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Expert Opinion on Biological Therapy

Jorien van der Schaft, Judith L Thijs, Floor M Garritsen, D Balak, Marjolein S de Bruin-Weller
For many years, oral immunosuppressive drugs such as cyclosporine A, azathioprine, mycophenolic acid and methotrexate were the only treatment options, in addition to topical treatment, in patients with severe atopic dermatitis (AD). Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha, is the first antibody-based treatment commercially available for the treatment of AD. In the near future, more antibody-based treatments and small molecules will become available in the treatment of severe AD. Areas covered: This review gives an overview of current and future therapies for severe AD, outlines options to optimize treatment with oral immunosuppressive drugs and gives an insight into the future of personalized treatment in AD...
February 15, 2019: Expert Opinion on Biological Therapy
Fabio Barra, Giovanni Grandi, Matteo Tantari, Carolina Scala, Fabio Facchinetti, Simone Ferrero
Endometriosis is a chronic benign estrogen dependent disease characterized by the presence of endometriotic glands and stroma outside the uterine cavity. Although combined hormonal contraceptives and progestins, currently available first-line treatments for endometriosis, are efficacious and well tolerated for treating disease-related pain, some women experience partial or no improvement of pain or its recurrence is frequent after discontinuation of the therapies. For these reasons, new drugs are under investigation for the treatment of endometriosis...
February 14, 2019: Expert Opinion on Biological Therapy
Martyna Filipska, Carlos Pedraz-Valdunciel, Imane Chaib, Rafael Rosell
Biological therapies, with immunotherapy leading the field, have arisen as one of the quickest expanding areas of research for cancer treatment in the last few years. The clear benefits for patients are undeniable, satisfying the long-awaited necessity of a target-specific therapy. However, its full potential remains still unexploited due to a lack of response in a majority of patients and pending reliable biomarkers. Areas covered: This review provides a summarizing view of the current biological therapies for lung cancer, focusing on immunotherapy - including immune checkpoint inhibitors, adoptive cell therapy and vaccines available in clinical/pre-clinical settings or currently in development...
February 14, 2019: Expert Opinion on Biological Therapy
Fabrizio Gallo, Gaetano Ninotta, Maurizio Schenone, Pierluigi Cortese, Claudio Giberti
Among the several options that have been proposed in recent years for the management of male stress urinary incontinence (SUI), stem cell therapy represents a new frontier in treatment. The aim of this paper is to update the current status of stem cell therapy in animal and human studies for the management of iatrogenic male SUI. Areas covered: A literature review was conducted based on MEDLINE/PubMed searches for English articles using a combination of the following keywords: stem cell therapy, urinary incontinence, prostatectomy, regenerative medicine, mesenchymal stem cells...
February 1, 2019: Expert Opinion on Biological Therapy
Sara Sayad-Fathi, Ebrahim Nasiri, Arash Zaminy
The sciatic nerve is one of the peripheral nerves that is most prone to injuries. After injury, the connection between the nervous system and the distal organs is disrupted, and delayed treatment results in distal organ atrophy and total disability. Regardless of great advances in the fields of neurosurgery, biological sciences, and regenerative medicine, total functional recovery is yet to be achieved. Areas covered: Cell-based therapy for the treatment of peripheral nerve injuries (PNIs) has brought a new perspective to the field of regenerative medicine...
January 31, 2019: Expert Opinion on Biological Therapy
Oliver von Richter, Lena Lemke, Halimuniyazi Haliduola, Rainard Fuhr, Thomas Koernicke, Ellen Schuck, Maria Velinova, Andrej Skerjanec, Johann Poetzl, Julia Jauch-Lembach
BACKGROUND: To compare the pharmacokinetics of Sandoz biosimilar adalimumab (GP2017) with reference adalimumab (Humira) in healthy volunteers (PK similarity study) and to compare the pharmacokinetics of GP2017 administered by autoinjector (AI) or prefilled syringe (PFS; delivery study). METHODS: Healthy male subjects were randomized to receive a single 40 mg subcutaneous injection of GP2017, US-licensed or EU-authorized reference adalimumab (US/EU-Humira; PK similarity study) or a single 40 mg subcutaneous injection of GP2017 via AI or PFS (delivery study)...
January 30, 2019: Expert Opinion on Biological Therapy
Marjolijn Duijvestein, Geert R D'Haens
Mucosal addressin cell adhesion molecule-1 (MAdCAM-1) expression in gut-associated lymphoid tissue is upregulated in patients with inflammatory bowel disease (IBD). Blocking adhesion molecules and thereby inhibiting migration of lymphocytes into sites of inflammation in the gut is an attractive new treatment target in drug development for IBD. Areas covered: This review discusses the preclinical and clinical experience on SHP647 (previously called PF-00547659 and PF-00547,659), a fully human IgG2K monoclonal antibody that binds to MAdCAM-1 to selectively reduce lymphocyte homing to the intestinal tract...
January 29, 2019: Expert Opinion on Biological Therapy
Enoch Kassa, Thomas A Ciulla, Rehan M Hussain, Pravin U Dugel
Dry age-related macular degeneration (AMD) and Stargardt Macular Dystrophy (STGD1) result in vision loss due to progressive atrophy of the macula and lack of effective treatments. Numerous studies have implicated complement-associated inflammation as a contributor to both diseases. Areas covered: The complement factor D inhibitor, lampalizumab, failed to halt geographic atrophy (GA) progression in phase 3 studies. The complement factor 3 (C3) inhibitor, APL-2, has shown potential to reduce GA growth in a phase 2 trial, supporting advancement to phase 3 trials...
January 26, 2019: Expert Opinion on Biological Therapy
Wenbin Liang, Lilit Gasparyan, Wael AlQarawi, Darryl R Davis
Inherited arrhythmias are an uncommon, but malignant family of cardiac diseases that result from genetic abnormalities in the ion channels and/or structural proteins within cardiomyocytes. Given the inherent differences between species and the limited reproducibility of in vitro heterologous cell models, progress in understanding the mechanisms underlying these malignant diseases has always languished far behind the clinical science and need. The ability to study human induced pluripotent stem cells (iPSCs) derived cardiomyocytes promises to change this paradigm as patient cells have the potential to become testing platforms for disease phenotyping or therapeutic discovery...
January 25, 2019: Expert Opinion on Biological Therapy
Randall Li, Suhail Hadi, Emma Guttman-Yassky
Atopic dermatitis (AD) is the most common inflammatory skin disease, yet until recently there were no safe systemic therapies approved for the long-term management of AD in adult patients. A deeper understanding of disease pathogenesis and identification of molecular and cellular changes has resulted in a rapidly evolving pipeline of therapeutics that holds promise for safer long-term control. Areas Covered: In this review, we highlight the growing arsenal of biologic and small molecule antagonists that target pathways implicated in AD pathogenesis...
January 23, 2019: Expert Opinion on Biological Therapy
Michael Shafique, Tawee Tanvetyanon
Immunotherapy, either as monotherapy or in combination with chemotherapy, has demonstrated superior efficacy to chemotherapy alone in the frontline setting. To date, there has been no randomized study comparing immunotherapy alone with chemo-immunotherapy. Areas Covered: This paper reviews the immunobiological rationale for combining chemotherapy with checkpoint inhibitors as well as the data from recent phase-3 studies to understand the risks and benefits associated with either therapeutic approach for diverse patient populations...
January 18, 2019: Expert Opinion on Biological Therapy
Raffaele Addeo, Massimo Ghiani, Francesco Merlino, Filippo Ricciardiello, Michele Caraglia
No abstract text is available yet for this article.
January 17, 2019: Expert Opinion on Biological Therapy
Kjell-Morten Myhr, Øivind Torkildsen, Andreas Lossius, Lars Bø, Trygve Holmøy
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. The latest development of B-cell depletion by anti-CD20 monoclonal antibodies has been a large step forward in the treatment of this devastating disease. Areas covered: In this manuscript, we review mechanisms of action, efficacy, safety and tolerance of anti-CD20 therapies for MS, including rituximab, ocrelizumab, and ofatumumab. Expert Opinion: B-cell depletion efficiently suppresses acute inflammatory disease activity in relapsing-remitting MS (RRMS), and may slow down progression in primary progressive MS (PPMS)...
January 11, 2019: Expert Opinion on Biological Therapy
Carla Felice, Daniela Pugliese, Alessandro Armuzzi
No abstract text is available yet for this article.
January 8, 2019: Expert Opinion on Biological Therapy
Eleftherios Pelechas, Alexandros Drosos
Biosimilars are highly similar molecules to other biological medicines that have already been authorised for use. Etanercept (ETN) was the first anti-tumour necrosis factor inhibitor (TNFi) approved by the Food and Drug Administration for the treatment of moderate to severe rheumatoid arthritis (RA) in November 1998 and in February 2000 by the European Medicines Agency. Twenty years later, the first ETN biosimilar has come of age. Areas covered: In this review we examined SB-4 as a biosimilar candidate to ETN, focusing on the available data...
January 8, 2019: Expert Opinion on Biological Therapy
Mohammad Rasoolian, Majid Kheirollahi, Younes Hosseini
MDA-7/Interleukin-24 (IL-24), as a pleiotropic cytokine, exhibits a specific tumor suppression property that has attracted a great deal of attention. While its anti-tumor induction is mostly attributed to endogenous gene expression, attachment of secreted MDA-7/IL-24 to cognate receptors also triggers the death of cancerous cell via different pathways. Therefore, precise targeting of secreted MDA-7/IL-24 to tumor cells would render it more efficacy and specificity. Areas covered: In order to target soluble cytokines, particularly MDA-7/IL-24 to the neighbor tumor sites and enhance their therapeutic efficiency, fusing with cell penetrating peptides (CPPs) or Tumor homing peptides (THPs) seems logical due to the improvement of their bystander effects...
January 5, 2019: Expert Opinion on Biological Therapy
Gionata Fiorino, Daniela Gilardi, Carmen Correale, Federica Furfaro, Giulia Roda, Laura Loy, Marjorie Argollo, Mariangela Allocca, Laurent Peyrin-Biroulet, Silvio Danese
Introduction Biosimilars represent great potential in cost saving and re-investment opportunities in healthcare and allow patients greater access to effective mAbs. Infliximab biosimilars are successfully used in all indications for whom the reference product (RP) was approved. Areas covered In late 2018, adalimumab biosimilars will also be available in patients with inflammatory bowel disease (IBD). ABP501, BI 695501, GP2017, and SB5 have been approved by the EMA for the same indications of the reference product (RP, Humira®)...
January 2, 2019: Expert Opinion on Biological Therapy
Andras Tarnok, Zoltan Kiss, Orsolya Kadenczki, Gabor Veres
At present, there a is significant amount of data related to biologics used in pediatric patients with Crohn's disease. This review characterizes the different biological drugs administered in this population. Areas covered: Biological therapy of CD, focusing on children, is summarized in this review. After mechanism of action and pharmacokinetics are described, mucosal healing on anti-TNF therapy, aspects of early therapy, long-term outcome and combination therapy are discussed. Moreover, loss of response and treatment optimization, as well as drug withdrawal are summarized...
January 2, 2019: Expert Opinion on Biological Therapy
Patrick J Atkinson, Grace S Kim, Alan G Cheng
Sound is integral to communication and connects us to the world through speech and music. Cochlear hair cells are essential for converting sounds into neural impulses. However, these cells are highly susceptible to damage from an array of factors, resulting in degeneration and ultimately irreversible hearing loss in humans. Since the discovery of hair cell regeneration in birds, there have been tremendous efforts to identify therapies that could promote hair cell regeneration in mammals. Areas covered: Here, we will review recent studies describing spontaneous hair cell regeneration and direct cellular reprograming as well as other factors that mediate mammalian hair cell regeneration...
December 25, 2018: Expert Opinion on Biological Therapy
Kejian Wang, Yue Han, William C Cho, Huang Zhu
Natural killer (NK) cell therapy has been proven to be safe and clinically effective for the treatment of multiple cancers, in particular blood cancers. Most of the clinical trials use primary NK cells from peripheral blood or umbilical cord blood, or NK-92 cells. Each cell source is confined by limitations, such as donor dependence, low persistence in vivo, and its difficulty to genetically modify. Thus, there is an urgent need to explore novel NK cell sources for clinical use. Areas covered: This article highlights the recent progress in utilizing stem cell-derived NK cells as anticancer therapies and strategies to improve their antitumor activities...
December 24, 2018: Expert Opinion on Biological Therapy
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