Expert Opinion on Biological Therapy最新文献

The potential role of biosimilars in healthcare sustainability in Latin America. 生物仿制药在拉丁美洲医疗保健可持续性方面的潜在作用。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-29 DOI: 10.1080/14712598.2025.2507173

Rony Schaffel, Paul Cornes, Manuel A Espinoza, David Gómez-Almaguer, Angelo Maiolino, Daniel Freire, Tobias Foierl

{"title":"The potential role of biosimilars in healthcare sustainability in Latin America.","authors":"Rony Schaffel, Paul Cornes, Manuel A Espinoza, David Gómez-Almaguer, Angelo Maiolino, Daniel Freire, Tobias Foierl","doi":"10.1080/14712598.2025.2507173","DOIUrl":"10.1080/14712598.2025.2507173","url":null,"abstract":"Introduction: Latin American (LatAm) countries face significant increases in healthcare expenditure, driven largely by population growth and aging, and the rising prevalence of cancer and other chronic diseases. Growing demand and high costs of biologic medicines present barriers to patient access in this region. Biosimilars can improve the affordability and accessibility of biologics, supporting long-term healthcare sustainability. However, their uptake in LatAm has generally been slow.Areas covered: Challenges and barriers to the use of biosimilars and potential strategies to increase biosimilar uptake in LatAm, drawing on learnings from Europe and the U.S.A.Expert opinion: Potential initiatives to drive biosimilar uptake across LatAm include (1) harmonized regulatory processes for biosimilars, with reimbursement policies that prioritize their use and incentives to encourage prescribing; (2) education for key stakeholders to limit misinformation about biosimilars, provide reassurance about safety and efficacy, and increase understanding and acceptance; (3) simplified health technology assessment processes for biosimilars that expedite or adapt some aspects of the traditional approach; and (4) coordinated regional efforts to enable national healthcare systems to purchase medicines in the most cost-effective way, with value frameworks to support decision-making and the implementation of centralized purchasing, competition policies, and risk-sharing agreements.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-15"},"PeriodicalIF":3.6,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075926","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

Comparing the noninfectious adverse effects of two rabbit anti-thymocyte globulin immunosuppression in kidney transplantation: a multicenter, retrospective study. 比较两种兔抗胸腺细胞球蛋白免疫抑制在肾移植中的非感染性不良反应：一项多中心、回顾性研究。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-29 DOI: 10.1080/14712598.2025.2512127

Mojtaba Shafiekhani, Ayda Esmaeili, Fatemeh-Sadat Emami, Kazem Heidari, Niloufar Saberi Moghadam, Shirinsadat Badri, Leila Kouti, Amir Hooshang Mohammadpour, Hadi Hamishehkar, Afshin Gharekhani, Maryam Amini-Pouya, Negin Zare, Fatemeh Abdoli, Mohammad Amin Jafarzadeh, Simin Dashti-Khavidaki

{"title":"Comparing the noninfectious adverse effects of two rabbit anti-thymocyte globulin immunosuppression in kidney transplantation: a multicenter, retrospective study.","authors":"Mojtaba Shafiekhani, Ayda Esmaeili, Fatemeh-Sadat Emami, Kazem Heidari, Niloufar Saberi Moghadam, Shirinsadat Badri, Leila Kouti, Amir Hooshang Mohammadpour, Hadi Hamishehkar, Afshin Gharekhani, Maryam Amini-Pouya, Negin Zare, Fatemeh Abdoli, Mohammad Amin Jafarzadeh, Simin Dashti-Khavidaki","doi":"10.1080/14712598.2025.2512127","DOIUrl":"https://doi.org/10.1080/14712598.2025.2512127","url":null,"abstract":"Background: Rabbit anti-thymocyte globulin (rATG) is widely used for induction immunosuppression in kidney transplantation; however, its administration carries some adverse effects. This study aimed to detect the incidence of thromboembolic events (TEEs) after kidney transplantation and the causality relationship between these events and rATG administration as induction therapy.Methods: This multicenter retrospective study included 654 kidney recipients from six Iranian centers receiving [Thymoglobulin® (rATG-A) or TGlobulin25™ or (rATG-B)]. Outcomes included TEEs within 30 days post-transplant, hematologic adverse effects, and graft-related outcomes. Risk factors were analyzed using multivariable regression.Results: TEEs occurred in 4.9% of patients, with no significant difference between rATG-A (4.0%) and rATG-B (5.9%) (p = 0.26). Independent risk factors included peripheral rATG infusion without heparin (p < 0.001), preexisting thromboembolic risk conditions (p < 0.001), cytomegalovirus (CMV) infection (p = 0.01), and recipient age >40 years (p = 0.02). No inter-band difference in thromboembolic risk was observed (odds ratio = 1.63, 95% confidence interval 0.71-3.76). Delayed graft function, rejection, mortality, and nephrectomy rates showed no inter-group differences.Conclusion: TEEs happened in about 5% of the patients. Peripheral administration of rATG without adding heparin, history of underlying diseases predisposing to TEEs, CMV infection, and recipient age over 40 years were found as risk factors for the occurrence of TEEs.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-8"},"PeriodicalIF":3.6,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173362","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 : 2025-05-26 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":"https://doi.org/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":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-26","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 : 2025-05-26 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":"1-8"},"PeriodicalIF":3.6,"publicationDate":"2025-05-26","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

Evolving global regulatory landscape for approval of biosimilars: current challenges and opportunities for convergence. 生物仿制药批准的全球监管格局的演变：当前的挑战和趋同的机遇。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-26 DOI: 10.1080/14712598.2025.2507832

Elif Car, Liese Barbier, Isabelle Huys, Steven Simoens, Arnold G Vulto

{"title":"Evolving global regulatory landscape for approval of biosimilars: current challenges and opportunities for convergence.","authors":"Elif Car, Liese Barbier, Isabelle Huys, Steven Simoens, Arnold G Vulto","doi":"10.1080/14712598.2025.2507832","DOIUrl":"https://doi.org/10.1080/14712598.2025.2507832","url":null,"abstract":"Introduction: Biosimilars promote price competition, improving affordability and access to biologics without compromising on quality, efficacy, and safety. Biosimilar approvals initially followed a cautious approach, with regulatory requirements developed independently across jurisdictions, complicating global development and increasing costs. Advancements in analytical sciences and two decades of accumulated experience with biosimilar approvals offer an opportunity to reevaluate regulatory requirements.Areas covered: A structured literature review was conducted using PubMed, Embase, and Web of Science, to identify challenges related to biosimilarity demonstration, offer a comprehensive understanding of regulatory requirements for biosimilars globally, and identify opportunities for regulatory convergence. Following title, abstract and full-text screening, 61 articles were included.Expert opinion: Biosimilar guidelines from stringent regulatory authorities such as EMA and USFDA are robust, yet further alignment of regulatory standards in the US and EU is possible to reflect scientific progress and clinical experience. Regulatory requirements for biosimilars in emerging markets appear to be disproportionate to scientific advancements and accumulated knowledge with biosimilars approval and clinical experience. Global harmonization of biosimilar guidelines, based on gained developments and regulatory experience, could accelerate development and approval process. This would facilitate earlier and enhanced access to safe and affordable biologics.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141875","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 'totality of evidence' and 'extrapolation' of SB17, a ustekinumab biosimilar. ustekinumab生物仿制药SB17的“证据总体”和“外推”。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-25 DOI: 10.1080/14712598.2025.2508838

Jae Hee Cheon, Byong Duk Ye, Alessandro Armuzzi, Florian Rieder, Giampiero Girolomoni, Luis Puig, Hojung Jung, Steven R Feldman

{"title":"The 'totality of evidence' and 'extrapolation' of SB17, a ustekinumab biosimilar.","authors":"Jae Hee Cheon, Byong Duk Ye, Alessandro Armuzzi, Florian Rieder, Giampiero Girolomoni, Luis Puig, Hojung Jung, Steven R Feldman","doi":"10.1080/14712598.2025.2508838","DOIUrl":"10.1080/14712598.2025.2508838","url":null,"abstract":"Introduction: SB17 is a ustekinumab (UST) biosimilar targeting interleukin-12/23 for treating immune-mediated inflammatory diseases (IMIDs). The development of UST biosimilars like SB17 may help address the high cost of innovator biologics, offering affordable alternatives without compromising efficacy or safety.Areas covered: This review encompasses the totality of evidence supporting SB17's similarity to UST, its regulatory approval, and indication extrapolation. It also discusses SB17's lower immunogenicity relative to UST.Expert opinion: The approval of UST biosimilars represents a significant advancement in managing chronic IMIDs including psoriasis, plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, providing cost-effective, efficacious alternatives. A randomized double-blind 28-week study involving over 500 patients with moderate-to-severe chronic plaque psoriasis demonstrated SB17's equivalence to UST, with more than 80% of patients achieving over 90% improvement in psoriasis severity indices. Treatment-emergent adverse events were comparable between SB17 and UST. Despite their potential to transform clinical outcomes, economic burdens, and drug utilization patterns, the adoption of UST biosimilars faces challenges, including concerns about equivalence and regulatory inconsistencies. Addressing these issues through education, consistent regulatory frameworks, real-world data, and ongoing monitoring is crucial for their successful integration into clinical practice.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-18"},"PeriodicalIF":3.6,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110248","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 evolocumab in statin-treated patients with cardiovascular risk factors: a systematic review and meta-analysis. evolocumab在他汀类药物治疗的心血管危险因素患者中的疗效和安全性：一项系统回顾和荟萃分析

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-24 DOI: 10.1080/14712598.2025.2511063

Mayank Jha, Siddharth Pravin Agrawal, Darshilkumar Maheta, Priyadarshini Bhattacharjee, Hritvik Jain, Jerome Zacks, William H Frishman, Wilbert S Aronow

{"title":"Efficacy and safety of evolocumab in statin-treated patients with cardiovascular risk factors: a systematic review and meta-analysis.","authors":"Mayank Jha, Siddharth Pravin Agrawal, Darshilkumar Maheta, Priyadarshini Bhattacharjee, Hritvik Jain, Jerome Zacks, William H Frishman, Wilbert S Aronow","doi":"10.1080/14712598.2025.2511063","DOIUrl":"10.1080/14712598.2025.2511063","url":null,"abstract":"Introduction: This systematic review and meta-analysis evaluated the lipid-lowering efficacy and safety of evolocumab in statin-treated patients at high cardiovascular risk, focusing on changes in LDL-C, TG, ApoB, HDL-C, and Lp(a) after 12 weeks.Methods: A comprehensive search identified randomized controlled trials comparing evolocumab to placebo in adults on statin therapy. Studies reporting baseline and 12-week lipid and safety data were included. Risk of bias was assessed using the Cochrane tool. Random-effects models were used to calculate mean differences (MD) or odds ratios (OR) with 95% confidence intervals (CI).Results: Five trials with 4,009 participants were analyzed. Evolocumab significantly reduced LDL-C (MD: -64.67; 95% CI: -66.72 to -62.61), TG, ApoB, and Lp(a), and increased HDL-C. No significant difference was observed in total TEAEs (OR: 0.97; 95% CI: 0.84 to 1.14) or serious TEAEs (OR: 1.23; 95% CI: 0.80 to 1.89) versus placebo.Conclusions: Evolocumab offers robust lipid-lowering benefits with a safety profile comparable to placebo in statin-treated patients. Limitations include short follow-up and variable statin regimens. Further long-term studies are needed to confirm cardiovascular outcome benefits.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024543525.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-11"},"PeriodicalIF":3.6,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144127042","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 recaticimab for the treatment of hypercholesterolemia. recaticimab治疗高胆固醇血症的评价。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-22 DOI: 10.1080/14712598.2025.2508837

Xuan L Tang, Amanda J Hooper, John R Burnett

{"title":"An evaluation of recaticimab for the treatment of hypercholesterolemia.","authors":"Xuan L Tang, Amanda J Hooper, John R Burnett","doi":"10.1080/14712598.2025.2508837","DOIUrl":"10.1080/14712598.2025.2508837","url":null,"abstract":"Introduction: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, by preventing the degradation of LDL receptors, either through interference in the binding of PCSK9 to LDL receptors or through silencing of PCSK9 at a molecular level, have revolutionized lipid-lowering treatment and offer the opportunity to further improve clinical outcomes for patients with hypercholesterolemia.Areas covered: We discuss the role of PCSK9 as a therapeutic target for hypercholesterolemia, describe the pharmacodynamics, pharmacokinetics, and metabolism of recaticimab, and report the recent clinical trials with this 'humanized' IgG1 monoclonal antibody (mAb) against PCSK9.Expert opinion: Recaticimab has a high affinity for PCSK9 that confers a prolonged duration of action. Recaticimab durably decreases LDL-cholesterol, non-HDL-cholesterol and apoB, but can also lower Lp(a). Recaticimab may offer advantages over current mAbs in clinical use in terms of its long half-life, dosing interval of up to 12 weeks, and potentially a lower cost; however, long-term concerns regarding immunogenicity remain. Longer-term studies in a variety of more diverse patient cohorts will be needed to further evaluate the efficacy, safety, and durability of recaticimab and to ascertain the optimal dosing schedule for cardiovascular outcome studies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-6"},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086013","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 patritumab deruxtecan for the treatment of EGFR-mutated non-small cell lung cancer. patritumab deruxtecan治疗egfr突变的非小细胞肺癌的评估。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-22 DOI: 10.1080/14712598.2025.2507833

Barliz Waissengrin, Karen L Reckamp

{"title":"An evaluation of patritumab deruxtecan for the treatment of EGFR-mutated non-small cell lung cancer.","authors":"Barliz Waissengrin, Karen L Reckamp","doi":"10.1080/14712598.2025.2507833","DOIUrl":"10.1080/14712598.2025.2507833","url":null,"abstract":"Introduction: Epidermal growth factor receptor (EGFR) mutations represent targetable alterations in non-small cell lung cancer (NSCLC). The treatment landscape in the frontline setting for patients with advanced EGFR-mutated NSCLC is evolving with increasing treatment options. EGFR tyrosine kinase inhibitors (TKIs) have significantly improved outcomes, but resistance inevitably develops, necessitating alternative strategies.Areas covered: Patritumab deruxtecan is a novel antibody-drug conjugate targeted human epidermal growth factor receptor-3 (HER3), delivering a topoisomerase-I inhibitor payload to HER3-expressing cancer cells. Phase I and II studies have demonstrated efficacy in patients with EGFR-mutant NSCLC with disease progression after prior therapies, including third-generation EGFR TKIs and platinum-based chemotherapy. The phase-II trial reported an objective response rate of 39% and a median progression-free survival of 5.5 months. Patritumab deruxtecan is associated with notable toxicities, including grade 3 and higher hematologic adverse events, gastrointestinal toxicity, and interstitial lung disease (ILD). ILD occurred in 5.3% of patients in the Phase-II study. Early detection and management are crucial for minimizing the risk of complications.Expert opinion: Patients with advanced EGFR-mutant NSCLC who have received TKI therapy and chemotherapy have limited treatment options. Patritumab deruxtecan demonstrates clinical activity in this population with manageable side effects, addressing an unmet need for patients.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-9"},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076898","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

With guselkumab, does the dual mechanisms to inhibit IL-23, help in ulcerative colitis? 使用guselkumab，抑制IL-23的双重机制是否有助于溃疡性结肠炎？

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2025-05-21 DOI: 10.1080/14712598.2025.2508836

Sheila A Doggrell

{"title":"With guselkumab, does the dual mechanisms to inhibit IL-23, help in ulcerative colitis?","authors":"Sheila A Doggrell","doi":"10.1080/14712598.2025.2508836","DOIUrl":"10.1080/14712598.2025.2508836","url":null,"abstract":"Introduction: Ulcerative colitis (UC) includes a dysregulated immune response. The conventional therapy includes immunosuppressants, and biologics targeting inflammatory mediators, but these are often inadequate, or subjects become unable to tolerate them.Areas covered: QUASAR: the induction and maintenance components of the phase 3 trial of guselkumab, which inhibits IL-23 by dual mechanisms, in subjects with moderate-to-severe UC. QUASAR enrolled those that had an inadequate response and/or intolerance to corticosteroids, immunosuppressants, biologics, or Janus kinase (JAK) inhibitors. In both parts of the trial, guselkumab improved clinical remission with no excess of adverse events.Expert opinion: For those enrolled throughout, after the maintenance part, the benefit with guselkumab on clinical remission was 24% percentage points (45 vs 21%), which is relatively small. There is no direct comparison of guselkumab with other IL-23 inhibitors in UC. Indirectly comparing trials suggests the clinical remission rates at the end of the trials was higher with guselkumab than with the other approved IL-23, inhibitors, mirikizumab or risankizumab (17 or 15% points, respectively). Thus, guselkumab may be more efficacious than the other 1 L-23 antagonists, possibly due to its additional action to block the CD64 receptor. However, this needs to be tested in a direct comparison trial.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-6"},"PeriodicalIF":3.6,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110251","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