Expert Opinion on Biological Therapy最新文献_第9页

The management of axial spondyloarthritis with cutting-edge therapies: advancements and innovations. 用前沿疗法治疗轴性脊柱关节炎：进步与创新。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-08-01 Epub Date: 2024-08-27 DOI: 10.1080/14712598.2024.2389987

Giuseppe Lopalco, Andrea Cito, Vincenzo Venerito, Florenzo Iannone, Fabian Proft

{"title":"The management of axial spondyloarthritis with cutting-edge therapies: advancements and innovations.","authors":"Giuseppe Lopalco, Andrea Cito, Vincenzo Venerito, Florenzo Iannone, Fabian Proft","doi":"10.1080/14712598.2024.2389987","DOIUrl":"10.1080/14712598.2024.2389987","url":null,"abstract":"Introduction: Axial involvement in spondyloarthritis has significantly evolved from the original 1984 New York criteria for ankylosing spondylitis, leading to an improved understanding of axial spondyloarthritis (axSpA) as a disease continuum encompassing non- radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). A clear definition for early axSpA has been established, underscoring the need for early intervention with biological and targeted synthetic drugs to mitigate pain, reduce functional impairment, and prevent radiographic progression.Areas covered: This review explores therapeutic strategies in axSpA management, focusing on biological and targeted synthetic therapies and recent advancements. Biologics targeting TNFα or IL-17 and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) are primary treatment options. These therapies significantly impact clinical outcomes, radiographic progression, and patient-reported functional improvement.Expert opinion: AxSpA treatment has evolved significantly, offering various therapeutic options. Biological DMARDs, particularly TNFα inhibitors, have transformed treatment, significantly enhancing patient outcomes. However, challenges persist for patients unresponsive or intolerant to existing therapies. Emerging therapeutic targets promise to address these challenges. Comprehensive management strategies and personalized approaches, considering extra-articular manifestations and individual patient factors, are crucial for achieving optimal outcomes in axSpA management.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"835-853"},"PeriodicalIF":3.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897216","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

Predisposition to conjunctivitis and male sex reduces drug survival of dupilumab in adults and adolescents. 易患结膜炎和男性性别会降低成人和青少年服用杜比鲁单抗的药物存活率。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-08-01 Epub Date: 2024-06-25 DOI: 10.1080/14712598.2024.2372367

Luca Mastorino, Irene Richiardi, Federica Gelato, Giovanni Cavaliere, Pietro Quaglino, Michela Ortoncelli, Simone Ribero

{"title":"Predisposition to conjunctivitis and male sex reduces drug survival of dupilumab in adults and adolescents.","authors":"Luca Mastorino, Irene Richiardi, Federica Gelato, Giovanni Cavaliere, Pietro Quaglino, Michela Ortoncelli, Simone Ribero","doi":"10.1080/14712598.2024.2372367","DOIUrl":"10.1080/14712598.2024.2372367","url":null,"abstract":"Background: There are currently limited data on dupilumab drug survival (DS), especially on factors possibly associated with drug discontinuation.Materials and methods: The primary endpoint of this study is to evaluate the parameters that may determine drug discontinuation and the predictive factors associated with dupilumab DS. We considered as independent associated factors: childhood onset of disease, gender, age of onset of AD, age of initiation of dupilumab, previous use of cyclosporine, initial mean EASI, atopic family history, and predisposition to allergic conjunctivitis.Results: On 413 patients DS was 94.5% at 1 year, 89.5% at 2 years, and 83.7% at 3 years, and after a mean follow-up of 40.5 months (±1.6) 53 patients had discontinued the drug permanently (12.8%). Univariate analysis showed that the only factor associated with a reduction in drug survival was a predisposition to allergic conjunctivitis (p 0.009). At multivariate Cox regression, male sex (HR, 2.34; 95% CI, 1.14-4.78; p 0.02) and predisposition to allergic conjunctivitis (HR, 2.61; 95% CI, 1.37-5.00; p 0.004) were associated with lower DS of dupilumab.Conclusion: Male gender and predisposition to allergic conjunctivitis are negative predictors for maintenance of response to treatment with dupilumab and consequently associated with lower DS rates.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"863-868"},"PeriodicalIF":3.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141442389","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

Looking ahead to CD3, T-cell engager bispecific antibodies for hematological malignancies. 展望治疗血液恶性肿瘤的 CD3、T 细胞吸引双特异性抗体。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-08-01 Epub Date: 2024-07-29 DOI: 10.1080/14712598.2024.2384086

Daniel R Reed, Lawrence G Lum

{"title":"Looking ahead to CD3, T-cell engager bispecific antibodies for hematological malignancies.","authors":"Daniel R Reed, Lawrence G Lum","doi":"10.1080/14712598.2024.2384086","DOIUrl":"10.1080/14712598.2024.2384086","url":null,"abstract":"Introduction: Since the approval of the bispecific antibody blinatumomab in 2017 for the treatment of acute lymphoblastic leukemia in relapse, the development of numerous bispecific antibody constructs has dramatically expanded in hematologic malignancies. Many have recently received Food Drug Administration and European Medicines Agency approvals in various stages of treatment for lymphomas, leukemias, and multiple myeloma.Areas covered: The purpose of this review is to provide an overview of bispecific antibody treatment including the mechanisms leading to effector T cells targeting tumor-associated antigens, the treatment indications, efficacies, toxicities, and challenges of the different constructs. A literature search was performed through access to PubMed and clinicaltrials.gov.Expert opinion: While there has been substantial success in the treatment of NHL, MM, and ALL, there are still hematologic malignancies such as AML where there has been limited progress. It is important to continue to investigate new designs, tumor antigen targets, and further refine where current approved bispecific antibodies fit in terms of sequencing of therapy. Hopefully, with the knowledge gained in recent years and the explosion of these therapies, patients with blood cancers will continue to benefit from these treatments for years to come.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"761-772"},"PeriodicalIF":3.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787660","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

Considerations for the development of monoclonal antibodies to address new viral variants in COVID-19. 开发针对 COVID-19 新病毒变异的单克隆抗体的考虑因素。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-08-01 Epub Date: 2024-08-06 DOI: 10.1080/14712598.2024.2388186

Arturo Casadevall, Scott McConnell, Daniele Focosi

{"title":"Considerations for the development of monoclonal antibodies to address new viral variants in COVID-19.","authors":"Arturo Casadevall, Scott McConnell, Daniele Focosi","doi":"10.1080/14712598.2024.2388186","DOIUrl":"10.1080/14712598.2024.2388186","url":null,"abstract":"Introduction: Monoclonal antibody (mAb) therapies proved safe and effective in preventing progression of COVID-19 to hospitalization, but most were eventually defeated by continued viral evolution. mAb combinations and those mAbs that were deliberatively selected to target conserved regions of the SARS-CoV-2 spike protein proved more resilient to viral escape variants as evident by longer clinical useful lives.Areas covered: We searched PubMed for literature covering the need, development, and use of mAb therapies for COVID-19. As much of humanity now has immunity to SARS-CoV-2, the population at most risk is that of immunocompromised individuals. Hence, there continues to be a need for mAb therapies for immunocompromised patients. However, mAb use in this population carries the risk for selecting mAb-resistant variants, which could pose a public health concern if they disseminate to the general population.Expert opinion: Going forward, structural knowledge of the interactions of Spike with its cellular receptor has identified several regions that may be good targets for future mAb therapeutics. A focus on designing variant-resistant mAbs together with cocktails that target several epitopes and the use of other variant mitigating strategies such as the concomitant use of small molecule antivirals and polyclonal preparations could extend the clinical usefulness of future preparations.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"787-797"},"PeriodicalIF":3.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859373","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

Real-life data of etanercept efficacy and safety in juvenile idiopathic arthritis: a 24-month retrospective study at a single center. 幼年特发性关节炎中依那西普疗效和安全性的真实数据：在一个中心进行的为期24个月的回顾性研究。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-08-01 Epub Date: 2024-08-06 DOI: 10.1080/14712598.2024.2388193

Ramazan Emre Yiğit, Kadir Ulu, Şengül Çağlayan, Betül Sözeri

{"title":"Real-life data of etanercept efficacy and safety in juvenile idiopathic arthritis: a 24-month retrospective study at a single center.","authors":"Ramazan Emre Yiğit, Kadir Ulu, Şengül Çağlayan, Betül Sözeri","doi":"10.1080/14712598.2024.2388193","DOIUrl":"10.1080/14712598.2024.2388193","url":null,"abstract":"Objective: The aim of this study was to assess the efficacy and safety of etanercept (ETA) use in juvenile idiopathic arthritis (JIA).Methods: The 24-month data of patients with JIA on etanercept in a single center were evaluated retrospectively. Response to treatment was assessed according to 10-joint Juvenile Arthritis Disease Activity Score (JADAS10), and JIA-American College of Rheumatology (ACR) improvement criteria. Safety assessments were based on adverse event (AE) reports.Results: The study included 152 patients with JIA. The mean age at diagnosis of JIA was 8.5 ± 4.4 years, and treatment with ETA started at a mean age of 11.1 ± 4.4 years. The mean duration of ETA use was 16 ± 11.1 months. The mean JADAS10 score at baseline was 18.5 ± 5.9. By the third month, it had reduced to 8.6 ± 6.6 and by the sixth month to 5.7 ± 6. By the twelfth month, the JADAS10 score was 4.9 ± 6.7, and by the twenty-fourth month, it had worsened to 7.3 ± 7.8. ACR50 response was achieved in 79.6% of patients at 3 months, 67.1% at 6 months, 79.3% at twelfth months, 70.7% at the twenty-fourth month. During ETA treatment, 10 patients required hospitalization for serious infections.Conclusion: Etanercept is a safe and effective option for patients with JIA. However, variations in response between JIA subtypes highlight the need for individualized treatment strategies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"855-862"},"PeriodicalIF":3.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859374","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 role of bDMARDs in the prevention and treatment of inflammatory-related comorbidities in Psoriatic Arthritis bDMARDs 在预防和治疗银屑病关节炎炎症相关并发症中的作用

IF 4.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-22 DOI: 10.1080/14712598.2024.2384090

Francesco Caso, Mauro Fatica, Mario Ferraioli, Matteo Megna, Luca Potestio, Angelo Ruggiero, Nello Tommasino, Francesco Maione, Raffaele Scarpa, Maria Sole Chimenti, Luisa Costa

引用次数: 0

Short and long-term economic implications of biosimilars. 生物仿制药的短期和长期经济影响。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-01-19 DOI: 10.1080/14712598.2024.2307353

Ahmad Z Al Meslamani

{"title":"Short and long-term economic implications of biosimilars.","authors":"Ahmad Z Al Meslamani","doi":"10.1080/14712598.2024.2307353","DOIUrl":"10.1080/14712598.2024.2307353","url":null,"abstract":"Introduction: Biosimilars are gaining popularity due to their ability to offer comparable therapeutic benefits at potentially lower costs.Areas covered: This article analyses studies that compare the cost savings of biosimilars with biologics. It also explores market competition dynamics and the impact of policies in countries. The focus is on the advantages of biosimilars in oncology and rheumatological treatments while considering broader economic implications for the pharmaceutical industry such as market displacement, pricing strategies and their influence on innovation and healthcare sustainability.Expert opinion: The introduction of biosimilars marks a shift in healthcare economics by offering cost reductions and long-term potential for economic balance. However, I also recognize challenges related to research methodologies and regulatory inconsistencies across countries. To fully capitalize on their potential, future research and development in the field of biosimilars must emphasize harmonized approaches and comprehensive studies that ensure both cost containment in healthcare and wider access, to high quality treatments.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"567-570"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139477560","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

Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. 修订日本生物仿制药开发对日本临床研究数据的要求。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-09 DOI: 10.1080/14712598.2024.2377300

Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka

{"title":"Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan.","authors":"Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka","doi":"10.1080/14712598.2024.2377300","DOIUrl":"10.1080/14712598.2024.2377300","url":null,"abstract":"Background: The 'Questions and Answers (Q&A)' document regarding Japanese biosimilar guideline elucidated that Japanese participant enrollment in at least one comparative clinical study was required for the marketing authorization application (MAA) of biosimilars in Japan.Research design and methods: To discuss the requirement of Japanese clinical study data for biosimilar development, the trend in comparative clinical studies conducted for approved biosimilars of monoclonal antibodies and fusion proteins was analyzed, and the consistency of the results between the overall population and the Japanese population according to the publicly available information was reviewed.Results: The number of comparative clinical studies enrolling Japanese participants was 25 cases, and the type and percentage were 13 (52%) and 12 (48%) cases of comparative pharmacokinetic study and comparative efficacy study, respectively. In all comparative clinical studies, consistent results between the overall population and the Japanese population were shown.Conclusions: Our study indicated that Japanese participant enrollment in comparative clinical studies may not always be necessary for biosimilar development when certain conditions are satisfied. This has been described in the revised Q&A document published by the Ministry of Health, Labour and Welfare in January 2024.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"637-645"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544666","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 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-14 DOI: 10.1080/14712598.2024.2350440

Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega

{"title":"Biosimilars and access to biologic therapy in immune-mediated diseases.","authors":"Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega","doi":"10.1080/14712598.2024.2350440","DOIUrl":"10.1080/14712598.2024.2350440","url":null,"abstract":"Background: The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability's impact on biologic therapy access for IMIDs.Research design and methods: A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed.Results: 267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions.Conclusion: The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals' therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"647-653"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852659","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

Streamlining biosimilar development based on 20 years' experience. 基于 20 年的经验，简化生物仿制药的开发。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-02-22 DOI: 10.1080/14712598.2024.2314612

Cecil Nick

{"title":"Streamlining biosimilar development based on 20 years' experience.","authors":"Cecil Nick","doi":"10.1080/14712598.2024.2314612","DOIUrl":"10.1080/14712598.2024.2314612","url":null,"abstract":"Introduction: Biosimilar clinical programs could be streamlined by prudent application of improved methodologies and knowledge accumulated over the past 20 years. This review focuses on whether complex comparative efficacy trials are routinely needed and how to achieve a more tailored approach to biosimilar development.Areas covered: Key learnings over the past 20 years are summarized. It is noted that a one size fits all approach to biosimilar development is not appropriate: biological medicines fall within a wide spectrum of complexity, with blurring at the interface between biological products and small molecules. The interrelationship between quality, potency, pharmacokinetics, pharmacology, immunogenicity, efficacy, and safety are reviewed. Current regulatory thinking is reviewed with a look into what future challenges lie ahead.Expert opinion: To tailor regulatory requirements for marketing approval of biosimilars, it is proposed that a biosimilarity report be introduced. This report would integrate quality, pharmacology, immunogenicity, efficacy and safety findings and address how the clinical program could be tailored based on the totality of evidence.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"571-581"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691583","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