Ashish Sharma, Carl D Regillo, Luke Nicholson, Nilesh Kumar, Nikulaa Parachuri, Taku Wakabayashi, Se Joon Woo, Baruch D Kuppermann
{"title":"The conundrum of abundance: challenges of having too many biosimilars.","authors":"Ashish Sharma, Carl D Regillo, Luke Nicholson, Nilesh Kumar, Nikulaa Parachuri, Taku Wakabayashi, Se Joon Woo, Baruch D Kuppermann","doi":"10.1080/14712598.2025.2506445","DOIUrl":"10.1080/14712598.2025.2506445","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-4"},"PeriodicalIF":3.6,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981442","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}
Bernadett Farkas, Jimmy K Limdi, Péter Bacsur, Edoardo Vincenzo Savarino, Luisa Bertin, Karishma Sethi-Arora, Pál Miheller, Fruzsina Vilmos, Fabiana Castiglione, Livio Bonacci, Milan Lukas, Nitsan Maharshak, Galia Berman, Željko Krznaric, Panu Wetwittayakhlang, Peter L Lakatos, Jakob Benedict Seidelin, Mohamed Attauabi, George Michalopoulos, Davide Giuseppe Ribaldone, Anna Kagramanova, Elena Chashkova, Patrícia Sarlós, Simone Saibeni, Ariella Bar-Gil Shitrit, Mariann Borsos, Tamás Resál, Zoltán Szepes, Tamás Molnár, Klaudia Farkas
{"title":"Second-line strategies after anti-TNF failure in chronically active, moderate-to-severe ulcerative colitis: a retrospective, multicentre cohort study.","authors":"Bernadett Farkas, Jimmy K Limdi, Péter Bacsur, Edoardo Vincenzo Savarino, Luisa Bertin, Karishma Sethi-Arora, Pál Miheller, Fruzsina Vilmos, Fabiana Castiglione, Livio Bonacci, Milan Lukas, Nitsan Maharshak, Galia Berman, Željko Krznaric, Panu Wetwittayakhlang, Peter L Lakatos, Jakob Benedict Seidelin, Mohamed Attauabi, George Michalopoulos, Davide Giuseppe Ribaldone, Anna Kagramanova, Elena Chashkova, Patrícia Sarlós, Simone Saibeni, Ariella Bar-Gil Shitrit, Mariann Borsos, Tamás Resál, Zoltán Szepes, Tamás Molnár, Klaudia Farkas","doi":"10.1080/14712598.2025.2500962","DOIUrl":"https://doi.org/10.1080/14712598.2025.2500962","url":null,"abstract":"<p><strong>Background: </strong>Many ulcerative colitis (UC) patients require the use of second-line agents after the failure of anti-TNF therapy.</p><p><strong>Research design and methods: </strong>We conducted a multicenter, retrospective study including 683 chronically active, moderate-to-severe UC patients who failed first-line anti-TNFs. The rate of treatment persistence and colectomy-free survival was assessed up to 3 years after the initiation of second-line therapy. Predictors for colectomy and persistence were investigated.</p><p><strong>Results: </strong>After the failure of the first-line anti-TNF, ustekinumab had superior persistence and colectomy-free survival rates compared to tofacitinib (<i>p</i> = 0.05; <i>p</i> = 0.001) and vedolizumab (<i>p</i> = 0.02; <i>p</i> = 0.05), but significant difference was only found in persistence rates in comparison with anti-TNFs (<i>p</i> < 0.001). Regardless of the number of prior anti-TNFs, significantly higher persistence (<i>p</i> = 0.05) and colectomy-free survival rates (<i>p</i> = 0.01) were observed over 2 years with ustekinumab than with vedolizumab or tofacitinib, whereas ustekinumab's superiority over tofacitinib seemed to disappear by the third year. Hypoalbuminaemia (<i>p</i> = 0.002) and shorter disease duration at second-line initiation (<i>p</i> = 0.03) increased, while concomitant immunomodulators (<i>p</i> = 0.05) reduced the risk for colectomy. Shorter disease duration (<i>p</i> = 0.01) and primary non-response to the previously used anti-TNF (<i>p</i> < 0.001) negatively influenced persistence with second-line non-TNF-targeted agents.</p><p><strong>Conclusion: </strong>After first-line anti-TNF failure, switching to a non-anti-TNF agent is worth considering in moderate-to-severe UC.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-10"},"PeriodicalIF":3.6,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959923","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}
Santeri Artturi Pakola, James Hugo Armstrong Clubb, Joao Manuel Santos, Riikka Havunen, Heini Lassus, Victor Cervera-Carrascon, Akseli Hemminki
{"title":"Oncolytic adenoviruses in platinum-resistant ovarian cancer: a new era in immunotherapy?","authors":"Santeri Artturi Pakola, James Hugo Armstrong Clubb, Joao Manuel Santos, Riikka Havunen, Heini Lassus, Victor Cervera-Carrascon, Akseli Hemminki","doi":"10.1080/14712598.2025.2501731","DOIUrl":"https://doi.org/10.1080/14712598.2025.2501731","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-4"},"PeriodicalIF":3.6,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993588","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}
Angelo Valerio Marzano, Carlo Alberto Maronese, Anna Balato, Antonio Costanzo, Annunziata Dattola, Maria Concetta Fargnoli, Paolo Gisondi, Stefano Piaserico, Francesca Prignano
{"title":"What is '<i>chronic</i>' pustular psoriasis? Identifying candidates for long-term subcutaneous spesolimab treatment.","authors":"Angelo Valerio Marzano, Carlo Alberto Maronese, Anna Balato, Antonio Costanzo, Annunziata Dattola, Maria Concetta Fargnoli, Paolo Gisondi, Stefano Piaserico, Francesca Prignano","doi":"10.1080/14712598.2025.2501728","DOIUrl":"https://doi.org/10.1080/14712598.2025.2501728","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-3"},"PeriodicalIF":3.6,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969428","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":"Perspectives on the de-escalation of anti-CD20 monoclonal antibodies in patients with multiple sclerosis.","authors":"Abdorreza Naser Moghadasi","doi":"10.1080/14712598.2025.2501730","DOIUrl":"https://doi.org/10.1080/14712598.2025.2501730","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-4"},"PeriodicalIF":3.6,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991322","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}
Lucas W Rowe, Zachary R Barry, Devin D Mackay, Kevin E Lai, Thomas A Ciulla
{"title":"Autoimmune neuro-ophthalmic disorders: pathophysiologic mechanisms and targeted biologic therapies.","authors":"Lucas W Rowe, Zachary R Barry, Devin D Mackay, Kevin E Lai, Thomas A Ciulla","doi":"10.1080/14712598.2025.2491603","DOIUrl":"https://doi.org/10.1080/14712598.2025.2491603","url":null,"abstract":"<p><strong>Introduction: </strong>Autoimmune neuro-ophthalmic disorders encompass a diverse array of conditions, including thyroid eye disease (TED), myasthenia gravis (MG), optic neuropathy due to giant cell arteritis (GCA), and optic neuritis related to multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). While traditional treatments have shown efficacy in managing symptoms, the rapid emergence of biologic therapies has brought forth new avenues for targeted intervention, revolutionizing treatment approaches for these conditions.</p><p><strong>Areas covered: </strong>This review highlights the pathophysiologic pathways and FDA-approved biologic therapies utilized in the management of autoimmune neuro-ophthalmic disorders. We explore multiple therapeutic approaches for autoimmune neuro-ophthalmic disorders, including IGF-1 R antagonism, IL-6 inhibition, complement inhibition, FcRn targeting, B-cell depletion and T-cell modulation. Literature from clinical trials, observational studies, and meta-analyses through 2024 was evaluated to assess efficacy, safety, and long-term outcomes.</p><p><strong>Expert opinion: </strong>Biologic therapies represent a significant advancement in autoimmune neuro-ophthalmic disorders, offering targeted approaches with improved efficacy and safety profiles compared to traditional treatments. Ongoing developments in biomarker identification and delivery systems suggest an increasingly personalized approach to treatment. Future advances will likely focus on optimizing patient selection, reducing costs, improving accessibility, and developing novel therapeutic targets.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":"25 5","pages":"1-22"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985495","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":"Ivonescimab in non-small cell lung cancer: harmonizing immunotherapy and anti-angiogenesis.","authors":"Yan Zhang, Xinyu Liu, Shengxiang Ren","doi":"10.1080/14712598.2025.2487512","DOIUrl":"10.1080/14712598.2025.2487512","url":null,"abstract":"<p><strong>Introduction: </strong>Immunotherapy combined with anti-angiogenesis has become a useful strategy in cancer treatment. Ivonescimab, the first-approved bispecific antibody targeting both immune checkpoint inhibition and anti-angiogenesis, represents a breakthrough over the conventional dual-drug combination approach. The emerging clinical evidence demonstrates promising efficacy and manageable safety profile of ivonescimab in the treatment of non-small cell lung cancer (NSCLC), suggesting its potential role as a cornerstone in the next generation of cancer immunotherapy.</p><p><strong>Areas covered: </strong>This review presents the pharmacological characteristics of ivonescimab, revisits relevant clinical trials and key data, and provides an in-depth analysis. Additionally, the potential of ivonescimab in NSCLC treatment is discussed, along with its clinical prospects.</p><p><strong>Expert opinion: </strong>The available clinical data demonstrate that simultaneously targeting both immune checkpoint inhibition and angiogenesis pathways through a single bispecific antibody represents a significant therapeutic advancement in NSCLC treatment. Ivonescimab's innovative dual-targeting mechanism, supported by promising efficacy data from the HARMONi trials and its manageable safety profile, appears to be fundamental to its potential to challenge current standards of care. As the first approved bispecific antibody with this unique mechanism of action, ivonescimab may not only transform current treatment paradigms but also pioneer a new direction in cancer immunotherapy.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-7"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751769","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":"Perspectives on the use of biological therapies for the treatment of asthma in low-middle income countries.","authors":"Betül Özdel Öztürk, Sevim Bavbek","doi":"10.1080/14712598.2025.2490064","DOIUrl":"10.1080/14712598.2025.2490064","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-4"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788195","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}
Islam Eljilany, Julia R Garcia, Basmala Jamal, Ahmad A Tarhini
{"title":"Monoclonal antibodies as adjuvant therapies for resected melanoma.","authors":"Islam Eljilany, Julia R Garcia, Basmala Jamal, Ahmad A Tarhini","doi":"10.1080/14712598.2025.2484305","DOIUrl":"10.1080/14712598.2025.2484305","url":null,"abstract":"<p><strong>Introduction: </strong>Systemic adjuvant therapy is indicated in patients with high-risk, resected melanoma to reduce recurrence risk and potentially improve survival rates. Monoclonal antibodies (mAbs) target immune checkpoints and have made significant advances as systemic adjuvant therapies.</p><p><strong>Areas covered: </strong>This review discusses the main clinical trials that tested adjuvant mAbs in resected high-risk melanoma, including anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) and anti-programmed cell death-1 (PD-1); in addition to newer immunotherapies being tested in the adjuvant setting, including anti-lymphocyte activation gene 3 (LAG-3). We also briefly discuss targeted therapies as an alternative choice. Moreover, we highlight the pros and cons of using mAbs in the adjuvant setting, the reported adverse events (AEs), and the quality of life impact. Finally, we report data related to biomarker studies tested in the context of these clinical trials.</p><p><strong>Expert opinion: </strong>Immune checkpoint inhibitors (ICIs) have been shown to significantly improve relapse-free survival (RFS) as adjuvant therapy for high-risk melanoma. The long-term impact on overall survival (OS) was demonstrated in two trials that tested ipilimumab as compared to placebo (EORTC18071) and interferon-α (ECOG-ACRIN E1609). Furthermore, emerging data with neoadjuvant therapy followed by surgery and adjuvant therapy utilizing ICIs have demonstrated improved outcomes in the management of locoregionally advanced disease when compared to upfront surgery followed by adjuvant therapy alone.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691446","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}