{"title":"An evaluation of nipocalimab for the treatment of generalized myasthenia gravis.","authors":"Carlo Antozzi, Marie Fitzgibbon","doi":"10.1080/14712598.2025.2561935","DOIUrl":"10.1080/14712598.2025.2561935","url":null,"abstract":"<p><strong>Introduction: </strong>Myasthenia gravis (MG) is an autoimmune disease caused by autoantibodies targeting the neuromuscular junction. MG, characterized clinically by fluctuating muscle weakness and fatigability, is traditionally treated primarily with corticosteroids and nonspecific immunosuppressive drugs. Despite their documented efficacy in a proportion of patients, current standard-of-care treatments are associated with moderate-to-severe side effects that underline the need for new targeted therapies. Nipocalimab, a fully human monoclonal antibody, binds to the neonatal Fc receptor (FcRn) with high affinity and specificity, causing selective reduction of circulating IgG and pathogenic IgG autoantibodies. The phase 3 study Vivacity-MG3 confirmed nipocalimab as an efficacious and safe treatment providing sustained disease control in seropositive patients with generalized MG (gMG).</p><p><strong>Areas covered: </strong>The efficacy and safety of nipocalimab in gMG from the phase 2 study Vivacity-MG (NCT03772587) and the phase 3 study Vivacity-MG3 (NCT04951622).</p><p><strong>Expert opinion: </strong>Clinical studies have demonstrated that nipocalimab provided rapid and sustained reduction of total IgG and pathogenic IgG autoantibodies together with sustained disease control over 6 months in a broad population of seropositive patients with gMG, with an acceptable safety profile. The long-term impact of nipocalimab on the course of gMG needs to be further investigated in real-world settings.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-12"},"PeriodicalIF":4.0,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184849","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}
{"title":"Efficacy and safety of rituximab in rheumatoid arthritis-associated interstitial lung disease: a systematic review and meta-analysis.","authors":"Mahmoud Ines, Zarrouk Zeineb, Bouden Selma, Saidane Olfa, Rouached Leila, Tekaya Rawdha, Ben Tekaya Aicha, Dziri Chadli, Abdelmoula Leila","doi":"10.1080/14712598.2025.2567868","DOIUrl":"10.1080/14712598.2025.2567868","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the effectiveness and safety of Rituximab (RTX) treatment among patients diagnosed with rheumatoid arthritis-associated interstitial lung disease (RA-ILD).</p><p><strong>Methods: </strong>We performed a systematic review with meta-analysis of studies involving patients with RA-ILD who were treated with RTX. Two investigators independently conducted the research.</p><p><strong>Results: </strong>Twenty studies met the criteria for data extraction for the systematic review with a good quality assessment according to an 18-criteria checklist using a modified Delphi method. The total number of patients was 14,523, including 1,619 who received RTX. Stabilization or improvement was observed in more than half of the patients in all studies. Evaluation based on pulmonary function tests (PFTs) noted disease progression in fewer than 20% of 7 out of 11 studies. Meta-analysis results revealed that, based on PFTs, the proportion of patients showing functional decline was 14.5% (95%CI, 7.6-25.8%) (95%PI, 2-69%); and according to the pulmonary high-resolution computed tomography (HRCT) evaluation, the proportion of worsening was 19.5% (95%CI, 8.1-40%) (95%PI, 1-84%). An overall acceptable safety profile was noted, with respiratory mortality ranging from 4% to 14%.</p><p><strong>Conclusion: </strong>Our review suggests that RTX appears to be an effective therapy in patients with RA-ILD, with a satisfactory safety profile.</p><p><strong>Protocol registration: </strong>https://www.crd.york.ac.uk/prospero identifier is CRD420251049957.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-13"},"PeriodicalIF":4.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148346","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}
Kyoungwan Nam, Taek Sang Kwon, Federico Di Biasio, Jaakko Itkonen, Dongkyu Kim, Anja Tuomioja-Busk, Nicolas Van Gelder, David Woods, Minyoung Jang
{"title":"Perceived benefits and cost savings of liquid formulation of intravenous infliximab: perspectives of seven European countries.","authors":"Kyoungwan Nam, Taek Sang Kwon, Federico Di Biasio, Jaakko Itkonen, Dongkyu Kim, Anja Tuomioja-Busk, Nicolas Van Gelder, David Woods, Minyoung Jang","doi":"10.1080/14712598.2025.2544756","DOIUrl":"10.1080/14712598.2025.2544756","url":null,"abstract":"<p><strong>Background: </strong>Following the approval of intravenous (IV) infliximab (IFX) in the 1990s, Celltrion developed the first monoclonal antibody biosimilar for IV IFX (Remsima®: Celltrion, South Korea), followed by the first and only subcutaneous IFX, (Remsima® SC). A liquid formulation of IV IFX has been developed that eliminates the need for reconstitution and introduces a 350 mg vial size not previously available with the powder formulation. This study evaluated the operational benefits and cost savings of the liquid formulation of IV IFX compared to the powder formulation, from the perspective of healthcare professionals across seven European countries.</p><p><strong>Research design and methods: </strong>Semi-structured interviews were conducted with 21 hospital pharmacists and nurses involved in IV IFX preparation from May to June 2025.</p><p><strong>Results: </strong>Interviewees noted that eliminating reconstitution reduced preparation time by 51% and resource costs by 20% per patient episode compared to the powder formulation, significantly alleviating healthcare professionals' workload.</p><p><strong>Conclusions: </strong>The liquid formulation of IV IFX streamlines preparation, enhances operational efficiency, and reduces costs compared to the powder formulation. These savings allow resource reallocation to patient care, improving cost-effectiveness of IV IFX therapy. Its adoption is expected to optimize healthcare delivery across European healthcare systems.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1017-1024"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793844","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}
Fruzsina Balogh, Dorottya Angyal, Adam Varga, Lorant Gonczi, Livia Lontai, Akos Ilias, Peter L Lakatos
{"title":"Efficacy and safety of biosimilars in gastroenterology: a focus on inflammatory bowel disease management.","authors":"Fruzsina Balogh, Dorottya Angyal, Adam Varga, Lorant Gonczi, Livia Lontai, Akos Ilias, Peter L Lakatos","doi":"10.1080/14712598.2025.2557626","DOIUrl":"10.1080/14712598.2025.2557626","url":null,"abstract":"<p><strong>Introduction: </strong>The introduction of biosimilars changed the management of biologicals in inflammatory bowel disease (IBD) since the approval of CT-P13, the first biosimilar to infliximab, by the European Medicines Agency (EMA) in September 2013 and by the U.S. Food and Drug Administration (FDA) in April 2016. Accumulating evidence in IBD suggests that biosimilar products have equivalent efficacy and safety to reference products and their use was associated with improved access and decrease in medication costs.</p><p><strong>Areas covered: </strong>This review discusses the current evidence on approved biosimilars of infliximab, adalimumab and ustekinumab in IBD. Authors review data on drug sustainability, efficacy, safety, immunogenicity, non-medical switch data and interchangeability of biosimilar agents.</p><p><strong>Expert opinion: </strong>The biosimilar concept seems to be successful and has led to increased use of biological/biosimilar agents in the treatment of IBD. Clinical trials with biosimilars in IBD and evidence from real world studies on infliximab and adalimumab biosimilars confirm that safety, efficacy and immunogenicity is comparable to the originator, and that switching from the originator or among biosimilars is safe. While payers are supporting mandatory biosimilar use, on the long run the price race can lead to obstacles and unaffordability of the development of new originator biological agents.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"967-978"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145000010","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}
Danilo Rocco, Luigi Della Gravara, Cristina Boccia, Cesare Gridelli
{"title":"Neoadjuvant therapy of NSCLC: a review of the use and impact of monoclonal antibodies.","authors":"Danilo Rocco, Luigi Della Gravara, Cristina Boccia, Cesare Gridelli","doi":"10.1080/14712598.2025.2555830","DOIUrl":"10.1080/14712598.2025.2555830","url":null,"abstract":"<p><strong>Introduction: </strong>From the 1960s and up until 2021, neoadjuvant chemotherapy has represented the standard of care for potentially resectable stage III (N2) Non-Small Cell Lung Cancer (NSCLC). However, in recent years, immunotherapy in the form of Immune Checkpoint Inhibitors (ICIs) has revolutionized oncology treatment strategies and several ICIs have been investigated for the neoadjuvant treatment of NSCLC, both in monotherapy and in combination with other ICIs or chemotherapy.</p><p><strong>Areas covered: </strong>Therefore, this paper aims to review the currently available data supporting the role of immunotherapy in the neoadjuvant setting, as well as to discuss the challenges associated with it. We undertook a comprehensive literature search of PubMed, Embase, Cochrane Library, of abstracts and posters from annual meetings of American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), and American Association for Cancer Research (AACR) up until November 2024.</p><p><strong>Expert opinion: </strong>We believe that in the near future ICI plus chemotherapy combinations will represent the new recommended standard of care in the neoadjuvant/perioperative setting. We look forward to the full results coming from the ongoing randomized phase III trials, that will help us guide our choice in terms of patient selection, regimen of choice, and response assessment.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"979-988"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145000040","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}
Miguel Sogbe, Paloma Sangro, Manuel de la Torre-Aláez, Bruno Sangro
{"title":"Tremelimumab for the treatment of hepatocellular carcinoma.","authors":"Miguel Sogbe, Paloma Sangro, Manuel de la Torre-Aláez, Bruno Sangro","doi":"10.1080/14712598.2025.2550711","DOIUrl":"10.1080/14712598.2025.2550711","url":null,"abstract":"<p><strong>Introduction: </strong>Hepatocellular carcinoma (HCC) remains a leading cause of cancer mortality globally. For years, systemic treatment options were limited to tyrosine kinase inhibitors with modest outcomes. The introduction of immunotherapy has transformed the treatment paradigm, establishing immunotherapy as first-line treatment for advanced disease. Among these, tremelimumab -an anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody- is a key therapeutic agent in the evolving management of HCC.</p><p><strong>Areas covered: </strong>This review offers a detailed examination of the pharmacological characteristics of tremelimumab and synthesizes evidence from clinical trials assessing its efficacy and safety as both monotherapy and in combination for HCC. It also explores ongoing studies and future perspectives on the role of tremelimumab across diverse stages in the management of HCC.</p><p><strong>Expert opinion: </strong>Tremelimumab has reshaped the treatment of HCC through its use as a single high-dose priming agent in combination with durvalumab. This approach effectively triggers durable immune responses with a favorable safety profile. Ongoing studies are evaluating its potential in earlier and intermediate stages of HCC, particularly as part of neoadjuvant and conversion therapy strategies. However, the lack of predictive biomarkers specific to tremelimumab remains a key limitation. Future research should focus on identifying patients most likely to benefit from tremelimumab-based combinations.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"925-934"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144948013","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}
{"title":"Treatment sequences in moderate-to-severe psoriasis: a hospital-based retrospective analysis.","authors":"Angela Boccia, Valentina Giunchi, Luca Girau, Carlotta Lunghi, Michelangelo La Placa, Federico Bardazzi, Elisabetta Poluzzi","doi":"10.1080/14712598.2025.2542508","DOIUrl":"10.1080/14712598.2025.2542508","url":null,"abstract":"<p><strong>Background: </strong>For moderate-to-severe psoriasis, clinical guidelines recommend biologic treatments after failure of at least one traditional systemic therapy. Biologics target different pathways, but a common challenge is loss of efficacy, often requiring a switch. This study explores real-world therapeutic management of moderate-to-severe psoriasis, focusing on biologic treatments.</p><p><strong>Methods: </strong>A retrospective study was conducted using health records of adult patients currently receiving biologics at Sant'Orsola Hospital in Bologna. Therapeutic sequences were investigated using state sequence analysis. Within-sequence Shannon entropy was calculated and used as the outcome in linear regression models. A directed acyclic graph informed the hierarchical regression models to identify factors influencing treatment duration.</p><p><strong>Results: </strong>The cohort included 364 patients. Adalimumab was the most common first-line biologic (27%), followed by secukinumab (18%) and etanercept (16%). Nearly half of patients (48%) switched treatments. Increasing age was associated with lower sequence heterogeneity (β = -0.001, <i>p</i> = 0.002). Ustekinumab demonstrated the longest median treatment duration (1,841 days), while etanercept had the shortest (639 days). After adjusting for confounding variables, ustekinumab maintained its positive effect on treatment duration (β = 0.285, <i>p</i> = 0.009).</p><p><strong>Conclusion: </strong>The treatment duration for ustekinumab was encouraging, supporting its potential role as a durable option in these patients.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1007-1015"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752803","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}
Rita Balsano, Martina Pino, Elisa Bocchero, Elena Valenzi, Tiziana Pressiani, Silvia Bozzarelli, Lorenza Rimassa
{"title":"Combining VEGF and PD-1/PD-L1 inhibition in advanced hepatocellular carcinoma: clinical trials, real-world evidence, and future directions.","authors":"Rita Balsano, Martina Pino, Elisa Bocchero, Elena Valenzi, Tiziana Pressiani, Silvia Bozzarelli, Lorenza Rimassa","doi":"10.1080/14712598.2025.2557625","DOIUrl":"10.1080/14712598.2025.2557625","url":null,"abstract":"<p><strong>Introduction: </strong>Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related death worldwide with most of patients diagnosed at advanced stage. Thus, systemic therapy remains a cornerstone of treatment. In recent years, immunotherapy has changed therapeutic scenario, being investigated also in combination with anti-vascular endothelial growth factor (VEGF) agents. This approach has demonstrated safety and efficacy in several trials, paving the way for their investigation in earlier disease stages and in different settings.</p><p><strong>Areas covered: </strong>A structured literature review was conducted using PubMed and ClinicalTrials.gov to identify published evidence supporting safety and efficacy of anti-programmed death-1/programmed death-ligand-1(PD-1/PD-L1) and anti-VEGF agents in different therapeutic settings and identifying ongoing clinical trials and key research directions.</p><p><strong>Expert opinion: </strong>Combination of anti-PD-1/PD-L1 and anti-VEGF agents has demonstrated safety and efficacy as a first-line treatment for advanced HCC, supported by results from phase 3 trials. These results suggest that further investigation is warranted to optimize first-line efficacy, second-line choice, and potential application in earlier disease stages. The clinical benefit of anti-PD-1/PD-L1 and anti-VEGF agents have also opened the door to a new clinical paradigm, where transitioning from systemic therapy to locoregional therapies, resection or even liver transplantation could be a feasible treatment strategy.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"989-1006"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145000056","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}
{"title":"How treatment choices influence the onset and outcomes of uveitis in juvenile idiopathic arthritis: a retrospective cohort study.","authors":"Sinan Işık, Selen Duygu Arık, Özlem Akgün, Vafa Guliyeva, Gülşah Kavrul Kayaalp, Şeyma Türkmen, Betül Sözeri, Nuray Aktay Ayaz","doi":"10.1080/14712598.2025.2545520","DOIUrl":"10.1080/14712598.2025.2545520","url":null,"abstract":"<p><strong>Objectives: </strong>Uveitis is a prevalent complication of juvenile idiopathic arthritis (JIA), leading to ocular morbidity. This study aimed to evaluate uveitis frequency in JIA patients on biologics and explore the impact of biologic selection on its occurrence.</p><p><strong>Methods: </strong>Among 2,385 JIA patients reviewed, 101 patients who developed uveitis were analyzed. This patients were categorized based on their uveitis development: under methotrexate, after discontinuation of methotrexate, and under biologics.</p><p><strong>Results: </strong>Uveitis frequency among all reviewed JIA patients was 6.3%. Among those who developed uveitis while receiving biologics, 30 were on etanercept and one on infliximab at the time of onset. When the entire cohort of JIA patients treated with biologics for joint symptoms was evaluated, it was observed that out of 365 patients using etanercept, uveitis developed in 30 individuals, in one out of 39 patients using infliximab, while no cases of uveitis were observed among 285 patients using adalimumab.</p><p><strong>Conclusion: </strong>In this study we observed a larger frequency of new onset uveitis in JIA patients treated with TNF receptor fusion proteins than those treated with anti-TNF monoclonal antibodies. Monoclonal anti-TNF-α agents may remain the preferred options. This study highlights the necessity of integrating uveitis risk assessment into JIA treatment strategies.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1025-1033"},"PeriodicalIF":4.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793843","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}