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Expert Opinion on Biological Therapy

Simonetta Viviani, Anna Guidetti
Hodgkin Lymphoma (HL) patients refractory to first line therapy or relapsed after autologous stem cell transplant have a dismal prognosis and their treatment represents an unmet medical need. Brentuximab vedotin (BV) is a second-generation antibody-drug conjugate (ADC) constituted by an anti-CD30 antibody linked to the cytotoxic drug monomethyl auristatin E. First administration of BV in relapsed and refractory HL patients in phase I study showed an impressive anti-lymphoma activity and prompted development of the drug...
July 12, 2018: Expert Opinion on Biological Therapy
Oliver Waidmann
Immunotherapy is on the way to become the new standard of care for advanced hepatocellular carcinoma (HCC) worldwide. With higher rates of objective responses, and overall less side effects compared to tyrosine-kinase inhibitors (TKIs) immunotherapeutics will probably replace sorafenib from standard first-line treatment. Areas Covered: This review covers recent clinical data on systemic agents and ongoing trials in patients with advanced HCC focusing on immunotherapy. Expert Opinion: In unselected patients with advanced HCC immunotherapeutics, namely the programmed cell death-1 (PD-1) antibodies, nivolumab and pembrolizumab have shown promising efficacy in therapy-naïve as well as pre-treated patients with advanced HCC...
July 11, 2018: Expert Opinion on Biological Therapy
Luisa Barzon, Giorgio Palù
Japanese encephalitis is the most common vaccine-preventable encephalitis in the Asia-Pacific region. Areas covered: We provide an overview on Japanese encephalitis virus and associated disease, review the results of studies on the immunogenicity and efficacy of the licensed vaccines and describe the new vaccines that are under development. We also discuss data on candidate anti-Japanese encephalitis drugs that have shown promising results in experimental models. Expert opinion: The global burden of the Japanese encephalitis and associated mortality is still high, thus emphasizing the need to achieve the highest vaccination coverage in endemic areas...
July 10, 2018: Expert Opinion on Biological Therapy
Allan L Goldstein, Enrico Garaci
No abstract text is available yet for this article.
July 9, 2018: Expert Opinion on Biological Therapy
Ulrich Kronthaler, Cornelius Fritsch, Otmar Hainzl, Andreas Seidl, Antonio da Silva
BACKGROUND: Biosimilars are approved biologics that match reference medicine in quality, safety, and efficacy. The development of Sandoz proposed biosimilar adalimumab (SPBA; GP2017) involved a target-directed, iterative state-of-the-art quality-by-design development program. Here, we describe the functional and pharmacological characterization of SPBA and its proposed mechanism of action in immune-mediated inflammatory diseases. METHODS: Sensitive in vitro binding and functional characterization studies, and non-clinical evaluations (pharmacokinetics, pharmacodynamics, and safety/toxicology) were performed as part of a stepwise approach to confirm the biosimilarity of SPBA with reference adalimumab...
July 2, 2018: Expert Opinion on Biological Therapy
Nicola Stoner
No abstract text is available yet for this article.
June 30, 2018: Expert Opinion on Biological Therapy
Ioannis Parodis, Alvaro Gomez, Martina Frodlund, Andreas Jönsen, Agneta Zickert, Christopher Sjöwall, Anders A Bengtsson, Iva Gunnarsson
OBJECTIVES: Recently, we demonstrated a negative impact of smoking on belimumab efficacy in patients with systemic lupus erythematosus (SLE). Here, we particularly investigated clinical effects of belimumab and a potential impact of smoking in mucocutaneous and articular SLE. METHODS: We surveyed 62 SLE patients treated between 2011 and 2017. Evaluation included the mucocutaneous descriptors of SLEDAI-2K (rash, alopecia, mucosal ulcers; mcSLEDAI-2K), CLASI, the arthritis SLEDAI-2K descriptor (arSLEDAI-2K) and the 28-joint count...
June 29, 2018: Expert Opinion on Biological Therapy
Renáta Bor, Anna Fábián, Klaudia Farkas, Tamás Molnár, Zoltán Szepes
Crohn's Disease (CD) is a chronic, recurring, idiopathic disease which is associated with imbalanced mucosal immune response, manifesting as a chronic inflammation of any location throughout the gastrointestinal tract. The purpose of currently available therapy is to suppress the heightened immune response. However, these treatments have no direct influence on the healing process of damaged tissues. The mesenchymal stem cell (MSC) therapy may represent a new alternative solution both in luminal and fistulizing CD, as it is able to inhibit the inflammation and promote the regeneration process at the same time...
June 25, 2018: Expert Opinion on Biological Therapy
Francesca Becherucci, Benedetta Mazzinghi, Marco Allinovi, Maria Lucia Angelotti, Paola Romagnani
Introduction Chronic kidney disease is a major healthcare problem worldwide and its cost is becoming no longer affordable. Indeed, restoring damaged renal structures or building a new kidney represent an ambitious and ideal alternative to renal replacement therapy. Streams of research have explored the possible application of pluripotent SCs (embryonic SCs and induced pluripotent SCs) in different strategies aimed at regenerate functioning nephrons and at understanding the mechanisms of kidney regeneration...
June 25, 2018: Expert Opinion on Biological Therapy
Isabel Andia, Nicola Maffulli
Regular engagement in sports produces many health benefits, but also exposes to increased injury risk. The quality of medical care available is crucial not only for sports trauma but also to avoid overuse syndromes and post-traumatic degenerative conditions. Areas Covered: We provide background information on some clinical needs in sport injuries and describe the main families of biological products used in clinical practice. We also discuss limitations of the current clinical experience. Expert opinion: Sport and exercise impairment affects different segments of the population with different needs...
June 25, 2018: Expert Opinion on Biological Therapy
Shiven S Patel, Thomas B Casale, Juan Carlos Cardet
Severe uncontrolled asthma is by definition refractory to traditional therapies or can be controlled only with therapies that have intolerable side effects. Monoclonal antibodies that target IL-5/IL-5Rα, IgE and IL-4Rα have shown favorable results in clinical trials, including reductions in asthma exacerbations and other important clinical outcomes. These biological agents offer treatment alternatives to patients with uncontrolled severe eosinophilic asthma. Areas Covered: This article reviews how the shifting emphasis towards identifying distinct asthma phenotypes has led to the approval of biological therapies that preferentially benefit patients with severe eosinophilic asthma...
June 23, 2018: Expert Opinion on Biological Therapy
Marco Tagliamento, Erika Rijavec, Giulia Barletta, Federica Biello, Giovanni Rossi, Francesco Grossi, Carlo Genova
Lung cancer represents the most common cause of cancer death worldwide. While the prognosis remains poor, immunotherapy is giving a positive impact on survival. Cancer vaccines represent a form of active immunotherapy that historically have given modest results in terms of efficacy. The overexpression of the EGFR by tumor cells was reported in more than half of cases of lung cancer, representing a mechanism of cancerogenesis. CIMAvax-EGF, a therapeutic vaccine for non-small cell lung cancer (NSCLC) developed in Cuba, consists of a human recombinant EGF able to induce antibodies against the autologous EGF, resulting in serum EGF withdrawal and lower EGF-EGFR interaction...
June 23, 2018: Expert Opinion on Biological Therapy
Anthony Donsante, Nicholas M Boulis
The neuronal ceroid lipofuscinoses (NCLs) are a subset of lysosomal storage diseases (LSDs) that cause myoclonic epilepsy, loss of cognitive and motor function, degeneration of the retina leading to blindness, and early death. Most are caused by loss-of-function mutations in either lysosomal proteins or transmembrane proteins. Current therapies are supportive in nature. NCLs involving lysosomal enzymes are amenable to therapies that provide an exogenous source of protein, as has been used for other LSDs. Those that involve transmembrane proteins, however, require new approaches...
June 23, 2018: Expert Opinion on Biological Therapy
Maria I Patrício, Alun R Barnard, Kanmin Xue, Robert E MacLaren
INTRODUCTION: Choroideremia is an X-linked inherited retinal degeneration that causes blindness in afflicted males by middle age. The causative gene, CHM, plays a key role in intracellular trafficking pathways, and its disruption impairs cell homeostasis. Areas covered: The mechanism by which mutations in CHM cause choroideremia is still under debate. Here we describe the molecular defects in choroideremia cells regarding both the deficiency of prenylation and the involvement of Rab GTPases...
June 22, 2018: Expert Opinion on Biological Therapy
Jennifer Osei, William Kelly, Kathryn Toffolo, Kaitlynn Donahough, Bennet Levy, Jonathan Bard, Jianxin Wang, Elad Levy, Norma Nowack, David Poulsen
OBJECTIVES: Thymosin beta 4 (Tβ4) has demonstrated neuroprotective potential in models of neurlogical injury. The neuroprotective potential of Tβ4 has been associated with increased miR-200a and miR-200b within the brain following stroke. Here we tested the hypothesis that Tβ4 treatment could also alter miRNA profiles within the plasma following severe traumatic brain injury (TBI). METHODS: We used the rat lateral fluid percusion injury model of severe TBI to test this hypothesis...
June 6, 2018: Expert Opinion on Biological Therapy
Marco Galluzzo, Marina Talamonti, Clara De Simone, Simone D'Adamio, Gaia Moretta, Sara Tambone, Giacomo Caldarola, Maria Concetta Fargnoli, Ketty Peris, Luca Bianchi
OBJECTIVES: To evaluate efficacy and safety of the anti-IL-17 drug secukinumab in a real-life large cohort of patients with moderate-to-severe plaque psoriasis in Central Italy. METHODS: Multicenter, retrospective study with an observation period of up to 52 weeks. Efficacy was assessed by Psoriasis Area and Severity Index (PASI) score; clinical and laboratory examinations were performed at baseline and at weeks 4, 12, 24, 36, and 52. RESULTS: A 90% and a 100% PASI score reduction (PASI90 and PASI100) were reported in 67...
June 6, 2018: Expert Opinion on Biological Therapy
Paul H Naylor, Cartha W Naylor
No abstract text is available yet for this article.
May 24, 2018: Expert Opinion on Biological Therapy
Elisavet Vasilopoulou, Paul R Riley, David A Long
There is an urgent need for new treatments for chronic kidney disease (CKD). Thymosin-β4 is a peptide that reduces inflammation and fibrosis and has the potential to restore endothelial and epithelial cell injury, biological processes involved in the pathophysiology of CKD. Therefore, thymosin-β4 could be a novel therapeutic direction for CKD. Areas covered: Here, we review the current evidence on the actions of thymosin-β4 in the kidney in health and disease. Using transgenic mice, two recent studies have demonstrated that endogenous thymosin-β4 is dispensable for healthy kidneys...
May 9, 2018: Expert Opinion on Biological Therapy
Ross J Thibodaux, Mallory W Triche, Luis R Espinoza
Psoriasis (PsO) is an inflammatory disorder characterized by proliferation of keratinocytes, and it may be associated with a systemic inflammatory articular disorder, psoriatic arthritis (PsA). The presentations of PsO and PsA are heterogeneous, and our understanding of pathogenesis has led to a better understanding of the role of the interleukin (IL)-23/T-helper 17 (Th17) axis. Areas covered: Ustekinumab is a monoclonal antibody against IL-12 and IL-23. The pathogenesis of PsO and PsA is a multifactorial process involving genetic, environmental, and lifestyle factors...
July 2018: Expert Opinion on Biological Therapy
Lorenzo Pilla, Soldano Ferrone, Cristina Maccalli
Cancer vaccines represent one of the oldest immunotherapy strategies. A variety of tumor-associated antigens have been exploited to investigate their immunogenicity as well as multiple strategies for vaccine administration. These efforts have led to the development of several clinical trials in tumors with different histological origins to test the clinical efficacy of cancer vaccines. However, suboptimal clinical results have been reported mainly due to the lack of optimized strategies to induce strong and sustained systemic tumor antigen-specific immune responses...
July 2018: Expert Opinion on Biological Therapy
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