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

Belimumab patient profile in Spain: evolution during the last decade and future directions.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI: 10.1080/14712598.2025.2479018

Tarek Carlos Salman-Monte, María José Cuadrado, María Galindo, Gerard Espinosa, Enrique Morales, José María Pego-Reigosa, Lucio Pallarés, Covadonga López, Carmen San Román, Íñigo Rúa-Figueroa

{"title":"Belimumab patient profile in Spain: evolution during the last decade and future directions.","authors":"Tarek Carlos Salman-Monte, María José Cuadrado, María Galindo, Gerard Espinosa, Enrique Morales, José María Pego-Reigosa, Lucio Pallarés, Covadonga López, Carmen San Román, Íñigo Rúa-Figueroa","doi":"10.1080/14712598.2025.2479018","DOIUrl":"10.1080/14712598.2025.2479018","url":null,"abstract":"Introduction: Belimumab (BEL), an anti B-lymphocyte stimulator monoclonal antibody, is the only approved biological therapy for systemic lupus erythematosus (SLE) and lupus nephritis (LN).Areas covered: This review discusses BEL's real-world use and its positioning in clinical practice guidelines, focusing on the evolution of its application and patient profile over the last decade in Spain.Expert opinion: Initially used for refractory and non-major SLE manifestations, BEL's application has expanded. International guidelines now recommend earlier use of BEL in treatment algorithms. With its 2021 approval for LN, BEL is increasingly used for renal manifestations and as a first-line therapy. Safety data confirm its tolerability without a significant increase in severe infections. However, real-world evidence in Spain reveals discrepancies with these recommendations for both SLE and LN. The optimal patient for BEL treatment is one with mild, moderate, or severe SLE that cannot be controlled with hydroxychloroquine (HCQ), with or without glucocorticoids (GC) and immunosuppressants (IS), in patients with a disease duration of ≤2 years, no initial organ damage, GC doses ≥5 mg/day, and a high risk of severe flares. Further studies are needed to determine the optimal timing for BEL initiation to improve patient outcomes and modify the disease course.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"425-435"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143614018","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 odronextamab for the treatment of multiple subtypes of relapsed/refractory B-cell non-Hodgkin lymphoma.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-24 DOI: 10.1080/14712598.2025.2479631

Elena Bayly-McCredie, Henry Miles Prince, Costas Kleanthes Yannakou, Salvatore Fiorenza

{"title":"An evaluation of odronextamab for the treatment of multiple subtypes of relapsed/refractory B-cell non-Hodgkin lymphoma.","authors":"Elena Bayly-McCredie, Henry Miles Prince, Costas Kleanthes Yannakou, Salvatore Fiorenza","doi":"10.1080/14712598.2025.2479631","DOIUrl":"10.1080/14712598.2025.2479631","url":null,"abstract":"Introduction: Patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) have a poor median survival rate when treated with traditional salvage therapies. Bispecific antibodies (BsAbs) are an emerging class of 'off-the-shelf' immunotherapies that show promising efficacy in this population. Odronextamab is a CD20×CD3 targeting bispecific antibody that is being investigated in multiple subtypes of relapsed/refractory B-NHL.Areas covered: This article describes the development of odronextamab from pre-clinical work through to ongoing clinical trials in relapsed/refractory B-NHL. The structure, safety, efficacy, and administration of odronextamab are discussed. Studies were selected for inclusion by performing a search in PubMed, EMBASE, Cochrane Library, and relevant conference abstracts from 2014 to 2024. The clinicaltrials.gov website and reference lists of the included studies were also reviewed.Expert opinion: Odronextamab has demonstrated manageable safety and promising efficacy in multiple subtypes of relapsed/refractory B-NHL. The low rates of immune effector cell-associated neurotoxicity syndrome (ICANS) and high response rates in rare aggressive subtypes of B-NHL are particularly noteworthy. High rates of severe infections remain a challenge with BsAbs, with further prophylactic efforts required to reduce the risk. Clinical trials of combination therapies with odronextamab are required to improve the utility of this BsAb across a wider range of settings and subtypes of B-NHL.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"331-343"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663030","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

Drawing on collective action theory to foster sustainable biosimilar markets - insights from co-creation workshops with UK and Belgian stakeholders. 借鉴集体行动理论，促进可持续的生物仿制药市场--从与英国和比利时利益相关者的共同创造研讨会中获得的启示。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-07 DOI: 10.1080/14712598.2025.2474604

Teresa Barcina Lacosta, Arnold G Vulto, Florian Turk, Isabelle Huys, Steven Simoens

{"title":"Drawing on collective action theory to foster sustainable biosimilar markets - insights from co-creation workshops with UK and Belgian stakeholders.","authors":"Teresa Barcina Lacosta, Arnold G Vulto, Florian Turk, Isabelle Huys, Steven Simoens","doi":"10.1080/14712598.2025.2474604","DOIUrl":"10.1080/14712598.2025.2474604","url":null,"abstract":"Background: Research has signaled the need for reformed biosimilar policy frameworks that adopt a behavioral approach, are informed by consensus-generating strategies and thus better align with the requirements of local healthcare communities.Research design and methods: Through a series of co-creation workshops, the current study explores the feasibility of applying learnings from Collective Action Theory to formulate evidence-based multistakeholder-supported policy recommendations.Results: Insights from the conducted workshops indicate that future policy frameworks would benefit from: 1) a working system of incentives and rewards aligned with stakeholder needs; 2) evaluating the cost-benefit balance for stakeholders prior to policy implementation; 3) involving multistakeholder panels in policy co-design; 4) adopting a long-term vision; 5) fostering coordination at the interface between levels of governance; 6) defining shared goals and efficient systems to monitor policy compliance; and 7) using policy outcome data to adapt current policy frameworks based on evolving needs. The incorporation of these elements to policies is expected to help prioritize long-term sustainable solutions, and balance short-term gains and long-term objectives in biosimilar markets.Conclusions: This study constitutes a first approach to developing multistakeholder-supported principles for sustainable biosimilar markets. This is a necessary step toward generating stakeholders' consensus on biosimilar policies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"437-446"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531481","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

Management of metastatic melanoma with combinations including PD-1 inhibitors.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 DOI: 10.1080/14712598.2025.2485315

Lara Valeska Maul, Egle Ramelyte, Reinhard Dummer, Joanna Mangana

{"title":"Management of metastatic melanoma with combinations including PD-1 inhibitors.","authors":"Lara Valeska Maul, Egle Ramelyte, Reinhard Dummer, Joanna Mangana","doi":"10.1080/14712598.2025.2485315","DOIUrl":"https://doi.org/10.1080/14712598.2025.2485315","url":null,"abstract":"Introduction: Melanoma is among the most immunogenic malignancies. The advent of immune checkpoint inhibitors (ICIs) has revolutionized the landscape of melanoma treatment. Long-term durable cancer control is possible in nearly 50% of non-resectable, metastatic melanoma patients with anti-CTLA4 and anti-PD-1 antibodies.Areas covered: This review provides a critical overview of the current data and future research directions on the management of metastatic melanoma with ICIs. We reviewed the efficacy and safety of combinations with PD-1 inhibitors through PubMed database research (Nov 2024-Mar 2025).Expert opinion: A decade after ipilimumab's approval, challenges remain. To cure more patients, the development of combinations is warranted. Combinations with a limited number of ipilimumab applications improve the overall survival outcome by approximately 10%, with a dramatic increase in adverse events including fatal events. Anti-LAG3/nivolumab is a promising alternative, offering similar efficacy to ipilimumab/nivolumab with better tolerability. In our opinion, ipilimumab/nivolumab combination should be the first-line therapy for high-risk patients (high LDH, brain or liver metastasis), while nivolumab/relatlimab or PD-1 monotherapy may be preferable for lower-risk cases. However, treatment decisions are increasingly complex, since most patients nowadays are pretreated in the (neo)-adjuvant setting. The key limitation today is the lack of biomarkers to guide individualized treatment strategies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-12"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751771","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 review of antibody-based immunotherapy clinical trials for adult acute myeloid leukemia (AML): monoclonal antibodies (mAbs) and beyond.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI: 10.1080/14712598.2025.2479014

Kaitlyn C Dykes, Edward D Ball

{"title":"A review of antibody-based immunotherapy clinical trials for adult acute myeloid leukemia (AML): monoclonal antibodies (mAbs) and beyond.","authors":"Kaitlyn C Dykes, Edward D Ball","doi":"10.1080/14712598.2025.2479014","DOIUrl":"10.1080/14712598.2025.2479014","url":null,"abstract":"Introduction: Antibody-based immunotherapies are a class of therapeutics under active investigation in clinical trials for the treatment of acute myeloid leukemia (AML). Our review provides a comprehensive examination of trials published to date, focusing on recurrent challenges and promising aspects of antibody-based therapeutics.Areas covered: We described antibody-based immunotherapies for AML, specifically, an overview of the most prominent antigen targets in published clinical trials investigating monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, and chimeric antigen receptor therapies. Manuscripts and abstracts describing clinical trials investigating antibody-based therapies for AML published through December 2024, identified by searching Google Scholar and PubMed, were included.Expert opinion: Antibody-based immunotherapies for AML have encountered limitations, including imperfect target antigens with significant associated toxicity such as myelosuppression, in addition to challenges specific to the AML patient population. The majority of trials have targeted CD33, CD123, CD371 (CLL1/Clec12), and CD47. For successful implementation of antibody-based therapeutics in AML treatment, future directions require creative applications of antibody-based therapeutics specifically engineered to minimize limiting toxicities and tailoring of therapies for this unique patient population.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"345-362"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604344","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

Chasing optimal first-in-human (FIH) starting dose for biotherapeutics in oncology.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-19 DOI: 10.1080/14712598.2025.2477190

Céline Amara

引用次数: 0

X-linked myotubular myopathy: an untreated treatable disease.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI: 10.1080/14712598.2025.2473430

Cristina Martin, Laurent Servais

{"title":"X-linked myotubular myopathy: an untreated treatable disease.","authors":"Cristina Martin, Laurent Servais","doi":"10.1080/14712598.2025.2473430","DOIUrl":"10.1080/14712598.2025.2473430","url":null,"abstract":"Introduction: X-linked myotubular myopathy (XLMTM) is a life-threatening congenital disorder characterized by severe respiratory and motor impairment. This disease presents significant therapeutic challenges, with various strategies being explored to address its underlying pathology. Among these approaches, gene replacement therapy has demonstrated substantial functional improvements in clinical trials. However, safety issues emerged across different therapeutic approaches, highlighting the need for further research.Areas covered: This review provides a comprehensive analysis of the data gathered from natural history studies, preclinical models and clinical trials, with a particular focus on gene replacement therapy for XLMTM. The different therapeutic strategies are addressed, including their outcomes and associated safety concerns.Expert opinion: Despite the encouraging potential of gene therapy for XLMTM, the occurrence of safety challenges emphasizes the urgent need for a more comprehensive understanding of the disease's complex phenotype. Enhancing preclinical models to more accurately mimic the full spectrum of disease manifestations will be crucial for optimizing therapeutic strategies and reducing risks in future clinical applications.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"379-394"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556395","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

Microbiota transplantation and administration of live biotherapeutic products for the treatment of dysbiosis-associated diseases.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-03-28 DOI: 10.1080/14712598.2025.2484303

Samantha Flores-Treviño, Paola Bocanegra-Ibarias, Daniel Salas-Treviño, María Teresa Ramírez-Elizondo, Eduardo Pérez-Alba, Adrián Camacho-Ortiz

{"title":"Microbiota transplantation and administration of live biotherapeutic products for the treatment of dysbiosis-associated diseases.","authors":"Samantha Flores-Treviño, Paola Bocanegra-Ibarias, Daniel Salas-Treviño, María Teresa Ramírez-Elizondo, Eduardo Pérez-Alba, Adrián Camacho-Ortiz","doi":"10.1080/14712598.2025.2484303","DOIUrl":"10.1080/14712598.2025.2484303","url":null,"abstract":"Introduction: The microbiota composition in humans varies according to the anatomical site and is crucial for maintaining homeostasis and an overall healthy state. Several gastrointestinal, vaginal, respiratory, and skin diseases are associated with dysbiosis. Alternative therapies such as microbiota transplantation can help restore microbiota normal composition and can be implemented to treat clinically relevant diseases.Areas covered: Current microbiota transplantation therapies conducted in clinical trials were included in this review (after searching on MEDLINE database from years 2017 to 2025) such as fecal microbiota transplantation (FMT) against recurrent Clostridioides difficile infection (rCDI) and vaginal microbiota transplantation (VMT) against bacterial vaginosis. Washed microbiota transplantation (WMT) and live biotherapeutic products (LBPs) were also reviewed.Expert opinion: In microbiota-based transplantation therapy, selecting optimal donors is a limitation. A stool or a vaginal microbiota bank should be implemented to overcome the time-consuming and expensive process of donor recruitment. Microbiota-based LBPs are also promising treatment alternatives for rCDI and other dysbiosis-associated diseases. Specific LBPs could be engineered out of donor fluids-derived strains to achieve the selection of specific beneficial microorganisms for the treatment of specific dysbiosis-associated diseases. Personalized microbiota-based treatments are promising solutions for dysbiosis-associated diseases, which remains an important necessity in clinical practice.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":3.6,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709313","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 as adjuvant therapies for resected melanoma.

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-03-26 DOI: 10.1080/14712598.2025.2484305

Islam Eljilany, Julia R Garcia, Basmala Jamal, Ahmad A Tarhini

{"title":"Monoclonal antibodies as adjuvant therapies for resected melanoma.","authors":"Islam Eljilany, Julia R Garcia, Basmala Jamal, Ahmad A Tarhini","doi":"10.1080/14712598.2025.2484305","DOIUrl":"10.1080/14712598.2025.2484305","url":null,"abstract":"Introduction: Systemic adjuvant therapy is indicated in patients with high-risk, resected melanoma management to reduce recurrence risk and potentially improve survival rates. Monoclonal antibodies (mAbs) target immune checkpoints and have made significant advances as adjuvant therapy.Areas covered: This review discusses the main clinical trials that tested adjuvant mAbs in resected high-risk melanoma, including anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) and anti-programmed cell death-1 (PD-1); in addition to newer immunotherapies being tested in the adjuvant setting, including anti-lymphocyte activation gene 3 (LAG-3). We also briefly discuss targeted therapies as an alternative choice. Moreover, we highlight the pros and cons of using mAbs in the adjuvant setting, the reported adverse events (AEs), and the quality of life impact. Finally, we report data related to biomarker studies tested in the context of these clinical trials.Expert opinion: Immune checkpoint inhibitors (ICIs) have been shown to significantly improve relapse-free survival (RFS) as adjuvant therapy for high-risk melanoma. In contrast, the long-term impact on overall survival (OS) was demonstrated in two studies that tested ipilimumab versus placebo (EORTC18071) and interferon-α (ECOG-ACRIN E1609). Furthermore, emerging data with neoadjuvant therapy followed by surgery and adjuvant therapy utilizing ICIs has demonstrated improved outcomes in the management of locoregionally advanced disease.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":3.6,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691446","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

Aflibercept biosimilars - so near, yet so far. Aflibercept生物仿制药--如此之近，却又如此之远。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-03-23 DOI: 10.1080/14712598.2025.2482663

Ashish Sharma, Se Joon Woo, Baruch D Kuppermann

引用次数: 0