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Abstracts tagged "belimumab"

  • Abstract Number: 0321 • ACR Convergence 2021

    Sequential Administration of Belimumab and Rituximab in Primary Sjögren’s Syndrome Reduces Minor Salivary Gland–Resident B Cells and Delays B-Cell Repopulation in Circulation

    André van Maurik1, David Gardner2, Saba Nayar2, Charlotte Smith2, Kenneth Clark1, Prafull Mistry1, Rajesh Punwaney3, David Roth3, Robert Henderson1, Xavier Mariette4 and Francesca Barone2, 1GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom, 2University of Birmingham, College of Medical and Dental Sciences, Birmingham, United Kingdom, 3GlaxoSmithKline, Collegeville, PA, 4Université Paris- Saclay, Rheumatology, Paris, France

    Background/Purpose: Primary Sjögren’s syndrome (pSS) is characterized by B-cell hyperactivity and elevated serum and saliva B-lymphocyte stimulator (BLyS) levels.1 Sequential administration of belimumab (BEL; anti-BLyS)…
  • Abstract Number: 0443 • ACR Convergence 2021

    Safety and Efficacy of Belimumab in the Treatment of Adult Idiopathic Inflammatory Myositis (Polymyositis and Dermatomyositis)

    Priyal Chadha1, Sonali Narain2, Preeya Nandkumar3, Cristine Sison4, Elena Schiopu5, Todd Levine6, James Tsang7 and Galina Marder8, 1SUNY Upstate Medical University, Syracuse, NY, 2Northwell Health, Great Neck, NY, 3Division of Rheumatology, Department of Medicine, Northwell, Great Neck, NY, 4Biostatistics Unit , Department of Molecular Medicine, Feinstein Institutes for Medical Research at Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 5University of Michigan, Ann Arbor, MI, 6Phoenix Neurological Associates, Phoenix, AZ, 7Center for Research Informatics & Innovation (CRII), Feinstein Institute for Medical Research at Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 8Division of Rheumatology, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY

    Background/Purpose: Treatment of Idiopathic Inflammatory Myositis (IIM) includes steroids and immunosuppressive agents. Targeting IL6, IL1, TNF for treatment of IIM has not been successful, and…
  • Abstract Number: 1302 • ACR Convergence 2021

    Year-3 Observational Follow-up of Belimumab Safety (Mortality and Malignancies) in Patients with SLE Who Completed a Phase 4, 52-Week, Randomized, Double-Blind Placebo-Controlled Safety Study

    Saira Sheikh1, Cheng-Chung Wei2, Dana Tegzova3, William Stohl4, Ricardo Acayaba de Toledo5, Tamara Mucenic6, Mauricio Abello Banfi7, Kathleen Maksimowicz-McKinnon8, Carlos Abud-Mendoza9, Sandra Navarra10, Mercedes Garcia11, Ignacio Garcia-De La Torre12, Regina Kurrasch13, Sofia Fernandes14, Julia Harris15, Saima Muzaffar14, Norma Lynn Fox13, Andrew Liu16, Holly Quasny17 and David Roth13, 1University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, 2Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan (Republic of China), 3Institute of Rheumatology, Prague, Czech Republic, 4University of Southern California Keck School of Medicine, Los Angeles, CA, 5Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Brazil, 6Hospital Moinhos de Vento, Porto Alegre, Brazil, 7Centro Integral de Reumatología del Caribe, Barranquilla, Colombia, 8Henry Ford Hospital, Wayne State University, Detroit, MI, 9Hospital Central “Dr Ignacio Morones Prieto”, Unidad Regional de Reumatología y Osteoporosis, Hospital Central and Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, 10University of Santo Tomas Hospital, Manila, Philippines, 11Hospital Interzonal General de Agudos José de San Martín, La Plata, Argentina, 12Centro de Estudios de Investigación Básica y Clínica, S.C., Guadalajara, Mexico, 13GlaxoSmithKline, Collegeville, PA, 14GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom, 15GlaxoSmithKline, Uxbridge, United Kingdom, 16GlaxoSmithKline, Brentford, United Kingdom, 17GlaxoSmithKline, Research Triangle Park, NC

    Background/Purpose: Belimumab (BEL) is a recombinant IgG1λ monoclonal antibody that is approved for treatment of systemic lupus erythematosus (SLE). Although clinical studies of BEL have…
  • Abstract Number: 1757 • ACR Convergence 2021

    Clinical Use of Belimumab for Systemic Lupus Erythematosus in the Setting of Advanced Chronic Kidney Disease and End-Stage Renal Disease on Dialysis: A Case Series

    Matthew Snyder1, Angel Chen1, Sonali Narain2 and Galina Marder2, 1Donald and Barbara Zucker School of Medicine at Hofstra/Northwell at Lenox Hill Hospital Program, New York, NY, 2Northwell Health, Great Neck, NY

    Background/Purpose: Belimumab is FDA approved for treatment of SLE and Lupus Nephritis. Patients with an eGFR < 30 ml/min/1.73m2 were excluded from clinical trials, thus…
  • Abstract Number: 860 • 2019 ACR/ARP Annual Meeting

    Efficacy of Belimumab in Patients of Black Race with Systemic Lupus Erythematosus and High Disease Activity or Renal Manifestations

    Luiz Sergio Guedes Barbosa 1, Amit Saxena 2, Ellen M Ginzler 3, Richard Furie4, David D'Cruz 5, Susan Burriss 6, Jennifer Gilbride 7, Michelle Miller 6, James Groark 6, David Roth 6 and Beulah Ji 8, 1NUTEC - Núcleo de Terapia Especializada em Cancerologia, Cuiaba, Brazil, 2New York University School of Medicine, New York, NY, 3State University of New York Downstate Medical Center, Brooklyn, NY, 4Northwell Health, Great Neck, NY, 5The Louise Coote Lupus Unit, Guy's Hospital, London, England, United Kingdom, 6GSK, Collegeville, PA, 7GSK, Stevenage, Hertfordshire, United Kingdom, 8GSK, Uxbridge, Middlesex, United Kingdom

    Background/Purpose: Black patients have more severe SLE and more frequent lupus nephritis vs other racial groups. Efficacy and safety of intravenous (IV) belimumab was demonstrated…
  • Abstract Number: 2544 • 2019 ACR/ARP Annual Meeting

    Results of the Open-label, Non-randomized 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment with Belimumab in Patients with SLE

    Sang-Cheol Bae1, Richard Dimelow 2, Beulah Ji 3, Regina Kurrasch 4, Saima Muzaffar 5, Raj Punwaney 4, David Roth 4, Paul Stober 4, Yeong-Wook Song 6, Wendy Xie 4 and Fengchun Zhang 7, 1Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 2GSK, Stevenage, United Kingdom, 3GSK, Uxbridge, Middlesex, United Kingdom, 4GSK, Collegeville, PA, 5GSK, Stevenage, Hertfordshire, 6Seoul National University Hospital, Seoul, Republic of Korea, 7Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (People's Republic)

    Background/Purpose: Belimumab is approved as add-on therapy in active, autoantibody-positive SLE. Safety and efficacy up to 13 years has been reported in adults, but potential…
  • Abstract Number: 2572 • 2019 ACR/ARP Annual Meeting

    Efficacy Analysis of Patients with Systemic Lupus Erythematosus Treated with Belimumab or Placebo Plus Standard Therapy in Phase 3 Trials by Baseline Levels of BLyS mRNA and Type 1 Interferon Inducible Gene Signature Status

    Angela R Jones-Leone1, Shaun Flint 2, Roger Abramino Levy 3, David Roth 4, Robert Henderson 2, Christel Wilkinson 2, Beulah Ji 5 and Damon L Bass 3, 1GlaxoSmithKline, Upper Providence, 2GlaxoSmithKline, Stevenage, United Kingdom, 3GlaxoSmithKline, Collegeville, PA, 4GSK, Collegeville, PA, 5GSK, Uxbridge, Middlesex, United Kingdom

    Background/Purpose: Belimumab (BEL) is a B-lymphocyte stimulator (BLyS) inhibitor approved as an add-on to standard of care (SoC) for patients with autoantibody-positive SLE with active…
  • Abstract Number: 2865 • 2019 ACR/ARP Annual Meeting

    Application of Bayesian Statistics to Support Approval of Intravenous Belimumab in Children with Systemic Lupus Erythematosus in the United States

    Ginto Pottackal1, James Travis 1, Rosemarie Neuner 1, Rebecca Rothwell 1, Gregory Levin 1, Lei Nie 1, Jing Niu 1, Anshu Marathe 1 and Nikolay Nikolov 1, 1FDA, Silver Spring, MD

    Background/Purpose: In April 2019, FDA approved the first treatment, intravenous (IV) belimumab (BEL), specifically for children 5 to 17 years of age with active, seropositive…
  • 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: 2627 • 2018 ACR/ARHP Annual Meeting

    Not All Clinical Responders in SLE Are Equal: Comparison of Subcutaneous Belimumab + Standard of Care Responders to Placebo + Standard of Care Responders

    William Stohl1, Milena Kurtinecz2, Joe Eastman3, Vanessa Castellano4, Chrysa Mahoney4, Tania Gonzalez-Rivera2 and Bonnie Pobiner4, 1Division of Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, 2GlaxoSmithKline, Philadelphia, PA, 3GlaxoSmithKline (at the time of the study), Research Triangle Park, NC, 4GlaxoSmithKline, Research Triangle Park, NC

    Background/Purpose: To determine whether degree of response among responders to subcutaneous (SC) belimumab (BEL) + standard of care (SoC) is greater than that for responders…
  • Abstract Number: 2676 • 2018 ACR/ARHP Annual Meeting

    SLE Patients with No Organ Damage Might Benefit More from Belimumab Treatment

    Ioannis Parodis1,2, Sharzad Emamikia1,2, Alvaro Gomez1 and Katerina Chatzidionysiou2,3, 1Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, 2Rheumatology, Karolinska University Hospital, Stockholm, Sweden, Stockholm, Sweden, 3Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

    Background/Purpose: In systemic lupus erythematosus (SLE), organ damage is associated with unfavourable disease courses and premature mortality. We aimed at investigating the impact of organ…
  • Abstract Number: 2867 • 2018 ACR/ARHP Annual Meeting

    Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus

    Hermine I. Brunner1, Carlos Abud-Mendoza2, Diego I. Viola3, Inmaculada Calvo4, Deborah M. Levy5, Julia Calderon Gallegos6, Manuel Ferrandiz7, Vyacheslav Chasnyk8, Vladmir Keltsev9, Jordi Anton10, Maria Paz11, Michael Shishov12, Alina Lucica Boteanu13, Michael Henrickson14, Damon Bass15, Kenneth Clark16, Anne Hammer15, Beulah Ji16, David Roth15, Herbert Struemper17, Mei-Lun Wang18, Alberto Martini19, Daniel J Lovell20 and Nicola Ruperto19, 1Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosy, Mexico, 3CAICI Institute, Rosario City, Santa Fe State, Argentina, 4Hospital Universitario La Fe, Valencia, Spain, 5Rheumatology, Hospital for Sick Children, Toronto, ON, Canada, 6Instituto de Ginecologia y Reproduccion, Santiago De Surco, Peru, 7Instituto Nacional de Salud del Nino, Lima, Peru, 8St Petersburg State Pediatric Medical Academy, St Petersburg, Russian Federation, 9City Clinical Hospital No.5, Tolyatti, Russian Federation, 10SJD Barcelona Children’s Hospital, Barcelona, Spain, 11Clinica Anglo Americana, Lima, Peru, 12Phoenix Children's Hospital, Phoenix, AZ, 13University Hospital Ramón y Cajal, Madrid, Spain, 14Cincinnati Children’s Medical Center, Cincinnati, OH, 15GlaxoSmithKline, Philadelphia, PA, 16GlaxoSmithKline, Stevenage, United Kingdom, 17GlaxoSmithKline, Research Triangle Park, NC, 18GlaxoSmithKline, Collegeville, PA, 19Universita di Genova Pediatria II, Genova, Italy, 20Cincinnati Children's Medical Center, Cincinnati, OH

    Background/Purpose: Belimumab (BEL) is approved in adults with active systemic lupus erythematosus (SLE). There are no approved biologic therapies for pediatric patients with childhood-onset SLE…
  • Abstract Number: 291 • 2018 ACR/ARHP Annual Meeting

    Factors Associated with High-Dose Corticosteroid Use in SLE Patients Post Initiation of SLE Therapy

    Krista Schroeder1, Steve Gelwicks1, Jim Paik2 and Robert W. Hoffman1, 1Eli Lilly and Company, Indianapolis, IN, 2HEOR, Eli Lilly and Company, Indianapolis, IN

    Background/Purpose: Systemic lupus erythematosus (SLE) therapies include non-steroidal anti-inflammatory drugs, antimalarials, systemic immunosuppressants, and biologics with corticosteroids as necessary. The majority of these current therapies…
  • Abstract Number: 1704 • 2018 ACR/ARHP Annual Meeting

    Clinical SLE Disease Activity Index Score of Zero May be a More Pragmatic Outcome Measure in SLE Studies

    Ioannis Parodis1,2, Sharzad Emamikia1,2, Iva Gunnarsson1,2, Ronald F. van Vollenhoven2,3 and Katerina Chatzidionysiou1,4, 1Rheumatology, Karolinska University Hospital, Stockholm, Sweden, Stockholm, Sweden, 2Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, 3Amsterdam Rheumatology and Immunology Center ARC, Department of Clinical Immunology & Rheumatology, University of Amsterdam, Amsterdam, The Netherlands, Amsterdam, Netherlands, 4Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

    Background/Purpose: Drug development in systemic lupus erythematosus (SLE) has been challenging. One of the reasons can be traced in the choice of outcome measures. In…
  • Abstract Number: 890 • 2017 ACR/ARHP Annual Meeting

    Synergetic B-Cell Immunomodulation with Rituximab and Belimumab Combination Treatment in Severe, Refractory SLE

    Tineke Kraaij1, Sylvia W.A. Kamerling1, Esther N.M. de Rooij1, Paul L. van Daele2, O.W. Bredewold1, Jaap A. Bakker3, Ingeborg Bajema4, Hans U. Scherer5, Rene E.M. Toes5, Tom W.J. Huizinga5, Ton Rabelink1, Cees van Kooten1 and Y.K. Onno Teng1, 1Nephrology, Leiden University Medical Center, Leiden, Netherlands, 2Immunology, Erasmus Medical Center, Rotterdam, Netherlands, 3Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, Netherlands, 4Pathology, Leiden University Medical Center, Leiden, Netherlands, 5Rheumatology, Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Neutrophil extracellular traps (NETs) are auto-antigenic DNA strands and potentially give rise to SLE-specific autoantibodies that can deposit in glomeruli. It has been shown…
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