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    23 results match your criteria Biologics in Therapy [Journal]

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    Healthcare Resource Utilization in Patients Receiving Omalizumab for Allergic Asthma in a Real-World Setting.
    Biol Ther 2014 Dec 5;4(1-2):57-67. Epub 2014 Nov 5.
    Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, UK.
    Introduction: Inadequately controlled asthma is associated with increased healthcare resource utilization. The eXpeRience registry was initiated to evaluate real-world outcomes in patients receiving omalizumab for uncontrolled persistent allergic asthma. The current analysis of data from the eXpeRience registry focuses on healthcare resource utilization and on absences from work or school. Read More

    Enhancing Patient Flexibility of Subcutaneous Immunoglobulin G Dosing: Pharmacokinetic Outcomes of Various Maintenance and Loading Regimens in the Treatment of Primary Immunodeficiency.
    Biol Ther 2014 Dec 14;4(1-2):41-55. Epub 2014 Aug 14.
    CSL Behring LLC, King of Prussia, PA, USA.
    Introduction: Standard treatment for patients with primary immunodeficiency (PID) is monthly intravenous immunoglobulin (IVIG), or weekly/biweekly subcutaneous immunoglobulin (SCIG) infusion. We used population pharmacokinetic modeling to predict immunoglobulin G (IgG) exposure following a broad range of SCIG dosing regimens for initiation and maintenance therapy in patients with PID.

    Methods: Simulations of SCIG dosing were performed to predict IgG concentration-time profiles and exposure metrics [steady-state area under the IgG concentration-time curve (AUC), IgG peak concentration (C max), and IgG trough concentration (C min) ratios] for various infusion regimens. Read More

    Switching to Omnitrope(®) from Other Recombinant Human Growth Hormone Therapies: A Retrospective Study in an Integrated Healthcare System.
    Biol Ther 2014 Dec 6;4(1-2):27-39. Epub 2014 Aug 6.
    Department of Pediatrics, Mount Sinai College of Medicine, New York, NY, USA.
    Introduction: This study was conducted using an integrated retrospective database to evaluate the effectiveness of Omnitrope(®) (Sandoz) on children with growth hormone deficiency (GHD), idiopathic short stature (ISS), and Turner Syndrome (TS) who switched from a non-Omnitrope recombinant human growth hormone (rhGH) preparation during routine clinical care.

    Methods: This was a retrospective study which identified patients with GHD, ISS, and TS during the study time period of January 1, 2006 and July 31, 2011. Patients were included if they switched to Omnitrope from another non-Omnitrope rhGH therapy during the study time period, were <18 years of age at time of switch, and on a prior rhGH therapy for at least 15 months pre-switch and on Omnitrope for 15 months post-switch. Read More

    Isoagglutinin Reduction in Human Immunoglobulin Products by Donor Screening.
    Biol Ther 2014 Dec 20;4(1-2):15-26. Epub 2014 May 20.
    CSL Behring, Berne, Switzerland.
    Introduction: Hemolysis is considered a class effect and a rare adverse event that can occur following therapy with human normal immunoglobulin for intravenous administration [i.e., intravenous immunoglobulin (IVIG)]. Read More

    One-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age.
    Biol Ther 2014 Dec 28;4(1-2):1-13. Epub 2014 Jan 28.
    Sandoz Biopharmaceuticals, HEXAL AG, Industriestr. 25, 83607, Holzkirchen, Germany.
    Background: This prospective, open-label, non-comparative, multicentre, long-term phase IV study is examining the efficacy and safety of somatropin [recombinant human growth hormone (rhGH)] in short children born small for gestational age (SGA) and its impact on the incidence of diabetes. This report is the first interim analysis of patients who have completed 1 year of treatment.

    Methods: A total of 278 pre-pubertal patients were enrolled. Read More

    Weekly Teriparatide for Delayed Unions of Atypical Subtrochanteric Femur Fractures.
    Biol Ther 2014 Dec 29;4(1-2):73-9. Epub 2014 Jan 29.
    Kitakyushu General Hospital, 5-10-10 Kokura-Minami, Kitakyushu, 800-0295, Japan.
    Introduction: The occurrence of atypical femur fractures (AFFs) in patients on prolonged bisphosphonate treatment has been gaining medical attention, but the use of pharmacotherapy for these fractures has not been explored in detail. The authors describe a case of AFFs successfully treated with once-weekly administration of 56.5 μg teriparatide (TPTD). Read More

    Cost-Effectiveness of Infliximab for the Treatment of Acute Exacerbations of Ulcerative Colitis in the Netherlands.
    Biol Ther 2013 21;3:45-60. Epub 2012 Dec 21.
    Merck & Co., Inc., 1 Merck Drive, Whitehouse Station, NJ USA.
    Introduction: Infliximab is registered for the treatment of moderate-to-severe active ulcerative colitis (UC) adult patients who have had an inadequate response, or are intolerant, or have medical contraindications to therapy including corticosteroids and 5-aminosalicylates or thiopurines (6-mercaptopurine [6-MP] or azathioprine [AZA]). The authors estimate the costs and effects and evaluate the cost-effectiveness of infliximab at the licensed dose of 5 mg/kg versus cyclosporine or surgery for the treatment of adult Dutch patients hospitalized with acute exacerbations of UC, refractory to intravenous steroids.

    Method: An existing decision analytical model was updated to simulate disease progression of hospitalized UC patients in the Netherlands, refractory to intravenous corticosteroids, and to estimate the costs and benefits associated with infliximab compared to cyclosporine and surgery over a 1-year time horizon. Read More

    Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden.
    Biol Ther 2013 28;3:35-43. Epub 2013 May 28.
    Department of Pediatrics, Skåne University Hospital, Malmö, Sweden.
    Introduction: A new treatment plan was implemented at Skåne University Hospital, on economic grounds, for children requiring recombinant human growth hormone (rhGH) treatment. This involved switching patients from treatment with originator rhGHs to treatment with a biosimilar rhGH, somatropin (Omnitrope(®)), using a Dialogue Teamwork approach. The feasibility of using this approach to implement the switch of treatment was assessed, as well as the impact of the switch on treatment efficacy and cost of therapy. Read More

    Current and Novel Treatment Options for Metastatic Colorectal Cancer: Emphasis on Aflibercept.
    Biol Ther 2013 28;3:25-33. Epub 2013 Feb 28.
    Department of Medical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center, Room HE120, PO BOX 2040, 3000 CA Rotterdam, The Netherlands.
    Worldwide, colorectal cancer (CRC) is the third most frequently diagnosed cancer in men and the second in women. Metastatic disease develops in more than half of the patients and carries a poor prognosis. Over the past three decades, significant advances have been made in the treatment of metastatic colorectal cancer (mCRC). Read More

    Brentuximab Vedotin in CD30+ Lymphomas.
    Biol Ther 2013 1;3:15-23. Epub 2013 Mar 1.
    Fox Chase Cancer Center, Lymphoma Service, Philadelphia, PA USA.
    Monoclonal antibodies (mAb) have become an effective treatment strategy for hematologic malignancies. CD30 is a rational target for therapy due to its limited expression on normal tissues and the strong and uniform expression on malignant cells in classical Hodgkin's lymphoma (cHL) and anaplastic large-cell lymphoma (ALCL). Brentuximab vedotin, an anti-CD30 antibody-drug conjugate, utilizes the targeting properties of mAb to deliver a cytotoxic agent inside the malignant cell. Read More

    Pediatric Ulcerative Colitis: The Therapeutic Road to Infliximab.
    Biol Ther 2013 4;3:1-14. Epub 2013 Jan 4.
    University of Colorado Denver School of Medicine, Department of Pediatrics, Children's Hospital Colorado, Digestive Health Institute, Anschutz Medical Campus, 13123 East 16th Avenue, B290, Denver, USA.
    Ulcerative colitis (UC) is a chronic inflammatory bowel disease that has significant morbidities in the pediatric population. Goals of medical therapy include induction and maintenance of remission while preserving the colon and it's function, while minimizing the risk of treatment related morbidities. For those children who do not respond to initial therapies and progress to develop moderately-to-severely active UC, there has been a dearth of available treatments to help induce remission, necessitating long-term corticosteroid usage, with associated comorbidities of chronic steroid treatment. Read More

    Human Plasma-Derived, Nanofiltered, C1-Inhibitor Concentrate (Cinryze®), a Novel Therapeutic Alternative for the Management of Hereditary Angioedema Resulting from C1-Inhibitor Deficiency.
    Biol Ther 2012 9;2. Epub 2012 May 9.
    3rd Department of Internal Medicine, Semmelweis University, Kutvolgyi ut 4, H-1225 Budapest, Hungary.
    Hereditary angioedema resulting from the deficiency of the C1 inhibitor (HAE-C1-INH) is a rare, but potentially life-threatening disorder characterized by paroxysmal episodes of subcutaneous or submucosal edema. Early diagnosis is essential. Management is aimed at the prompt elimination of full-fledged attacks, as well as at the prevention of edematous episodes. Read More

    Axitinib in Metastatic Renal Cell Carcinoma.
    Biol Ther 2012 16;2. Epub 2012 Oct 16.
    Cleveland Clinic, Taussig Cancer Institute, 9500 Euclid Avenue Desk R 35, 44195 Cleveland, Ohio USA.
    Targeted agents have revolutionized the management of metastatic renal cell carcinoma (RCC). Axitinib, an inhibitor of vascular endothelial growth factor receptor (VEGFR), has been an important addition to currently available therapies for advanced RCC. Its ability to inhibit VEGFRs at nanomolar concentrations distinguishes it as a potent tyrosine kinase inhibitor, with increased selectivity for VEGFR-1, 2, and 3 at clinically applicable concentrations. Read More

    Aflibercept: a Potent Vascular Endothelial Growth Factor Antagonist for Neovascular Age-Related Macular Degeneration and Other Retinal Vascular Diseases.
    Biol Ther 2012 29;2. Epub 2012 May 29.
    Retinal Imaging Research and Reading Center, Wilmer Eye Institute, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Maumenee 745, 21287 Baltimore, Maryland USA.
    Introduction: In the western hemisphere, age-related macular degeneration (AMD) is the leading cause of visual loss in the elderly. Currently approved therapies for AMD include argon laser, photodynamic therapy, and antivascular endothelial growth factor (VEGF) therapy. The index review discusses aflibercept (VEGF Trap-Eye) in the context of current anti-VEGF therapies for neovascular AMD and other retinal vascular diseases. Read More

    Treatment of Systemic Juvenile Idiopathic Arthritis with Tocilizumab - the Role of Anti-Interleukin-6 Therapy After a Decade of Treatment.
    Biol Ther 2012 1;2. Epub 2012 Feb 1.
    Division of Rheumatology, Childrens Hospital Los Angeles, Los Angeles, CA USA.
    With the recent approval of tocilizumab as the first biologic for the treatment of systemic juvenile idiopathic arthritis (sJIA), an important unmet medical need for this historically challenging disease has now been met. The purpose of this review article is to revisit the established therapeutic options for sJIA, to summarize the history of the clinical trials with tocilizumab, and to discuss its role in the treatment of sJIA. Read More

    Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data.
    Biol Ther 2011 16;1. Epub 2011 Dec 16.
    CDMA, Endocrinology, Sandoz International BU Biopharmaceuticals, Holzkirchen, Germany.
    Introduction: Recombinant human growth hormone (rhGH) is effective and safe when used to treat growth hormone deficiency (GHD) in children. However, it has been suggested that switching between different types of rhGH can have a detrimental effect on patients.

    Methods: The current analysis assessed the efficacy and safety of rhGH in children who received continuous Omnitrope® (Sandoz GmbH, Kundl, Austria) therapy either with lyophilized powder for solution or ready-to-use solution, with children who received 9 months of treatment with Genotropin® (Pfizer Limited, Sandwich, UK) followed by Omnitrope solution thereafter. Read More

    Rotarix in Japan: Expectations and Concerns.
    Biol Ther 2011 14;1. Epub 2011 Dec 14.
    Department of Molecular Microbiology and Immunology, Graduate School of Biomedical Sciences, and the Global Center of Excellence, Nagasaki University, Nagasaki, 852-8523 Japan.
    A live-attenuated, orally-administered, monovalent, human rotavirus vaccine, Rotarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium), was licensed and launched in 2011 as the first rotavirus vaccine in Japan. The rotavirus causes a substantial disease burden with an estimated 790,000 outpatient visits, 27,000-78,000 hospitalizations, and approximately 10 deaths each year in Japan. Since a recent clinical trial showed that Rotarix was as efficacious in Japan as in other industrialized countries, it is expected that the annual number of rotavirus hospitalizations will be reduced to between 1000-3000, and that outpatient visits will be reduced to 200,000. Read More

    New Frontiers in Subcutaneous Immunoglobulin Treatment.
    Biol Ther 2011 14;1. Epub 2011 Dec 14.
    CSL Behring LLC, King of Prussia, PA USA ; Case Western Reserve University, Cleveland, OH USA.
    Subcutaneous immunoglobulin (SCIG) treatment provides stable serum immunoglobulin G (IgG) levels, is associated with fewer systemic adverse events than intravenous immunoglobulin (IVIG) treatment, and offers the convenience of home therapy. In clinical practice, IVIG is still used preferentially for initiation of treatment in newly diagnosed patients with primary immunodeficiency (PI) and for immunomodulatory therapy, such as treatment of peripheral neuropathies, when high doses are believed to be necessary. The authors discuss recent experience in using SCIG in place of IVIG in these settings. Read More

    Clinical consequences of reduced dosing schedule during treatment of a patient with Pompe's disease.
    Biol Ther 2011 12;1. Epub 2011 Aug 12.
    Department of Rehabilitation, Hospital Universitario Virgen del Rocío, Seville, Spain.
    Introduction: Pompe's disease is a metabolic myopathy caused by a deficiency of the enzyme alpha-glucosidase. Patients with late-onset Pompe's disease have progressive muscle weakness, which also affects pulmonary function. Since the advent of specific treatment for Pompe's disease, enzyme replacement therapy with alpha-glucosidase, the prognosis of the disease has changed. Read More

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