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Abstracts tagged "belimumab"

  • Abstract Number: 893 • 2017 ACR/ARHP Annual Meeting

    Efficacy and Safety of Belimumab in Combination with Azathioprine for Remission Maintenance in Granulomatosis with Polyangiitis and Microscopic Polyangiitis: A Multicenter Randomized, Placebo-Controlled Study

    David Jayne1, Daniel Blockmans2, Raashid Luqmani3, Beulah Ji4, Yulia Green5, Leanne Hall6, David Roth7 and Peter A. Merkel8, 1Vasculitis and Lupus Clinic, Department of Medicine, University of Cambridge, Cambridge, United Kingdom, 2General Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium, 3Botnar Research Centre, University of Oxford, Oxford, United Kingdom, 4GSK Stockley Park, Uxbridge, United Kingdom, 5GSK Stockley Park, Stockley Park, United Kingdom, 6GSK Stevenage, Stevenage, United Kingdom, 7GSK Collegeville, Collegeville, PA, 8Division of Rheumatology, University of Pennsylvania, Philadelphia, MN

    Background/Purpose: GPA (Wegener’s) and MPA are organ- and life-threatening systemic vasculitides characterized by the presence of ANCA-associated vasculitis (AAV), implicating B cells in disease pathogenesis.…
  • Abstract Number: 2590 • 2017 ACR/ARHP Annual Meeting

    Subcutaneous Belimumab Plus Standard of Care Demonstrated Improvement in Multiple Organ Domains Versus Placebo Plus Standard of Care in Patients with Active Systemic Lupus Erythematosus (SLE)

    Andrea Doria1, Bonnie Pobiner2, William Eastman3, Milena Kurtinecz4, Anne Hammer2, James Groark5 and Damon Bass5, 1Division of Rheumatology, University of Padova, Padova, Italy, 2GSK Research Triangle Park, Research Triangle Park, NC, 3GSK, Research Triangle Park, NC, 4GSK, Philadelphia, PA, 5GSK Collegeville, Collegeville, PA

     Background/Purpose : Organ manifestation domain score improvement was assessed with subcutaneous (SC) belimumab (BEL) plus standard SLE care (SoC) in active, autoantibody-positive SLE. Methods:  BLISS-SC…
  • Abstract Number: 2593 • 2017 ACR/ARHP Annual Meeting

    Baseline Characteristics of Patients Diagnosed with Systemic Lupus Erythematosus Initiating Treatment with Intravenous Belimumab

    Christopher F Bell1, Julie Priest2,3, Justyna Amelio4, Xue Song5, Hong Kan6, Marni Stott-Miller7, Brendan Limone5, Virginia Noxon5 and Karen H. Costenbader8, 1GSK US Value, Evidence and Outcomes, Research Triangle Park, NC, 2GSK US Value, Evidence and Outcomes (at the time of Study)*, Research Triangle Park, NC, 3US Health Outcomes Durham, *ViiV Healthcare (Present), Durham, NC, 4GSK Real World Evidence & Epidemiology, Stevenage, United Kingdom, 5Truven Health Analytics, an IBM company, Ann Arbor, MI, 6Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 7GSK Real World Evidence & Epidemiology, Uxbridge, United Kingdom, 8Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

    Background/Purpose: Belimumab, an inhibitor of B lymphocyte stimulator, is approved in adults with active, autoantibody-positive systemic lupus erythematosus (SLE) receiving standard of care. Methods: Retrospective…
  • Abstract Number: 2594 • 2017 ACR/ARHP Annual Meeting

    Frequency of Infusions Among Patients Diagnosed with Systemic Lupus Erythematosus Initiating Treatment with Intravenous Belimumab

    Christopher F Bell1, Julie Priest2,3, Marni Stott-Miller4, Hong Kan5, Justyna Amelio6, Xue Song7, Brendan Limone7, Virginia Noxon7 and Karen H. Costenbader8, 1GSK US Value, Evidence and Outcomes, Research Triangle Park, NC, 2GSK US Value, Evidence and Outcomes (at the time of Study)*, Research Triangle Park, NC, 3US Health Outcomes Durham, *ViiV Healthcare (Present), Durham, NC, 4GSK Real World Evidence & Epidemiology, Uxbridge, United Kingdom, 5Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 6GSK Real World Evidence & Epidemiology, Stevenage, United Kingdom, 7Truven Health Analytics, an IBM company, Ann Arbor, MI, 8Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

    Background/Purpose: Belimumab, an inhibitor of B lymphocyte stimulator, is approved for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) receiving standard…
  • Abstract Number: 2604 • 2017 ACR/ARHP Annual Meeting

    The Effect of Subcutaneous Belimumab on Corticosteroid Use in Patients with Systemic Lupus Erythematosus (SLE): A Phase 3, Randomized, Placebo-Controlled Study

    Ronald F van Vollenhoven1, April Thompson2, Bonnie Pobiner2, Joe Eastman2, Anne Hammer2, James Groark3 and Damon Bass3, 1Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 2GSK Research Triangle Park, Research Triangle Park, NC, 3GSK Collegeville, Collegeville, PA

    Background/Purpose: Reduced corticosteroid use is considered a key goal in SLE treatment. This concept of ‘steroid-sparing’, seen with intravenous (IV) belimumab based on cumulative steroid…
  • Abstract Number: 2812 • 2017 ACR/ARHP Annual Meeting

    Healthcare Resource Utilization and Costs in Patients with Systemic Lupus Erythematosus before and after Initiating Treatment with Intravenous Belimumab: A US Claims Database Analysis

    Christopher F Bell1, Julie Priest2,3, Marni Stott-Miller4, Hong Kan5, Justyna Amelio6, Xue Song7, Brendan Limone7, Virginia Noxon7 and Karen H. Costenbader8, 1GSK US Value, Evidence and Outcomes, Research Triangle Park, NC, 2GSK US Value, Evidence and Outcomes (at the time of Study)*, Research Triangle Park, NC, 3US Health Outcomes Durham, *ViiV Healthcare (Present), Durham, NC, 4GSK Real World Evidence & Epidemiology, Uxbridge, United Kingdom, 5Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 6GSK Real World Evidence & Epidemiology, Stevenage, United Kingdom, 7Truven Health Analytics, an IBM company, Ann Arbor, MI, 8Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

    Background/Purpose: Belimumab, an inhibitor of B lymphocyte stimulator, is approved in adults with active, autoantibody-positive systemic lupus erythematosus (SLE) receiving standard of care. There is…
  • Abstract Number: 2923 • 2017 ACR/ARHP Annual Meeting

    A Propensity Score-Matched Study of Organ Damage in Patients with Systemic Lupus Erythematosus from the BLISS Long-Term Extension Trials Versus the Toronto Lupus Cohort: A Post Hoc Longitudinal Analysis

    Murray Urowitz1, Robert L. Ohsfeldt2,3, Ron Wielage3, Kari A. Kelton3, Yumi Asukai4 and Sulabha Ramachandran5, 1Medicine, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital and University of Toronto, Toronto, ON, Canada, 2Texas A&M University, Texas, TX, 3Medical Decision Modeling Inc., Indianapolis, IN, 4GSK, Uxbridge, Middlesex, United Kingdom, 5Value Evidence and Outcomes, GlaxoSmithKline, Renaissance Centre, PA

    Background/Purpose: Two Phase 3, randomized controlled trials (BLISS 52/76) studied the efficacy and safety of belimumab plus standard of care (SoC) in systemic lupus erythematosus…
  • Abstract Number: 3235 • 2016 ACR/ARHP Annual Meeting

    Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients with Systemic Lupus Erythematosus: Up to 7 Years of Treatment Exposure

    Vibeke Strand1, Pam Berry2, Sulabha Ramachandran2 and James Fettiplace3, 1Stanford University School of Medicine, Palo Alto, CA, 2GSK, Philadelphia, PA, 3GSK, Uxbridge, Middlesex, United Kingdom

    Background/Purpose: Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that causes long-term organ damage over time and impairment in health-related quality of life (HRQoL).…
  • Abstract Number: 3247 • 2016 ACR/ARHP Annual Meeting

    Safety and Efficacy of Belimumab with Background Mycophenolate for Early Diffuse Cutaneous Systemic Sclerosis: A Randomized, Placebo Controlled, Pilot Trial

    Jessica K. Gordon1, Eliza Pelrine2, Yuo-Yu Lee3, Cynthia Magro4, Elana J. Bernstein5, Horatio F. Wildman6 and Robert F. Spiera1, 1Rheumatology, Hospital for Special Surgery, New York, NY, 2Hospital for Special Surgery, New York, NY, 3Epidemiology and Biostatistics, Hospital for Special Surgery, New York, NY, 4Pathology, Weill Cornell Medical College, New York, NY, 5Department of Medicine, Division of Rheumatology, Columbia University, New York, NY, 6Dermatology, Weill Cornell Medical College, New York, NY

    Background/Purpose: Abnormalities of B cell function are part of the pathogenesis of systemic sclerosis (SSc), and B-lymphocyte stimulator (BLyS) is increased in the serum and…
  • Abstract Number: 748 • 2016 ACR/ARHP Annual Meeting

    A Phase 4, Multicenter, Randomized, Open-Label Study to Evaluate the Effect of Belimumab on Vaccine Responses in Patients with Systemic Lupus Erythematosus

    Winn Chatham1, Aneureka Chadha2, James Fettiplace3, Christi Kleoudis4, Damon Bass5, David Roth5 and David Gordon5, 1University of Alabama at Birmingham, Birmingham, AL, 2Austin Regional Clinic, Austin, TX, 3GSK, Uxbridge, Middlesex, United Kingdom, 4Parexel, Raleigh-Durham, NC, 5GSK, Philadelphia, PA

    Background/Purpose:  Intravenous (IV) belimumab 10 mg/kg is approved in patients with active, autoantibody-positive systemic lupus erythematosus (SLE) as add-on to standard SLE therapy (SoC). This…
  • Abstract Number: 765 • 2016 ACR/ARHP Annual Meeting

    High Baseline B Lymphocyte Stimulator (BLyS) Levels Predict Response While Smoking and Organ Damage at Baseline Predict Failure to Belimumab in Three Swedish Clinical Practice Settings

    Ioannis Parodis1, Christopher Sjöwall2, Andreas Jönsen3, Agneta Zickert1, Daniel Ramsköld1, Martina Frodlund2, Laurent Arnaud1, Vivianne Malmström1, Anders A. Bengtsson3 and Iva Gunnarsson1, 1Department of Medicine, Rheumatology Unit, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden, 2Rheumatology/AIR, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden, 3Lund University, Department of Clinical Sciences, Rheumatology, Lund, Sweden

    Background/Purpose:  Belimumab is a biologic drug approved to treat Systemic Lupus Erythematosus (SLE). The efficacy of belimumab has been demonstrated in phase III clinical trials.…
  • Abstract Number: 768 • 2016 ACR/ARHP Annual Meeting

    7-Year Safety and Efficacy of Belimumab in Patients with Systemic Lupus Erythematosus

    Richard A. Furie1, Daniel J. Wallace2, Cynthia Aranow3, James Fettiplace4, Barbara Wilson5, Prafull Mistry6, David A Roth7 and David Gordon7, 1Northwell Health, Great Neck, NY, 2Cedars-Sinai Medical Center, UCLA, Los Angeles, CA, 3The Feinstein Institute for Medical Research, Manhasset, NY, 4GSK, Uxbridge, Middlesex, United Kingdom, 5GSK, Research Triangle Park, NC, 6GSK, Stevenage, Hertfordshire, United Kingdom, 7GSK, Philadelphia, PA

    Background/Purpose: The availability of published long-term data from systemic lupus erythematosus (SLE) clinical trials is limited [1]. To complement existing belimumab data, we examined the…
  • Abstract Number: 769 • 2016 ACR/ARHP Annual Meeting

    Response to Belimumab in SLE Patients with High Disease Activity: Data from a Multicentric Clinical-Practice Based Study Cohort

    Luca Iaccarino1, Silvano Bettio2, Rossella Reggia3, Giacomo Emmi4, Fulvia Ceccarelli5, Chiara Tani6, Maria Gerosa7, Marcello Govoni8, Alesandra Bortoluzzi9, Salvatore De Vita10, Ginevra De Marchi11, Rossella De Angelis12, Andrea Di Matteo12, Carlo Salvarani13, Giulia Pazzola13, Elena Bartoloni-Bocci14, Laura Andreoli15, Margherita Zen16, Fabrizio Conti17, Marta Mosca6, Pier Luigi Meroni18, Roberto Gerli14, Angela Tincani19, Andrea Doria20 and Lorenzo Emmi21, 1Department of Medicine-DIMED, University of Padova, Padova, Italy, 2Rheumatology Unit, Univeristy of Padova, Padova, Italy, 3Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy, 4Medical Pathology, Careggi University Hospital, Firenze, Italy, 5Sapienza University of Rome, Rome, Italy, 6Rheumatology Unit, University of Pisa, Pisa, Italy, 7University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy, 8Medical Sciences, UOC of Rheumatology, University Hospital S. Anna, Cona Ferrara, Italy, 9UOC of Rheumatology, University Hospital S. Anna, Cona Ferrara, Italy, 10Clinic of Rheumatology, Department of Medical and Biological Sciences, University Hospital "Santa Maria della Misericordia", Udine, Italy, Udine, Italy, 11Rheumatology Clinic, DSMB, University of Udine, Udine, Italy, 12Polytechnic university of Marche, Rheumatologic Clinic, Iesi, Italy, 13Rheumatology Unit, Internal Medicine Department, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy, 14Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy, 15University of Brescia, Spedali Civili, Brescia, Italy, 16Division of Rheumatology, University of Padova, Padova, Italy, 17Rheumatology Unit, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy, 18Rheumatology Department, University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy, 19Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia, Italy, 20Rheumatology Unit, Department of Medicine - DIMED, University of Padova, Padova, Italy, 21Internal Interdisciplinary Medicine Center for Autoimmune Systemic Diseases, Lupus Clinic,, Internal Interdisciplinary Medicine Center for Autoimmune Systemic Diseases, Lupus Clinic, AOU Careggi, Florence, Italy

    Background/Purpose: To investigate effectiveness and identify predictors of response to belimumab in patients with active SLE in clinical practice setting. Methods: One hundred eighty eight…
  • Abstract Number: 816 • 2016 ACR/ARHP Annual Meeting

    Clinical Response to Treatment with Belimumab and Mycophenolate Mofetil Is Associated with Decrease in B Cell, TGF-β and PDGF Signaling in Systemic Sclerosis

    Viktor Martyanov1, Jessica K. Gordon2, Tammara A. Wood1, Robert F. Spiera2 and Michael L. Whitfield1, 1Department of Molecular and Systems Biology, Geisel School of Medicine at Dartmouth, Hanover, NH, 2Rheumatology, Hospital for Special Surgery, New York, NY

    Background/Purpose: While B cell signaling is thought to be important in the pathogenesis of systemic sclerosis (SSc), the experience with B cell targeting therapies in…
  • Abstract Number: 1763 • 2016 ACR/ARHP Annual Meeting

    Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients with Systemic Lupus Erythematosus Following 7 Years of Treatment Exposure: Impact of Clinical Characteristics over Time

    Vibeke Strand1, Pam Berry2, Xiwu Lin2, Yumi Asukai3, James Fettiplace3 and Sulabha Ramachandran2, 1Stanford University School of Medicine, Palo Alto, CA, 2GSK, Philadelphia, PA, 3GSK, Uxbridge, Middlesex, United Kingdom

    Background/Purpose: Despite improvements in medical care leading to improved survival, systemic lupus erythematosus (SLE) adversely affects patients’ health related quality of life (HRQoL). To explore…
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