Expert Opinion on Biological Therapy最新文献_第6页

Perspectives on the use of biological therapies for the treatment of asthma in low-middle income countries. 对中低收入国家使用生物疗法治疗哮喘的看法。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub Date: 2025-04-06 DOI: 10.1080/14712598.2025.2490064

Betül Özdel Öztürk, Sevim Bavbek

引用次数: 0

Monoclonal antibodies as adjuvant therapies for resected melanoma. 单克隆抗体作为切除黑色素瘤的辅助治疗。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub 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 to reduce recurrence risk and potentially improve survival rates. Monoclonal antibodies (mAbs) target immune checkpoints and have made significant advances as systemic adjuvant therapies.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. The long-term impact on overall survival (OS) was demonstrated in two trials that tested ipilimumab as compared to placebo (EORTC18071) and interferon-α (ECOG-ACRIN E1609). Furthermore, emerging data with neoadjuvant therapy followed by surgery and adjuvant therapy utilizing ICIs have demonstrated improved outcomes in the management of locoregionally advanced disease when compared to upfront surgery followed by adjuvant therapy alone.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","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

Autoantibody targeting therapies in post COVID syndrome and myalgic encephalomyelitis/chronic fatigue syndrome. COVID后综合征和肌痛性脑脊髓炎/慢性疲劳综合征的自身抗体靶向治疗

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub Date: 2025-04-15 DOI: 10.1080/14712598.2025.2492774

Felix Wohlrab, Mailam Eltity, Friederike Ufer, Friedemann Paul, Carmen Scheibenbogen, Judith Bellmann-Strobl

引用次数: 0

Biological therapies in thrombocytopenia and primary antiphospholipid syndrome: where are we now? 血小板减少症和原发性抗磷脂综合征的生物治疗：我们现在在哪里？

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub Date: 2025-04-06 DOI: 10.1080/14712598.2025.2484844

Massimo Radin, Alice Barinotti, David Galarza, Irene Cecchi, Sofia Camerlo, Antonella Vaccarino, Dario Roccatello, Alessandro Morotti, Savino Sciascia

引用次数: 0

Perceptions of patients with inflammatory bowel diseases on switching from reference product adalimumab to biosimilar adalimumab-atto. 炎症性肠病患者从参考产品阿达木单抗转向生物仿制药阿达木单抗-atto的认知

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub Date: 2025-04-02 DOI: 10.1080/14712598.2025.2488222

Catherine Pham, Deana Bitar, Fang Niu, Kim Ngoc Le, Rita Lai-Han Hui, Thomas Delate

{"title":"Perceptions of patients with inflammatory bowel diseases on switching from reference product adalimumab to biosimilar adalimumab-atto.","authors":"Catherine Pham, Deana Bitar, Fang Niu, Kim Ngoc Le, Rita Lai-Han Hui, Thomas Delate","doi":"10.1080/14712598.2025.2488222","DOIUrl":"10.1080/14712598.2025.2488222","url":null,"abstract":"Background: There may be patient concerns with switching to a biosimilar product. The purpose of this study was to describe the perspectives of patients with inflammatory bowel disease (IBD) after switching from reference product (RP) adalimumab to adalimumab-atto.Research design and methods: This was a telephonic survey of US patients with IBD conducted in June-July 2023 among adult, English-speaking patients who were switched to biosimilar adalimumab-atto from RP adalimumab within the previous 100 days, and were receiving adalimumab-atto at the time of the survey. Consented participants were queried on adalimumab-atto safety and effectiveness, cost, product preference, and education received for the switch. Descriptive statistics were used to depict responses.Results: Of the 250 patients contacted, 154 participants completed the survey. Respondents (77.9%) reported no concerns with loss of disease control, potential side effects (67.9%), or cost (89.5%) after switching. About 28.7% reported a preference for adalimumab-atto, while 39.3% reported no preference between products. About 43.7% reported being satisfied/very satisfied with the education they received, while 65.1% stated they did not feel they knew enough about adalimumab-atto.Conclusions: There was widespread satisfaction with adalimumab-atto after switching from RP adalimumab. Nevertheless, participants reported limited knowledge of adalimumab-atto, suggesting a need for enhanced education on biosimilars.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-4"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751774","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

Safety and effectiveness of efgartigimod for intravenous infusion in patients with generalized myasthenia gravis: an interim analysis of Japanese post-marketing surveillance. 静脉输注艾夫加替莫德治疗广泛性重症肌无力的安全性和有效性：日本上市后监测的中期分析

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub Date: 2025-04-09 DOI: 10.1080/14712598.2025.2490063

Hirofumi Teranishi, Koichi Tsuda, Rumiko Kanzaki, Tomoyo Hayashi, Daisuke Harada

{"title":"Safety and effectiveness of efgartigimod for intravenous infusion in patients with generalized myasthenia gravis: an interim analysis of Japanese post-marketing surveillance.","authors":"Hirofumi Teranishi, Koichi Tsuda, Rumiko Kanzaki, Tomoyo Hayashi, Daisuke Harada","doi":"10.1080/14712598.2025.2490063","DOIUrl":"10.1080/14712598.2025.2490063","url":null,"abstract":"Background: Efgartigimod for intravenous infusion (efgartigimod-IV) is approved in Japan for generalized myasthenia gravis (gMG). Post-marketing surveillance was mandated by regulatory authorities to assess the safety and effectiveness of efgartigimod in patients with gMG.Research design and methods: Patients with gMG who received efgartigimod-IV between May 2022 and September 2023 were registered. The interim analysis data were cutoff in June 2024 and included patients whose institutions agreed to publication.Results: The safety analysis set consisted of 373 patients: 53.35% (n = 199) anti-acetylcholine receptor antibody positive, 14.21% (n = 53) anti-muscle-specific receptor kinase antibody positive, and 31.64% (n = 118) double-seronegative. Adverse drug reaction and serious adverse drug reaction were reported in 21.45% (80/373) and 4.29% (16/373) of patients, respectively. Although six deaths were reported, none of them were related to efgartigimod. The effectiveness analysis set consisted of 246 patients. After three weeks from the first administration, mean score of MG-Activities of Daily Living decreased from 7.5 to 4.4: -3.1 points improvement (standard deviation: 2.95, p < 0.001). No remarkable differences were observed in the response to efgartigimod between the subgroups of patient baseline characteristics, e.g. autoantibody profiles.Conclusions: In real-world settings, efgartigimod-IV was well tolerated and effective in patients with gMG.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-8"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810853","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 : 2025-05-01 Epub Date: 2025-03-23 DOI: 10.1080/14712598.2025.2482663

Ashish Sharma, Se Joon Woo, Baruch D Kuppermann

引用次数: 0

Management of metastatic melanoma with combinations including PD-1 inhibitors. PD-1抑制剂联合治疗转移性黑色素瘤

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub 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":"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":"2025-05-01","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

Incidence of therapy switch in patients with moderate to severe palmoplantar psoriasis treated with anti-IL 17 and anti-IL 23 monoclonal antibodies: a retrospective observational study. 抗il - 17和抗il - 23单克隆抗体治疗中重度掌跖牛皮癣患者的治疗转换发生率：一项回顾性观察研究

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub Date: 2025-03-20 DOI: 10.1080/14712598.2025.2480756

Alessandra Michelucci, Flavia Manzo Margiotta, Filippo Fanetti, Brittany Chittano, Cristian Fidanzi, Salvatore Panduri, Riccardo Morganti, Marco Romanelli, Valentina Dini

{"title":"Incidence of therapy switch in patients with moderate to severe palmoplantar psoriasis treated with anti-IL 17 and anti-IL 23 monoclonal antibodies: a retrospective observational study.","authors":"Alessandra Michelucci, Flavia Manzo Margiotta, Filippo Fanetti, Brittany Chittano, Cristian Fidanzi, Salvatore Panduri, Riccardo Morganti, Marco Romanelli, Valentina Dini","doi":"10.1080/14712598.2025.2480756","DOIUrl":"10.1080/14712598.2025.2480756","url":null,"abstract":"Background: The aim of this study is to confront the effectiveness of anti-IL 17 versus anti-IL 23 mAb in treating palmoplantar psoriasis by comparing the incidence of patients that required a therapy switch to another mAb class. Furthermore, we calculated the mean time intercurrent the beginning therapy with mAbs and the necessity to switch class due to ineffectiveness.Research design and methods: We enrolled 116 patients with moderate to severe palmoplantar psoriasis. Patients with the pustular variant were excluded from this study. We performed statistical analysis to calculate the incidence of therapy switch in anti-IL 17 and anti-IL 23 mAb therapies.Results: The results of both univariate and multivariate statistical analysis demonstrated that patients in therapy with anti-IL 23 mAb have a lower incidence of therapy switch compared to patients in therapy with anti-IL 17 drugs. The median switch time is 105 months. No other significant factors predictive of therapy switch were found.Conclusions: This real-life evidence confirms the reduced necessity of therapy switch in patients with palmoplantar psoriasis treated with anti-IL 23 antibodies, compared to those treated with IL 17 inhibitors.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-6"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663036","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. 用于治疗生态失调相关疾病的微生物群移植和活体生物治疗产品的施用。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-01 Epub 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":"2025-05-01","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