Abstracts tagged "clinical trial"

Abstract Number: 1802 • ACR Convergence 2021
Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials
Xenofon Baraliakos¹, Atul Deodhar², Roberto Ranza³, Simona Rednic⁴, Francesco Ciccia⁵, Fabiana Ganz⁶, Tianming Gao⁶, Apinya Lertratanakul⁶, In-Ho Song⁶, Andrew Ostor⁷ and Laura Coates⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²Oregon Health & Science University, Portland, OR, ³Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, ⁴Emergency Clinical County Hospital, Rheumatology and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania, ⁵University of Campania “Luigi Vanvitelli", Naples, Italy, ⁶Abbvie Inc., North Chicago, IL, ⁷Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
Background/Purpose: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor…
Abstract Number: 0441 • ACR Convergence 2021
A Randomized, Double-blind, Placebo-controlled Study of Arimoclomol in Patients with Inclusion Body Myositis
Pedro Machado¹, Richard Barohn², Michael McDermott³, Thomas Blaetter⁴, Tom Lloyd⁵, Aziz Shaibani⁶, Miriam Freimer⁷, Anthony Amato⁸, Emma Ciafaloni³, Sarah Jones⁹, Tahseen Mozaffar¹⁰, Summer Gibson¹¹, Matthew Wicklund¹², Todd Levine¹³, Claus Sundgreen⁴, Tim Carstensen⁴, Karen Bonefeld⁴, Anders Jørgensen⁴, Karina Phonekeo⁴, Andrew Heim¹⁴, Laura Herbelin¹⁴, Michael Hanna¹⁵ and Mazen Dimachkie¹⁴, ¹Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ²University of Missouri - Columbia, Columbia, MO, ³University of Rochester, Rochester, NY, ⁴Orphazyme A/S, Copenhagen, Denmark, ⁵Johns Hopkins University, Baltimore, MD, ⁶Nerve and Musle Center, Houston, TX, ⁷Ohio State University, Columbus, OH, ⁸Brigham and Women's Hospital, Boston, MA, ⁹University of Virginia, Charlottesville, VA, ¹⁰University of California Irvine, Irvine, CA, ¹¹University of Utah, Salt Lake City, UT, ¹²University of Colorado, Denver, CO, ¹³Phoenix Neurological Associates, Phoenix, AZ, ¹⁴University of Kansas Medical Center, Kansas City, KS, ¹⁵University College London, London, United Kingdom
Background/Purpose: Inclusion body myositis (IBM) is the most common idiopathic inflammatory myopathy occurring in patients over the age of 45 years. Since immune suppression has…
Abstract Number: 0926 • ACR Convergence 2021
Predictors of 1-Year Treatment Response Among Upadacitinib-Treated Patients with Ankylosing Spondylitis: A Post Hoc Analysis
Marina Magrey¹, Sofia Ramiro², Marcelo Medeiros Pinheiro³, Tianming Gao⁴, Fabiana Ganz⁴, In-Ho Song⁴, Ana Biljan⁵, Nigil Haroon⁶ and Martin Rudwaleit⁷, ¹Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH, ²Leiden University Medical Center, Leiden, Netherlands, ³Universidade Federal de São Paulo, São Paulo, Brazil, ⁴AbbVie Inc., North Chicago, IL, ⁵Abbvie Inc., Chicago, IL, ⁶Division of Rheumatology, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada, ⁷University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany
Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase inhibitor that has demonstrated efficacy and safety among patients with ankylosing spondylitis (AS) in the phase 2/3…
Abstract Number: 1332 • ACR Convergence 2021
Validation of the PROMIS-29 Profile in Patients with Active Psoriatic Arthritis Using Data from a Phase 3, Randomized, Placebo-Controlled Study Evaluating Guselkumab (TREMFYA®)
Ana-Maria Orbai¹, Laura Coates², Atul Deodhar³, Christopher Ritchlin⁴, Alexa Kollmeier⁵, Marlies Neuhold⁶, Yi-Hsuan Liu⁷, Yan Liu⁷ and Chenglong Han⁷, ¹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen-Cilag, Zug, Switzerland, ⁷Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: It is important to assess symptoms of pain, fatigue, anxiety, depression, sleep disturbance, and impaired physical function in patients (pts) with psoriatic arthritis (PsA),…
Abstract Number: 1680 • ACR Convergence 2021
Impact of Race on the Efficacy and Safety of Tofacitinib in Patients with RA: A Post Hoc Analysis of Phase 2, 3, and 3b/4 Clinical Trials
Grace Wright¹, Eduardo Mysler², Yi-Hsing Chen³, Cassandra Kinch⁴, Arne Yndestad⁵, Kenneth Kwok⁶, Mary Jane Cadatal⁷, Rebecca Germino⁸ and Alexis Ogdie⁹, ¹Grace C Wright MD PC, and Association of Women in Rheumatology, New York, NY, ²Organización Médica de Investigación, Buenos Aires, Argentina, ³Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), ⁴Pfizer Canada ULC, Kirkland, QC, Canada, ⁵Pfizer Inc, Oslo, Norway, ⁶Pfizer Inc, New York, NY, ⁷Pfizer Inc, Manila, Philippines, ⁸Pfizer Inc, Groton, CT, ⁹Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: While racial disparities in clinical outcomes for RA patients (pts) receiving bDMARDs or csDMARDs have been described,1 there remains a paucity of data on…
Abstract Number: 1741 • ACR Convergence 2021
Anifrolumab Results in Favorable Responses Regardless of SLE Disease Duration: Post Hoc Analysis of Data from 2 Phase 3 Trials
Kenneth Kalunian¹, Maria Dall'Era², Richard Furie³, Eric Morand⁴, Konstantina Psachoulia⁵, Emmanuelle Maho⁶, Catharina Lindholm⁷ and Raj Tummala⁵, ¹University of California, La Jolla, CA, ²University of California San Francisco, San Francisco, CA, ³Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁴Monash University, Melbourne, Australia, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁷BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Background/Purpose: In 2 phase 3 trials, TULIP-1 and TULIP-2, anifrolumab, a type I IFN receptor mAb, improved disease activity in patients with SLE.1,2 Here, we…
Abstract Number: 1803 • ACR Convergence 2021
Long-term Safety of Guselkumab (TREMFYA®) in Patients with Active Psoriatic Arthritis: Pooled Results from 3 Randomized Clinical Trials Through up to 2 Years
Proton Rahman¹, Christopher Ritchlin², Philip Mease³, Philip S Helliwell⁴, Wolf-Henning Boehncke⁵, Iain McInnes⁶, May Shawi⁷, Anne Marilise Marrache⁸, Alexa Kollmeier⁹, Xie Xu¹⁰, Jenny Yu¹⁰, Yanli Wang¹⁰, Shihong Sheng¹⁰ and Alice Gottlieb¹¹, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵Geneva University Hospitals, Geneva, Switzerland, ⁶University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Inc., Toronto, ON, Canada, ⁹Janssen Research & Development, LLC, La Jolla, CA, ¹⁰Janssen Research & Development, LLC, Spring House, PA, ¹¹Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Guselkumab (GUS), a targeted IL-23 inhibitor, demonstrated significant improvements in signs and symptoms of psoriatic arthritis (PsA) and a favorable safety profile through week…
Abstract Number: 0443 • ACR Convergence 2021
Safety and Efficacy of Belimumab in the Treatment of Adult Idiopathic Inflammatory Myositis (Polymyositis and Dermatomyositis)
Priyal Chadha¹, Sonali Narain², Preeya Nandkumar³, Cristine Sison⁴, Elena Schiopu⁵, Todd Levine⁶, James Tsang⁷ and Galina Marder⁸, ¹SUNY Upstate Medical University, Syracuse, NY, ²Northwell Health, Great Neck, NY, ³Division of Rheumatology, Department of Medicine, Northwell, Great Neck, NY, ⁴Biostatistics Unit , Department of Molecular Medicine, Feinstein Institutes for Medical Research at Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁵University of Michigan, Ann Arbor, MI, ⁶Phoenix Neurological Associates, Phoenix, AZ, ⁷Center for Research Informatics & Innovation (CRII), Feinstein Institute for Medical Research at Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁸Division of Rheumatology, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Background/Purpose: Treatment of Idiopathic Inflammatory Myositis (IIM) includes steroids and immunosuppressive agents. Targeting IL6, IL1, TNF for treatment of IIM has not been successful, and…
Abstract Number: 0958 • ACR Convergence 2021
Risk Factors for Major Adverse Cardiovascular Events in Patients Aged ≥ 50 Years with RA and ≥ 1 Additional Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Christina Charles-Schoeman¹, Maya Buch², Maxime Dougados³, Deepak L Bhatt⁴, Jon Giles⁵, Ivana Vranic⁶, Joseph Wu⁷, Cunshan Wang⁷, Sujatha Menon⁷, Jose L Rivas⁸, Arne Yndestad⁹, Carol A Connell⁷ and Zoltan Szekanecz¹⁰, ¹Department of Medicine, University of California, Los Angeles, Los Angeles, CA, ²University of Leeds, Leeds, United Kingdom, ³Université de Paris . Department of Rheumatology - Hôpital Cochin. Assistance Publique - Hôpitaux de Paris . INSERM (U1153): Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité. Paris, France., Paris, France, ⁴Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ⁵Columbia University, New York, NY, ⁶Pfizer Inc, Tadworth, Surrey, United Kingdom, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer SLU, Madrid, Spain, ⁹Pfizer Inc, Oslo, Norway, ¹⁰Division of Rheumatology, University of Debrecen, Faculty of Medicine, Debrecen, Hungary
Background/Purpose: To identify independent risk factors for major adverse cardiovascular (CV) events (MACE) in ORAL Surveillance (NCT02092467), a long-term, randomized, open-label, non-inferiority, Phase 3b/4 safety…
Abstract Number: 1333 • ACR Convergence 2021
Guselkumab (TREMFYA®) Provides Consistent and Durable Pain Improvement in Patients with Active Psoriatic Arthritis: Results of 2 Phase 3, Randomized, Controlled Clinical Trials
Peter Nash¹, Lai-Shan Tam², Wen-Chan Tsai³, Ying-Ying Leung⁴, Daniel Furtner⁵, Shihong Sheng⁶, Yanli Wang⁶, May Shawi⁷, Alexa Kollmeier⁸, Jonathan Sherlock⁹ and Daniel Cua⁶, ¹Griffith University, Brisbane, Australia, ²Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China (People's Republic), ³Janssen Research & Development, LLC, Kaohsiung City, Taiwan (Republic of China), ⁴Singapore General Hospital and Duke-NUS Medical School, Singapore, Singapore, ⁵Janssen, a division of Johnson & Johnson Pte. Ltd., Singapore, Singapore, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Research & Development, LLC, La Jolla, CA, ⁹Janssen Research & Development, LLC and University of Oxford, Spring House, PA
Background/Purpose: Guselkumab (GUS), a targeted inhibitor of IL-23p19, demonstrated significant efficacy v placebo (PBO) in achieving ACR20 response at week (W) 24 in patients (pts)…
Abstract Number: 1684 • ACR Convergence 2021
Incidence of Infections in Patients Aged ≥ 50 Years with RA and ≥ 1 Additional Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Andra R Bălănescu¹, Gustavo Citera², Virginia Pascual-Ramos³, Carol A Connell⁴, David Gold⁵, All-shine Chen⁴, Harry Shi⁶, Andrea B Shapiro⁷, Janet Pope⁸ and Hendrik Schulze-Koops⁹, ¹“Carol Davila” University of Medicine and Pharmacy, Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, Bucharest, Romania, ²Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ³Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, Montréal, QC, Canada, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Inc, Peapack, NJ, ⁸University of Western Ontario, London, ON, Canada, ⁹Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany
Background/Purpose: Previous clinical trial and real-world data suggest that risk of serious infection events (SIEs) and opportunistic infections (OIs) is similar with tofacitinib 5 mg…
Abstract Number: 1742 • ACR Convergence 2021
Efficacy of Anifrolumab in Serological Subgroups of Patients with SLE Participating in 2 Phase 3 Trials
Ian N. Bruce¹, Ronald Van Vollenhoven², Yoshiya Tanaka³, Eric Morand⁴, Richard Furie⁵, Konstantina Psachoulia⁶, Emmanuelle Maho⁷, Catharina Lindholm⁸, Christi Kleoudis⁹ and Raj Tummala⁶, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ³University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴Monash University, Melbourne, Australia, ⁵Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁶BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁷BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁸BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁹BioPharmaceuticals R&D, AstraZeneca, Durham, NC
Background/Purpose: In the TULIP-2 and TULIP-1 trials of patients with SLE, the type I IFN receptor mAb anifrolumab resulted in higher BILAG–based Composite Lupus Assessment…
Abstract Number: 1804 • ACR Convergence 2021
Targeted Safety Analyses of Guselkumab (TREMFYA®): Long-term Results from Randomized Clinical Trials in Patients with Active Psoriatic Arthritis and Moderate to Severe Psoriasis
Philip Mease¹, Peter Foley², Kristian Reich³, Soumya Chakravarty⁴, May Shawi⁵, Ya-Wen Yang⁶, Megan Miller⁷, Alexa Kollmeier⁸, Xie Xu⁷, Jenny Yu⁷, Yanli Wang⁷, Shihong Sheng⁷, Yin You⁷ and Iain McInnes⁹, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²University of Melbourne, Carlton, Australia, ³University Medical Center Hamburg-Eppendorf, Hamburg, Germany, ⁴Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁵Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁶Janssen Global Services, LLC, Horsham, PA, ⁷Janssen Research & Development, LLC, Spring House, PA, ⁸Janssen Research & Development, LLC, La Jolla, CA, ⁹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Guselkumab (GUS), a human monoclonal antibody that specifically binds to the p19 subunit of IL-23, demonstrated efficacy and a favorable safety profile in active…
Abstract Number: 0449 • ACR Convergence 2021
Identification of Serum Protein Biomarkers at Baseline to Distinguish Radiographic Progressors from Non-Progressors in Patients with Active Psoriatic Arthritis
Orla Coleman¹, Bruna Wundervald², Ruoyi Zhou³, James Waddington³, Robert LJ Graham⁴, Ciaren Graham⁴, Geoff McMullan⁴, Andrew C. Parnell⁵, Vinod Chandran⁶, Philip Mease⁷, Gaia Gallo⁸, Venkatesh Krishnan⁸, Stephen Pennington⁹ and Oliver FitzGerald¹⁰, ¹Atturos, Bray, Ireland, ²Atturos, Maynooth, Ireland, ³Atturos, Belfield, Ireland, ⁴Queen’s University Belfast, Belfast, Northern Ireland, United Kingdom, ⁵Maynooth University, Maynooth, Ireland, ⁶Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁷Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁸Eli Lilly and Company, Indianapolis, IN, ⁹University College Dublin, Dublin, Ireland, ¹⁰Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland
Background/Purpose: A delay in diagnosis and management of patients with PsA leads to poor radiographic and functional outcomes [1]. The need to identify which patients…
Abstract Number: 0967 • ACR Convergence 2021
Antigen-specific and Bystander Autoreactive T Cell Control in Peripheral Blood of ACPA+ Rheumatoid Arthritis Patients Administered Antigen-specific Tolerising Immunotherapy
Pascale Wehr¹, Ranjeny Thomas², Nishta Ramnoruth³, Swati Patel³, Jamie Rossjohn⁴ and Hugh Reid⁴, ¹University of Queensland Diamantina Institute, Brisbane, Australia, ²University of Queensland, Diamantina Institute, Brisbane, Australia, ³University Of Queensland, Brisbane, Australia, ⁴Monash University, Melbourne, Australia
Background/Purpose: The control of autoreactive T cells in an antigen-specific manner in autoimmune diseases is a major clinical research goal. Various regulatory immune signatures have…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].