Expert Opinion on Biological Therapy最新文献_第3页

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

Review on recommendations on the use of biologic therapy for the management of moderate-severe psoriasis in Saudi Arabia: an expert opinion. 沙特阿拉伯中重度牛皮癣生物治疗建议综述：专家意见

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-24 DOI: 10.1080/14712598.2025.2495986

Mohammed Fatani, Abdullah Aldugaither, Mufaddal Alaithan, Amaal Alruwaili, Sultan Mubarki, Mohammed Alajlan, Yousef Binamer, Aymen Alharbi, Bedor AlOmari, Issam Hamada

{"title":"Review on recommendations on the use of biologic therapy for the management of moderate-severe psoriasis in Saudi Arabia: an expert opinion.","authors":"Mohammed Fatani, Abdullah Aldugaither, Mufaddal Alaithan, Amaal Alruwaili, Sultan Mubarki, Mohammed Alajlan, Yousef Binamer, Aymen Alharbi, Bedor AlOmari, Issam Hamada","doi":"10.1080/14712598.2025.2495986","DOIUrl":"https://doi.org/10.1080/14712598.2025.2495986","url":null,"abstract":"Introduction: Psoriasis is a chronic inflammatory skin disorder with a significant global burden, impacting patients both physically and psychologically. While its exact etiology remains unclear, genetic predisposition and environmental triggers play key roles.Areas covered: Biologic therapies have revolutionized psoriasis management, offering targeted and effective disease control. However, despite their proven benefits, these treatments remain underutilized, limiting optimal outcomes and contributing to disparities in care. This expert consensus examines current challenges in biologics use and provides evidence-based recommendations for managing moderate-to-severe psoriasis in Saudi Arabia.Expert opinion: Optimizing biologic therapy use is crucial for improving patient outcomes and reducing disease burden. By addressing gaps in clinical practice, this consensus aims to streamline management approaches and reduce treatment disparities in Saudi Arabia.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-8"},"PeriodicalIF":3.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998405","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

Addressing practical challenges with bispecific antibody therapy in multiple myeloma. 解决多发性骨髓瘤双特异性抗体治疗的实际挑战。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-18 DOI: 10.1080/14712598.2025.2495984

Sreeraj Vasudevan, Bhavesh Mohan Lal, Nikhil Vojjala, Meera Mohan

{"title":"Addressing practical challenges with bispecific antibody therapy in multiple myeloma.","authors":"Sreeraj Vasudevan, Bhavesh Mohan Lal, Nikhil Vojjala, Meera Mohan","doi":"10.1080/14712598.2025.2495984","DOIUrl":"https://doi.org/10.1080/14712598.2025.2495984","url":null,"abstract":"Introduction: Bispecific antibodies (bsAbs) have demonstrated impressive standalone effectiveness in relapsed and refractory multiple myeloma, as evidenced by clinical trials and real-world findings. Current clinical studies are investigating these drugs as both monotherapies and in combination treatments for earlier stages of myeloma, including newly diagnosed cases.Areas covered: With many options available in clinical settings, several questions emerge: How can one bsAb be chosen over another? What is the best way to administer bsAbs, including initial step-up and continuous dosing schedules? How can unique toxicities be managed, and what strategies should be used to address disease relapses following bsAb treatment?Expert opinion: Tocilizumab is being investigated in the prevention of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Steroids can be used to safely treat CRS in myeloma patients on bsAb therapy. This may allow a safe outpatient step-up dosing program. Despite improved infection management with intravenous immunoglobulin prophylaxis, infection risks continue as long as patients are on therapy. This indicates alternative strategies like less frequent dosing or finite duration therapy are needed. Optimal management of disease relapse after bsAb therapy and the sequencing of bsAb and chimeric antigen receptor (CAR) T-cell therapies require further investigation.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-7"},"PeriodicalIF":3.6,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980668","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

Psoriasis and cancer: the role of inflammation, immunosuppression, and cancer treatment. 银屑病与癌症的作用：炎症、免疫抑制和癌症治疗。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-04 DOI: 10.1080/14712598.2025.2471093

Manfredo Bruni, Fabio Lobefaro, Cristina Pellegrini, Mirco Mastrangelo, Giulio Gualdi, Maria Esposito, Paolo Antonetti, Paolo De Sanctis, Paolo Amerio, Maria Concetta Fargnoli

{"title":"Psoriasis and cancer: the role of inflammation, immunosuppression, and cancer treatment.","authors":"Manfredo Bruni, Fabio Lobefaro, Cristina Pellegrini, Mirco Mastrangelo, Giulio Gualdi, Maria Esposito, Paolo Antonetti, Paolo De Sanctis, Paolo Amerio, Maria Concetta Fargnoli","doi":"10.1080/14712598.2025.2471093","DOIUrl":"10.1080/14712598.2025.2471093","url":null,"abstract":"Introduction: The relationship between psoriasis, immunomodulatory therapies, and the risk of malignancies is complex and still debated. The scarcity of evidence in this field makes clinicians hesitate to prescribe biological therapies for 'difficult-to-treat' patients.Areas covered: Based on a comprehensive MEDLINE/PUBMED search of articles published up to November 2024, this review synthesizes the current evidence on the association between psoriasis and cancer. This review specifically addresses four key aspects: the overall cancer risk in psoriatic patients, the potential role of cytokines involved in psoriasis pathogenesis in tumor development, the association between biological therapies and the incidence of new malignancies in this population, and the risk of cancer recurrence or progression in patients with a history of malignancy who are treated with biologics.Expert opinion: Biological therapies do not significantly elevate malignancy risk compared to non-biological treatments or the general population. Evidence is also reassuring for patients with prior malignancy, showing no tumor progression or recurrence. These findings support the timely use of biological treatments in 'difficult-to-treat' patients. Regular cancer screenings and risk-factor minimization should always be recommended for psoriatic patients undergoing immunomodulatory therapies. Multidisciplinary management involving oncologists is suggested, particularly for patients with active and advanced oncological disease.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"395-411"},"PeriodicalIF":3.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540680","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