Abstracts tagged "clinical trial"

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…
Abstract Number: 1751 • ACR Convergence 2021
Voclosporin Is Effective in Achieving Complete Renal Response Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials
Anca Askanase¹, Simrat Randhawa², Laura Lisk³ and Paola Mina-Osorio⁴, ¹Columbia University Medical Center, New York, NY, ²Aurinia Pharmaceuticals Inc., Seattle, WA, ³Aurinia Pharmaceuticals Inc., Victoria, ON, Canada, ⁴Aurinia Pharmaceuticals Inc., New York, NY
Background/Purpose: Voclosporin is a novel calcineurin inhibitor recently approved for the treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy.…
Abstract Number: 1817 • ACR Convergence 2021
Comparison of Composite Indices for Disease Activity in Patients with Psoriatic Arthritis Treated with Upadacitinib: A Post-Hoc Analysis from SELECT-PsA 1
Josef Smolen¹, Ennio Lubrano², Mitsumasa Kishimoto³, Andra R Bălănescu⁴, Vibeke Strand⁵, Tianming Gao⁶, Nancy Vranich⁶, Ralph Lippe⁷ and William Tillett⁸, ¹Medical University of Vienna, Vienna, Austria, ²Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy, ³Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ⁴“Carol Davila” University of Medicine and Pharmacy, Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, Bucharest, Romania, ⁵Stanford University School of Medicine, Portola Valley, CA, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Deutschland GmbH & Co. KG, Berlin, Germany, ⁸Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom
Background/Purpose: Achieving low disease activity (LDA) or remission is a main treatment target in PsA. Composite indices used to assess disease activity include Disease Activity…
Abstract Number: 0496 • ACR Convergence 2021
Safety and Efficacy of Rituximab for Systemic Sclerosis: A Double-Blind, Parallel-Group Comparison, Investigators Initiated Confirmatory Randomized Clinical Trial (DESIRES Study)
Satoshi Ebata¹, Ayumi Yoshizaki¹, Koji Oba², Kosuke Kashiwabara³, Keiko Ueda³, Yukari Umemura⁴, Takeyuki Watadani⁵, Takemichi Fukasawa¹, Shunsuke Miura¹, Asako Yoshizaki-Ogawa¹, Yoshihide Asano¹, Naoko Okiyama⁶, Masanari Kodera⁷, Minoru Hasegawa⁸ and Shinichi Sato¹, ¹Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, ²Department of Biostatistics, School of Public Health, Graduate School of Medicine, and Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, ³Clinical Research Support Center, The Tokyo University Hospital, Tokyo, Japan, ⁴Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan, ⁵Department of Diagnostic Radiology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan., Tokyo, Japan, ⁶Department of Dermatology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan., Ibaraki, Japan, ⁷Department of Dermatology, Japan Community Health Care Organization Chukyo Hospital, Aichi, Japan., Aichi, Japan, ⁸Department of Dermatology, Division of Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan., Fukui, Japan
Background/Purpose: Systemic sclerosis (SSc) is a systemic autoimmune disease belonging to collagen diseases, characterized by fibrosis of various organs including the skin and lungs, and…
Abstract Number: 1237 • ACR Convergence 2021
Predictors of Response: Baseline Characteristics and Early Treatment Responses Associated with Achievement of Remission and Low Disease Activity Among Upadacitinib-Treated Patients with Rheumatoid Arthritis
Arthur Kavanaugh¹, Zoltan Szekanecz², Edward Keystone³, Andrea Rubbert-Roth⁴, Stephen Hall⁵, Ricardo Xavier⁶, Joaquim Pereira⁷, In-Ho Song⁸, Naomi Martin⁹, Yanna Song⁸, Samuel Anyanwu⁸ and Peter Nash¹⁰, ¹Division of Rheumatology, Allergy and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, ²Division of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ³Keystone Consulting Enterprises Inc., Toronto, ON, Canada, ⁴Kantonspital St Gallen, St.Gallen, Switzerland, ⁵Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, ⁶Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, ⁷Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte and Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal, ⁸AbbVie Inc., North Chicago, IL, ⁹AbbVie Inc., Saint-Laurent, QC, Canada, ¹⁰Griffith University, Brisbane, Australia
Background/Purpose: Early prediction of response to treatment with upadacitinib (UPA) 15 mg once daily (QD) could help optimize therapy in patients (pts) with RA.1-4 The…
Abstract Number: 1391 • ACR Convergence 2021
Rituximab Is Superior to Placebo in Polymyalgia Rheumatica Patients: A Double Blind Randomized Controlled Proof of Principle Trial
Diane Marsman¹, Nathan den Broeder², Frank van den Hoogen³, Alfons den Broeder¹ and Aatke van der Maas⁴, ¹Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands, ²Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, ³Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ⁴St Maartenskliniek, Nijmegen, Gelderland, Netherlands
Background/Purpose: Corticosteroids remain the cornerstone of polymyalgia rheumatica treatment, but their use has several disadvantages such as long treatment duration and glucocorticoid-related adverse events.1,2 Data…
Abstract Number: 1696 • ACR Convergence 2021
Clinical Outcomes up to Week 48 of Ongoing Filgotinib RA Long-term Extension Trial of Biologic DMARD Inadequate Responders Initially on Filgotinib or Placebo in a Phase 3 Trial
Maya Buch¹, Tsutomu Takeuchi², Vijay Rajendran³, Jacques-Eric Gottenberg⁴, Alena Pechonkina⁵, YingMeei Tan⁶, Qi Gong⁵, Katrien Van Beneden⁷ and Roberto Caporali⁸, ¹University of Leeds, Leeds, United Kingdom, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Galapagos NV, Mechelen, Belgium, ⁴National Reference Center for Rare East South-West Autoimmune Systemic Diseases RESO, Strasbourg University Hospitals, Strasbourg, France, ⁵Gilead Sciences, Inc., Foster City, CA, ⁶Gilead Sciences, Inc, San Diego, CA, ⁷Galapagos, NV, Mechelen, Belgium, ⁸Policlinico S. Matteo University, Pavia, Italy
Background/Purpose: The preferential Janus kinase-1 inhibitor filgotinib (FIL) is approved to treat RA in Europe and Japan. We assessed FIL efficacy and safety in patients…
Abstract Number: 1752 • ACR Convergence 2021
Efficacy of Voclosporin in Recent Onset Lupus Nephritis
Meggan Mackay¹, Matt Truman², Nicole England², Vanessa Birardi³ and Paola Mina-Osorio⁴, ¹Feinstein Institutes for Medical Research, Manhasset, NY, ²Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc, Rockville, MD, ⁴Aurinia Pharmaceuticals Inc., New York, NY
Background/Purpose: Voclosporin is a novel calcineurin inhibitor recently approved for the treatment of adults with active lupus nephritis (LN) in combination with background immunosuppressive therapy.…
Abstract Number: 1823 • ACR Convergence 2021
Efficacy of Upadacitinib in Patients with Active Psoriatic Arthritis and a Low or High Swollen Joint Count: A Subgroup Analysis of 2 Phase 3 Studies
Laure Gossec¹, Dafna Gladman², Erin McDearmon-Blondell³, Philipp Sewerin⁴, Christopher Ritchlin⁵, Dai Feng⁶, Apinya Lertratanakul⁷, Roberto Ranza⁸, Lai-Shan Tam⁹, Antonio Marchesoni¹⁰, Laura Coates¹¹ and Peter Nash¹², ¹Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ²Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³AbbVie Inc., Elmhurst, IL, ⁴Department and Hiller Research Unit of Rheumatology, Heinrich Heine University Duesseldorf, Duesseldorf, Germany, ⁵Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁶AbbVie Inc., East Brunswick, NJ, ⁷AbbVie Inc., North Chicago, IL, ⁸Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, ⁹Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China (People's Republic), ¹⁰Dipartimento di Reumatologia, ASST Gaetano Pini-CTO, Milano, Italy, ¹¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ¹²Griffith University, Brisbane, Australia
Background/Purpose: Although most patients with psoriatic arthritis (PsA) enrolled in clinical trials have polyarticular arthritis, patients in clinical practice may present with oligoarthritis. Data on…

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