Pub Date : 2024-04-01Epub Date: 2024-03-21DOI: 10.1080/14712598.2024.2330948
M Doortje Reijman, D Meeike Kusters, Albert Wiegman
Introduction: Heterozygous familial hypercholesterolemia (HeFH) is a common genetic disorder caused by pathogenic variants in the LDL-C metabolism. Lifelong exposure to elevated LDL-C levels leads to a high risk of premature cardiovascular disease. To reduce that risk, children with HeFH should be identified and treated with lipid-lowering therapy. The cornerstone consists of statins and ezetimibe, but not in all patients this lowers the LDL-C levels to treatment targets. For these patients, more intensive lipid-lowering therapy is needed.
Areas covered: In this review, we provide an overview of the monoclonal antibodies which are currently available or being tested for treating HeFH in childhood.
Expert opinion: Monoclonal antibodies that inhibit PCSK9 are first in line lipid-lowering treatment options if oral statin and ezetimibe therapy are insufficient, due to intolerance or very high baseline LDL-C levels. Both evolocumab and alirocumab have been shown to be safe and effective in children with HeFH. For children, evolocumab has been registered from the age of 10 years old and alirocumab from the age of 8 years old. The costs of these new agents are much higher than oral therapy, which makes it important to only use them in a selected patient population.
{"title":"Current and emerging monoclonal antibodies for treating familial hypercholesterolemia in children.","authors":"M Doortje Reijman, D Meeike Kusters, Albert Wiegman","doi":"10.1080/14712598.2024.2330948","DOIUrl":"10.1080/14712598.2024.2330948","url":null,"abstract":"<p><strong>Introduction: </strong>Heterozygous familial hypercholesterolemia (HeFH) is a common genetic disorder caused by pathogenic variants in the LDL-C metabolism. Lifelong exposure to elevated LDL-C levels leads to a high risk of premature cardiovascular disease. To reduce that risk, children with HeFH should be identified and treated with lipid-lowering therapy. The cornerstone consists of statins and ezetimibe, but not in all patients this lowers the LDL-C levels to treatment targets. For these patients, more intensive lipid-lowering therapy is needed.</p><p><strong>Areas covered: </strong>In this review, we provide an overview of the monoclonal antibodies which are currently available or being tested for treating HeFH in childhood.</p><p><strong>Expert opinion: </strong>Monoclonal antibodies that inhibit PCSK9 are first in line lipid-lowering treatment options if oral statin and ezetimibe therapy are insufficient, due to intolerance or very high baseline LDL-C levels. Both evolocumab and alirocumab have been shown to be safe and effective in children with HeFH. For children, evolocumab has been registered from the age of 10 years old and alirocumab from the age of 8 years old. The costs of these new agents are much higher than oral therapy, which makes it important to only use them in a selected patient population.</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":"140157861","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}
Pub Date : 2024-04-01Epub Date: 2024-03-27DOI: 10.1080/14712598.2024.2336068
Andreas V Madsen, Peter Kristensen, Steffen Goletz
{"title":"IgG-VHH bispecific fusion antibodies: challenges and opportunities as therapeutic agents.","authors":"Andreas V Madsen, Peter Kristensen, Steffen Goletz","doi":"10.1080/14712598.2024.2336068","DOIUrl":"10.1080/14712598.2024.2336068","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":"140305318","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}
Bispecific antibodies (BsAbs) represent a novel and potentially effective approach in cancer immunotherapy. These antibodies feature two unique binding domains, enabling them to simultaneously atta...
{"title":"Bispecific antibodies in immunotherapy for adult acute leukemia: latest updates from the 65th American Society of Hematology 2023 annual meeting","authors":"Lijie Han, Haizhou Xing, Weijie Cao, Yongping Song, Zhongxing Jiang, Jifeng Yu","doi":"10.1080/14712598.2024.2333793","DOIUrl":"https://doi.org/10.1080/14712598.2024.2333793","url":null,"abstract":"Bispecific antibodies (BsAbs) represent a novel and potentially effective approach in cancer immunotherapy. These antibodies feature two unique binding domains, enabling them to simultaneously atta...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140170600","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}
Pub Date : 2024-03-04DOI: 10.1080/14712598.2024.2326169
Hong De Sa, Richard T. Maziarz, Arpita P. Gandhi
The success of an allogeneic hematopoietic stem cell transplantation (alloHCT) is measured by cure from the underlying malignancy, immune reconstitution (IR), and freedom from graft-versus-host dis...
{"title":"The impact of omidubicel on immune reconstitution and infections in cord blood transplant patients","authors":"Hong De Sa, Richard T. Maziarz, Arpita P. Gandhi","doi":"10.1080/14712598.2024.2326169","DOIUrl":"https://doi.org/10.1080/14712598.2024.2326169","url":null,"abstract":"The success of an allogeneic hematopoietic stem cell transplantation (alloHCT) is measured by cure from the underlying malignancy, immune reconstitution (IR), and freedom from graft-versus-host dis...","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140025955","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}
Pub Date : 2024-03-01Epub Date: 2024-02-23DOI: 10.1080/14712598.2024.2321374
Na-Qiong Wu, Zhi-Fan Li, Meng-Ying Lu, Jian-Jun Li
Introduction: Dyslipidemia significantly contributes to atherosclerotic cardiovascular disease (ASCVD). Patients with lipid-rich vulnerable plaques are particularly susceptible to cardiovascular complications. Despite available lipid-lowering therapies (LLTs), challenges in effective lipid management remain.
Areas covered: This article reviews monoclonal antibody (mAb) therapy in dyslipidemia, particularly focusing on vulnerable plaques and patients. We have reviewed the definitions of vulnerable plaques and patients, outlined the efficacy of traditional LLTs, and discussed in-depth the mAbs targeting PCSK9. We extensively discuss the potential mechanisms, intracoronary imaging, and clinical evidence of PCSK9mAbs in vulnerable plaques and patients. A brief overview of promising mAbs targeting other targets such as ANGPTL3 is also provided.
Expert opinion: Research consistently supports the potential of mAb therapies in treating adult dyslipidemia, particularly in vulnerable patients. PCSK9mAbs are effective in regulating lipid parameters, such as LDL-C and Lp(a), and exhibit anti-inflammatory and anti-thrombotic properties. These antibodies also maintain endothelial and smooth muscle health, contributing to the stabilization of vulnerable plaques and reduction in adverse cardiovascular events. Future research aims to further understand PCSK9 and other targets like ANGPTL3, focusing on vulnerable groups. Overall, mAbs are emerging as a promising and superior approach in dyslipidemia management and cardiovascular disease prevention.
{"title":"Monoclonal antibodies for dyslipidemia in adults: a focus on vulnerable patients groups.","authors":"Na-Qiong Wu, Zhi-Fan Li, Meng-Ying Lu, Jian-Jun Li","doi":"10.1080/14712598.2024.2321374","DOIUrl":"10.1080/14712598.2024.2321374","url":null,"abstract":"<p><strong>Introduction: </strong>Dyslipidemia significantly contributes to atherosclerotic cardiovascular disease (ASCVD). Patients with lipid-rich vulnerable plaques are particularly susceptible to cardiovascular complications. Despite available lipid-lowering therapies (LLTs), challenges in effective lipid management remain.</p><p><strong>Areas covered: </strong>This article reviews monoclonal antibody (mAb) therapy in dyslipidemia, particularly focusing on vulnerable plaques and patients. We have reviewed the definitions of vulnerable plaques and patients, outlined the efficacy of traditional LLTs, and discussed in-depth the mAbs targeting PCSK9. We extensively discuss the potential mechanisms, intracoronary imaging, and clinical evidence of PCSK9mAbs in vulnerable plaques and patients. A brief overview of promising mAbs targeting other targets such as ANGPTL3 is also provided.</p><p><strong>Expert opinion: </strong>Research consistently supports the potential of mAb therapies in treating adult dyslipidemia, particularly in vulnerable patients. PCSK9mAbs are effective in regulating lipid parameters, such as LDL-C and Lp(a), and exhibit anti-inflammatory and anti-thrombotic properties. These antibodies also maintain endothelial and smooth muscle health, contributing to the stabilization of vulnerable plaques and reduction in adverse cardiovascular events. Future research aims to further understand PCSK9 and other targets like ANGPTL3, focusing on vulnerable groups. Overall, mAbs are emerging as a promising and superior approach in dyslipidemia management and cardiovascular disease prevention.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139905433","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}
Pub Date : 2024-03-01Epub Date: 2024-02-27DOI: 10.1080/14712598.2024.2322062
Lukas Pekar, Simon Krah, Stefan Zielonka
{"title":"Taming the beast: engineering strategies and biomedical potential of antibody-based cytokine mimetics.","authors":"Lukas Pekar, Simon Krah, Stefan Zielonka","doi":"10.1080/14712598.2024.2322062","DOIUrl":"10.1080/14712598.2024.2322062","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930722","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}
Pub Date : 2024-03-01Epub Date: 2024-03-20DOI: 10.1080/14712598.2024.2326646
Seb Tucknott, Helen McAteer
Introduction: Immune-mediated inflammatory diseases (IMIDs) are increasingly managed effectively with biologic medicines. However, with relatively high unit costs, there remains a meaningful pressure to ensure streamlined, equitable, and inclusive prescription of biologics in the UK. Despite an increased awareness of the benefits of patient-centric shared decision making, patients remain on the periphery of biologic selection for the treatment of IMIDs.
Areas covered: We provide a patient perspective on core issues in the commissioning, prescription, and decision making around biologics for IMIDs in the UK, focusing on England. In particular, the crucial aspect of determining 'value' for different stakeholders, who necessarily have different priorities, is considered.
Expert opinion: There are disparities in commissioning, access to, and prescription of biologics for IMIDs in the UK. This creates an unequal treatment model and drives patient dissatisfaction with an 'experience lottery' for the management of disease. A more transparent approach to prescribing decisions, made in close consultation with patients, is essential for improving equity and experience with biologic treatment of IMIDs.
{"title":"Equity, expense, and expertise in biologic commissioning: adding the patient to the equation.","authors":"Seb Tucknott, Helen McAteer","doi":"10.1080/14712598.2024.2326646","DOIUrl":"10.1080/14712598.2024.2326646","url":null,"abstract":"<p><strong>Introduction: </strong>Immune-mediated inflammatory diseases (IMIDs) are increasingly managed effectively with biologic medicines. However, with relatively high unit costs, there remains a meaningful pressure to ensure streamlined, equitable, and inclusive prescription of biologics in the UK. Despite an increased awareness of the benefits of patient-centric shared decision making, patients remain on the periphery of biologic selection for the treatment of IMIDs.</p><p><strong>Areas covered: </strong>We provide a patient perspective on core issues in the commissioning, prescription, and decision making around biologics for IMIDs in the UK, focusing on England. In particular, the crucial aspect of determining 'value' for different stakeholders, who necessarily have different priorities, is considered.</p><p><strong>Expert opinion: </strong>There are disparities in commissioning, access to, and prescription of biologics for IMIDs in the UK. This creates an unequal treatment model and drives patient dissatisfaction with an 'experience lottery' for the management of disease. A more transparent approach to prescribing decisions, made in close consultation with patients, is essential for improving equity and experience with biologic treatment of IMIDs.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140179520","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}
Pub Date : 2024-03-01Epub Date: 2024-02-23DOI: 10.1080/14712598.2024.2316180
Antonio Tursi, Giammarco Mocci, Angelo Del Gaudio, Alfredo Papa
Introduction: The therapeutic armamentarium for managing Crohn's disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD.
Area covered: This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs).
Expert opinion: RW studies reported that biologic agents included in this analysis have higher remission rates and lower adverse event rates than findings from RCTs for treating patients with CD. All biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available. Finally, anti-TNF-α agents, particularly IFX, have a higher rate of adverse events (AEs) than VDZ and UST. Therefore, patients at higher risk of AEs may benefit from other biologics than anti-TNF-α. However, further long-term RW studies are needed to confirm these findings.
{"title":"Clinical use of biologics for Crohn's disease in adults: lessons learned from real-world studies.","authors":"Antonio Tursi, Giammarco Mocci, Angelo Del Gaudio, Alfredo Papa","doi":"10.1080/14712598.2024.2316180","DOIUrl":"10.1080/14712598.2024.2316180","url":null,"abstract":"<p><strong>Introduction: </strong>The therapeutic armamentarium for managing Crohn's disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD.</p><p><strong>Area covered: </strong>This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs).</p><p><strong>Expert opinion: </strong>RW studies reported that biologic agents included in this analysis have higher remission rates and lower adverse event rates than findings from RCTs for treating patients with CD. All biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available. Finally, anti-TNF-α agents, particularly IFX, have a higher rate of adverse events (AEs) than VDZ and UST. Therefore, patients at higher risk of AEs may benefit from other biologics than anti-TNF-α. However, further long-term RW studies are needed to confirm these findings.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139697195","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}
Pub Date : 2024-03-01Epub Date: 2024-02-27DOI: 10.1080/14712598.2024.2323596
Michelle Greenman, Blair McNamara, Levent Mutlu, Alessandro D Santin
{"title":"Targeting cervical cancer with anti-PD-1 antibodies: what is new?","authors":"Michelle Greenman, Blair McNamara, Levent Mutlu, Alessandro D Santin","doi":"10.1080/14712598.2024.2323596","DOIUrl":"10.1080/14712598.2024.2323596","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930723","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}