Abstracts tagged "pharmacokinetics"

Abstract Number: 1568 • ACR Convergence 2021
AR882, a Potent and Selective Uricosuric Agent, Showed Effectiveness in Patients with Various Degrees of Renal Impairment
zancong shen¹, Elizabeth Polvent², vijay hingorani³, Rongzi Yan⁴, Shunqi Yan⁵ and Litain Yeh⁶, ¹Arthrosi Therapeutics, Inc., San Diego, CA, ²Arthrosi Therapeutics, Inc., Roseville, CA, ³Vanguard Healthsciences, Inc., San Diego, CA, ⁴Arthrosi Therapeutics, Inc, Irvine, CA, ⁵Arthrosi Therapeutics, Inc., Laguna Hills, CA, ⁶Arthrosi Therapeutics, Inc., Irvine, CA
Background/Purpose: AR882 is a novel, potent and selective uric acid transporter 1 (URAT1) inhibitor in Phase 2 development for the treatment of hyperuricemia and gout.…
Abstract Number: L16 • 2019 ACR/ARP Annual Meeting
GLCCI1 Polymorphism Is Associated with Prednisone Response in Giant Cell Arteritis: A Multicenter Prospective Study
Samuel Deshayes¹, Venceslas Bourdin ², Christian Creveuil ³, Jonathan Boutemy ¹, Eric Liozon ⁴, Xavier Kyndt ⁵, Laurent Sailler ⁶, Grégory Pugnet ⁶, Hubert de Boysson ¹, Eric Hachulla ⁷, Marc André ⁸, Julie Magnant ⁹, Jacques Boddaert ¹⁰, Olivier Fain ¹¹, Arsène Mékinian ¹¹, Mohamed Hamidou ¹², Loïc Guillevin ¹³, Cédric Landron ¹⁴, Isabelle Marie ¹⁵, Yannick Chène ³, Laurent Becquemont ¹⁶, Céline Verstuyft ² and Boris Bienvenu ¹⁷, ¹Department of Internal Medicine, Caen University Hospital, Caen, France, ²INSERM UMR_S1178, Medicine Faculty, CESP, Paris-Sud University, Le Kremlin Bicêtre, Paris, France, ³Biomedical Reserch Unit, Caen University Hospital, Caen, France, ⁴Department of Internal Medicine and Clinical Immunology, Limoges University Hospital, Limoges, France, ⁵Department of Internal Medicine and Nephrology, Valenciennes Hospital, Valenciennes, France, ⁶Department of Internal Medicine, Toulouse University Hospital, Toulouse, France, ⁷Department of Internal Medicine and Clinical Immunology, Lille University Hospital, Lille, France, ⁸Department of Internal Medicine, Clermont-Ferrand University Hospital, Clermont-Ferrand, France, ⁹Department of Internal Medicine, Tours University Hospital, Tours, France, ¹⁰Department of Geriatrics, Pitié-Salpêtrière-Charles Foix University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France, ¹¹Department of Internal Medicine, Saint Antoine University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, ¹²Department of Internal Medicine, Nantes University Hospital, Nantes, France, ¹³Department of Internal Medicine, Cochin University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, ¹⁴Department of Internal Medicine, Poitiers University Hospital, Poitiers, France, ¹⁵Department of Internal Medicine, Rouen University Hospital, Rouen, France, ¹⁶INSERM UMR_S1178, Medicine Faculty, CESP, Paris-Sud University, Le Kremlin Bicêtre, Le Kremblin Bicêtre, France, ¹⁷Department of Internal Medicine, Saint Joseph Hospital, Marseille, France
Background/Purpose: Giant cell arteritis (GCA) is the most common cause of primary vasculitis in adults. Corticosteroids are the cornerstone of the treatment. However, approximately 50%…
Abstract Number: 530 • 2019 ACR/ARP Annual Meeting
Phase I Evaluation of the PDE4 Inhibitor LY2775240: Head to Head Comparison with Apremilast Using an Ex Vivo Pharmacodynamic Assay
Daniel Dairaghi¹, Karen Cox ¹, Stephen Ho ¹, Paul Klekotka ², Diane Phillips ¹, Jean Lim ³, Shweta Urva ¹ and Dipak Patel ², ¹Eli Lilly and Company, Indianapolis, IN, ²Eli Lilly and Company, San Diego, CA, ³Eli Lilly and Company, singapore, Singapore
Background/Purpose: LY2775240 is a potent and selective phosphodiesterase (PDE4) inhibitor being investigated as a potential treatment for inflammatory disorders, such as psoriasis. PDE4 is expressed…
Abstract Number: 1398 • 2019 ACR/ARP Annual Meeting
Sarilumab and Tocilizumab Receptor Occupancy (RO), and Effects on C-Reactive Protein (CRP) Levels, in Patients with Rheumatoid Arthritis (RA)
Christine Xu¹, Patrick Nolain ², Qiang Lu ³, Anne Paccaly ⁴, Melitza Iglesias-Rodriguez ⁵, Gregory St John ⁶, Chad Nivens ⁴, Rafael Maldonado ⁷, Tomonori Ishii ⁸, Ernest Choy ⁹ and Vanaja Kanamaluru ³, ¹Sanofi, Bridgewater, NJ, ²Sanofi-Aventis, Montpellier, France, ³Sanofi, Bridgewater, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, ⁵Sanofi Genzyme, Cambridge, MA, ⁶Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁷Pompeu Fabra University, Barcelona, Spain, ⁸Tohoku University Hospital, Sendai, Japan, ⁹Cardiff University School of Medicine, Cardiff, United Kingdom
Background/Purpose: The in vitro binding affinity of sarilumab (KD 61.9 pM) for the human interleukin-6 receptor (IL-6R) is 15–22-fold higher than that of tocilizumab. This…
Abstract Number: 2175 • 2019 ACR/ARP Annual Meeting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of the Anti-ADAMTS-5 Nanobody®, M6495, in Healthy Male Subjects: A Phase I, Placebo-Controlled, First-in-Human Study
Hans Guehring¹, Torben Balchen ², Kosalaram Goteti ³, Jesper Sonne ⁴, Christoph Ladel ¹, Victor Ona ¹, Flavie Moreau ⁵, Anne Bay-Jensen ⁶ and Asger Reinstrup Bihlet ⁶, ¹Merck KGaA, Darmstadt, Germany, ²DanTrials ApS c/o Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ³EMD Serono Research and Development Institute, Inc., Billerica, MA, ⁴Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ⁵EMD Serono Research and Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁶Nordic Bioscience, Herlev, Denmark
Background/Purpose: Osteoarthritis (OA) is a serious disease characterized by progressive joint failure and cartilage degeneration. In OA, ADAMTS-5 protease is upregulated, resulting in enhanced cleavage…
Abstract Number: 2415 • 2019 ACR/ARP Annual Meeting
Evaluation of Pharmacokinetics and Immunogenicity Following Subcutaneous Administration of Abatacept in Primary Sjogren ’s Syndrome (pSS) and RA Patients
Yash Gandhi¹, Mehmooda Shaikh ², Blisse Vakkalagadda ¹, Grigor Abelian ¹, Neelanjana Ray ¹, Robert Wong ¹ and Bindu Murthy ¹, ¹Bristol-Myers Squibb, Princeton, ²Bristol-Myers Squibb, Princeton, NJ
Background/Purpose: Abatacept (ABA) has proven efficacy in autoimmune diseases and is being evaluated in pSS. The purpose of this investigation was to evaluate the pharmacokinetics…
Abstract Number: 2536 • 2019 ACR/ARP Annual Meeting
Distribution and Predictors of Whole Blood Hydroxychloroquine Levels in Clinical Rheumatology Practices in the United States
Thierry Dervieux¹, Kelley Brady ¹, Don Thomas ², John Conklin ¹, Eugene Fung ³, Claudia Ibarra ¹ and Michelle Petri ⁴, ¹Exagen, Vista, CA, ²Walter Reed National Military Medical Center, Bethesda, MD, ³Arthritis & Osteoporosis Clinic, Waco, TX, ⁴Johns Hopkins University School of Medicine, Baltimore, MD
Background/Purpose: Therapeutic drug monitoring of whole blood Hydroxychloroquine (HCQ) can help identify patients at risk of flares due to underexposure (e.g. severe non-adherence, < 200…
Abstract Number: 2563 • 2019 ACR/ARP Annual Meeting
PK/PD, Safety and Exploratory Efficacy of Subcutaneous Anifrolumab in SLE: A Phase-II Study in Interferon Type I High Patients with Active Skin Disease
Ian Bruce¹, Alireza Nami ², Erik Schwetje ³, M Edward Pierson ⁴, Yen Lin Chia ⁵, Denison Kuruvilla ⁵, Gabriel Abreu ⁶, Raj Tummala ³ and Catharina Lindholm ⁶, ¹University of Manchester, Manchester, United Kingdom, Manchester, England, United Kingdom, ²Joint & Muscle Medical Care, Charlotte, NC, US, Charlotte, NC, ³AstraZeneca, Gaithersburg, MD, USA, Gaithersburg, MD, ⁴AstraZeneca, Gaithersburg, MD, US, Gaithersburg, MD, ⁵AstraZeneca, South San Francisco, CA, US, South San Francisco, CA, ⁶AstraZeneca, Gothenburg, Sweden, Gothenburg, Sweden
Background/Purpose: Anifrolumab, a fully human anti–IFN Type I receptor mAb, is under investigation for the treatment of SLE at a dose of 300 mg intravenously…
Abstract Number: 1728 • 2018 ACR/ARHP Annual Meeting
Pharmacokinetics of Cyclophosphamide in Scleroderma Treated By Cyclophosphamide Versus Transplantation
David Adams¹, Keith Sullivan², Ivan Spasojevic¹, Ping Fan¹, Mario Sampson³, Michael Cohen-Wolkowiez³, E. William St Clair⁴, Rob Woolson⁵, Jan Storek⁶, Mary Ellen Csuka⁷, Ashley Pinckney⁵, Beverly Welch⁸, Ellen Goldmuntz⁹, Daniel E. Furst¹⁰, Leslie Crofford¹¹, Lynette Keyes-Elstein¹², Maureen Mayes¹³, Peter McSweeney¹⁴ and Richard Nash¹⁴, ¹Medicine, Duke University Medical Center, Durham, NC, ²Duke University Medical Center, Durham, NC, ³Pediatrics-Infectious Disease, Duke University Medical Center, Durham, NC, ⁴Rheumatology, Duke University Medical Center, Durham, NC, ⁵Rho Federal Systems, Inc., Chapel Hill, NC, ⁶University of Calgary, Calgary, AB, Canada, ⁷Medicine, Medical College of Wisconsin, Milwaukee, WI, ⁸National Institutes of Health, Bethesda, MD, ⁹NIAID, NIH, Bethesda, MD, ¹⁰University of Washington, Seattle, WA, ¹¹Division of Rheumatology and Immunology, Vanderbilt University Medical Center, Nashville, TN, ¹²Clinical Statistics, Rho Federal Systems, Inc., Chapel Hill, NC, ¹³Rheumatology, University of Texas at Houston, Houston, TX, ¹⁴Colorado Blood Cancer Institute, Denver, CO
Background/Purpose: The pharmacokinetics (PK) of cyclophosphamide (CP) and its primary active metabolite, 4-hydroxycyclophosphamide (4-OH-CP) have not been adequately studied in scleroderma. The hypothesis of this…
Abstract Number: 1922 • 2018 ACR/ARHP Annual Meeting
Characterization of the Pharmacology and Pharmacokinetics of Cntx-4975, a High-Purity, Synthetic Trans-Capsaicin in Clinical Development for the Treatment of Moderate to Severe OA Knee Pain
James Campbell, Randall Stevens and Peter Hanson, Centrexion Therapeutics, Boston, MA
Background/Purpose: CNTX-4975, a highly purified, synthetic trans-capsaicin and long-acting, non-opioid analgesic in phase 3 trials for moderate to severe OA knee pain, has demonstrated safety…
Abstract Number: 2525 • 2018 ACR/ARHP Annual Meeting
Correlation Analysis between Sirukumab Exposure and Selected Safety Events Following Subcutaneous Administration Using Pooled Phase 3 Data in Rheumatoid Arthritis
Yan Xu¹, Yanli Zhuang¹, Chuanpu Hu¹, Benjamin Hsu², Zhenhua Xu¹, Amarnath Sharma¹ and Honghui Zhou¹, ¹Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, ²Immunology Clinical Development, Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: To characterize the exposure-response (ER) relationship between systemic exposure to sirukumab (an anti- interleukin-6 [IL-6] human monoclonal antibody) and the occurrence of selected safety…
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: 1752 • 2017 ACR/ARHP Annual Meeting
Pharmacokinetics of Rituximab and Clinical Outcomes in Patients with ANCA-Associated Vasculitis
Divi Cornec¹, Brian Kabat¹, John Mills¹, Melissa Cheu², Amber Hummel¹, Darrell Schroeder¹, Matthew Cascino³, Paul Brunetta³, David Murray¹, Melissa Snyder¹, Fernando Fervenza¹, Gary S. Hoffman⁴, Cees G.M. Kallenberg⁵, Carol A. Langford⁶, Peter A. Merkel⁷, Paul A. Monach⁸, Philip Seo⁹, Robert F. Spiera¹⁰, E. William St Clair¹¹, John H. Stone¹², David Barnidge¹ and Ulrich Specks¹³, ¹Mayo Clinic, Rochester, MN, ²Genentech Inc., South San Francisco, CA, ³Genentech, Inc., South San Francisco, CA, ⁴Rheumatology, Cleveland Clinic, Cleveland, OH, ⁵Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands, ⁶Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, ⁷University of Pennsylvania, Philadelphia, MN, ⁸Boston University School of Medicine, Boston, MA, ⁹Medicine, Johns Hopkins University, Baltimore, MD, ¹⁰Rheumatology, Hospital for Special Surgery, New York, NY, ¹¹Rheumatology, Duke University Medical Center, Durham, NC, ¹²Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, ¹³Mayo Clinic College of Medicine, Rochester, MN
Background/Purpose: Response to rituximab (RTX) is variable in patients with ANCA-associated vasculitis (AAV), and predictors of treatment efficacy/relapse risk would be useful. Previous studies have…
Abstract Number: 1809 • 2017 ACR/ARHP Annual Meeting
Lack of Placental Transfer of Certolizumab Pegol during Pregnancy: Results from a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study
Eliza Chakravarty¹, Frauke Förger², Bincy Abraham³, Ann Flynn⁴, Anna Moltó⁵, René-Marc Flipo⁶, Astrid van Tubergen⁷, Laura Shaughnessy⁸, Jeff Simpson⁸, Marie Teil⁹, Eric Helmer¹⁰, Maggie Wang⁸ and Xavier Mariette¹¹, ¹Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ²Department of Rheumatology and Clinical Immunology and Allergology, Inselspital, University of Bern, Bern, Switzerland, ³Houston Methodist Hospital, Houston, TX, ⁴University of Utah, Salt Lake City, UT, ⁵Hôpital Cochin, AP-HP, Paris, France, ⁶Centre Hospitalier Régional Universitaire de Lille, Lille, France, ⁷Maastricht University Medical Center, Maastricht, Netherlands, ⁸UCB Pharma, Raleigh, NC, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Brussels, Belgium, ¹¹INSERM U1184, Université Paris-Sud, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, France
Background/Purpose: There is a need for effective and safe treatment during pregnancy in women affected by chronic active inflammatory diseases such as rheumatoid arthritis. Adequate…
Abstract Number: 192 • 2016 ACR/ARHP Annual Meeting
Pharmacodynamic and Pharmacokinetic Study of Verinurad in Adult Male Subjects with Mild, Moderate, and Severe Renal Impairment: A Phase 1, Open-Label Study
William B Smith¹, Jesse Hall², Jolene Berg³, Michal Kazimir⁴, Amy Yamamoto², Caroline Lee², Susan Walker² and Thomas C. Marbury⁵, ¹Volunteer Research Group, Knoxville, TN, ²Ardea Biosciences, Inc., San Diego, CA, ³DaVita Clinical Research, Minneapolis, MN, ⁴DaVita Clinical Research, Lakewood, CO, ⁵Orlando Clinical Research Center, Orlando, FL
Background/Purpose: Verinurad (RDEA3170) is a high-affinity, selective URAT1 inhibitor in development for the treatment of gout and asymptomatic hyperuricemia. This Phase 1, single-dose, open-label study…

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