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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: 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…
  • Abstract Number: 1247 • ACR Convergence 2023

    Pharmacokinetic, Pharmacodynamic, and Safety Profile of Subcutaneous Belimumab in Pediatric Patients with Systemic Lupus Erythematosus: Analysis of Data from a Multicenter, Open-Label Trial

    Hermine Brunner1, Diego Oscar Viola2, Richard Dimelow3, Inmaculada Calvo Penadés4, Christel Wilkinson5, Juan Cruz Rizo Rodriguez6, Alina Boteanu7, Sylvia Kamphuis8, Kirsten Minden9, Gerd Horneff10, Jordi Anton11, Masaaki Mori12, Yuichi Yamasaki13, Jose Miyar Olaiz14, Rebecca Marino15, Andre van Maurik16, Mohamed Okily17, Emad Yanni18 and Paul WIlde19, 1Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, 2CAICI Institute, Pediatric Rheumatology, Santa Fe, Argentina, 3GlaxoSmithKline, Clinical Pharmacology Modelling and Simulation, Stevenage, United Kingdom, 4Hospital Universitario y Politécnico La Fe, Pediatric Rheumatology Unit, València, Spain, 5GlaxoSmithKline, Clinical Statistics, Stevenage, United Kingdom, 6Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, San Luis Potosí, Mexico, 7Hospital Universitario Ramón y Cajal, Departamento de Reumatología, Madrid, Spain, 8Erasmus University Medical Center, Department of Pediatric Rheumatology, Rotterdam, Netherlands, 9Charité Universitätsmedizin Berlin, Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Berlin, Germany, 10Asklepios Klinik Sankt Augustin GmbH, Bonn, Germany, 11Hospital Sant Joan de Déu, Pediatric Rheumatology Department, Universitat de Barcelona, Barcelona, Spain, 12Tokyo Medical and Dental University Hospital, Department of Lifetime Clinical Immunology, Tokyo, Japan, 13Kagoshima University Hospital, Department of Pediatrics, Kagoshima, Japan, 14GlaxoSmithKline, Safety Evaluation and Risk Management, Brentford, United Kingdom, 15GlaxoSmithKline, Safety Evaluation and Risk Management, Durham, NC, 16GlaxoSmithKline, Clinical Pharmacology and Experimental Medicine, Brentford, United Kingdom, 17GlaxoSmithKline, Clinical Development, ImmunoInflammation, Brentford, United Kingdom, 18GlaxoSmithKline, Clinical Development, Rockville, MD, 19GlaxoSmithKline, Clinical Development, Brentford, United Kingdom

    Background/Purpose: Belimumab (BEL) is an approved treatment for SLE, in addition to standard therapy. Intravenous (IV) BEL is approved in patients (pts) ≥5 years of…
  • Abstract Number: 1459 • ACR Convergence 2023

    Unveiling the Impact of Neuropsychiatric Involvement in Systemic Lupus Erythematosus on Damage Accrual

    Dionysis Nikolopoulos1, Nursen Cetrez2, Julius Lindblom2 and Ioannis Parodis2, 1Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, 2Karolinska Institutet, Stockholm, Sweden

    Background/Purpose: The link between neuropsychiatric involvement in systemic lupus erythematosus (NPSLE) and heightened morbidity, mortality, and organ damage, as well as detrimental impacts on health-related…
  • Abstract Number: 1460 • ACR Convergence 2023

    Impact of Neuropsychiatric Involvement on Health-related Quality of Life in Patients with Systemic Lupus Erythematosus

    Dionysis Nikolopoulos1, Nursen Cetrez2, Julius Lindblom2 and Ioannis Parodis2, 1Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, 2Karolinska Institutet, Stockholm, Sweden

    Background/Purpose: Substantial proportions of systemic lupus erythematosus (SLE) patients report severe fatigue and adverse Health-related Quality of Life (HRQoL). Particularly neuropsychiatric manifestations have been associated…
  • Abstract Number: 1502 • ACR Convergence 2023

    Introduction of Belimumab Within Five Years of the Onset of Systemic Lupus Erythematosus (SLE) Contributes to the Better Therapeutic Response; A Multi-center Retrospective Cohort Study

    Kanako Kojima1, Kunihiro Ichinose1, Toshimasa Shimizu1, Masataka Umeda1, Takahisa Suzuki2, Yoshikazu Nakashima3, Akitomo Okada4, Yoshiro Horai5, Keita Fujikawa6, Toshiyuki Aramaki7, Taiichiro Miyashita8, Masako Furuyama3, Naoki Matsuoka9 and Atsushi Kawakami10, 1Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, 2Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan, 3Nagasaki Kita Hospital, Nagasaki, Japan, 4National Hospital Organization Nagasaki Medical Center, Omura, Japan, 5Sasebo City General Hospital, Sasebo, Japan, 6Japan Community Healthcare Organization, Isahaya General Hospital, Isahaya, Japan, 7Sasebo Chuo Hospital, Sasebo, Japan, 8Miyashita Rheumatology Clinic, Omura, Japan, 9Nagasaki Medical Hospital of Rheumatology, Nagasaki, Japan, 10Nagasaki University, Nagasaki, Japan

    Background/Purpose: Belimumab (BEL), B cell-targeted biologic agent for systemic lupus erythematosus (SLE), is cumulating evidence such as reducing glucocorticoids and preventing the progressionof organ damage.…
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