ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 1397 • ACR Convergence 2023

    Sustainability of Clinical Response at Week 52 to Upadacitinib Among Patients with Axial SpA: Data from the SELECT-AXIS 1 and SELECT-AXIS 2 Trials

    Victoria Navarro-Compán1, Lianne Gensler2, Martin Rudwaleit3, Fabiana Ganz4, Shirley Chen4, Jayne Stigler4, Anna Schmagel4 and Xenofon Baraliakos5, 1Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, 2University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, 3University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, 4AbbVie, Inc., North Chicago, IL, 5Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany

    Background/Purpose: Upadacitinib 15 mg (UPA), an oral Janus kinase inhibitor, has shown efficacy and tolerability through 14 weeks in patients (pts) with active radiographic axial…
  • Abstract Number: 1511 • ACR Convergence 2023

    B-Cell Recovery in a Randomized Controlled Trial of B-Cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis

    Ed Vital1, Dario Roccatello2, David Black3, Rhian Jacob-Moffatt4, Cary M. Looney5, Elsa Martins5, Huiyan (Ashley) Mao3, Thomas Schindler6, Himanshi Seghal5, Jay Garg7, Jorge Ross Terres7 and Richard Furie8, 1University of Leeds, Leeds, United Kingdom, 2University of Torino, Torino, Italy, 3Hoffmann-La Roche Ltd, Mississauga, ON, Canada, 4F. Hoffmann-La Roche Ltd, Welwyn Garden City, United Kingdom, 5F. Hoffmann-La Roche Ltd, Basel, Switzerland, 6F. Hoffmann-La Roche Ltd, Basle, Switzerland, 7Genentech, Inc., South San Francisco, CA, 8Northwell Health, Manhasset, NY

    Background/Purpose: Patients with LN who received obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, with standard-of-care (MMF) immunosuppression (Phase II NOBILITY; NCT02550652; PMID 34615636) showed…
  • Abstract Number: 1988 • ACR Convergence 2023

    Extended-Release versus Immediate-Release Triamcinolone Acetonide for Osteoarthritis of the Knee with Comorbid Diabetes Type 2 Diabetes Mellitus: A Post Hoc Analysis

    Andrew Spitzer1, Helena Rodbard2, Sheikh Usman Iqbal3, Masato Nakazawa3, Mary DiGiorgi3 and Roy Winston3, 1Cedars-Sinai Medical Center, Los Angeles, CA, 2Endocrine and Metabolic Consultants, Rockville, MD, 3Pacira BioSciences, Inc., Tampa, FL

    Background/Purpose: Intraarticular (IA) corticosteroids are generally considered safe and effective to treat osteoarthritis of the knee (OAK) but may cause hyperglycemia that may last for…
  • Abstract Number: 2242 • ACR Convergence 2023

    Irrespective of the Number of Erosions at Baseline, Patients with Psoriatic Arthritis Treated with Ixekizumab Show Improved Clinical Outcomes

    M. Elaine Husni1, Vinod Chandran2, Jeffrey Lisse3, Rebecca Bolce3, Carlos Diaz3, Baojin Zhu3, Elaine Lui4 and Laura Coates5, 1Cleveland Clinic / Department of Rheumatic and Immunologic Diseases, Cleveland, OH, 2Schroeder Arthritis Institute, Krembil Research Institute, University Health Network and Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, 3Eli Lilly and Company, Indianapolis, IN, 4Brightech International, An Everest Clinical Research Company, Somerset, NJ, 5University of Oxford, Oxford, United Kingdom

    Background/Purpose: Psoriatic arthritis (PsA) is a chronic and progressive disease characterized by high rates of early joint erosions, which have been associated with impaired quality…
  • Abstract Number: 2487 • ACR Convergence 2023

    Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of Moderate-to-Severe Activity

    Nan Shen1, Stanislav Ignatenko2, Alexander Gordienko3, Josefina Cortés Hernández4, Nancy Agmon-Levin5, Pongthorn Narongroeknawin6, Katarzyna Romanowska -Prochnicka7, Hana Ciferska8, Masanari Kodera9, James Cheng-Chung Wei10, Piotr Leszczynski11, Joung-Liang Lan12, Eduardo Mysler13, Rafal Wojciechowski14, Tunde Tarr15, Elena Vishneva16, Yi-Hsing Chen17, Yuko Kaneko18, Stephanie Finzel19, Alberta Hoi20, Ajchara Koolvisoot21, Shin-Seok Lee22, Lie Dai23, Hiroshi Kaneko24, Bernadette Rojkovich25, Lingyun Sun26, Eugeny Zotkin27, Jean-Francois Viallard28, Masao Katayama29, Berta Paula Magallares-Lopez30, Tirtha Sengupta31, Carol Sips32 and Stephen J Oliver32, 1Shanghai Institute of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University (SJTUSM), Shanghai, China, 2Charité Research Organisation GmbH, Berlin, Germany, 3SM Kirov Military Medical Academy, St. Petersburg, Russia, 4Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain, 5Yabludowicz Center for Autoimmune Disease, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel, 6Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand, 7Department of Systemic Connective Tissue Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland, 8Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, 9Department of Dermatology, Japan Community Healthcare Organization Chukyo Hospital, Nagoya, Japan, 10Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, 11Department of Internal Medicine, Poznan University of Medicine Sciences, Poznan, PL, Poznań, Poland, 12China Medical University Hospital, Taichung, Taiwan, 13Organizacion Medica de Investigacion, Buenos Aires, Argentina, 14Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland, 15Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, 16LLC Family Clinic, Yekaterinburg, RU, Yekaterinburg, Russia, 17Taichung Veterans General Hospital, Taichung, Taiwan, 18Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, 19Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, 20Monash University, Department of Medicine, Sub-faculty of Clinical and Molecular Medicine, Melbourne, Australia, 21Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 22Chonnam National University Medical School & Hospital, Gwangju, South Korea, 23Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, 24Division of Rheumatic Disease, National Center for Global Health and Medicine, Tokyo, Japan, 25Department of Rheumatology and Physiotherapy, Polyclinic of the Hospitaller Brothers of St. John of God, Semmelweis University, Budapest, Hungary, 26Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China, 27VA Nasonova Research Institute of Rheumatology, Moscow, Russia, 28CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France, 29National Hospital Organization, Nagoya Medical Center, Nagoya, JP, Nagoya, Japan, 30Department of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain, 31Novartis Pharma India, Hyderabad, Hyderabad, India, 32Novartis Pharma AG, Basel, Switzerland

    Background/Purpose: Ianalumab is a novel defucosylated human IgG1 mAb targeting the receptor for B cell Activating Factor belonging to the TNF Family (BAFF-R) providing potent…
  • Abstract Number: 0440 • ACR Convergence 2023

    Baseline T Cell and B Cell-related Markers and HLA-DRB1 Shared Epitope Alleles Predict the Therapeutic Efficacy of Abatacept in Patients with Moderate to Severe Rheumatoid Arthritis

    Ting Wang1, Natalia V. Giltiay2, Christian Lood2 and Bobby Kwanghoon Han2, 1University of Washington, Seattle, WA, 2Division of Rheumatology, University of Washington, Seattle, WA

    Background/Purpose: Abatacept, a CTLA-4-Ig fusion protein, is widely used as a treatment for rheumatoid arthritis (RA). However, data on predictive biomarkers associated with therapeutic response…
  • Abstract Number: 0749 • ACR Convergence 2023

    Impact of Sprifermin on Denuded Areas of Subchondral Bone (dABs): A Post Hoc Analysis of the FORWARD Study

    Felix Eckstein1, Wolfgang Wirth2, Philip Conaghan3, Marc Hochberg4, Ali Guermazi5, Jade Andrade6, Luping Zhao6 and Niti Goel7, 1Paracelsus Medical University, Institute of Anatomy & Ludwig Boltzmann Institute, and Chondrometrics GmbH, Salzburg, Austria, 2Paracelsus Medical University, Institute of Anatomy & Ludwig Boltzmann Institute, and Chondrometrics GmbH, Freilassing, Germany, 3University of Leeds, Leeds, United Kingdom, 4University of Maryland School of Medicine, Baltimore, MD, 5Boston University, Boston, MA, 6TrialSpark, New York, NY, 7TrialSpark, Duke University, Durham, NC

    Background/Purpose: Sprifermin, recombinant human fibroblast growth factor 18 (rhFGF-18), is being investigated as a potential disease-modifying osteoarthritis drug. The Phase 2 FORWARD study demonstrated that…
  • Abstract Number: 1112 • ACR Convergence 2023

    AR882, a Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Profile Following Multiple Doses

    Zancong Shen1, Elizabeth Polvent2, sarah Morris3, Rongzi Yan4, Shunqi Yan5, Robert Keenan6 and Li-Tain Yeh7, 1Arthrosi Therapeutics, San Diego, CA, 2Arthrosi Therapeutics, Inc., Roseville, CA, 3Arthrosi Therapeutics Inc, San Diego, CA, 4Arthrosi Therapeutics, Inc, Irvine, CA, 5Arthrosi Therapeutics, Inc., Laguna Hills, CA, 6Arthrosi Therapeutics, Chapel Hill, NC, 7Arthrosi Therapeutics, Inc., Irvine, CA

    Background/Purpose: The uric acid transporter inhibitor (URAT1) is responsible for the reabsorption of filtered uric acid from the renal tubular lumen. Uricosuric agents inhibit URAT1…
  • Abstract Number: 1422 • ACR Convergence 2023

    Long-Term Safety of Risankizumab in Patients with Psoriatic Disease: Integrated Analysis of Psoriasis and Psoriatic Arthritis Clinical Trial Data

    Kenneth Gordon1, Andrew Blauvelt2, Herve Bachelez3, Laura Coates4, Blair Kaplan5, Willem Koetse5, Leonidas Drogaris5, Ranjeeta Sinvhal5 and Kim A Papp6, 1Medical College of Wisconsin, Milwaukee, WI, 2Oregon Medical Research Center, Portland, OR, 3APHP Hopital Saint-Louis, Universite de Paris, Paris, France, 4University of Oxford, Oxford, United Kingdom, 5AbbVie, Inc., North Chicago, IL, 6Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada

    Background/Purpose: Risankizumab, an interleukin-23 inhibitor, was efficacious and well tolerated in plaque psoriasis (PsO) and psoriatic arthritis (PsA) clinical trials.The objective of this integrated data…
  • Abstract Number: 1512 • ACR Convergence 2023

    Rituximab Objective Outcome Measures Trial in SLE (ROOTS): Randomised and Rescue Therapy Outcomes from a Randomised Controlled Trial

    Khaled Mahmoud, Michelle Wilson, Md Yuzaiful Md Yusof, Sarah Brown, Elizabeth Hensor and Ed Vital, University of Leeds, Leeds, United Kingdom

    Background/Purpose: New medicines in SLE have not met endpoints in placebo-controlled RCTs when other evidence indicates they are effective. Reasons suggested are inclusion of patients…
  • Abstract Number: 1991 • ACR Convergence 2023

    Therapeutic Efficacy of Intra Articular Injection of Human Bone Marrow Derived Mesenchymal Stem Cells in Knee Osteoarthritis; Randomized, Double-blind, Placebo-controlled Clinical Trial

    Ji Won Yang, Bong-Woo Lee, Jennifer Lee and Ji Hyeon Ju, Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Background/Purpose: Osteoarthritis (OA) is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury. Mesenchymal stem…
  • Abstract Number: 2245 • ACR Convergence 2023

    Drug Survival of Risankizumab vs Other Biologics After 13 Months of Treatment Among Patients with PsA in the Multicountry Postmarketing Observational VALUE Study

    Lars Erik1, Kim A Papp2, Andrew Östör3, Vassilis Stakias4, Tshepiso Madihlaba4, Ralph Lippe5, Ran Liu4 and Diamant Thaçi6, 1Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark, 2Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, 3Monash University & Emeritus Research; Australian National University, Melbourne, Australia, 4AbbVie, Inc., North Chicago, IL, 5AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, 6Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany

    Background/Purpose: Risankizumab (RZB) is an optimized IL-23 inhibitor (IL-23i) currently approved for the treatment of plaque psoriasis (PsO), PsA, and Crohn's disease. In a post…
  • Abstract Number: 2488 • ACR Convergence 2023

    Efficacy and Safety of ABBV-599 High Dose (Elsubrutinib 60 mg and Upadacitinib 30 mg) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: A Phase 2, Double-blind, Placebo-controlled Trial

    Joan Merrill1, Yoshiya Tanaka2, David D'Cruz3, Karina Vila-Rivera4, Daniel Siri5, Xiaofeng Zeng6, Kristin D'Silva7, Ling Cheng7, Thierry Sornasse7, Thao Doan7, Denise Kruzikas7 and Alan Friedman7, 1Oklahoma Medical Research Foundation, Oklahoma City, OK, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3King's College London, London, United Kingdom, 4GCM Medical, San Juan, PR, 5CAICI SRL, Rosario, Argentina, 6Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 7AbbVie, Inc., North Chicago, IL

    Background/Purpose: ABBV-599 is a novel combination of elsubrutinib (ELS; a selective BTK inhibitor) and upadacitinib (UPA; a JAK inhibitor) that targets non-overlapping signaling pathways associated…
  • Abstract Number: 0443 • ACR Convergence 2023

    The Potential of an Oral TNFα Inhibitor with TNFR1 Specificity: Results of a Phase 1b Proof-of-mechanism Trial in Psoriasis

    Anna Fishbein1, Mai Anh Nguyen2, Ohn Chow3, Tiago Matos4, Caroline Dreis5, Hong Zhang3, Marion Poirel6, Johann Gassenhuber5, Michael Dufault3, Wagner Frank-Dietrich7, Laurent Perrin8, Markus Rehberg5, Markus Kohlmann5 and Nassr Nassr5, 1Sanofi, Bridgewater, NJ, 2Sanofi, Berlin, Germany, 3Sanofi, Cambridge, MA, 4Sanofi, Amsterdam, Netherlands, 5Sanofi, Frankfurt, Germany, 6IT&M Stats, Neuilly-sur-Seine, France, 7Charité Research Organisation, Berlin, Germany, 8Sanofi, Montpellier, France

    Background/Purpose: TNFα inhibition is a cornerstone of therapy for rheumatologic disease, yet there is no orally administered TNFα inhibitor available. A novel oral TNFα inhibitor…
  • Abstract Number: 0775 • ACR Convergence 2023

    Effectiveness of Dose Reduction and Withdrawal Strategies of TNF Inhibitors in Psoriatic Arthritis and Axial Spondyloarthritis: Long Term Extension of the DRESS-PS Study

    Amy Peeters, C.A.J Michielsens, Elien Mahler, Lise Verhoef, Alfons den Broeder, Nathan den Broeder and Noortje van Herwaarden, Sint Maartenskliniek, Nijmegen, Netherlands

    Background/Purpose: Tumor Necrosis Factor inhibitors (TNFi) are effective in PsA and axial SpA, but are associated with increased infections risk, patient burden and high costs.…
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