Abstracts tagged "clinical trial"

Abstract Number: 1225 • ACR Convergence 2021
Baseline Extracellular Matrix Biomarkers Predict Abatacept Treatment Response in MTX-Naive, ACPA+ Patients with Early RA
Paul Emery¹, Yoshiya Tanaka², Vivian Bykerk³, Clifton Bingham⁴, Tom WJ Huizinga⁵, Gustavo Citera⁶, Chun Wu⁷, Sarah Hu⁷, Peter Schafer⁷, Jinqi Liu⁷, Sean Connolly⁷, Robert Wong⁸ and Roy Fleischmann⁹, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Division of Rheumatology, Hospital for Special Surgery, New York City, NY, ⁴Johns Hopkins University, Baltimore, MD, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Basking Ridge, NJ, ⁹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Predictive biomarkers reflecting RA processes and treatment (tmt) efficacy are urgently needed to inform medical options. Markers of bone remodeling and extracellular matrix (ECM)…
Abstract Number: 1345 • ACR Convergence 2021
Long-Term Safety and Effectiveness of Upadacitinib in Patients with Psoriatic Arthritis: Results at 56 Weeks from the SELECT-PsA 1 Study
Iain McInnes¹, Koji Kato², Marina Magrey³, Joseph Merola⁴, Mitsumasa Kishimoto⁵, Cesar Pacheco Tena⁶, Derek Haaland⁷, Liang Chen⁸, Yuanyuan Duan⁹, Patrick Zueger¹⁰, Jianzhong Liu¹¹, Ralph Lippe¹², Aileen Pangan¹¹ and Frank Behrens¹³, ¹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ²AbbVie Inc, Shinagawa- Ku, Japan, ³Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH, ⁴Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁵Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Yokohama, Japan, ⁶Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico, ⁷McMaster University, Hamilton, Ontario and The Waterside Clinic, Oro Medonte, ON, Canada, ⁸AbbVie Inc., North Chicago, ⁹AbbVie Inc, North Chicago, ¹⁰AbbVie Inc., Mettawa, IL, ¹¹AbbVie Inc., North Chicago, IL, ¹²AbbVie Deutschland GmbH & Co. KG, Berlin, Germany, ¹³Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany
Background/Purpose: In the SELECT-PsA 1 study, through 24 weeks (wks), once daily upadacitinib 15 mg (UPA15) and 30 mg (UPA30) showed improvements in musculoskeletal symptoms,…
Abstract Number: 1691 • ACR Convergence 2021
Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis
Gerd Burmester¹, Stanley Cohen², Kevin Winthrop³, Peter Nash⁴, Andrea Rubbert-Roth⁵, Atul Deodhar³, Ori Elkayam⁶, Eduardo Mysler⁷, Yoshiya Tanaka⁸, Jianzhong Liu⁹, Ana Paula Lacerda⁹, Bosny Pierre-Louis⁹, Tim Shaw¹⁰ and Philip Mease¹¹, ¹Charité University Medicine Berlin, Berlin, Germany, ²Metroplex Clinical Research Center, Dallas, TX, ³Oregon Health & Science University, Portland, OR, ⁴Griffith University, Brisbane, Australia, ⁵Kantonspital St Gallen, St.Gallen, Switzerland, ⁶Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, ⁷Organización Medica de Investigación, Rheumatology, Buenos Aires, Argentina, ⁸University of Occupational and Environmental Health, Kitakyushu, Japan, ⁹AbbVie Inc., North Chicago, IL, ¹⁰AbbVie Inc., North Chicago, ¹¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA
Background/Purpose: The efficacy and safety of the oral Janus kinase inhibitor, upadacitinib (UPA), has been evaluated for several rheumatic diseases. The objective of this analysis…
Abstract Number: 1748 • ACR Convergence 2021
The Peroxisome Proliferator-Activated Receptor-γ (PPAR) Agonist Pioglitazone Improves Vascular and Metabolic Dysfunction in Patients with Systemic Lupus Erythematosus (SLE)
Sarfaraz Hasni¹, Yenealem Temesgen-Oyelakin², Michael Davis³, Sarthak Gupta⁴, Elaine Poncio⁵, Mohammad Naqi¹, Xinghao Wang⁶, Christopher Oliveira⁷, Dillon Claybaugh¹, Amit Dey¹, Shajia Lu¹, Philip Carlucci⁸, Zerai Manna¹, Yinghui Shi¹, Isabel Ochoa⁵, Donald Thomas⁹, Theo Heller¹⁰, Massimo Gadina¹¹, Jun Chu⁴, Monica Purmalek¹, Xiaobai Li¹², Martin Playford¹³, Nehal Mehta¹³ and Mariana Kaplan¹, ¹National Institutes of Health, Bethesda, MD, ²National Institutes of Health (NIH), Bethesda, MD, ³NIAMS, Bethesda, MD, ⁴National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD, ⁵NIH/NIAMS, Bethesda, MD, ⁶NIAMS/NIH, Bethesda, MD, ⁷National Institutes of Health (NIH), Vienna, VA, ⁸New York University School of Medicine, New York, NY, ⁹Arthritis and Pain Associates of Prince George's County, Silver Spring, MD, ¹⁰NIDDK/National Institutes of Health, Bethesda, MD, ¹¹National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, ¹²Clinical Center, National Institutes of Health, Bethesda, MD, ¹³NHLBI/National Institutes of Health, Bethesda, MD
Background/Purpose: Premature cardiovascular events in SLE are associated with significant mortality and morbidity with no effective treatments described to date. Both immune dysregulation characteristics of…
Abstract Number: 1807 • ACR Convergence 2021
Relationships Between Fatigue and Hemoglobin/C-Reactive Protein Levels and Associations Between Fatigue and Clinical Response in Patients with Active Psoriatic Arthritis: Results from Two Randomized Controlled Trials of Guselkumab (TREMFYA®)
Proton Rahman¹, Philip Mease², Atul Deodhar³, Laure Gossec⁴, Arthur Kavanaugh⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Yan Liu⁸, Xiwu Lin⁸, May Shawi⁹ and Chenglong Han⁸, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ³Oregon Health & Science University, Portland, OR, ⁴Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁵University of California San Diego, La Jolla, CA, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada
Background/Purpose: Fatigue is a key patient (pt)-reported symptom of psoriatic arthritis (PsA).1,2 Utilizing data from the Phase 3 DISCOVER-1 (D1) and -2 (D2) studies, these…
Abstract Number: 0477 • ACR Convergence 2021
TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial
Gregory Sullivan¹, Mary Kelley², Annabelle Iserson¹, Perry Peters², Ashild Peters², Candace Flint¹, Judy Gendreau³, Herb Harris¹, Ben Vaughn⁴ and Seth Lederman⁵, ¹Tonix Pharmaceuticals, Inc., Chatham, NJ, ²Tonix Pharmaceuticals, Inc., San Diego, CA, ³Gendreau Consulting, LLC, Poway, CA, ⁴Rho, Inc., Cary, NC, ⁵Tonix Pharmaceuticals, Inc., South Dartmouth, MA
Background/Purpose: Fibromyalgia (FM) is characterized by chronic widespread pain, fatigue, and nonrestorative sleep, a symptom constellation suggestive of a pathological disturbance in central pain processing…
Abstract Number: 1230 • ACR Convergence 2021
Impact of Serologic Status on Clinical Responses to Upadacitinib or Abatacept in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE Study
Andrea Rubbert-Roth¹, Jeffrey Sparks², Arnaud Constantin³, Ricardo Xavier⁴, Yanna Song⁵, Jessica Suboticki⁵ and Roy Fleischmann⁶, ¹Kantonspital St Gallen, St.Gallen, Switzerland, ²Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³Toulouse University Hospital, Toulouse Cedex 9, France, ⁴Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, ⁵AbbVie Inc., North Chicago, IL, ⁶University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In patients with RA who had a prior inadequate response or intolerance to biologic DMARDs, the oral Janus kinase inhibitor, upadacitinib (UPA), demonstrated superiority…
Abstract Number: 1350 • ACR Convergence 2021
Sustained Improvement in Physical Function, Disease Impact and Health-Related Quality of Life in Patients with Psoriatic Arthritis Treated with Bimekizumab: 3-Year Results from a Phase 2b Open-Label Extension Study
Laure Gossec¹, Akihiko Asahina², Alice Gottlieb³, Laura Coates⁴, Barbara Ink⁵, Deepak Assudani⁶, Jason Coarse⁷, Scarlett Hellot⁸, Jason Eells⁶ and Philip Mease⁹, ¹Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, ²Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ³Icahn School of Medicine at Mount Sinai, New York, NY, ⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ⁵UCB Celltech, Slough, UK, Slough, United Kingdom, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Raleigh, NC, ⁸UCB Pharma, Colombes, France, ⁹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17F and IL-17A, and has demonstrated clinical improvements in joint and skin…
Abstract Number: 1692 • ACR Convergence 2021
Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study
Ronald F van Vollenhoven¹, Tsutomu Takeuchi², Jacob Aelion³, Nilmo Chavez⁴, Pablo Mannucci⁵, Atul Singhal⁶, Jerzy Swierkot⁷, Alan Friedman⁸, Nasser Khan⁸, Yihan Li⁹, Xianwei Bu⁹, Justin Klaff⁸ and Vibeke Strand¹⁰, ¹Amsterdam University Medical Centers, Department of Rheumatology and Clinical Immunology, Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, ⁴Instituto Guatemalteco de Seguridad Social, Ciudad de Guatemala, Guatemala, ⁵Aprillus Asistencia e Investigación, Buenos Aires, Argentina, ⁶Southwest Rheumatology Research LLC, Dallas, TX, ⁷Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, ⁸AbbVie Inc., North Chicago, IL, ⁹AbbVie Inc., North Chicago, ¹⁰Stanford University School of Medicine, Portola Valley, CA
Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, demonstrated significant improvements in signs, symptoms, and structural inhibition as monotherapy (mono) vs methotrexate (MTX) in MTX-naïve…
Abstract Number: 1750 • ACR Convergence 2021
Itolizumab, a Novel anti-CD6 Therapy, in Systemic Lupus Erythematosus Patients: Interim Safety Results from the Phase 1b EQUALISE Dose-escalation Study
Kenneth Kalunian¹, Richard Furie², Jai Radhakrishnan³, Vandana Mathur⁴, Krishna Polu⁴, Stephen Connelly⁴, Joel Rothman⁴, Cherie Ng⁴, Leslie Chinn⁵, Maple Fung⁶, Dolca Thomas⁷ and Chaim Putterman⁸, ¹UC San Diego, La Jolla, CA, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³Columbia University, New York, NY, ⁴Equillium, Inc., La Jolla, CA, ⁵Equillium, Inc., South San Francisco, CA, ⁶Equillium, Inc., San Diego, CA, ⁷Equillium, Inc., Brooklyn, NY, ⁸Albert Einstein College of Medicine, Bronx, NY
Background/Purpose: CD6, a co-stimulatory receptor predominantly expressed on T cells, promotes CD4+ T cell proliferation and differentiation into Th1/Th17 cells. The CD6 ligand, activated leukocyte…
Abstract Number: 1816 • ACR Convergence 2021
Treatment of Non-biologic-DMARD-IR PsA Patients with Upadacitinib or Adalimumab Results in the Modulation of Distinct Functional Pathways: Proteomics Analysis of a Phase 3 Study
Thierry Sornasse¹, Jaclyn Anderson², Koji Kato³, Apinya Lertratanakul⁴, Christopher Ritchlin⁵ and Iain McInnes⁶, ¹AbbVie Inc, Redwood City, CA, ²AbbVie Inc, Gurnee, IL, ³AbbVie Inc, Shinagawa- Ku, Japan, ⁴AbbVie Inc., North Chicago, IL, ⁵Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁶University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Treatment of non-biologic-DMARD-IR (DMARD-IR) PsA patients with upadacitinib (UPA) at 15 mg QD, an oral JAK1 selective inhibitor, resulted in improvement in musculoskeletal symptoms,…
Abstract Number: 0488 • ACR Convergence 2021
Efficacy and Safety of Brepocitinib (Tyrosine Kinase 2/Janus Kinase 1 Inhibitor) for the Treatment of Active Psoriatic Arthritis: Results from a Phase 2b Randomized Controlled Trial
Philip Mease¹, Philip S Helliwell², Paula Silwinska-Stanczyk³, Malgorzata Miakisz⁴, Andrew Ostor⁵, Elena Peeva⁶, Michael Vincent⁶, Vanja Sikirica⁷, Randall Winnette⁸, Ruolun Qiu⁶, Gang Li⁷, Gang Feng⁶, Jean Beebe⁶ and David Martin⁶, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³REUMATIKA – Centrum Reumatologii NZOZ, Warsaw, Poland, ⁴Twoja Przychodnia Centrum Medyczne Nowa Sol, Nowa Sol, Poland, ⁵Monash University, Cabrini Hospital & Emeritus Research, Melbourne, Australia, ⁶Pfizer Inc, Cambridge, MA, ⁷Pfizer Inc, Collegeville, PA, ⁸Pfizer Inc, New York, NY
Background/Purpose: Brepocitinib is a small-molecule tyrosine kinase 2/Janus kinase 1 inhibitor that has shown promising results in an oral formulation for plaque psoriasis and alopecia…
Abstract Number: 1234 • ACR Convergence 2021
Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy
Martin Bergman¹, Maya Buch², Yoshiya Tanaka³, Gustavo Citera⁴, Sami Bahlas⁵, Ernest Wong⁶, Yanna Song⁷, Namita Tundia⁷, Jessica Suboticki⁷ and Vibeke Strand⁸, ¹Martin Jan Bergman, MD, Ridley Park, PA, ²University of Leeds, Leeds, United Kingdom, ³University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁵Medicine, King Abdulaziz University, Jeddah, Saudi Arabia, ⁶Rheumatology, Queen Alexandra Hospital, Portsmouth, United Kingdom, ⁷AbbVie Inc., North Chicago, IL, ⁸Stanford University School of Medicine, Portola Valley, CA
Background/Purpose: Routine Assessment of Patient Index Data 3 (RAPID3) is a pooled index of 3 patient-reported measures: patient global assessment, pain, and physical function. RAPID3…
Abstract Number: 1363 • ACR Convergence 2021
Identification of PsA Phenotypes with Machine Learning Analytics Using Data from a Phase 3 Clinical Trial Program of Guselkumab in a Bio-naïve Population of Patients with PsA
Pascal Richette¹, Marijn Vis², Sarah Ohrndorf³, William Tillett⁴, Marlies Neuhold⁵, Michel van Speybroeck⁶, Elke Theander⁷, Wim Noel⁸, May Shawi⁹, Alexa Kollmeier¹⁰ and Alen Zabotti¹¹, ¹Lariboisiere Hospital, Paris, France, ²Erasmus MC, Badhoevedorp, Netherlands, ³Charité University Medicine Berlin, Berlin, Germany, ⁴Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁵Janssen-Cilag, Zug, Switzerland, ⁶Janssen Pharmaceutica, Belgium, Belgium, ⁷Janssen Cilag, Lund, Sweden, ⁸Janssen Pharmaceutica, Vilvoorde, Belgium, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ¹⁰Janssen Research & Development, LLC, La Jolla, CA, ¹¹University of Udine, Udine, Italy
Background/Purpose: Psoriatic arthritis (PsA) is mainly described based on the individual domains or clinical components of the disease.1,2 The aim of this post hoc analysis…
Abstract Number: 1694 • ACR Convergence 2021
Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs
Ronald van Vollenhoven¹, Stephen Hall², Alvin Wells³, Sebastian Meerwein⁴, Yanna Song⁵, Jessica Suboticki⁵ and Roy Fleischmann⁶, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ²Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, ³Rheumatology and Immunotherapy Center, Franklin, WI, ⁴AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, ⁵AbbVie Inc., North Chicago, IL, ⁶Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Sustained clinical remission (REM) is the primary treatment goal for patients with rheumatoid arthritis (RA), with low disease activity (LDA) being an appropriate target…

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