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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