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REVIEW
M Doortje Reijman, D Meeike Kusters, Albert Wiegman
INTRODUCTION: Heterozygous familial hypercholesterolemia (HeFH) is a common genetic disorder caused by pathogenic variants in the LDL-C metabolism. Lifelong exposure to elevated LDL-C levels leads to a high risk of premature cardiovascular disease. To reduce that risk, children with HeFH should be identified and treated with lipid-lowering therapy. The cornerstone consists of statins and ezetimibe, but not in all patients this lowers the LDL-C levels to treatment targets. For these patients, more intensive lipid-lowering therapy is needed...
March 19, 2024: Expert Opinion on Biological Therapy
#22
REVIEW
Paolo Dapavo, Martina Burlando, Claudio Guarneri, Matteo Megna, Alessandra Narcisi, Marina Talamonti, Paolo Gisondi
INTRODUCTION: The introduction of biologics for the treatment of plaque psoriasis is one of the major therapeutic advances of the last decades in dermatology. The efficacy of this class of drugs can be influenced by multiple factors including obesity, being overweight, prior treatment failures, and disease severity. AREAS COVERED: Most of the currently available approved biologics are limited by their lack of dosing flexibility for adapting the therapy to the complexity of real-world patients with psoriasis...
March 5, 2024: Expert Opinion on Biological Therapy
#23
REVIEW
Eloy E Ordaya, Raymund R Razonable
INTRODUCTION: Anti-spike monoclonal antibodies (mAbs) were previously authorized for the prevention and treatment of COVID-19 in immunocompromised patients. However, they are no longer authorized in the US due to their lack of neutralizing activity against current circulating SARS-CoV-2 Omicron variants. AREAS COVERED: We summarized the available data on emergent mAbs in the early stages of clinical development. Consistent with data on prior mAbs, these novel agents have been well tolerated and demonstrated a good safety profile in early clinical trials...
March 3, 2024: Expert Opinion on Biological Therapy
#24
REVIEW
Gabriele Roccuzzo, Eleonora Gherardi, Michele Maio, Piergiorgio Malagoli, Angelo Valerio Marzano, Aurora Parodi, Nicola Pimpinelli, Francesco Spagnolo, Anna Maria Di Giacomo, Pietro Quaglino
INTRODUCTION: Immunomodulating therapies harness the power of the immune system to combat disease. In advanced melanoma, immune checkpoint inhibitors have significantly improved survival outcomes by activating the immune system to recognize and eliminate cancer cells. In psoriasis, interleukin inhibitors effectively suppress inflammation and improve disease symptoms. AREAS COVERED: We provide a meta-opinion-based consensus paper on the analogies and differences in treatment mechanisms, duration, frequency between immunotherapy for advanced melanoma and biologics for psoriasis...
February 29, 2024: Expert Opinion on Biological Therapy
#25
REVIEW
Sheila A Doggrell
INTRODUCTION: There is no cure for Alzheimer's disease, which is the sixth leading cause of death in the U.S.A.. Lecanemab is anti-Aβ monoclonal antibody approved for the treatment of early Alzheimer's disease but is only marginally effective. Other antibodies are being developed including solanezumab. AREAS COVERED: A phase 3 clinical trial of solanezumab in preclinical Alzheimer's disease. In the A4 study, solanezumab did not reduce the decline in cognition or function and had no effect on brain amyloid burden...
February 27, 2024: Expert Opinion on Biological Therapy
#26
EDITORIAL
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
No abstract text is available yet for this article.
February 26, 2024: Expert Opinion on Biological Therapy
#27
EDITORIAL
Michelle Greenman, Blair McNamara, Levent Mutlu, Alessandro D Santin
No abstract text is available yet for this article.
February 23, 2024: Expert Opinion on Biological Therapy
#28
EDITORIAL
Lukas Pekar, Simon Krah, Stefan Zielonka
No abstract text is available yet for this article.
February 22, 2024: Expert Opinion on Biological Therapy
#29
REVIEW
Na-Qiong Wu, Zhi-Fan Li, Meng-Ying Lu, Jian-Jun Li
INTRODUCTION: Dyslipidemia significantly contributes to atherosclerotic cardiovascular disease (ASCVD). Patients with lipid-rich vulnerable plaques are particularly susceptible to cardiovascular complications. Despite available lipid-lowering therapies (LLTs), challenges in effective lipid management remain. AREAS COVERED: This article reviews monoclonal antibody (mAb) therapy in dyslipidemia, particularly focusing on vulnerable plaques and patients. We have reviewed the definitions of vulnerable plaques and patients, outlined the efficacy of traditional LLTs, and discussed in-depth the mAbs targeting PCSK9...
February 20, 2024: Expert Opinion on Biological Therapy
#30
REVIEW
Hong De Sa, Richard T Maziarz, Arpita P Gandhi
INTRODUCTION: The success of an allogeneic hematopoietic stem cell transplantation (alloHCT) is measured by cure from the underlying malignancy, immune reconstitution (IR), and freedom from graft-versus-host disease, without the continued need for immunosuppressive therapy. AREAS COVERED: Effective IR is critical to the success of alloHCT wherein poor IR can potentially increase the risk of infection and disease relapse. Different stem cell sources give rise to varying patterns of IR...
March 2024: Expert Opinion on Biological Therapy
#31
JOURNAL ARTICLE
Anhye Kim, Jang Hee Hong, Wonsuk Shin, Hyounggyoon Yoo, Jin-Gyu Jung, Jean-Yves Reginster, SungHyun Kim, YunJu Bae, JeeHye Suh, Sera Kim, EunKyung Lee, Stuart Silverman
BACKGROUND: This study's objective was to demonstrate pharmacokinetic (PK) similarity and safety of denosumab biosimilar, CT‑P41, and United States - licensed reference denosumab (US-denosumab) in healthy male Asian adults, considering also pharmacodynamic (PD) outcomes. RESEARCH DESIGN AND METHODS: This double-blind, two-arm, parallel-group, Phase 1 study randomized (1:1) healthy males to a single (60-mg) subcutaneous dose of CT‑P41 or US-denosumab...
February 13, 2024: Expert Opinion on Biological Therapy
#32
REVIEW
Antonio Tursi, Giammarco Mocci, Angelo Del Gaudio, Alfredo Papa
INTRODUCTION: The therapeutic armamentarium for managing Crohn's disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD. AREA COVERED: This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs)...
February 6, 2024: Expert Opinion on Biological Therapy
#33
JOURNAL ARTICLE
Cecil Nick
INTRODUCTION: Biosimilar clinical programs could be streamlined by prudent application of improved methodologies and knowledge accumulated over the past twenty 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...
February 5, 2024: Expert Opinion on Biological Therapy
#34
REVIEW
Julia Lang-Meli, Christoph Neumann-Haefelin, Robert Thimme
INTRODUCTION: More than 350 million people worldwide live with chronic viral hepatitis and are thus at risk for severe complications like liver cirrhosis and hepatocellular carcinoma (HCC). To meet the goals of the World Health Organization (WHO) global hepatitis strategy, there is an urgent need for new immunotherapeutic approaches. These are particularly required for chronic hepatitis B virus infection and - B/D coinfection. AREAS COVERED: This review summarizes data on mechanisms of CD8+ T cells failure in chronic hepatitis B, D, C and E virus infection...
January 30, 2024: Expert Opinion on Biological Therapy
#35
REVIEW
Ilenia Di Cola, Piero Ruscitti
INTRODUCTION: Currently, the therapeutic management of Still's disease, a multisystemic inflammatory rare disorder, is directed to target the inflammatory symptoms and signs of patients. The treatment varies from glucocorticoids to disease-modifying antirheumatic drugs (DMARDs), both conventional synthetic and biological (bDMARDs). Usually, in refractory patients, bDMARDs are administered. AREAS COVERED: Amongst bDMARDs, IL-1 and IL-6 inhibitors are frequently used, as data reported from both clinical trials and 'real-life' experiences...
January 29, 2024: Expert Opinion on Biological Therapy
#36
JOURNAL ARTICLE
Antonio Tursi, Giammarco Mocci, Franco Scaldaferri, Daniele Napolitano, Rossella Maresca, Daniela Pugliese, Gianluca Semprucci, Edoardo Savarino, Antonio Cuomo, Laura Donnarumma, Giorgia Bodini, Andrea Pasta, Giovanni Maconi, Giovanni Cataletti, Giuseppe Pranzo, Stefano Rodinò, Ladislava Sebkova, Francesco Costa, Antonio Ferronato, Federica Gaiani, Manuela Marzo, Ileana Luppino, Giulia Fabiano, Pietro Paese, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Laurino Grossi, Mariaelena Serio, Antonella Scarcelli, Roberto Lorenzetti, Leonardo Allegretta, Stefania Chiri, Giuseppina Grasso, Elisabetta Antonelli, Gabrio Bassotti, Rocco Spagnuolo, Francesco Luzza, Libera Fanigliulo, Giulia Rocco, Carlotta Sacchi, Costantino Zampaletta, Chiara Rocchi, Laura Bolognini, Emanuele Bendia, Maria Antonia Bianco, Pietro Capone, Costantino Meucci, Raffaele Colucci, Paolo Tonti, Viviana Neve, Nicola Della Valle, Carla Felice, Roberta Pica, Andrea Cocco, Giacomo Forti, Francesca Maria Onidi, Paolo Usai Satta, Davide Checchin, Antonietta Gerarda Gravina, Raffaele Pellegrino, Marcello Picchio, Alfredo Papa
BACKGROUND: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting. RESEARCH DESIGN AND METHODS: This is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, ≤1) and the safety of UST...
January 22, 2024: Expert Opinion on Biological Therapy
#37
REVIEW
Chang-Yu Hsieh, Tsen-Fang Tsai
INTRODUCTION: In 2022, U.S. Food and Drug Administration (FDA) approved the first biologics, intravenous spesolimab, for acute flare of generalized pustular psoriasis (GPP). The drug works by blocking IL-36 signaling, the key pathway of GPP. Among the known mutations causing GPP, IL36RN mutations are most common, and the presence of IL36RN mutations had been found to affect the clinical manifestations and treatment response of GPP. AREAS COVERED: Literature search was conducted in PubMed, Embase and ClinicalTrials...
January 22, 2024: Expert Opinion on Biological Therapy
#38
JOURNAL ARTICLE
Dina V Hingorani
INTRODUCTION: Antibody drug conjugates (ADCs) have emerged as a potent tool in cancer treatment, where cytotoxic drugs are linked to antibodies targeting specific antigens. While conventional ADC synthesis methods have seen success as commercials therapeutics, there is a growing interest in next-generation ADCs, looking at homogeneity of the drug-to-antibody ratio. AREAS COVERED: The article provides a high-level overview for achieving said homogeneity by site-directed conjugations via encompassing engineered amino acids, enzyme-mediated strategies, peptide sequences, affinity peptides, and beyond...
January 21, 2024: Expert Opinion on Biological Therapy
#39
JOURNAL ARTICLE
Ahmad Z Al Meslamani
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...
January 17, 2024: Expert Opinion on Biological Therapy
#40
JOURNAL ARTICLE
Marco Caminati, Claudio Micheletto, Francesca Norelli, Bianca Olivieri, Giancarlo Ottaviano, Roberto Padoan, Giorgio Piacentini, Michele Schiappoli, Gianenrico Senna, Francesco Menzella
INTRODUCTION: Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha subunit, effectively blocks both IL-4 and IL-13 mediated pathways. Its introduction has represented a significant advancement in the treatment of severe asthma and other Type 2 (T2) conditions, including nasal polyps, atopic dermatitis, and eosinophilic esophagitis. To date, Dupilumab has demonstrated optimal efficacy and safety profile. AREAS COVERED: The safety profile of dupilumab has been extensively studied, especially for its effects on blood eosinophil count...
January 10, 2024: Expert Opinion on Biological Therapy
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