Expert Opinion on Biological Therapy最新文献

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Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. 比较阿达木单抗生物仿制药研究中评估免疫原性和互换性的抗药抗体信噪比。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-19 DOI: 10.1080/14712598.2024.2428299
Lena Lemke, Andrew Blauvelt, Ines Brückmann, Hillel P Cohen, Jamie Fan, Davide Guerrieri, Matej Horvat, Johann Poetzl, Claudia Torella, Qingfeng Wang, Oliver von Richter
{"title":"Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies.","authors":"Lena Lemke, Andrew Blauvelt, Ines Brückmann, Hillel P Cohen, Jamie Fan, Davide Guerrieri, Matej Horvat, Johann Poetzl, Claudia Torella, Qingfeng Wang, Oliver von Richter","doi":"10.1080/14712598.2024.2428299","DOIUrl":"10.1080/14712598.2024.2428299","url":null,"abstract":"<p><strong>Background: </strong>To support an interchangeability designation for Sandoz adalimumab biosimilar (GP2017), antidrug antibody (ADA) signal-to-noise (S/N) ratios were assessed in the GP2017 ADACCESS trial to directly assess potential changes in immunogenicity.</p><p><strong>Research design and methods: </strong>ADACCESS was a 51-week trial in patients with moderate-to-severe plaque psoriasis that included patients treated continuously with reference adalimumab (cH), and patients who experienced four switches between reference adalimumab and GP2017 (H2H). ADAs were measured every 6 weeks during the switching phase using an electrochemiluminescence assay. A non-parametric analysis was performed to estimate the 90% confidence interval (CI) of the median of difference in ADA S/N ratios between the cH and H2H treatment groups at week 41. If the 90% CI was within the margin of -0.16 to 0.16 (representing assay noise), this was considered a non-clinically meaningful difference in immunogenicity.</p><p><strong>Results: </strong>The 90% CIs of the median of difference in ADA S/N ratios between the two treatment groups were within the defined margin of -0.16 to 0.16 at week 41, and at all other time points. Efficacy and safety data were also similar between the treatment groups.</p><p><strong>Conclusion: </strong>Analysis of ADA S/N ratios showed no increase in immunogenicity following up to four switches between reference adalimumab and GP2017.</p><p><strong>Trial registration: </strong>NCT02016105.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-11"},"PeriodicalIF":3.6,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638267","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
Endoscopic endpoints in biologic clinical trials and beyond: the case for Crohn's Disease. 生物临床试验中的内窥镜终点及其他:克罗恩病案例。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-18 DOI: 10.1080/14712598.2024.2430614
Marlou P M Adriaanse, Mark Löwenberg, Geert R A M D'Haens
{"title":"Endoscopic endpoints in biologic clinical trials and beyond: the case for Crohn's Disease.","authors":"Marlou P M Adriaanse, Mark Löwenberg, Geert R A M D'Haens","doi":"10.1080/14712598.2024.2430614","DOIUrl":"10.1080/14712598.2024.2430614","url":null,"abstract":"<p><strong>Introduction: </strong>Standardized evaluation of endoscopic disease activity using valid, responsive and reliable instruments is crucial for optimizing the efficiency of clinical trials with therapeutic agents for Crohn's disease (CD). Achieving endoscopic remission and/or mucosal healing is associated with improved long-term outcomes, making it an important treatment goal.</p><p><strong>Areas covered: </strong>Several endoscopic indices have been used over the past two decades, though they lack complete validation. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn's Disease (SES-CD) demonstrate fair reliability and responsiveness to treatment. The CDEIS is rather complex and time-consuming, and both endoscopic indices are prone to variability. The Lewis Score and Capsule Endoscopy CD Activity Index (CECDAI) provide useful alternative instruments using video capsule endoscopy, but they need further validation. The Rutgeerts score predicts post-surgical recurrence but lacks evaluation for follow-up.</p><p><strong>Expert opinion: </strong>While recent guidelines emphasize co-primary clinical and endoscopic endpoints to improve trial effectiveness, these are typically based on expert consensus rather than empirical data. We advocate to use SES-CD as the preferred endoscopic index given its simplicity, strong correlation with CDEIS, and treatment responsiveness. Future research should focus on establishing clinically relevant cutoff values for endoscopic response and endoscopic remission in CD trials, including post-operative settings.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-10"},"PeriodicalIF":3.6,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616807","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
Bispecific therapeutics: a state-of-the-art review on the combination of immune checkpoint ‎inhibition with costimulatory and non-checkpoint targeted therapy. 双特异性疗法:关于免疫检查点抑制与成本刺激和非检查点靶向疗法相结合的最新综述。
IF 4.3 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-18 DOI: 10.1080/14712598.2024.2426636
Samin Mortaheb, Parmida Sadat Pezeshki, Nima Rezaei
{"title":"Bispecific therapeutics: a state-of-the-art review on the combination of immune checkpoint ‎inhibition with costimulatory and non-checkpoint targeted therapy.","authors":"Samin Mortaheb, Parmida Sadat Pezeshki, Nima Rezaei","doi":"10.1080/14712598.2024.2426636","DOIUrl":"10.1080/14712598.2024.2426636","url":null,"abstract":"<p><strong>Introduction: </strong>Immune checkpoint inhibitors (ICIs) have revolutionized the field of cancer immunotherapy and have enhanced the survival of patients with malignant tumors. However, the overall efficacy of ICIs remains unsatisfactory and is faced with two major concerns of resistance development and occurrence of immune-related adverse events (irAEs). Bispecific antibodies (bsAbs) have emerged as promising strategies with unique mechanisms of action to achieve a better efficacy and safety than monoclonal antibodies (mAbs) or even their combination. BsAbs along with other bispecific platforms such as bispecific fusion proteins, nanobodies, and CAR-T cells may help to avoid development of resistance and reduce irAEs caused by on-target/off-tumor binding effects of mAbs.</p><p><strong>Areas covered: </strong>A literature search was performed using PubMed for English-language articles to provide a comprehensive overview of preclinical and clinical studies on bsAbs specified for both immune checkpoints and non-checkpoint molecules as a well-enhanced class of therapeutics.</p><p><strong>Expert opinion: </strong>Identifying suitable targets and selecting effective engineering platforms enhance the potential of bsAbs to address the challenges associated with conventional therapies such as ICIs, positioning them as a promising class of therapeutics in the landscape of cancer immunotherapy.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-17"},"PeriodicalIF":4.3,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582643","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
Immunobiology of biliary tract cancer and recent clinical findings in approved and upcoming immune checkpoint inhibitors. 胆道癌的免疫生物学以及已批准和即将批准的免疫检查点抑制剂的最新临床发现。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-18 DOI: 10.1080/14712598.2024.2431088
Carmelo Laface, Emanuela Fina, Angela Dalia Ricci, Deniz Can Guven, Francesca Ambrogio, Simona De Summa, Elsa Vitale, Raffaella Massafra, Oronzo Brunetti, Alessandro Rizzo
{"title":"Immunobiology of biliary tract cancer and recent clinical findings in approved and upcoming immune checkpoint inhibitors.","authors":"Carmelo Laface, Emanuela Fina, Angela Dalia Ricci, Deniz Can Guven, Francesca Ambrogio, Simona De Summa, Elsa Vitale, Raffaella Massafra, Oronzo Brunetti, Alessandro Rizzo","doi":"10.1080/14712598.2024.2431088","DOIUrl":"10.1080/14712598.2024.2431088","url":null,"abstract":"<p><strong>Introduction: </strong>Recently, immunotherapy has offered new hope for treating biliary tract cancer (BTC). However, several issues are to be considered, including the lack of validated predictive biomarkers that could help to identify patient groups which are most likely to benefit from such therapeutic approaches.</p><p><strong>Areas covered: </strong>In the current article, we will provide an overview of recent results and ongoing and future research directions of immunotherapy in BTC, with a special focus on recently published, practice-changing data, and ongoing active and recruiting clinical trials.</p><p><strong>Expert opinion: </strong>At this moment, dozens of clinical trials in phases I to III are evaluating the role of cancer immunotherapy in this setting, with the hope of adding more therapeutic options for BTC patients. Future research must focus on the development of novel agents and combinations, but the validation of biomarkers remains an urgent need. As more research results emerge, novel combinatorial strategies are destined to further transform the treatment paradigm for this heterogeneous and aggressive tumor type.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-12"},"PeriodicalIF":3.6,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638268","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
Emerging peptide-based technology for biofilm control. 基于肽的生物膜控制新兴技术。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-15 DOI: 10.1080/14712598.2024.2430623
Karen O Osiro, Nona Hashemi, José Brango-Vanegas, Samuel M D Oliveira, Octavio L Franco
{"title":"Emerging peptide-based technology for biofilm control.","authors":"Karen O Osiro, Nona Hashemi, José Brango-Vanegas, Samuel M D Oliveira, Octavio L Franco","doi":"10.1080/14712598.2024.2430623","DOIUrl":"https://doi.org/10.1080/14712598.2024.2430623","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644252","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
An evaluation of risankizumab for the treatment of moderate-to-severe ulcerative colitis. 评估利桑珠单抗治疗中重度溃疡性结肠炎的效果。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-13 DOI: 10.1080/14712598.2024.2428311
Amanda M Johnson, Edward V Loftus
{"title":"An evaluation of risankizumab for the treatment of moderate-to-severe ulcerative colitis.","authors":"Amanda M Johnson, Edward V Loftus","doi":"10.1080/14712598.2024.2428311","DOIUrl":"https://doi.org/10.1080/14712598.2024.2428311","url":null,"abstract":"<p><strong>Introduction: </strong>Risankizumab (RZB) is a recombinant IgG<sub>1</sub> humanized monoclonal antibody which selectively inhibits interleukin (IL)-23 though high-affinity binding of the p19 subunit. RZB was approved for use in Crohn's disease (CD) in 2022 and received regulatory approval for ulcerative colitis (UC) in the United States in June 2024.</p><p><strong>Areas covered: </strong>We will examine currently available therapies for UC, provide an overview of the IL-23 pathway, discuss available trial data for RZB in UC, and comment on how RZB may fit into the current UC treatment paradigm and future directions in the field.</p><p><strong>Expert opinion: </strong>RZB appears to be an effective agent for inducing and maintaining remission in patients with both treatment-naïve and refractory UC, with a favorable safety profile. The selective blockade of IL-23 has demonstrated potential advantages in efficacy over combined IL-12/23 inhibition for other disease states like CD and psoriasis, although where it will be positioned amidst other clinically available advanced therapies in UC requires further study.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-11"},"PeriodicalIF":3.6,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616804","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 systematic review of the efficacy and safety of anti-amyloid beta monoclonal antibodies in treatment of Alzheimer's disease. 抗淀粉样蛋白 beta 单克隆抗体治疗阿尔茨海默病的疗效和安全性系统综述。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-12 DOI: 10.1080/14712598.2024.2416947
Akanksha Chhabra, Siddhant Solanki, Prithvi Saravanabawan, Arun Venkiteswaran, NagaTarang Nimmathota, Nishi Manojkumar Modi
{"title":"A systematic review of the efficacy and safety of anti-amyloid beta monoclonal antibodies in treatment of Alzheimer's disease.","authors":"Akanksha Chhabra, Siddhant Solanki, Prithvi Saravanabawan, Arun Venkiteswaran, NagaTarang Nimmathota, Nishi Manojkumar Modi","doi":"10.1080/14712598.2024.2416947","DOIUrl":"10.1080/14712598.2024.2416947","url":null,"abstract":"<p><strong>Introduction: </strong>Alzheimer's disease can cause dementia through brain matter degradation. This study investigates the monoclonal antibody usage for AD treatment, following PRISMA 2020 guidelines, and aims to discern the monoclonal antibody that offers the optimal balance of efficacy and safety for individuals with AD.</p><p><strong>Methods: </strong>A systematic search was conducted across databases such as PubMed, Cochrane Library, and clinical trial registries for randomized controlled trials. The quality of studies was assessed using the Cochrane risk of bias 2 tool. Cognitive function and daily activities were evaluated using MMSE, ADAS-Cog, and CDR-SB test data.</p><p><strong>Results: </strong>According to CDR-SB measurements, lecanemab showed effectiveness in reducing brain amyloid and cognitive decline, with a change from baseline of 1.21. Aducanumab resulted in a decrease of -0.39 (-22%). Bapineuzumab showed no significant benefit, with scores of 2.4 (2.8). Gantenerumab, scoring 1.69 (1.37, 2.01), reduces amyloid, particularly in early Alzheimer's stages. Crenezumab was ineffective, with a score of 3.61.</p><p><strong>Conclusion: </strong>The findings provide various perspectives. Lecanemab showed the most promise in brain amyloid reduction and decelerating cognitive decline compared to the other therapies. Further research is needed, highlighting the necessity of AD therapeutic research to alter AD's trajectory and provide reliable treatment.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD42024504358.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-9"},"PeriodicalIF":3.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461282","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
Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective. 2018 年至 2023 年欧盟孤儿维护生物药品评估:监管视角。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-11 DOI: 10.1080/14712598.2024.2422360
Paolo Caferra, Thomas Fraisse, Maria Letizia Trincavelli, Laura Marchetti, Anna Maria Piras
{"title":"Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective.","authors":"Paolo Caferra, Thomas Fraisse, Maria Letizia Trincavelli, Laura Marchetti, Anna Maria Piras","doi":"10.1080/14712598.2024.2422360","DOIUrl":"10.1080/14712598.2024.2422360","url":null,"abstract":"<p><strong>Objectives: </strong>Orphan medicinal products (OMPs) authorized by the European Union (EU) benefit from market exclusivity, fee waivers, and national incentives. Maintaining orphan status during a marketing authorization application requires meeting eligibility criteria, especially demonstrating significant benefit (SB), which is challenging. This study identifies key features linked to successful orphan status maintenance for biological OMPs approved in the EU between 2018 and 2023.</p><p><strong>Methods: </strong>Data from European public assessment reports and orphan maintenance assessment reports were analyzed.</p><p><strong>Results: </strong>Among the 50 biological OMP maintained orphan designations, 68.0% had to demonstrate SB over existing treatments, with 91.2% leveraging the clinically relevant advantage area, utilizing better clinical efficacy (83.9%) and efficacy in subpopulations (38.7%) subdomains. However, 32.0% did not need to demonstrate SB due to a lack of alternative treatments, most of which were ultra-orphan drugs. Advanced therapy medicinal products and monoclonal antibodies were the most numerous OMP categories, whereas oncology and immunomodulation were the preferred therapeutic areas.</p><p><strong>Conclusion: </strong>The Orphan Regulation is essential in advancing treatments for rare diseases, fostering innovation while addressing unmet medical needs. Nonetheless, the insufficient return on investment criterion remains underused, whereas refining major contribution to patient care guidelines and incorporating real-world evidence may enhance regulatory evaluations.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-19"},"PeriodicalIF":3.6,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497636","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
Pooled safety analysis from the VOLTAIRE clinical trials of adalimumab-adbm and adalimumab reference product in patients with rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis. 阿达木单抗-adbm和阿达木单抗参比产品在类风湿性关节炎、克罗恩病和慢性斑块型银屑病患者中的VOLTAIRE临床试验汇总安全性分析。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-11 DOI: 10.1080/14712598.2024.2426637
Stanley Cohen, Shaun Bender, Amy Shaberman, Richard Vinisko, Dottie McCabe
{"title":"Pooled safety analysis from the VOLTAIRE clinical trials of adalimumab-adbm and adalimumab reference product in patients with rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis.","authors":"Stanley Cohen, Shaun Bender, Amy Shaberman, Richard Vinisko, Dottie McCabe","doi":"10.1080/14712598.2024.2426637","DOIUrl":"10.1080/14712598.2024.2426637","url":null,"abstract":"<p><strong>Objectives: </strong>This analysis reported the incidence of safety endpoints across five phase 3 randomized controlled clinical trials in patients with rheumatoid arthritis (RA), Crohn's disease (CD), and chronic plaque psoriasis (PsO) who received ≥ 1 dose of adalimumab-adbm or adalimumab reference product (RP).</p><p><strong>Methods: </strong>Exposure-adjusted incidence rates for safety endpoints were calculated per 100 patient-years and reported by disease indication and treatment arm. Subgroup analyses by patient age and sex were also conducted.</p><p><strong>Results: </strong>The mean length of follow-up was 62 weeks, 48 weeks, and 32 weeks for patients with RA, CD, and PsO, respectively. Rates of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) were similar among patients with RA and PsO, but slightly higher among those with CD. Incidence rates of all safety endpoints were consistent between the adalimumab-adbm and adalimumab RP treatment arms within each indication Subgroup analyses of patients with RA, CD, and PsO showed no between-group differences by age and sex.</p><p><strong>Conclusions: </strong>In patients with RA, CD, and PsO, there were no differences between biosimilar adalimumab-adbm or the adalimumab RP regarding the rate of AEs, SAEs, discontinuations due to AEs, deaths, or any AEs of special interest.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-6"},"PeriodicalIF":3.6,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582644","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
An evaluation of ravulizumab for the treatment of neuromyelitis optica spectrum disorder. 评估雷珠单抗治疗神经脊髓炎视网膜频谱紊乱症的效果。
IF 3.6 3区 医学
Expert Opinion on Biological Therapy Pub Date : 2024-11-07 DOI: 10.1080/14712598.2024.2423002
Denis T Balaban, Michael Levy, Ray Borrow, Monique R Anderson
{"title":"An evaluation of ravulizumab for the treatment of neuromyelitis optica spectrum disorder.","authors":"Denis T Balaban, Michael Levy, Ray Borrow, Monique R Anderson","doi":"10.1080/14712598.2024.2423002","DOIUrl":"10.1080/14712598.2024.2423002","url":null,"abstract":"<p><strong>Introduction: </strong>Following the CHAMPION-NMOSD trial, the FDA recently granted approval for ravulizumab, a humanized monoclonal antibody against complement C5 protein in AQP-4 seropositive neuromyelitis optica spectrum disorder (NMOSD). Similar to eculizumab, ravulizumab offers near-complete prevention of NMOSD relapses, but has a longer half-life, providing decreased infusion frequency and increased convenience for patients. While targeting the complement pathway has clear advantages, patients are at risk for infection with encapsulated organisms, in particular <i>Neisseria meningitidis</i>.</p><p><strong>Areas covered: </strong>In this paper, we discuss the details of the CHAMPION-NMOSD trial and discuss challenges in meningitis prevention and strategies for switching therapies.</p><p><strong>Expert opinion: </strong>Ravulizumab improves on eculizumab's success as a highly effective NMOSD therapy by decreasing infusion frequency, thereby increasing patient convenience. We predict that ravulizumab will eventually replace eculizumab but may not have a similar impact on inebelizumab or satralizumab. Patients taking C5 complement inhibitors have an increased risk of serious meningococcal infections, such as invasive meningococcal disease (IMD), and have incomplete protection against IMD despite immunization. Thus, we recommend that in addition to standard pre-immunizations against <i>Neisseria meningitidis</i>, patients should also be assessed for starting on appropriate antibiotic prophylaxis against IMD, based on local resistance patterns.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-6"},"PeriodicalIF":3.6,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497635","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
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