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  • Abstract Number: L13 • ACR Convergence 2021

    Efficacy and Safety of Subcutaneous Belimumab (BEL) and Rituximab (RTX) Sequential Therapy in Patients with Systemic Lupus Erythematosus: The Phase 3, Randomized, Placebo-Controlled BLISS-BELIEVE Study

    Cynthia Aranow1, Cornelia Allaart2, Zahir Amoura3, Ian N Bruce4, Patricia Cagnoli5, Richard Furie1, Paul Peter Tak6, Murray Urowitz7, Ronald van Vollenhoven8, Kenneth L Clark6, Mark Daniels9, Norma Lynn Fox10, Yun Irene Gregan10, James Groark11, Robert B Henderson9, Mary Oldham9, Don Shanahan9, Andre van Maurik9, David A Roth10 and YK Onno Teng2, 1Feinstein Institutes for Medical Research, Northwell Health, Great Neck, NY, 2Leiden University Medical Center, Leiden, Netherlands, 3Centre National de reference pour le Lupus, Service de Medecine Interne 2, Institut E3M, Hopital Pitié-Salpétrière, Paris, France, 4NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Trust and Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, 5University of Michigan Medical Center, Ann Arbor, MI, 6GlaxoSmithKline (At the time of the author's contribution to this study), Stevenage, United Kingdom, 7Toronto Western Hospital, University of Toronto, Lupus Clinic, Toronto, ON, Canada, 8Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 9GlaxoSmithKline, Stevenage, United Kingdom, 10GlaxoSmithKline, Collegeville, PA, 11GlaxoSmithKline (At the time of the author's contribution to this study), Collegeville, PA

    Background/Purpose: Disease control remains an unmet need in SLE. The rationale for sequential BEL and RTX therapy in SLE was previously published.1 This study evaluated…
  • Abstract Number: 1711 • 2018 ACR/ARHP Annual Meeting

    Utility of the Lupus Low Disease Activity State (LLDAS) in Discriminating Responders in the BLISS-52 and BLISS-76 Phase 3 Trials of Intravenous Belimumab in Systemic Lupus Erythematosus

    Shereen Oon1, Molla Huq2, Vera Golder3, Emily Ong4, Eric Morand5 and Mandana Nikpour6, 1The University of Melbourne at St Vincent's Hospital, Fitzroy, Australia, 2The University of Melbourne at St Vincent's Hospital, Melbourne, Australia, 3School of Clinical Sciences at Monash Health, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, 4School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, 5Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, 6The University of Melbourne, Melbourne, Australia, Melbourne, Australia

    Background/Purpose: Measurement of treatment response in SLE clinical trials has been based on measurement of change from baseline; however a treat-to-target analysis has seldom been…
  • Abstract Number: 1840 • 2017 ACR/ARHP Annual Meeting

    Comparison of Different Definitions of Remission in Systemic Lupus Erythematosus (SLE)– a Study Based on the BLISS-76 Clinical Trial

    Sharzad Emamikia1, Cidem Gentline1, Elizabeth V. Arkema2, Laurent Arnaud3, Katerina Chatzidionysiou1,4 and Ronald F van Vollenhoven5,6, 1Department of Medicine, (ClinTRID), Karolinska Institute, Stockholm, Sweden, 2Clinical Epidemiology Unit, Department of Medicine, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden, 3Department of Rheumatology, Université de Strasbourg, Strasbourg, France, 4On behalf of the SRQ/ARTIS registry, Stockholm, Sweden, 5Department of Medicine, (ClinTRID), Karolinska Institute, Solna, Sweden, 6AMC, F4-214, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands

    Background/Purpose: Remission in SLE is a desirable target, however there is no gold standard for the definition of remission. An international task force agreed on…
  • 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: 1585 • 2013 ACR/ARHP Annual Meeting

    Corticosteroid Use Across 52 Weeks Of Belimumab Therapy In Patients With Systemic Lupus Erythematosus: Combined Analyses From The BLISS Trials

    Ronald F. van Vollenhoven1, Michelle Petri2, Daniel J. Wallace3, David Roth4, Charles T. Molta4, Anne Hammer5, Tom Tang5 and April Thompson5, 1The Karolinska Institute, Stockholm, Sweden, 2Johns Hopkins University School of Medicine, Baltimore, MD, 3Cedars-Sinai Medical Center, Los Angeles, CA, 4GlaxoSmithKline, King of Prussia, PA, 5GlaxoSmithKline, Research Triangle Park, NC

    Background/Purpose: Patients with systemic lupus erythematosus (SLE) frequently receive corticosteroids (CS) as standard therapy. We examined the effects of belimumab on CS dose across 52…
  • Abstract Number: 0803 • ACR Convergence 2025

    Improved Efficacy and Safety Outcomes in Patients with SLE Treated with Belimumab (BEL) Versus Immunosuppressants (IS), in Addition to Antimalarials (AM) and Glucocorticoids (GC): A Post Hoc Summary of Five Phase 3 Trials

    Mariele Gatto1, Karen H. Costenbader2, Andreas Schwarting3, Julia Harris4, Ciara O'Shea5, Roger A. Levy6 and Andrea Doria7, 1Academic Rheumatology Centre, Department of Clinical and Biological Sciences, University of Turin, Mauriziano Hospital, Turin, Italy, 2Harvard Medical School and Brigham and Women's Hospital, Boston, MA, 3Johannes Gutenberg University Mainz, University Medical Centre, Mainz, Germany, 4GSK, Biostatistics, London, United Kingdom, 5Global Medical Affairs, GSK, Dublin, Ireland, 6GSK, Specialty Care, Global Medical Affairs, Collegeville, PA, 7University of Padova, Padova, Italy

    Background/Purpose: Chronic GC and IS use increases damage accrual and mortality. The 2023 EULAR SLE recommendations support initiation of biologics such as BEL, a human…
  • Abstract Number: 0650 • ACR Convergence 2025

    Obinutuzumab Demonstrates Steroid-Sparing Effects and Consistent Benefit In Patients with Lupus Nephritis When Using Multiple Primary Endpoint Definitions: A Secondary Analysis of Phase III Trial Results

    Brad Rovin1, Jay Garg2, Richard Furie3, Rachel Jones4, Amit Saxena5, Pasquale Esposito6, Elsa Martins7, Claire Petry7, Nicolas Frey7, Bongin Yoo2, Imran Hassan8, Thomas Schindler7, Theodore Omachi9, William Pendergraft2, Mittermayer Santiago10, Gustavo Aroca Martínez11 and Ana Malvar12, 1The Ohio State University, Columbus, OH, 2Genentech, Inc., South San Francisco, CA, 3Division of Rheumatology, Northwell Health, Great Neck, NY, 4Renal Medicine, Cambridge University Hospitals, Cambridge, England, United Kingdom, 5Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, 6Clinica Nefrologica, Dialisi, Trapianto, Department of Internal Medicine, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genova, Italy, 7F. Hoffmann-La Roche Ltd, Basel, Switzerland, 8Hoffmann-La Roche Ltd, Mississauga, ON, Canada, 9Genentech, Inc., South San Francisco, 10Bahiana School of Medicine and Public Health and UFBA, Federal University of Bahia, and Clínica SER da Bahia, Salvador, Bahia, Brazil, 11Universidad Simón Bolívar, Barranquilla, Colombia y Clínica de la Costa, Barranquilla, Colombia, 12Organización Médica de Investigación, Buenos Aires, Argentina

    Background/Purpose: The Phase III REGENCY study (NCT04221477) demonstrated superiority of obinutuzumab (OBI) over placebo (PBO) in achieving complete renal response (CRR) at Week 76 when…
  • Abstract Number: 1531 • ACR Convergence 2025

    Achieving Remission and Low Disease Activity with Belimumab Versus Placebo in Patients with SLE Excluding the Glucocorticoid Component from Target Definitions: A Post Hoc Analysis of Five Phase 3 Trials

    Ioannis Parodis1, Julius Lindblom2, Roger A. Levy3, Alexander Tsoi1, Margherita Zen4, Dionysis Nikolopoulos5, Munther Khamashta6, Ryan Tomlinson7, Anca Askanase8, Ronald van Vollenhoven9 and Mandana Nikpour10, 1Karolinska Institutet and Karolinska University Hospital, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, 2Karolinska Institutet, Stockholm, Sweden, 3GSK, Specialty Care, Global Medical Affairs, Collegeville, PA, 4University of Padua, Department of Medicine, Division of Rheumatology, Padua, Italy, 5Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, 6GSK, Medical Affairs, Dubai, United Arab Emirates, 7GSK, Development – R&D, Collegeville, PA, 8Columbia University Medical Center, New York, NY, 9Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands, 10University of Sydney School of Public Health and Department of Rheumatology, Royal Prince Alfred Hospital, Sydney, Victoria, Australia

    Background/Purpose: An integrated post hoc analysis of five Phase 3 trials in adults with SLE showed greater benefit of belimumab (BEL) than placebo (PBO), plus…
  • Abstract Number: 2467 • ACR Convergence 2025

    Complete Renal Responses and Safety for Belimumab Versus Placebo in a Post Hoc Mycophenolate Mofetil Subgroup with Active Proliferative Lupus Nephritis

    Richard Furie1, Hans-Joachim Anders2, George Bertsias3, Ana Delgado4, Roger A. Levy5, Paula Curtis6, Ciara O'Shea7, Ryan Tomlinson8 and Brad Rovin9, 1Division of Rheumatology, Northwell Health, Great Neck, NY, 2Hospital of LMU Munich, Department of Medicine IV, Munich, Germany, 3Rheumatology and Clinical Immunology, University Hospital of Heraklion and University of Crete Medical School and Foundation for Research and Technology-Hellas (FORTH), Infections and Immunity, Institute of Molecular Biology and Biotechnology, Heraklion, Greece, 4GSK, Immunology Medical Affairs, London, United Kingdom, 5GSK, Specialty Care, Global Medical Affairs, Collegeville, PA, 6GSK, Biostatistics, London, United Kingdom, 7Global Medical Affairs, GSK, Dublin, Ireland, 8GSK, Development – R&D, Collegeville, PA, 9The Ohio State University, Columbus, OH

    Background/Purpose: Belimumab, a human IgG1λ monoclonal antibody that selectively binds B-lymphocyte stimulator, was first approved in 2011. It is the only biologic approved for LN…
  • Abstract Number: 0659 • ACR Convergence 2024

    Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial

    Richard Furie1, Jorge A. Ross Terres2, Elsa Martins3, Imran Hassan4, Thomas Schindler3, Jay Garg5, William F. Pendergraft III6, Ana Malvar7 and Brad Rovin8, 1Northwell Health, Manhasset, NY, 2Genentech, Inc,, San Francisco, 3F. Hoffmann-La Roche Ltd, Basel, Switzerland, 4Hoffmann-La Roche Ltd, Mississauga, Canada, 5Genentech, Inc., South San Francisco, CA, 6Genentech, Inc., Chapel Hill, NC, 7Organización Médica de Investigación, Buenos Aires, Argentina, 8The Ohio State University, Columbus, OH

    Background/Purpose: Lupus nephritis (LN) is the most common severe organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, placebo-controlled, Phase II NOBILITY trial (NCT02550652) demonstrated…
  • Abstract Number: 0665 • ACR Convergence 2024

    Belimumab Induces Early and Sustained Resolution of Lupus Thrombocytopenia and Lupus Arthritis

    Nicolai Leuchten1, Ioannis Parodis2, Ralph Brinks3 and Martin Aringer1, 1University Medical Center and Faculty of Medicine TU Dresden, Dresden, Germany, 2Karolinska Institutet, Karolinska University Hospital; Örebro University, Solna, Sweden, 3University Witten/Herdecke, Witten, Germany

    Background/Purpose: Belimumab has well-established efficacy in improving overall SLE disease activity and in preventing flares and organ damage. In clinical routine, however, the primary goal…
  • Abstract Number: 1494 • ACR Convergence 2024

    Trajectories of Disease Evolution upon Treatment Initiation in Systemic Lupus Erythematosus: Pooled Results from Three Randomized Clinical Trials of Belimumab

    Ioannis Parodis1, Julius Lindblom2, Alexandre Tsoi3, Dionysis Nikolopoulos4 and Lorenzo Beretta5, 1Karolinska Institutet, Karolinska University Hospital; Örebro University, Solna, Sweden, 2Karolinska Institutet, Stockholm, Sweden, 3Karolinska Institute, Stockholm, Sweden, 4Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, 5Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MIlano, Milan, Milan, Italy

    Background/Purpose: The efficacy of belimumab in treating SLE has been demonstrated in several phase 3 randomized clinical trials (RCTs). These trials showed belimumab efficacy on…
  • Abstract Number: 1554 • ACR Convergence 2024

    Belimumab Increases SLE Responder Index-4 Response Rates versus Placebo in Early Active Systemic Lupus Erythematosus: A Large Integrated Analysis of Belimumab Trials

    Karen Costenbader1, Joan Merrill2, Marta Mosca3, Holly Quasny4, Christine Henning5, Steven Bloom6, Julia Harris6, Ciara O’Shea7, Tatsuya Atsumi8 and Ronald van Vollenhoven9, 1Brigham and Women’s Hospital, Division of Rheumatology, Inflammation and Immunity, Harvard Medical School, Boston, MA, 2Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Program, Oklahoma City, OK, 3University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, 4GSK, Clinical Sciences, Durham, NC, 5GSK, Global Medical Affairs, Durham, NC, 6GSK, Immunology Biostatistics, Brentford, United Kingdom, 7GSK, Rheumatology, Global Medical Affairs, Dublin, Ireland, 8Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, 9Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands

    Background/Purpose: There are benefits of early treatment for autoimmune diseases; however, data are not available for patients (pts) with SLE as there is no definition…
  • Abstract Number: 2402 • ACR Convergence 2024

    Belimumab Reduces Disease Flares versus Placebo in Adults with Early Active Systemic Lupus Erythematosus: Results of a Large Integrated Analysis

    Marta Mosca1, Karen Costenbader2, Joan Merrill3, Holly Quasny4, Christine Henning5, Steven Bloom6, Julia Harris6, Ciara O’Shea7, Tatsuya Atsumi8 and Ronald Van Vollenhoven9, 1University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, 2Brigham and Women's Hospital/ Harvard Medical School, Boston, MA, 3Oklahoma Medical Research Foundation, Oklahoma City 73104, OK, 4GSK, Clinical Sciences, Durham, NC, 5GSK, Global Medical Affairs, Durham, NC, 6GSK, Immunology Biostatistics, Brentford, United Kingdom, 7GSK, Rheumatology, Global Medical Affairs, Dublin, Ireland, 8Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, 9Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands

    Background/Purpose: SLE flares are associated with increased risk of organ damage/mortality; flare prevention is a key treatment goal.1 Initiating treatment earlier has benefits in autoimmune…
  • Abstract Number: 0550 • ACR Convergence 2023

    Harnessing Machine Learning to Predict Neuropsychiatric Events in Systemic Lupus Erythematosus

    Nursen Cetrez1, Julius Lindblom1, Raffaele Da Mutten2, Dionysis Nikolopoulos2 and Ioannis Parodis1, 1Karolinska Institutet, Stockholm, Sweden, 2Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden

    Background/Purpose: Neuropsychiatric systemic lupus erythematosus (NPSLE) is linked to increased morbidity, mortality, and adverse health-related quality of life. Early disease, a history of NPSLE, aPL…
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