanca,Enrica Antonia Martino,Ernesto Vigna,Antonella Bruzzese,Francesco Mendicino,Paola De Luca,Eugenio Lucia,Virginia Olivito,Valentina Fragliasso,Antonino Neri,Fortunato Morabito,Massimo Gentile","doi":"10.1080/14712598.2024.2404079","DOIUrl":"https://doi.org/10.1080/14712598.2024.2404079","url":null,"abstract":"INTRODUCTIONFollicular lymphoma (FL) is an indolent non-Hodgkin lymphoma that shows a progressive increase in relapses and refractory in its natural history, and a median survival of approximately 18-20 years. The advent of anti-CD20 monoclonal antibodies has changed the FL therapeutic algorithm, with an increase in progression-free survival. T-cell-dependent bispecific antibodies (BsAbs) represent an emerging drug class against FL.AREAS COVEREDIn this review, we selected papers from the principal databases (PubMed, Medline, Medscape, ASCO, ESMO) between January 2021 and June 2024, using the keywords 'mosunetuzumab' and 'follicular lymphoma' to provide an overview of mosunetuzumab-axgb, a pioneering BsAb. Its mechanism of action, efficacy, safety and future perspectives were analyzed.EXPERT OPINIONmosunetuzumab grants a directing T-cell mediated cytotoxicity and allows a step-up dosing that reduces adverse events, such as cytokine release syndrome, with promising tolerability. At the same time, it improves outcomes in the evolving landscape of FL management, even in post-CAR-T FL patients. Prognostic factors and targetable mechanisms of resistance need to be explored.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142223905","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}
{"title":"The immunologic role of IL-23 in psoriatic arthritis: a potential therapeutic target.","authors":"Qin-Yi Su, Heng-Yan Gao, Yue-Ru Duan, Jing Luo, Wei-Ze Wang, Xi-Chao Qiao, Sheng-Xiao Zhang","doi":"10.1080/14712598.2024.2401148","DOIUrl":"10.1080/14712598.2024.2401148","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriatic arthritis (PsA) is a debilitating chronic condition characterized by inflammation of the joints, bones, enthesis, and skin. The pivotal role of interleukin-23 (IL-23) in the pathogenesis of PsA has become increasingly evident. This proinflammatory cytokine is markedly elevated in patients with PsA, suggesting its potential as a therapeutic target. Consequently, IL-23 inhibitors have emerged as promising first-line biologic treatments for PsA.</p><p><strong>Areas covered: </strong>This review delves into the immunopathogenic mechanisms of IL-23 at the cellular and molecular levels in PsA. Furthermore, it provides the recent efficacy and safety profiles of IL-23 inhibitors. We conducted a literature search in PubMed for the following terms: 'IL-23 and psoriatic arthritis,' 'Ustekinumab,' 'Guselkumab,' 'Risankizumab,' and 'Tildrakizumab.' In addition, we retrieved clinical trials involving IL-23 inhibitors registered in ClinicalTrials.gov, EudraCT, and ICTRP.</p><p><strong>Expert opinion: </strong>Despite the promising outcomes observed with IL-23 inhibitors, several challenges persist. The long-term effects of these agents require further investigation through prospective studies, and their limited accessibility worldwide necessitates urgent attention. Additionally, ongoing research is warranted to explore other potential drug targets within the IL-23/IL-23 R axis. The development of reliable biomarkers could greatly enhance early detection, tailored management strategies, and personalized treatment approaches for patients with PsA.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125222","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}
{"title":"The current status of immunotherapy and future horizon in the treatment of metastatic and locally advanced gastroesophageal adenocarcinoma.","authors":"Izuma Nakayama, Kohei Shitara","doi":"10.1080/14712598.2024.2395921","DOIUrl":"10.1080/14712598.2024.2395921","url":null,"abstract":"<p><strong>Introduction: </strong>Immunochemotherapy with PD-1 blockade has been established as the current standard first-line therapy for patients with mGEA. Reviewing the history of clinical trials offers valuable insight into the evolution of immune oncology in mGEA, paving the way for future advancements in this field.</p><p><strong>Areas covered: </strong>This review summarizes the findings of previous clinical trials related to immunotherapy for patients with GEA in the metastatic and locally advanced setting. We also introduce ongoing clinical trials to address the current challenging issues in clinical practice.</p><p><strong>Expert opinion: </strong>In general, GEA exhibits intermediate immunogenic characteristics with heterogeneous expressions, and responders to anti-PD-(L)1 therapy are mostly enriched to patients with specific genomic profiles such as MSI-H, high PD-L1 expression, high TMB, and EBV-associated type. Co-administration with anti-angiogenic agents or simultaneous blockade of immune checkpoint molecules is being explored to offer benefit of immunotherapy for more patients. We hope that CLDN18.2 and upcoming targets like FGFR2b will complement the treatment niche of immunotherapy in the field of mGEA. Bispecific antibodies, antibody drug conjugates, CAR-T, and vaccine are anticipated to enhance efficacy and expand the scope of immunotherapy.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016859","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}
Giuseppe Privitera, Cristina Bezzio, Arianna Dal Buono, Roberto Gabbiadini, Laura Loy, Luca Brandaleone, Giacomo Marcozzi, Giulia Migliorisi, Alessandro Armuzzi
{"title":"How comparative studies can inform treatment decisions for Crohn's disease.","authors":"Giuseppe Privitera, Cristina Bezzio, Arianna Dal Buono, Roberto Gabbiadini, Laura Loy, Luca Brandaleone, Giacomo Marcozzi, Giulia Migliorisi, Alessandro Armuzzi","doi":"10.1080/14712598.2024.2389985","DOIUrl":"10.1080/14712598.2024.2389985","url":null,"abstract":"<p><strong>Introduction: </strong>As new therapies for the treatment of Crohn's disease (CD) are approved, there is an increasing need for evidence that clarifies their positioning and sequencing.</p><p><strong>Areas covered: </strong>Comparative effectiveness research (CER) aims to inform physicians' decisions when they choose which intervention (drug or treatment strategy) to administer to their patients. Pragmatic head-to-head trials represent the best tools for CER, but only a few have been published in the IBD field. Network meta-analyses can point toward the superiority of one drug over another, but they do not reflect everyday clinical practice. Finally, real-world evidence complements that coming from head-to-head trials and network meta-analyses, assessing the real-life effectiveness of therapeutic interventions.</p><p><strong>Expert opinion: </strong>There is insufficient evidence to create a definitive therapeutic algorithm for CD, but some general considerations can be made. Anti-TNF-α agents seemingly represent the most 'sustainable' first-line choice, considering benefit-harm ratio and costs; vedolizumab, ustekinumab, and risankizumab may be considered as first-line choice when safety issues become prominent. In the event of pharmacodynamic failure, out-of-class swap is to be preferred - possibly with anti-IL23p19 as the best option, with unclear data regarding upadacitinib positioning; a second anti-TNF-α could be considered, as a second choice, after pharmacokinetic failure.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916434","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}
Letizia Mazzini, Fabiola De Marchi, Leonora Buzanska, Antonia Follenzi, Joel Clinton Glover, Maurizio Gelati, Ivan Lombardi, Margherita Maioli, Fatima Mesa-Herrera, Dinko Mitrečić, Cristina Olgasi, Augustas Pivoriūnas, Rosario Sanchez-Pernaute, Chiara Sgromo, Marzena Zychowicz, Angelo Vescovi, Daniela Ferrari
{"title":"Current status and new avenues of stem cell-based preclinical and therapeutic approaches in amyotrophic lateral sclerosis.","authors":"Letizia Mazzini, Fabiola De Marchi, Leonora Buzanska, Antonia Follenzi, Joel Clinton Glover, Maurizio Gelati, Ivan Lombardi, Margherita Maioli, Fatima Mesa-Herrera, Dinko Mitrečić, Cristina Olgasi, Augustas Pivoriūnas, Rosario Sanchez-Pernaute, Chiara Sgromo, Marzena Zychowicz, Angelo Vescovi, Daniela Ferrari","doi":"10.1080/14712598.2024.2392307","DOIUrl":"10.1080/14712598.2024.2392307","url":null,"abstract":"<p><strong>Introduction: </strong>Cell therapy development represents a critical challenge in amyotrophic lateral sclerosis (ALS) research. Despite more than 20 years of basic and clinical research, no definitive safety and efficacy results of cell-based therapies for ALS have been published.</p><p><strong>Areas covered: </strong>This review summarizes advances using stem cells (SCs) in pre-clinical studies to promote clinical translation and in clinical trials to treat ALS. New technologies have been developed and new experimental <i>in vitro</i> and animal models are now available to facilitate pre-clinical research in this field and to determine the most promising approaches to pursue in patients. New clinical trial designs aimed at developing personalized SC-based treatment with biological endpoints are being defined.</p><p><strong>Expert opinion: </strong>Knowledge of the basic biology of ALS and on the use of SCs to study and potentially treat ALS continues to grow. However, a consensus has yet to emerge on how best to translate these results into therapeutic applications. The selection and follow-up of patients should be based on clinical, biological, and molecular criteria. Planning of SC-based clinical trials should be coordinated with patient profiling genetically and molecularly to achieve personalized treatment. Much work within basic and clinical research is still needed to successfully transition SC therapy in ALS.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003956","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}