Min Ho Park, Jae Hong Seo, Jung-Ho Park, Min-Ki Seong, Keon Uk Park, Min Kyoon Kim, Myungchul Chang, Su-Jin Koh, Moon Hee Lee, Seung Taek Lim, Youngbum Yoo, So Yeon Oh, Sung Hyun Kim, K. Ahn, Taehong Park, Hana Ju, Eric Hyungseok Baek, Sinhye Kim, Nahyun Kim, Eunkyung Lee, Tae Hyun Kim
{"title":"Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study.","authors":"Min Ho Park, Jae Hong Seo, Jung-Ho Park, Min-Ki Seong, Keon Uk Park, Min Kyoon Kim, Myungchul Chang, Su-Jin Koh, Moon Hee Lee, Seung Taek Lim, Youngbum Yoo, So Yeon Oh, Sung Hyun Kim, K. Ahn, Taehong Park, Hana Ju, Eric Hyungseok Baek, Sinhye Kim, Nahyun Kim, Eunkyung Lee, Tae Hyun Kim","doi":"10.1080/14712598.2024.2334386","DOIUrl":"https://doi.org/10.1080/14712598.2024.2334386","url":null,"abstract":"BACKGROUND\u0000The trastuzumab biosimilar CT-P6 is approved for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC). The objective of this post-marketing surveillance (PMS) study was to evaluate the real-world safety and effectiveness of CT-P6 in patients with HER2-positive cancers.\u0000\u0000\u0000RESEARCH DESIGN AND METHODS\u0000This open-label, observational, prospective, PMS study collected data via investigator surveys from 35 centers in the Republic of Korea (5 October 2018-4 October 2022). Eligible patients with HER2-positive EBC, MBC, or MGC started CT-P6 treatment during routine clinical practice, followed by 1-year observation. Evaluations included adverse events (AEs), adverse drug reactions (ADRs), and effectiveness.\u0000\u0000\u0000RESULTS\u0000Safety was analyzed in 642 patients (494 EBC, 94 MBC, 54 MGC). Overall, 325 (50.6%) patients experienced 1316 AEs, and 550 ADRs occurred in 199 (31.0%) patients. Unexpected ADRs occurred in 62 (9.7%) patients. Unexpected ADRs and ADRs of special interest did not raise any new safety signals. Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response.\u0000\u0000\u0000CONCLUSIONS\u0000In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140655835","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}
Wenqing Jia, Xiaonan Shen, Zichao Guo, Xi Cheng, Ren Zhao
{"title":"The future of cancer vaccines against colorectal cancer","authors":"Wenqing Jia, Xiaonan Shen, Zichao Guo, Xi Cheng, Ren Zhao","doi":"10.1080/14712598.2024.2341744","DOIUrl":"https://doi.org/10.1080/14712598.2024.2341744","url":null,"abstract":"Colorectal cancer (CRC) is the second most lethal malignancy worldwide. Immune checkpoint inhibitors (ICIs) benefit only 15% of patients with mismatch repair-deficient/microsatellite instability (d...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140634969","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":"Sibeprenlimab, which neutralizes a PRoliferation inducing ligand (APRIL), as a new approach to treating IgA nephropathy","authors":"Sheila A Doggrell","doi":"10.1080/14712598.2024.2346111","DOIUrl":"https://doi.org/10.1080/14712598.2024.2346111","url":null,"abstract":"Immunoglobulin A (IgA) nephropathy is a common immune-mediated kidney disease leading to high blood pressure and may progress to kidney failure. None of the present treatments are disease-modifying...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140625452","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}
Rini Patadia, Thomas B. Casale, John Fowler, Shiven Patel, Juan Carlos Cardet
{"title":"Advancements in biologic therapy in eosinophilic asthma","authors":"Rini Patadia, Thomas B. Casale, John Fowler, Shiven Patel, Juan Carlos Cardet","doi":"10.1080/14712598.2024.2342527","DOIUrl":"https://doi.org/10.1080/14712598.2024.2342527","url":null,"abstract":"Asthma encompasses a spectrum of phenotypes often categorized into two groups- type 2 high (T2 high) and type 2 low (T2 low). T2 high includes atopic and eosinophilic presentations whereas T2 low i...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140585741","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}
Dimitra Stergianou, Theodora Kanni, Christina Damoulari, Evangelos Giamarellos-Bourboulis
{"title":"An evaluation of secukinumab for the treatment of moderate-to-severe hidradenitis suppurativa","authors":"Dimitra Stergianou, Theodora Kanni, Christina Damoulari, Evangelos Giamarellos-Bourboulis","doi":"10.1080/14712598.2024.2343112","DOIUrl":"https://doi.org/10.1080/14712598.2024.2343112","url":null,"abstract":"Until recently, biologic therapy for hidradenitis suppurativa was limited to anti-tumor necrosis factor (TNF) blockade with adalimumab (ADA). However, not all patients respond to treatment with ADA...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140585766","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":"Antimicrobial peptides in bone regeneration: mechanism and potential","authors":"ZhiCheng Wang, XiaoMan Chen, Liang Yan, WenJie Wang, PeiJia Zheng, Atashbahar Mohammadreza, Qi Liu","doi":"10.1080/14712598.2024.2337239","DOIUrl":"https://doi.org/10.1080/14712598.2024.2337239","url":null,"abstract":"Antimicrobial peptides (AMPs) are small-molecule peptides with a unique antimicrobial mechanism. Other notable biological activities of AMPs, including anti-inflammatory, angiogenesis, and bone for...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140585753","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":"Luspatercept in low-risk myelodysplastic syndromes: a paradigm shift in treatment strategies.","authors":"Matteo Molica, Marco Rossi","doi":"10.1080/14712598.2024.2336086","DOIUrl":"10.1080/14712598.2024.2336086","url":null,"abstract":"<p><strong>Introduction: </strong>In patients with myelodysplastic syndromes (MDS), anemia is prevalent affecting 80%-85% of low-risk (LR-MDS) patients, with 40% eventually requiring red blood cell (RBC) transfusions. Except forlenalidomide, exclusively approved for those with deletion of chromosome 5q,erythropoiesis-stimulating agents (ESAs) are the primary treatment choice for low-risk patients. Those unresponsive to ESAs face limited alternatives, eventually necessitating long-term RBC transfusions, leading to secondary iron overload and adversely affecting quality of life (QoL).</p><p><strong>Area covered: </strong>Luspatercept is a pioneering erythroid maturation agent. It received approval by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for treating adults experiencing transfusion-dependent anemia associated with LR-MDS or β-thalassemia. Recently, the FDA approved luspatercept as first- line therapy in patients with very low- to intermediate-risk MDS who require RBC transfusions and have not previously received ESAs. This review summarizes the historical impact of luspatercept intreating LR-MDS unresponsive to ESAs and illustrates its potential benefit asfrontline therapy in MDS and its employment in patients with myelofibrosis-induced anemia.</p><p><strong>Expert opinion: </strong>Luspatercept has revolutionized the therapeutic paradigm of LR-MDS, for which there was a limited therapeutic arsenal, especially in the setting of patients who did not respond or fail after ESA treatment.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140329788","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}
Ashish Sharma, Nilesh Kumar, Nikulaa Parachuri, Anat Loewenstein, Francesco Bandello, Baruch D Kuppermann
{"title":"Global experience of faricimab in clinical settings - a review.","authors":"Ashish Sharma, Nilesh Kumar, Nikulaa Parachuri, Anat Loewenstein, Francesco Bandello, Baruch D Kuppermann","doi":"10.1080/14712598.2024.2336087","DOIUrl":"10.1080/14712598.2024.2336087","url":null,"abstract":"<p><strong>Introduction: </strong>Faricimab is a bispecific antibody that acts to reduce neoangiogenesis in exudative retinal vascular disorders. It is approved for use in neovascular age-related macular degeneration and diabetic macular edema. We review the published efficacy and safety of faricimab in clinical settings.</p><p><strong>Areas covered: </strong>A comprehensive literature review was conducted. Based on the 14 published real-world studies, 1127 patients (1204 eyes) were treated with faricimab. The majority of studies (14) included pre-treated patients. Most studies (13) showed central macular thickness improvement. However visual acuity improved in only half of the studies analyzed. Four studies demonstrated an extension of the treatment. Only 4 eyes (0.33%) reported intraocular inflammation and 3 eyes (0.24%) reported retinal pigment epithelial tear.</p><p><strong>Expert opinion: </strong>The clinical experience with faricimab to date has the potential to provide a stable visual outcome with reduced treatment burden in cases that are resistant to other approved anti-VEGF agents. There are no major safety concerns based on this data analysis.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140318068","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":"CAR T cells for solid tumors - developments to watch in 2023.","authors":"Marcel P Trefny, Sebastian Kobold","doi":"10.1080/14712598.2024.2334399","DOIUrl":"10.1080/14712598.2024.2334399","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206547","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}