Journals Expert Opinion on Biological T...

Expert Opinion on Biological Therapy
Emiliano Barbieri, Enrica Antonia Martino, Elena Rivolti, Micol Quaresima, Ernesto Vigna, Antonino Neri, Fortunato Morabito, Massimo Gentile
INTRODUCTION: Gain/amplification of 1q (+1q) represents one of the most prevalent cytogenetic abnormalities (CAs) observed in multiple myeloma (MM). Historical studies predating the advent of anti-CD38 monoclonal antibodies (moAbs) implicated + 1q in poor prognoses, prompting its integration into novel staging systems. However, with the emergence of daratumumab and isatuximab, two pivotal anti-CD38 moAbs, the landscape of MM therapy has undergone a profound transformation...
May 17, 2024: Expert Opinion on Biological Therapy
Yan Jiang, Yanan Huo, Yufeng Li, Xijian Kong, Bingwu Wang, Feng Liu, Xin Zheng, Yukun Li, Yunfa Yang, Yongsheng Xu, Qingyun Xue, Zhitian Hu, Yanfeng Xiao, Wen Ma, Yinhan Guo, Wei Yu, Weibo Xia
BACKGROUND: This study aimed to assess the efficacy and safety of MW031 in Chinese postmenopausal women with osteoporosis. PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 448 postmenopausal women with osteoporosis were randomized 3:1 to receive MW031 and placebo for 12 months. The primary efficacy endpoint was the percentage change from baseline in BMD at lumbar spine in month 12. The safety and immunogenicity profiles were also included...
May 16, 2024: Expert Opinion on Biological Therapy
Viktoria Moschetti, Susanne Buschke, Julia Bertulis, Kathrin Hohl, Dorothy McCabe
OBJECTIVE: This study compared the relative bioavailability of citrate-free high-concentration and reference formulations of the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers. METHODS: Healthy volunteers ( N  = 200) aged 18-55 years and with body mass index of 18.5-29.9 kg/m2 and no prior exposure to adalimumab were randomized in a 1:1 ratio to receive a single subcutaneous injection of either adalimumab-adbm 40 mg/0...
May 13, 2024: Expert Opinion on Biological Therapy
Sundar Jagannath, Carolyn C Jackson, Jordan M Schecter, Nikoletta Lendvai, Huabin Sun, Muhammad Akram, Nitin Patel, Thomas G Martin
INTRODUCTION: Ciltacabtagene autoleucel (cilta-cel), a BCMA-targeting CAR-T therapy, is approved in the United States and Europe for patients with relapsed/refractory multiple myeloma (RRMM) and ≥ 1 prior line of therapy (LOT), including a proteasome inhibitor and an immunomodulatory drug, and are lenalidomide refractory. AREAS COVERED: We examine recent long-term data in heavily pretreated RRMM (LEGEND-2, CARTITUDE-1) and earlier LOTs (CARTITUDE-4) compared with standard therapy and discuss the rationale for investigating cilta-cel as frontline therapy for transplant-eligible and transplant-ineligible patients (CARTITUDE-5, CARTITUDE-6)...
May 13, 2024: Expert Opinion on Biological Therapy
Katharina Marlies Duda, Bettina Wedi
INTRODUCTION: Chronic spontaneous urticaria (CSU) poses significant challenges, especially in pediatric and adolescent patients, impacting physical, emotional, and social well-being. Recent biologic breakthroughs offer promise, however, data on safety and efficacy in this population remain limited. AREAS COVERED: This review examines current biologic treatments in pediatrics and adolescents with CSU and explores the rapidly emerging landscape. EXPERT OPINION: Despite omalizumab's approval for allergic asthma in children since 2009, its delayed approval for CSU raises questions...
May 10, 2024: Expert Opinion on Biological Therapy
William David Wells-Gatnik, Paolo Martelletti
INTRODUCTION: Approximately 50% of patients that receive a CGRP(r) MoAb for the preventative treatment of migraine are expected to discontinue therapy. For patients that discontinue CGRP(r) MoAb therapy, few clinical options are available. One potential option is to switch CGRP(r) MoAbs, however, data concerning the efficacy of this intervention is scarce. AREAS COVERED: This manuscript aims to summarize all available data concerning the potential efficacy of switching CGRP(r) MoAbs following previous medication discontinuation...
May 10, 2024: Expert Opinion on Biological Therapy
Jaromir Tomasik, Dominik Bilicki, Grzegorz Władysław Basak
INTRODUCTION: The prognosis for large B-cell lymphoma (LBCL) patients who did not respond or relapsed after chimeric antigen receptor (CAR)-T therapy remains dismal, with no established consensus on the most effective salvage regimen. METHODS: We conducted a random-effects meta-analysis of complete response (CR) and overall response rates (ORR) to first-line treatments for CAR-T-relapsed/refractory LBCL. We followed the predefined protocol available at PROSPERO (CRD42023473854)...
May 9, 2024: Expert Opinion on Biological Therapy
Hao Sun, Haizhou Xing, Lijie Han, Yongping Song, Zhongxing Jiang, Yanyan Liu, Jifeng Yu
INTRODUCTION: At the 65th American Society of Hematology (ASH) 2023 Annual Meeting, the latest advancements in CD20×CD3 BsAbs for B-cell lymphoma (BCL) were highlighted, particularly in relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). AREAS COVERED: This summary highlights some of the major studies on CD20×CD3 BsAbs for BCL. EXPERT OPINION/COMMENTARY: CD20×CD3 is the most widely studied BsAb, with promising results in patients with R/R DLBCL and R/R FL ≥ two prior lines of systemic therapy...
May 8, 2024: Expert Opinion on Biological Therapy
Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega
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)...
May 2, 2024: Expert Opinion on Biological Therapy
Min Ho Park, Jae Hong Seo, Jung Ho Park, Min-Ki Seong, Keon Uk Park, Min Kyoon Kim, Myungchul Chang, Su-Jin Koh, Moon Hee Lee, Seung Taek Lim, Young Bum Yoo, So Yeon Oh, Sung Hyun Kim, Keum Young Ahn, Tae Hong Park, Hana Ju, Eric Hyungseok Baek, Sinhye Kim, Nahyun Kim, Eunkyung Lee, Tae Hyun Kim
BACKGROUND: The trastuzumab biosimilar CT-P6 is approved for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC). The objective of this post-marketing surveillance (PMS) study was to evaluate the real-world safety and effectiveness of CT-P6 in patients with HER2-positive cancers. RESEARCH DESIGN AND METHODS: This open-label, observational, prospective, PMS study collected data via investigator surveys from 35 centers in the Republic of Korea (5 October 2018-4 October 2022)...
April 25, 2024: Expert Opinion on Biological Therapy
Wenqing Jia, Xiaonan Shen, Zichao Guo, Xi Cheng, Ren Zhao
INTRODUCTION: Colorectal cancer (CRC) is the second most lethal malignancy worldwide. Immune checkpoint inhibitors (ICIs) benefit only 15% of patients with mismatch repair-deficient/microsatellite instability (dMMR/MSI) CRC. The majority of patients are not suitable due to insufficient immune infiltration. Cancer vaccines are a potential approach for inducing tumor-specific immunity within the solid tumor microenvironment. AREA COVERED: In this review, we have provided an overview of the current progress in CRC vaccines over the past three years and briefly depict promising directions for further exploration...
April 21, 2024: Expert Opinion on Biological Therapy
Sheila A Doggrell
INTRODUCTION: Immunoglobulin A (IgA) nephropathy is a common immune-mediated kidney disease leading to high blood pressure and may progress to kidney failure. None of the present treatments are disease-modifying or prolong life. The levels of A Proliferation Inducing Ligand (APRIL) are raised in subjects with IgA nephropathy. Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to, and neutralizes, APRIL. AREAS COVERED: A phase 2 clinical trial of intravenous sibeprenlimab (VIS649) in IgA nephropathy: NCT04287985...
April 20, 2024: Expert Opinion on Biological Therapy
Rini Patadia, Thomas B Casale, John Fowler, Shiven Patel, Juan Carlos Cardet
INTRODUCTION: Asthma encompasses a spectrum of phenotypes often categorized into two groups- type 2 high (T2 high) and type 2 low (T2 low). T2 high includes atopic and eosinophilic presentations whereas T2 low is non-atopic, non-eosinophilic, and oft associated with neutrophilic inflammation. Eosinophilic asthma is often driven by IgE, IL-4, IL-5, and IL-13 and TSLP. This can lead to eosinophilic inflammatory response in the airways which in turn can be used as target for treatment. AREAS COVERED: The article will focus on biologic therapy that is currently being used in eosinophilic asthma management in mainly the adult population including clinical trials and co-morbidities that can be treated using the same biologics...
April 15, 2024: Expert Opinion on Biological Therapy
Dimitra Stergianou, Theodora Kanni, Christina Damoulari, Evangelos Giamarellos-Bourboulis
INTRODUCTION: Until recently, biologic therapy for hidradenitis suppurativa was limited to anti-tumor necrosis factor (TNF) blockade with adalimumab (ADA). However, not all patients respond to treatment with ADA. This highlighted the need for more therapeutic options. Interleukin (IL)-17/T-helper17 (Th17) axis may play an important role in the pathophysiology of HS. Recently, the IL-17A inhibitor secukinumab, which targets IL-17A specifically and prevents it from interacting with the IL-17 receptor, has been FDA-approved for HS...
April 11, 2024: Expert Opinion on Biological Therapy
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April 4, 2024: Expert Opinion on Biological Therapy
ZhiCheng Wang, XiaoMan Chen, Liang Yan, WenJie Wang, PeiJia Zheng, Atashbahar Mohammadreza, Qi Liu
INTRODUCTION: Antimicrobial peptides (AMPs) are small-molecule peptides with a unique antimicrobial mechanism. Other notable biological activities of AMPs, including anti-inflammatory, angiogenesis, and bone formation effects, have recently received widespread attention. These remarkable bioactivities, combined with the unique antimicrobial mechanism of action of AMPs, have led to their increasingly important role in bone regeneration. AREAS COVERED: In this review, on the one hand, we aimed to summarize information about the AMPs that are currently used for bone regeneration by reviewing published literature in the PubMed database...
April 3, 2024: Expert Opinion on Biological Therapy
Sara Boskovic, Silvia Borriello, Fabrizio D'Ascenzo, Nadia Sciamarrelli, Francois Rosset, Luca Mastorino, Dapavo Paolo, Pier Paolo Bocchino, Ovidio De Filippo, Simone Ribero, Gaetano De Ferrari, Pietro Quaglino
No abstract text is available yet for this article.
April 1, 2024: Expert Opinion on Biological Therapy
Matteo Molica, Marco Rossi
INTRODUCTION: In patients with myelodysplastic syndromes (MDS), anemia is prevalent affecting 80%-85% of low-risk (LR-MDS) patients, with 40% eventually requiring red blood cell (RBC) transfusions. Except forlenalidomide, exclusively approved for those with deletion of chromosome 5q,erythropoiesis-stimulating agents (ESAs) are the primary treatment choice for low-risk patients. Those unresponsive to ESAs face limited alternatives, eventually necessitating long-term RBC transfusions, leading to secondary iron overload and adversely affecting quality of life (QoL)...
March 30, 2024: Expert Opinion on Biological Therapy
Andreas V Madsen, Peter Kristensen, Steffen Goletz
No abstract text is available yet for this article.
March 27, 2024: Expert Opinion on Biological Therapy
Marcel P Trefny, Sebastian Kobold
No abstract text is available yet for this article.
March 25, 2024: Expert Opinion on Biological Therapy
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