Use the journals feature with a free QxMD account.
Use Read by QxMD to access full text via your institution or open access sources.
Read also provides personalized recommendations to keep you up to date in your field.
Existing User
Sign InNew to Read
Sign Up#21
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
#22
EDITORIAL
Lukas Pekar, Simon Krah, Stefan Zielonka
No abstract text is available yet for this article.
February 22, 2024: Expert Opinion on Biological Therapy
#23
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
#24
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
#25
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
#26
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
#27
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
#28
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
#29
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
#30
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
#31
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
#32
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
#33
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
#34
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
#35
JOURNAL ARTICLE
Ahmad Z Al Meslamani
INTRODUCTION: Asthma is a global health problem, with alarming prevalence and mortality rates. Biologic therapies, particularly monoclonal antibodies such as omalizumab, have emerged as promising alternatives, targeting specific immune pathways. This article assesses the efficacy of these biologics in asthma management and attempts to reveal factors associated with their response and failure dynamics. AREA COVERED: This article explores the efficacy of biologics in asthma, biomarkers, and the relationship between asthma phenotypes (including eosinophilic and non-eosinophilic (neutrophilic) types) and biologic treatments; particularly their effectiveness for each subtype...
January 4, 2024: Expert Opinion on Biological Therapy
#36
EDITORIAL
Stefano Molica, Marco Rossi, David Allsup
No abstract text is available yet for this article.
2024: Expert Opinion on Biological Therapy
#37
REVIEW
Kamila Polgarova, Marek Trneny
INTRODUCTION: Significant proportion of patients with diffuse large B-cell lymphoma (DLBCL) is refractory or relapse (R/R) after the treatment. The prognosis of this patient cohort remains poor. Novel strategies mainly based on immunotherapy and targeted agents are currently being studied. Glofitamab is novel T-cell-engaging bispecific antibody possessing a 2:1 structure with bivalent CD20 binding. Its safety and efficacy in R/R B-cell non-Hodgkin lymphoma including DLBCL were evaluated in phase I-II NP30179 trial...
2024: Expert Opinion on Biological Therapy
#38
REVIEW
Alexander K Tsai, Sana Kagalwalla, Jenna Langer, Thuy Le-Kumar, Vikas Le-Kumar, Emmanuel S Antonarakis
INTRODUCTION: Immunotherapies have revolutionized the management of various malignancies but have only recently been evaluated systematically in prostate cancer. Pembrolizumab, a programmed-death 1 (PD-1) blocking antibody, has been utilized in a small subset of prostate cancer patients with mismatch repair deficiency/microsatellite instability, but has now been assessed in broader populations of metastatic prostate cancer patients. AREAS COVERED: The results of four pembrolizumab-based phase III clinical trials for metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) patients, including KEYNOTE-641, KEYNOTE-921, KEYNOTE-991, and KEYLYNK-010 are summarized...
2024: Expert Opinion on Biological Therapy
#39
RANDOMIZED CONTROLLED TRIAL
Barbara Vogg, Johann Poetzl, Rachid El Galta, Rainard Fuhr, Arnd Schwebig, Susmit Sekhar
BACKGROUND: This Phase I study compared the pharmacokinetic (PK) and pharmacodynamic (PD) similarity of GP2411 proposed denosumab biosimilar to reference denosumab (a monoclonal antibody for specific pro-resorptive conditions). RESEARCH DESIGN AND METHODS: Healthy males (28-65 years, 50-90 kg) were randomized to a single sub-therapeutic subcutaneous injection of 35 mg GP2411, EU-Xgeva® or US-Xgeva®, and followed for 39 weeks...
2024: Expert Opinion on Biological Therapy
#40
JOURNAL ARTICLE
A Chiricozzi, S M Ferrucci, L Di Nardo, N Gori, A Balato, M Ortoncelli, M Maurelli, M Galluzzo, M Munera Campos, T Seremet, G Caldarola, C De Simone, E Ippoliti, T Torres, S Gkalpakiotis, C Conrad, J M Carrascosa, L Bianchi, G Argenziano, S Ribero, G Girolomoni, A V Marzano, K Peris
BACKGROUND: Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. RESEARCH DESIGN AND METHODS: A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts...
December 18, 2023: Expert Opinion on Biological Therapy
Make the most of Read.
Download the mobile app.
Download the mobile app.
Fetching more papers... 
