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

Long-term effectiveness and safety of ustekinumab in patients with Crohn's disease: real-world evidence. ustekinumab治疗克罗恩病患者的长期有效性和安全性：真实世界证据

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-09-01 Epub Date: 2025-09-04 DOI: 10.1080/14712598.2025.2556909

Yumei Wu, Linlin Zhou, Mengqi Huang, Chengcheng Tian, Yu Wang, Qiming Huang, Jing Hu, Qiuyuan Liu, Juan Wu, Peipei Zhang, Qiao Mei, Wei Han

{"title":"Long-term effectiveness and safety of ustekinumab in patients with Crohn's disease: real-world evidence.","authors":"Yumei Wu, Linlin Zhou, Mengqi Huang, Chengcheng Tian, Yu Wang, Qiming Huang, Jing Hu, Qiuyuan Liu, Juan Wu, Peipei Zhang, Qiao Mei, Wei Han","doi":"10.1080/14712598.2025.2556909","DOIUrl":"10.1080/14712598.2025.2556909","url":null,"abstract":"Background: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist approved for the treatment of Crohn's disease (CD). Although UST has demonstrated good efficacy and safety in CD, long-term real-world data in Chinese patients are relatively scarce.Methods: A single-center, observational retrospective study was conducted in the First Affiliated Hospital of Anhui Medical University. Comprehensive baseline demographic characteristics, clinical parameters, potential predictors of clinical remission of CD patients treated with UST from January 2020 to January 2024 were collected and analyzed.Results: A total of 348 CD patients were included. At week 52, the clinical remission rate was 70.95%, endoscopic remission 24.68%, C-Reactive Protein (CRP) normalization 54.11%, and fecal calprotectin (FCP) normalization 48.57%. Prior biologic exposure, CRP reduction at week 8, and baseline hemoglobin level were independent predictors of clinical remission. The mean survival duration with UST was 172 weeks (SE = 6, 95% CI: 160-185).Conclusions: This study demonstrated favorable effectiveness, persistence, and safety of UST in CD patients. Prior biologic exposure, early CRP reduction and hemoglobin level were associated with clinical remission at 52 weeks.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1035-1046"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144948053","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

Personalized therapy in metastatic colorectal cancer: biomarker-driven use of biologics. 转移性结直肠癌的个体化治疗：生物标志物驱动的生物制剂应用。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-09-01 Epub Date: 2025-09-21 DOI: 10.1080/14712598.2025.2556911

Francesco Sullo, Chiara Gallio, Laura Matteucci, Alessandro Bittoni, Margherita Muratore, Luca Esposito, Bianca Ceredi, Graziana Gallo, Paola Ulivi, Ilario Giovanni Rapposelli, Alessandro Passardi

{"title":"Personalized therapy in metastatic colorectal cancer: biomarker-driven use of biologics.","authors":"Francesco Sullo, Chiara Gallio, Laura Matteucci, Alessandro Bittoni, Margherita Muratore, Luca Esposito, Bianca Ceredi, Graziana Gallo, Paola Ulivi, Ilario Giovanni Rapposelli, Alessandro Passardi","doi":"10.1080/14712598.2025.2556911","DOIUrl":"10.1080/14712598.2025.2556911","url":null,"abstract":"Introduction: Metastatic colorectal cancer (mCRC) remains a leading cause of cancer mortality worldwide, with limited long-term survival despite therapeutic advances. The increasing understanding of its molecular heterogeneity has paved the way for precision medicine approaches aiming to optimize treatment efficacy and reduce unnecessary toxicity.Areas covered: This review provides an in-depth analysis of the current and emerging molecular targets in mCRC, including RAS, BRAF, HER2, and microsatellite instability. We discuss the clinical relevance of tumor sidedness, hyperselection panels, EGFR ligand expression, and rare alterations such as NTRK, RET, and ALK fusions. The review also explores the evolving role of KRAS G12C inhibitors, HER2-targeted therapies, and the application of liquid biopsy - particularly circulating tumor DNA (ctDNA) - in treatment monitoring, rechallenge strategies, and resistance detection. Literature was selected through a comprehensive review of recent clinical trials, consensus guidelines, and translational studies.Expert opinion: Personalized treatment is now an attainable goal in mCRC. While promising, broader implementation of molecular-driven strategies requires overcoming challenges such as resistance mechanisms, assay standardization, and equitable access. The integration of innovative agents with real-time molecular monitoring holds the key to a more dynamic and effective management of mCRC.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"947-965"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144992021","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 zanidatamab, a novel, anti-HER2 biparatopic antibody, for the treatment of biliary tract cancer. 一种新型抗her2双异位抗体zanidatamab用于胆道癌治疗的评估。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-09-01 Epub Date: 2025-09-06 DOI: 10.1080/14712598.2025.2556903

Jeesun Yoon, Do-Youn Oh

{"title":"An evaluation of zanidatamab, a novel, anti-HER2 biparatopic antibody, for the treatment of biliary tract cancer.","authors":"Jeesun Yoon, Do-Youn Oh","doi":"10.1080/14712598.2025.2556903","DOIUrl":"10.1080/14712598.2025.2556903","url":null,"abstract":"Introduction: Zanidatamab is a humanized biparatopic IgG antibody that selectively inhibits HER2 signaling pathway by targeting two distinct epitopes in the extracellular domains II and IV of HER2. Zanidatamab received accelerated approval from the United States Food and Drug Administration for the treatment of HER2-positive (immunohistochemistry [IHC] 3+) biliary tract cancer (BTC) in November 2024. Additionally, zanidatamab received approval for the treatment of HER2 IHC 3+ BTC from the European Medicines Agency in June 2025, and from National Medical Products Administration of China in May 2025.Areas covered: We review the currently available advanced BTC treatments from the perspective of targeted therapy, discuss the implications of HER2 as a therapeutic target in BTC, and discuss the available clinical trial data for zanidatamab for BTC treatment. We then comment on how zanidatamab can fit into the current standard of care for advanced BTC treatment, and the directions of future development strategies.Expert opinion: Zanidatamab appears to be effective for controlling disease progression and maintaining a durable response in patients with previously-treated unresectable or metastatic HER2-positive BTC, with acceptable safety profiles. Based on these favorable data, further investigations using zanidatamab as an earlier line of therapy for BTC are ongoing.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"935-946"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144948027","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

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 : 2025-08-01 Epub 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":"913-924"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","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

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 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-08-01 Epub Date: 2025-09-18 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":"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.Areas 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":"821-833"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","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

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 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-08-01 Epub 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":"835-846"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","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

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 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-08-01 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":"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":"873-885"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","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

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 : 2025-08-01 Epub Date: 2025-07-30 DOI: 10.1080/14712598.2025.2541795

Shin Nishio

引用次数: 0

Treatment progress of inherited epidermolysis bullosa. 遗传性大疱性表皮松解症的治疗进展。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-30 DOI: 10.1080/14712598.2025.2525860

Wen-Ming Wang, Hao Feng, Qian-Nan Jia, Hong-Zhong Jin

引用次数: 0

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-08-01 Epub Date: 2025-08-07 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":"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":"887-898"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","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