ACR Meeting Abstracts

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Abstracts tagged "safety and systemic lupus erythematosus (SLE)"

  • Abstract Number: 2642 • 2018 ACR/ARHP Annual Meeting

    Atacicept Dose Rationale for a Phase 3 Study in Patients with High Disease Activity and Auto-Antibody Positive SLE

    Jinshan Shen1, Orestis Papasouliotis2, Eileen Samy1, Philipp Haselmayer3, Peter Chang4, Victor Ona1 and Amy H. Kao1, 1EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, 2Merck Institute for Pharmacometrics, an affiliate of Merck KGaA, Darmstadt, Germany, Lausanne, Switzerland, 3Merck KGaA, Darmstadt, Germany, 4EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA

    Background/Purpose: Atacicept targets the B-cell-stimulators BLyS and APRIL, and is in development for the treatment of patients (pts) with SLE. Here, we integrated non-clinical and…
  • Abstract Number: 2585 • 2017 ACR/ARHP Annual Meeting

    Safety Profile in SLE Patients Treated with Atacicept in a Phase IIb Study (ADDRESS II) and Its Extension Study

    Joan T. Merrill1, Daniel J. Wallace2, Cristina Vazquez-Mateo3, Amy H. Kao3, Patricia Fleuranceau-Morel3, Peter Chang4 and David A. Isenberg5, 1Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, 2Cedars-Sinai Medical Center, UCLA, Los Angeles, CA, 3EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, 4EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA, 5Centre for Rheumatology Research, University College London, London, England

    Background/Purpose: Atacicept targets the B-cell stimulating factors, BLyS and APRIL, and has demonstrated a clinical response in SLE patients (pts) with high disease activity (HDA;…
  • Abstract Number: 764 • 2016 ACR/ARHP Annual Meeting

    Atacicept: Integrated Safety Profile from Phase II Randomized Placebo-Controlled Studies in Autoimmune Diseases

    Patricia Fraser, Wai Chin and Amy Kao, EMD Serono, Billerica, MA

    Background/Purpose:  Atacicept, a recombinant fusion protein, targets both BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand), B cell activating factors involved in the pathogenesis…
  • 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: 738 • 2015 ACR/ARHP Annual Meeting

    Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BCL-2 Inhibitor Venetoclax (ABT-199) in a Phase 1 Single and Multiple Ascending Dose Study in Female Patients with Systemic Lupus Erythematosus

    Peng Lu1, Roy Fleischmann2, Craig Curtis3, Stanislav Ignatenko4, Monali Desai5, Shekman L. Wong5, Kristie M. Grebe1, Jiewei Zeng5, Jeroen Medema5 and James Stolzenbach5, 1AbbVie Inc., Worcester, MA, 2University of Texas Southwestern Medical Center, Dallas, TX, 3Compass Research Center, Orlando, FL, 4Charité Research Organization, Berlin, Germany, 5AbbVie Inc., North Chicago, IL

    Background/Purpose: Apoptosis is needed to eliminate auto-reactive T and B cells during immune responses; failure of elimination is important in development of systemic lupus erythematosus…
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