Expert Opinion on Biological Therapy最新文献

Bintrafusp alfa and its unsuccessful development journey towards cervical cancer treatment. Bintrafusp α及其在宫颈癌治疗中的不成功发展历程。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-30 DOI: 10.1080/14712598.2025.2541795

Shin Nishio

引用次数: 0

Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28‑week results of the randomized, double-blind, Phase 3 STELLAR-2 study. ustekinumab生物类似药Bmab 1200与参考ustekinumab治疗中重度斑块性银屑病的疗效和安全性：28周随机、双盲、3期star -2研究结果

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-29 DOI: 10.1080/14712598.2025.2538608

Jacek C Szepietowski, Adam Reich, Steven R Feldman, Grazyna Pulka, Lally Mekokishvili, Nino Tsiskarishvili, Inese Svarca, Airi Poder, Gursharan Singh, Sarika Deodhar, Kuldeep Kumar, Ashwani Marwah, Subramanian Loganathan, Sandeep N Athalye, Elena Wolff-Holz

{"title":"Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28‑week results of the randomized, double-blind, Phase 3 STELLAR-2 study.","authors":"Jacek C Szepietowski, Adam Reich, Steven R Feldman, Grazyna Pulka, Lally Mekokishvili, Nino Tsiskarishvili, Inese Svarca, Airi Poder, Gursharan Singh, Sarika Deodhar, Kuldeep Kumar, Ashwani Marwah, Subramanian Loganathan, Sandeep N Athalye, Elena Wolff-Holz","doi":"10.1080/14712598.2025.2538608","DOIUrl":"10.1080/14712598.2025.2538608","url":null,"abstract":"Background: STELLAR-2 assessed the equivalent efficacy of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Safety, immunogenicity, and pharmacokinetics (PK) were also evaluated.Research design and methods: In this double-blind, parallel-group, Phase 3 study, patients were randomized 1:1 to Bmab 1200 or reference ustekinumab in Treatment Period (TP)1, and at Week 16, those who responded to reference ustekinumab (improvement in Psoriasis Area and Severity Index [PASI] score ≥ 50%) were re-randomized (1:1) to continue reference ustekinumab or switch to Bmab 1200 in TP2. The primary endpoint was the change in PASI from baseline to Week 12. Equivalent efficacy was established if 90% and 95% confidence intervals (CIs) for the treatment difference were within predefined equivalence margins of ± 10% and ± 13%, respectively.Results: Overall, 384 patients were randomized (Bmab 1200: N = 191; reference ustekinumab: N = 193) in TP1. At Week 12, the least squares mean treatment difference (0.6800%; 90% CI: -1.27, 2.63; 95% CI: -1.64, 3.00) was within the predefined equivalence margins for 90% and 95% CIs. Safety, immunogenicity, and PK were comparable between treatment groups.Conclusions: Bmab 1200 and reference ustekinumab had similar efficacy, safety, immunogenicity, and PK in patients with moderate-to-severe plaque psoriasis.Trial registration: www.clinicaltrialsregister.eu identifier is 2021-006668-25; www.clinicaltrials.gov identifier is NCT05335356.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-12"},"PeriodicalIF":4.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706899","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

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-28 DOI: 10.1080/14712598.2025.2540471

Matti Aapro, Peyman Hadji, Daniele Santini, Ralf Schmidmaier, Richard Eastell

{"title":"Biosimilars in osteoporosis treatment: focus on denosumab.","authors":"Matti Aapro, Peyman Hadji, Daniele Santini, Ralf Schmidmaier, Richard Eastell","doi":"10.1080/14712598.2025.2540471","DOIUrl":"https://doi.org/10.1080/14712598.2025.2540471","url":null,"abstract":"Introduction: Osteoporosis is a significant public health issue due to its associated morbidity, mortality, and economic burden. Despite available effective treatments, a treatment gap persists, characterized by delayed diagnosis, undertreatment, and poor adherence. Biosimilars, such as biosimilars for denosumab, offer an opportunity to improve treatment accessibility and affordability for osteoporosis and cancer-related bone loss.Areas covered: This review explores the current treatment challenges in osteoporosis, the potential of denosumab biosimilars in improving access and outcomes, and the necessity of a multidisciplinary, patient-centered approach.Expert opinion: The emergence of biosimilars for denosumab offers an opportunity to enhance accessibility and affordability of osteoporosis treatment, as biosimilars provide effective and economic versions of reference biologic therapies. A multidisciplinary approach is vital in managing osteoporosis, central to which is the patient, whose preferences, values, and lifestyle must guide the treatment plan. Healthcare providers play a crucial role in educating patients, promoting adherence to prescribed treatments, and involving patients in their own care to improve health outcomes.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728966","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 randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis. 一项随机、双盲、平行设计、重复给药、两组、多中心研究，比较denosumab生物类似药AVT03对绝经后骨质疏松症妇女的疗效、安全性、免疫原性和药代动力学特征。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-28 DOI: 10.1080/14712598.2025.2538609

Mamuka Lortkipanidze, Tobie de Villiers, Grzegorz Kania, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Masna Rai, Halimu Haliduola, Hendrik Otto, Abid Sattar, Steffen Leutz, Fausto Berti

{"title":"A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis.","authors":"Mamuka Lortkipanidze, Tobie de Villiers, Grzegorz Kania, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Masna Rai, Halimu Haliduola, Hendrik Otto, Abid Sattar, Steffen Leutz, Fausto Berti","doi":"10.1080/14712598.2025.2538609","DOIUrl":"10.1080/14712598.2025.2538609","url":null,"abstract":"Background: To demonstrate comparative efficacy of AVT03, a proposed denosumab biosimilar, versus reference product (RP) in postmenopausal women with osteoporosis.Research design and methods: Participants received AVT03 or RP; 60 mg subcutaneous on Day 1 and Month 6. At Month 12, AVT03 group received 3rd dose while RP group received either a 3rd dose of RP or a dose of AVT03. Primary endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months and area under the effect curve (AUEC)0-6 months of percent change from baseline (%Cfb) in serum C-terminal telopeptide of type I collagen (sCTX-1). Safety and immunogenicity were evaluated.Results: The 95% confidence interval (CI)s of the least squares means difference between treatments for percent change from baseline in lumbar spine BMD to Month 12 (-0.58, 0.82) were entirely contained within the prespecified margin (-1.45%, 1.45%), supporting demonstration of comparative efficacy. The 95% CIs of the geometric mean ratio between treatments for AUEC0-6 months of %Cfb sCTX-1 (0.97, 1.03) were entirely contained within the prespecified margin (0.80, 1.25), supporting demonstration of pharmacodynamic similarity. Safety and immunogenicity profiles were comparable throughout.Conclusion: Data supported demonstration of comparative efficacy between AVT03 and RP denosumab. Safety and immunogenicity profiles were similar.Trial registration: www.clinicaltrials.gov identifier is NCT05395091.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":4.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144689617","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

Advanced therapies targeting IL-23: clinical outcomes in ulcerative colitis. 靶向IL-23的先进疗法：溃疡性结肠炎的临床结果。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-23 DOI: 10.1080/14712598.2025.2539423

Silvia Salvatori, Irene Marafini, Antonio Fonsi, Giovanni Monteleone

{"title":"Advanced therapies targeting IL-23: clinical outcomes in ulcerative colitis.","authors":"Silvia Salvatori, Irene Marafini, Antonio Fonsi, Giovanni Monteleone","doi":"10.1080/14712598.2025.2539423","DOIUrl":"https://doi.org/10.1080/14712598.2025.2539423","url":null,"abstract":"Introduction: Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by a relapsing-remitting colonic inflammation. Despite advances in understanding UC pathogenesis, a definitive cure remains elusive. Current therapies aim to promote symptom resolution, mucosal healing, and ideally histologic remission. Moderate-to-severe UC patients may require advanced therapies, including biologics and small molecules, targeting pathways that have been implicated in the UC pathogenesis.Areas covered: This review provides an in-depth analysis of current and emerging therapies targeting the interleukin (IL)-23 pathway in moderate-to-severe UC. It discusses both ustekinumab, a nonselective IL-12/23p40 blocker, and selective IL-23p19 inhibitors (i.e. mirikizumab, guselkumab, and risankizumab), covering their mechanisms of action, clinical efficacy, and safety profiles from registrative and post-marketing studies. The review also explores promising oral therapies under investigation, including IL-23 receptor (IL-23 R) antagonists and TYK2 inhibitors, highlighting their early-phase results.Expert opinion: IL-23p19 inhibitors have shown significant efficacy in inducing and maintaining remission in UC, with favorable safety profiles. Oral agents represent an exciting frontier, potentially improving patient adherence and accessibility. Direct comparative trials are needed to refine therapeutic positioning in personalized treatment algorithms.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144697955","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

Progress in the use of type I interferon blockade in systemic lupus erythematosus. I型干扰素阻断治疗系统性红斑狼疮的研究进展。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-22 DOI: 10.1080/14712598.2025.2536888

Iolanda Miceli, Eric F Morand, Sarah A Jones

{"title":"Progress in the use of type I interferon blockade in systemic lupus erythematosus.","authors":"Iolanda Miceli, Eric F Morand, Sarah A Jones","doi":"10.1080/14712598.2025.2536888","DOIUrl":"https://doi.org/10.1080/14712598.2025.2536888","url":null,"abstract":"Introduction: The successful clinical trials of the type I interferon (IFN) receptor monoclonal antibody, anifrolumab, have proven the benefit of IFN blockade in systemic lupus erythematosus (SLE), and paved the way for novel therapies targeting this pathway.Areas covered: This review will cover the updated evidence regarding the efficacy and safety of anifrolumab since its positive phase III trial in 2020. In addition, indications of the clinical benefit of emerging IFN-targeting therapies, such as monoclonal antibodies targeting IFN-producing cells and small molecule inhibitors of IFN signaling, currently in phase II/III clinical trials will be discussed.Expert opinion: Evidence from clinical trials and real-world studies have revealed the potential for IFN blockade to reduce disease activity and flares, improve glucocorticoid (GC) tapering and increase the attainment of treat-to-target goals in SLE, including in refractory patients. The efficacy of IFN blockade across different SLE disease manifestations and patient subgroups remains under investigation, as well as the ability of such treatments to reduce end organ damage. Regardless, it is clear that IFN blockade has earned a place as part of the standard of care in SLE. Future studies are needed to define whether IFN blockade moves toward being a first line treatment.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144689618","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

Clinical use of biologics in juvenile idiopathic arthritis: lessons learned from real-world studies. 生物制剂在青少年特发性关节炎中的临床应用：来自现实世界研究的经验教训。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-18 DOI: 10.1080/14712598.2025.2536351

Sıla Atamyıldız Uçar, Betül Sözeri

{"title":"Clinical use of biologics in juvenile idiopathic arthritis: lessons learned from real-world studies.","authors":"Sıla Atamyıldız Uçar, Betül Sözeri","doi":"10.1080/14712598.2025.2536351","DOIUrl":"10.1080/14712598.2025.2536351","url":null,"abstract":"Introduction: This review aims to summarize real-world evidence on the use of biologic therapies in juvenile idiopathic arthritis (JIA), including systemic and non-systemic subtypes, and to explore treatment strategies.Areas covered: The evolving therapeutic landscape of JIA, emphasizing the differential efficacy and safety profiles of biologic agents such as IL-1 and IL-6 inhibitors, TNF inhibitors, secukinumab and abatacept across JIA subtypes. Special attention is given to real-world registry data, observational studies, and cohort analyses evaluating treatment responses, disease remission rates, flare risk after biologic discontinuation, and the effectiveness of biosimilars. Evidence regarding biologic switching strategies and the challenges of treating difficult-to-manage subtypes such as systemic JIA and enthesitis-related arthritis are also addressed.Expert opinion: Earlier use of biologic agents may become more widely accepted, particularly in high-risk JIA subtypes. This shift has the potential to promote earlier remission, reduce long-term joint damage and corticosteroid dependency, and minimize hospitalization and complications. However, this approach must be carefully balanced against increased treatment costs and potential long-term dependence on biologics.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-12"},"PeriodicalIF":3.6,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642111","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

Predicting and overcoming poor patient responses to sublingual immunotherapy for allergic diseases. 预测和克服不良反应的患者舌下免疫治疗过敏性疾病。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-07 DOI: 10.1080/14712598.2025.2531035

Maria Angela Tosca, Chiara Ferrecchi, Talia D'ambrosio, Matteo Naso, Chiara Trincianti, Mattia Giovannini, Giorgio Ciprandi

{"title":"Predicting and overcoming poor patient responses to sublingual immunotherapy for allergic diseases.","authors":"Maria Angela Tosca, Chiara Ferrecchi, Talia D'ambrosio, Matteo Naso, Chiara Trincianti, Mattia Giovannini, Giorgio Ciprandi","doi":"10.1080/14712598.2025.2531035","DOIUrl":"https://doi.org/10.1080/14712598.2025.2531035","url":null,"abstract":"Introduction: Allergen immunotherapy (AIT) is the only disease-modifying treatment for allergic rhinitis and asthma. Sublingual immunotherapy (SLIT) is commonly used in clinical practice. Although its effectiveness has been proven in randomized controlled trials and real-world studies, poor or no responses may occur in some cases.Area covered: The present review aims to summarize the main possible factors involved in ineffective SLIT treatment, including immunological mechanisms, molecular and diagnostic errors, non-purified extracts, inadequate dosage, and patients' intrinsic and extrinsic characteristics. Possible remedies are also reported to predict and overcome poor patient response to guarantee optimal treatment efficacy.Expert opinion: Identifying the reason for SLIT ineffectiveness is clinically relevant. Allergologists should carefully investigate the possible cause of poor or no response to SLIT. Identification is important as the potential removal of the interfering problems might allow SLIT to continue. The most common causes of poor SLIT efficacy include diagnostic errors, incorrect allergen dosage and schedule, poor quality extract, comorbidity, impaired immune system function, and inadequate adherence.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144575050","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

Comparative efficacy, safety and immunogenicity of biosimilars and their reference biologic drugs in ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials. 强直性脊柱炎生物仿制药及其参比生物药物的比较疗效、安全性和免疫原性：随机对照试验的系统回顾和荟萃分析。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-29 DOI: 10.1080/14712598.2025.2512126

Chin Hang Yiu, Chung Hin Or, Khalid Almutairi, Jacques Raubenheimer, Richard O Day, Christine Y Lu

{"title":"Comparative efficacy, safety and immunogenicity of biosimilars and their reference biologic drugs in ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials.","authors":"Chin Hang Yiu, Chung Hin Or, Khalid Almutairi, Jacques Raubenheimer, Richard O Day, Christine Y Lu","doi":"10.1080/14712598.2025.2512126","DOIUrl":"10.1080/14712598.2025.2512126","url":null,"abstract":"Introduction: This systematic review and meta-analysis aimed to compare the efficacy, safety, and immunogenicity of biosimilars and reference biologics (adalimumab, etanercept, infliximab) in the treatment of ankylosing spondylitis (AS).Methods: We conducted a systematic search of four electronic databases through 6 January 2025, supplemented by trial registry searches for unpublished trials. We included head-to-head randomized controlled trials (RCTs) that compared biosimilars with reference biologics in patients with AS. Effect measures were summarized using random-effects meta-analysis, and the risk of bias was assessed using the Cochrane RoB 2 tool. The overall certainty of evidence was assessed using the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) system.Results: Six head-to-head RCTs (2,107 participants) were included. Biosimilars demonstrated similar efficacy to reference biologics in achieving ASAS20 (risk ratio [RR] 1.01, 95% confidence interval [CI] 0.96-1.07) and ASAS40 (RR 1.00, 95% CI 0.94-1.05) responses. No significant differences were observed in other efficacy (e.g. disease activity indices), safety (e.g. adverse events), or immunogenicity outcomes (e.g. anti-drug antibodies). Sensitivity and subgroup analyses confirmed the robustness of these findings.Conclusions: This study provides evidence supporting the clinical equivalence of biosimilars to reference biologics in AS treatment, reinforcing their potential as safe and effective alternatives.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024528886.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"761-771"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141776","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

The potential of factor XII inhibitors in preventing hereditary angioedema attacks. 因子XII抑制剂在预防遗传性血管性水肿发作中的潜力。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-26 DOI: 10.1080/14712598.2025.2512128

James K Y Hooi, Jane C Y Wong, Philip H Li

{"title":"The potential of factor XII inhibitors in preventing hereditary angioedema attacks.","authors":"James K Y Hooi, Jane C Y Wong, Philip H Li","doi":"10.1080/14712598.2025.2512128","DOIUrl":"10.1080/14712598.2025.2512128","url":null,"abstract":"Introduction: Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of subcutaneous and/or submucosal swelling (angioedema). Current HAE-specific medications primarily focus on either inhibiting plasma bradykinin or kallikrein, or replacing C1-esterase inhibitor, but they are frequently limited in efficacy and accessibility. In contrast, Factor XII (FXII) inhibitors may provide a novel therapeutic approach by targeting the contact system at an upstream level, potentially addressing some of these limitations.Areas covered: This review explores the role of FXII in HAE and assesses FXII inhibition as a promising prophylactic treatment strategy. By synthesizing findings from both preclinical and clinical studies and real-world observational studies, the review highlights the efficacy, safety, and practical benefits of FXII inhibitors, such as garadacimab.Expert opinion: FXII inhibition represents a promising new strategy for HAE management and may address current unmet needs in prophylactic therapies. The early experiences of garadacimab highlights FXII as a viable and druggable target, paving the way for broader applications in bradykinin-mediated disorders. Despite its potential, uncertainties remain regarding long-term safety, cost, and accessibility. Future research will help redefine the role of FXII inhibition in advancing personalized care and improving the quality of life for patients with HAE.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"703-710"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136140","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