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Expert Opinion on Biological Therapy

Priscilla de Graaff, Coen Govers, Harry Wichers, Reno Debets
Adoptive T-cell treatments of solid cancers have evolved into a robust therapy with objective response rates surpassing those of standardized treatments. Unfortunately, only a limited fraction of patients shows durable responses, which is considered to be due to a T cell-suppressive tumour microenvironment (TME). Here we argue that naturally occurring β-glucans can enable reversion of such T cell suppression by engaging innate immune cells and enhancing numbers and function of lymphocyte effectors. Areas covered: This review summarizes timely reports with respect to absorption, trafficking and immune stimulatory effects of β-glucans, particularly in relation to innate immune cells...
September 15, 2018: Expert Opinion on Biological Therapy
Peipei Ren, Zhujun Cao, Ruidong Mo, Yuhan Liu, Lichang Chen, Ziqiang Li, Tianhui Zhou, Jie Lu, Yunye Liu, Qing Guo, Rong Chen, Huijuan Zhou, Xiaogang Xiang, Wei Cai, Hui Wang, Shisan Bao, Yumin Xu, Honglian Gui, Qing Xie
BACKGROUND: The effect of nucleos(t)ide analogs (NAs) versus interferon (IFN) on the occurrence of hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB) is controversial. We assessed whether antiviral strategy affected HCC development in CHB patients at different HCC risks. METHODS: 1112 CHB patients with antiviral therapy were included in this retrospective study. Patients treated with NAs only were classified into NAs group (n = 682) while those received IFN treatment with or without NAs were defined as IFN group (n = 430)...
September 13, 2018: Expert Opinion on Biological Therapy
Kiichiro Ninomiya, Katsuyuki Hotta
Platinum-based chemotherapy had long played a role as standard therapy for the first-line treatment of advanced or recurrent non-small cell lung cancer (NSCLC). However, immune checkpoint inhibitors such as pembrolizumab, a monoclonal antibody that prevents programmed death protein 1 (PD-1) receptor, have brought a paradigm shift in this field. Areas covered: In this article, we review the relevant literatures and ongoing trials on the first-line treatment of pembrolizumab. Especially, in two pivotal phase III trials, KEYNOTE-024 and -189, both pembrolizumab monotherapy and combined pembrolizumab plus chemotherapy significantly prolonged overall survival (OS) compared to the existing platinum-based chemotherapy...
September 12, 2018: Expert Opinion on Biological Therapy
Paurvi Shinde, Vinita Bharat, Annabelle Rodriguez-Oquendo, Beiyan Zhou, Anthony T Vella
Due to the ability of pathogen-associated molecular patters and tumor necrosis factor receptor (TNFR) family costimulatory agonists to boost T cell responses, studies have combined Toll-like receptor (TLR) ligands with TNFR family costimulatory receptor agonists to induce impressive and long-lasting T cell responses. Although some studies have determined how these combinatorial vaccines promote enhanced T cell responses, much remains unknown about the mechanism used by these combinations to promote synergistic T cell responses - especially in settings of infectious diseases or cancer...
September 12, 2018: Expert Opinion on Biological Therapy
Vaihere Delaune, Lorenzo A Orci, Stéphanie Lacotte, Andrea Peloso, Jacques Schrenzel, Vladimir Lazarevic, Christian Toso
Non-alcoholic fatty liver disease (NAFLD) has the potential to progress to hepatocellular carcinoma (HCC). However, limited therapies are currently available for the treatment of advanced HCC, and one must strive to search for novel strategies. Areas covered: We provide insight on current knowledge related to gut microbiota and NAFLD, summarize the sequence linking obesity to HCC and highlight gut dysbiosis in obesity and its consequences on the liver. We detail the impact of the gut microbiota on immune checkpoint inhibitors, and speculate on the role of fecal microbiota transplantation (FMT) in NAFLD and in improving anti-neoplastic immune response...
September 10, 2018: Expert Opinion on Biological Therapy
Rehan M Hussain, Thomas A Ciulla, Audina M Berrocal, Ninel Z Gregori, Harry W Flynn, Byron L Lam
Stargardt macular dystrophy (STGD1) is a hereditary retinal degeneration that lacks effective treatment options. Gene therapy, stem cell therapy, and pharmacotherapy with visual cycle modulators (VCMs) and complement inhibitors are discussed as potential treatments. Areas covered: Investigational therapies for STGD1 aim to reduce toxic bisretinoids and lipofuscin in the retina and retinal pigment epithelium (RPE). These agents include C20-D3-vitamin A (ALK-001), isotretinoin, VM200, emixustat, and A1120. Avacincaptad pegol is a C5 complement inhibitor that may reduce inflammation-related RPE damage...
September 10, 2018: Expert Opinion on Biological Therapy
Richard Flint, Angie Rantell, Linda Cardozo
Overactive bladder is a common condition that can have a negative impact on quality of life. Botulinum Toxin A is a third line treatment for overactive bladder following conservative measures and anticholinergic medication. At present, OnabotulinumtoxinA is the only preparation licensed for this indication. More recently, trials have been undertaken to compare the efficacy of this to AbobotulinumtoxinA. Areas covered: This article aims to provide an overview of AbobotulinumtoxinA, which is currently not yet licensed for overactive bladder or neurogenic detrusor overactivity...
September 10, 2018: Expert Opinion on Biological Therapy
Oshrat E Tayer-Shifman, Cheryl F Rosen, Laura Wakani, Zahi Touma
Cutaneous lupus erythematosus (CLE) encompasses a spectrum of dermatologic manifestations which can occur with or without systemic lupus erythematosus (SLE). Treatment of CLE is challenging as the traditional treatments are off label and often fail and there is no drug specifically approved for CLE. The knowledge gained from the emerging trials on biologic therapy in SLE has provided insight into the utility of biologic therapy for CLE. Areas covered: An overview is provided on the biological agents studied for CLE discussing their immunological target, their efficacy in treating the various CLE manifestations and the outcome measures used...
September 5, 2018: Expert Opinion on Biological Therapy
Xin Gao, David F McDermott
Renal cell carcinoma (RCC) is a highly immunogenic neoplasm, and cytokine-based immunotherapies have been used for decades with limited success. In recent years, antibody-based immunotherapies targeting immune checkpoint receptors PD-1 and CTLA-4 have demonstrated clinical efficacy in metastatic RCC (mRCC) patients, leading to FDA approval of the combination of nivolumab and ipilimumab in treatment-naïve patients with intermediate- or poor-risk disease in April 2018. Areas covered: The pharmacodynamics and pharmacokinetics of nivolumab and ipilimumab are reviewed...
September 2018: Expert Opinion on Biological Therapy
Pranab Chatterjee, Suman Kanungo, Shanta Dutta
Cholera remains a public health threat. The development of safe, effective, easy-to-administer, heat-stable, and cheap killed whole cell oral cholera vaccines (OCVs) has provided an additional tool to counter cholera. In this meta-opinion, we review the challenges of delivering OCVs through the existing public health infrastructure in vulnerable areas. Areas covered: We provide an overview of the available vaccines against cholera, the existing evidence about the effectiveness of a two-dose as well as a single-dose OCV strategy...
September 2018: Expert Opinion on Biological Therapy
Dominique Bremond-Gignac, Henri Copin, Moncef Benkhalifa
Ocular surface diseases with limbal insufficiency represent a therapeutic challenge for restoring vision. This corneal deficiency includes both classical ocular diseases (as chemical burns) and rare ocular diseases (as congenital aniridia and ocular cicatricial pemphigoid). Areas covered: Our understanding of limbal epithelial stem cells (LESCs) has increased the potential for treatment options. Pharmacological treatment strategies (as regenerating agent ophthalmic solutions) and especially surgical treatment strategies are available...
September 2018: Expert Opinion on Biological Therapy
Mitchell Evers, Margot Jak, J H W Leusen
In more recent years, anti-CD20 monoclonal antibodies have become the backbone in the treatment of chronic lymphocytic leukemia (CLL). Historically, these antibodies were typically combined with chemotherapeutic agents. At present, therapeutic outcomes are significantly improving with the introduction of several novel targeted drugs to the clinical repertoire. Areas covered: In this review, we summarize the current clinical standard together with the latest developments in the field of anti-CD20 antibodies against CLL...
September 2018: Expert Opinion on Biological Therapy
Vincenzo di Noia, Ettore D'Argento, Sara Pilotto, Giulia Grizzi, Mario Caccese, Roberto Iacovelli, Giampaolo Tortora, Emilio Bria
Over the last decade, epidermal growth factor receptor (EGFR) signaling was investigated as a potential target for tyrosine kinase inhibitors in the treatment of non-small-cell lung cancer (NSCLC). Necitumumab is a fully humanized IgG1 monoclonal antibody directed against the binding domain of EGFR, approved in combination with cisplatin-gemcitabine for the first-line treatment of squamous NSCLC. Areas covered: The purpose of this manuscript is to systematically review the state of the art of necitumumab for the treatment of metastatic NSCLC, focusing on predictive factors, cost-effectiveness, and future potential combinations with additional agents...
September 2018: Expert Opinion on Biological Therapy
Joost van Haasteren, Stephen C Hyde, Deborah R Gill
Ex-vivo gene therapy has had significant clinical impact over the last couple of years and in-vivo gene therapy products are being approved for clinical use. Gene therapy and gene editing approaches have huge potential to treat genetic disease and chronic illness. Areas covered: This article provides a review of in-vivo approaches for gene therapy in the lung and liver, exploiting non-viral and viral vectors with varying serotypes and pseudotypes to target-specific cells. Antibody responses inhibiting viral vectors continue to constrain effective repeat administration...
September 2018: Expert Opinion on Biological Therapy
Rubén Queiro, Pablo Coto-Segura
Ustekinumab (UST) is a recently approved drug for the treatment of psoriatic arthritis (PsA). The ACR response rates in randomized clinical trials (RCTs) with this drug have been slightly lower than that reported in RCTs of anti-TNF and anti-IL17 therapies. Therefore, the position that this drug may occupy in the treatment algorithms of PsA is not clear. More information is needed on the true efficacy of this agent under real clinical practice conditions. In this review of real-world evidence studies, it is shown that UST is effective and safe to treat PsA; nevertheless, it is necessary to homogenize the way in which the main outcomes and treatment objectives of these studies are presented...
September 2018: Expert Opinion on Biological Therapy
Zdenka Hruskova, Vladimir Tesar
Treatment of systemic lupus erythematosus (SLE) represents a challenge due to variable disease manifestations, clinical course, and outcome. Long-term outcome in SLE remain unsatisfactory and a search for new therapeutic options is definitely warranted. Despite expectations, most clinical trials performed in SLE and lupus nephritis in the last decade did not reach primary outcome, and the only drug that has been licensed is belimumab. Areas covered: Results of negative trials testing monoclonal antibodies and other biologic agents in SLE are briefly summarized...
September 2018: Expert Opinion on Biological Therapy
Vito Di Lernia, Mohamad Goldust
Psoriasis in elderly patients is considered to be of emerging clinical relevance because of the increase in the aged segment of the population. Psoriasis in such a group raises significant management challenges. There is an age-related immunosuppression, a high frequency of comorbidities, and polypharmacy, which enhances the potential risk of drug interactions or side effects when an additional systemic treatment must be administered. Despite the aging of the general population, clinical studies focusing on treatment of geriatric psoriasis are limited...
August 2018: Expert Opinion on Biological Therapy
Letizia Mazzini, Daniela Ferrari, Pavle R Andjus, Leonora Buzanska, Roberto Cantello, Fabiola De Marchi, Maurizio Gelati, Rashid Giniatullin, Joel C Glover, Mariagrazia Grilli, Elena N Kozlova, Margherita Maioli, Dinko Mitrečić, Augustas Pivoriunas, Rosario Sanchez-Pernaute, Anna Sarnowska, Angelo L Vescovi
Amyotrophic Lateral Sclerosis (ALS) is a progressive, incurable neurodegenerative disease that targets motoneurons. Cell-based therapies have generated widespread interest as a potential therapeutic approach but no conclusive results have yet been reported either from pre-clinical or clinical studies. Areas covered: This is an integrated review of pre-clinical and clinical studies focused on the development of cell-based therapies for ALS. We analyze the biology of stem cell treatments and results obtained from pre-clinical models of ALS and examine the methods and the results obtained to date from clinical trials...
August 2018: Expert Opinion on Biological Therapy
Leire Iturriaga, Raquel Hernáez-Moya, Itsasne Erezuma, Alireza Dolatshahi-Pirouz, Gorka Orive
Osteoarthritis (OA) is a progressive joint disease that compromises the structural integrity of cartilage tissue. Conventional treatments based on medication or surgery are nowadays inefficient and cell-based therapy has emerged as one of the most promising methods for cartilage regeneration. The first therapy developed for cartilage defects was autologous chondrocyte implantation, but in the last few decades stem cells (SCs) from different sources have been proposed as a possible alternative for OA. Areas covered: SC sources and available delivery procedures (scaffolds/hydrogels) are presented, along with the main issues arisen in this regard...
August 2018: Expert Opinion on Biological Therapy
Simonetta Viviani, Anna Guidetti
Hodgkin's lymphoma (HL) patients refractory to first-line therapy or relapsed after autologous stem cell transplantation 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. The first administration of BV in relapsed and refractory HL patients in a phase I study showed an impressive antilymphoma activity and prompted development of the drug...
August 2018: Expert Opinion on Biological Therapy
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