Abstracts tagged "clinical trial"

Abstract Number: 1745 • ACR Convergence 2024
Use of Statins and Its Association with Major Adverse Cardiovascular Outcomes with Tofacitinib versus TNF Inhibitors in a Risk-Enriched Population of Patients with Rheumatoid Arthritis
Jon Giles¹, christina Charles-Schoeman², Maya H. Buch³, Maxime Dougados⁴, Zoltan Szekanecz⁵, Ted Mikuls⁶, Steven R Ytterberg⁷, Gary G Koch⁸, Kenneth Kwok⁹, Mary Jane Cadatal¹⁰, Sujatha Menon¹¹, Yan Chen¹², Annette M Diehl¹², Jose L Rivas¹³, Arne Yndestad¹⁴ and Deepak L Bhatt¹⁵, ¹Cedars Sinai Medical Center, Los Angeles, CA, ²UCLA Medical Center, Santa Monica, CA, ³Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ⁴Université de Paris; Department of Rheumatology, Hôpital Cochin; Assistance Publique-Hôpitaux de Paris; and INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France, ⁵Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ⁶University of Nebraska Medical Center, Omaha, NE, ⁷Division of Rheumatology, Mayo Clinic, Rochester, MN, ⁸Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁹Pfizer Inc, New York, NY, ¹⁰Pfizer Inc, Manila, Philippines, ¹¹Pfizer Inc, Groton, CT, ¹²Pfizer Inc, Collegeville, PA, ¹³Pfizer SLU, Madrid, Spain, ¹⁴Pfizer Inc, Oslo, Norway, ¹⁵Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher incidence of…
Abstract Number: 2056 • ACR Convergence 2024
Deucravacitinib Treatment Did Not Impact Immune Response to SARS-CoV-2 Vaccines and Infection in Patients with Plaque Psoriasis: Results from the Phase 3 POETYK Long-Term Extension Trial
Kevin Winthrop¹, Joseph Merola², Akimichi Morita³, Diamant Thaçi⁴, Jianzhong Zhang⁵, Aditi Basu Ba⁶, Ian M. Catlett⁷, John Schwarz⁶ and Yi Luo⁶, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²UT Southwestern Medical Center, Newton, MA, ³Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁵Department of Dermatology, Peking University People’s Hospital, Beijing, China, ⁶Bristol Myers Squibb, Princeton, ⁷Bristol Myers Squibb, Princeton, NJ
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 2355 • ACR Convergence 2024
Efficacy of Risankizumab Across Distinct PsA Phenotypes Identified with Machine Learning Analytics Using Data from Biologic DMARD-Naive Patients in Two Phase 3 Clinical Trials
Laure Gossec¹, Andra Balanescu², Maria Antonietta D'Agostino³, Alexis Ogdie⁴, Philipp Sewerin⁵, Yu Deng⁶, Linyu Shi⁶, Yoshiyuki Sugimoto⁷, Sheng Zhong⁶, Yunzhao Xing⁶, Ralph Lippe⁶ and Mitsumasa Kishimoto⁸, ¹Sorbonne Université, Paris, France, ²UNIVERSITY OF MEDICINE AND PHARMACY CAROL DAVILA, Bucharest, Romania, ³Versailles-Saint-Quentin University (INSERM U1173, Laboratoire d’Excellence INFLAMEX); University Hospital Ambroise Paré, Versailles, France, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Germany, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie GK, Tokyo, Tokyo, Japan, ⁸Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan
Background/Purpose: Risankizumab (RZB), an IL-23 p19 inhibitor, is well tolerated and provides long-term efficacy through 100 weeks in adults with PsA, demonstrated by the phase…
Abstract Number: 2583 • ACR Convergence 2024
Apremilast Reduces Axial Inflammation in Patients with Psoriatic Arthritis as Assessed by CANDEN MRI Scoring: Results from a Phase 4 Study
Mikkel Ostergaard¹, Walter Maksymowych², Robert Lambert², Mikael Boesen³, Guillermo J. Valenzuela⁴, Michael R. Bubb⁵, Olga Kubassova⁶, Xenofon Baraliakos⁷, Carlo Selmi⁸, Stephen Colgan⁹, Yuri Klyachkin¹⁰, Cynthia Deignan¹¹, Zhenwei Zhou¹¹ and Philip Mease¹², ¹Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ²University of Alberta, Edmonton, AB, Canada, ³Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ⁴Guillermo Valenzuela MD PA/ IRIS Rheumatology, Plantation, FL, ⁵University of Florida, Gainesville, FL, ⁶Image Analysis Group, Philadelphia, PA, ⁷Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁸Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, ⁹Amgen, Halton Hills, ON, Canada, ¹⁰Amgen, Lexington, KY, ¹¹Amgen Inc., Thousand Oaks, CA, ¹²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Apremilast is an oral phosphodiesterase-4 inhibitor with a unique immunomodulatory mechanism of action and is approved for the treatment of psoriatic arthritis (PsA). Although…
Abstract Number: 0178 • ACR Convergence 2024
Are Participants in Gout Clinical Trials Representative of People with Gout in the General Population?
Jendy Liu, Gregory Gamble and Nicola Dalbeth, University of Auckland, Auckland, New Zealand
Background/Purpose: Ensuring study participants are representative of the general population is important to ensure that efficacy and safety findings of clinical trials are generalizable in…
Abstract Number: 0511 • ACR Convergence 2024
Do High Rheumatoid Factor Levels Impact Response to Certolizumab Pegol in Patients with Inadequately Controlled Rheumatoid Arthritis? A Post Hoc Analysis of a Phase 3b Trial
Josef Smolen¹, Ted Mikuls², James Galloway³, Ulf Müller-Ladner⁴, Jeffrey Curtis⁵, Motomu Hashimoto⁶, Tsutomu Takeuchi⁷, Ernest Choy⁸, Yoshiya Tanaka⁹, Carlos Cara¹⁰, Bernard Lauwerys¹¹, Nicola Tilt¹², Baran Ufuktepe¹³ and Peter C. Taylor¹⁴, ¹Medical University of Vienna, Vienna, Austria, ²University of Nebraska Medical Center, Omaha, NE, ³Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ⁴Justus-Liebig University Giessen, Bad Nauheim, Germany, ⁵University of Alabama at Birmingham, Hoover, AL, ⁶Osaka Metropolitan University, Osaka, Japan, ⁷Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁸Cardiff University School of Medicine, Cardiff, United Kingdom, ⁹Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ¹⁰UCB Pharma, Madrid, Spain, ¹¹UCB Pharma, Brussels, Belgium, ¹²UCB Pharma, Slough, United Kingdom, ¹³UCB Pharma, Istanbul, Turkey, ¹⁴University of Oxford, Oxford, United Kingdom
Background/Purpose: In pts with RA, high RF levels are associated with poor prognosis, higher disease activity, and decreased response to monoclonal antibodies targeting tumor necrosis…
Abstract Number: 0661 • ACR Convergence 2024
Validity, Reliability and Responsiveness of Lupus Impact Tracker and LupusPRO: AURORA Trial
Meenakshi Jolly¹, Matt Truman², Ronald Flauto³ and Kathryn Dao⁴, and AURORA, ¹Rush University Medical Center, Chicago, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals, Rockville, MD, ⁴Aurinia Pharmaceuticals, Dallas
Background/Purpose: Voclosporin used in addition to Mycophenolate Mofetil and low dose oral steroids in patients with active Lupus Nephritis (LN) was found to be superior…
Abstract Number: 0827 • ACR Convergence 2024
Oral Corticosteroid-Sparing Effects of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Results up to 7.4 Years from the Long-Term Access Programme
Paneez Khoury¹, Jared Silver², Gerhard Wolff³, Robert Price⁴, Rejina Verghis⁵, Emmeline Igboekwe² and Michael E Wechsler⁶, ¹National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, ²US Medical Affairs-Respiratory, GSK, Durham, ³Clinical Development-Respiratory, GSK, Collegeville, ⁴Biostatistics, GSK, Stevenage, United Kingdom, ⁵Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, ⁶Department of Medicine, National Jewish Health, Denver, CO
Background/Purpose: EGPA is a severe, rare, relapsing/remitting inflammatory disease, in which chronic or high oral corticosteroid (OCS) doses lead to adverse effects, adding to disease…
Abstract Number: 1380 • ACR Convergence 2024
Rapid, Clinically Meaningful Pain Improvements Are Associated with Improvements in Other Patient-Reported Outcomes in RA Patients Treated with Upadacitinib
Manish Jain¹, Arthur Kavanaugh², Angela Crowley³, Avani Joshi⁴, Patrick Zueger⁵, Diane Caballero⁶, Andrew Garrison⁶ and Peter C. Taylor⁷, ¹Endeavor Health Swedish Hospital and Captain James A, Chicago, IL, ²University of California San Diego, La Jolla, CA, ³Illinois Bone and Joint Institute, Hinsdale Orthopaedics, Hinsdale, IL, ⁴AbbVie, North Chicago, IL, ⁵AbbVie Inc, North Chicago, IL, ⁶AbbVie Inc., North Chicago, IL, ⁷University of Oxford, Oxford, United Kingdom
Background/Purpose: Pain is a crucial symptom for patients with RA; early and effective treatment can help alleviate it.1 In this post hoc analysis, we investigated…
Abstract Number: 1476 • ACR Convergence 2024
Individualizing NSAIDs in Axial Spondyloarthritis Through a Series of N-of-1 Clinical Trials with Bayesian Analysis
Mark Hwang¹, Seokhun Kim², Shervin Assassi³, Joyce Samuel⁴, Charles Green², Jon Tyson⁴ and John Reveille⁵, ¹Department of Internal Medicine, Division of Rheumatology, John P. and Katherine G. McGovern School of Medicine, UTHealth Houston, Houston, TX, ²UTHealth Houston, Houston, ³UTHealth Houston Division of Rheumatology, Houston, TX, ⁴UTHealth Houston, Houston, TX, ⁵UTHealth Houston Division of Rheumatology, Houston
Background/Purpose: Nonsteroidal anti-inflammatory drugs (NSAIDs) are first line pharmacological treatment for Axial Spondyloarthritis (axSpA), yet individual responses to different NSAIDs vary significantly. This study aims…
Abstract Number: 1757 • ACR Convergence 2024
Bimekizumab Treatment Resulted in Improvements in MRI Inflammatory and Structural Lesions in the Sacroiliac Joints of Patients with Axial Spondyloarthritis: 52-Week Results and Post Hoc Analyses from Two Phase 3 Studies
Walter Maksymowych¹, Sofia Ramiro², Denis Poddubnyy³, Xenofon Baraliakos⁴, Robert Lambert¹, Ute Massow⁵, Thomas Vaux⁶, Chetan Prajapati⁶, Alexander Marten⁵, Natasha de Peyrecave⁷ and Mikkel Ostergaard⁸, ¹University of Alberta, Edmonton, AB, Canada, ²Leiden University Medical Center, Bunde, Netherlands, ³Charite-Universitatsmedizin Berlin, Berlin, Germany, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵UCB Pharma, Monheim am Rhein, Germany, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Brussels, Belgium, ⁸Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark
Background/Purpose: The impact of bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL-17A, on structural lesions in patients (pts)…
Abstract Number: 2085 • ACR Convergence 2024
The Effects of Pioglitazone on Metabolic Dysregulation in Inclusion Body Myositis: An Open-Label Pilot Study
Brittany Adler¹, Michael Bene¹, Cissy Zhang², Julie Paik¹, Christopher Mecoli¹, Thomas Lloyd³, Eleni Tiniakou⁴, Erika Darrah¹, Lisa Christopher-Stine¹, Albert Mears¹, Megan McGowan¹, Ruben Pagkatipunan¹, Anne Le² and Jemima Albayda⁵, ¹Johns Hopkins University, Baltimore, MD, ²Gigantest, Baltimore, MD, ³Baylor College of Medicine, Houston, TX, ⁴Johns Hopkins University, Lutherville Timonium, MD, ⁵Johns Hopkins School of Medicine, Baltimore, MD
Background/Purpose: Inclusion body myositis (IBM) is a progressive muscle disease for which there is no effective treatment. Mitochondrial dysregulation is a pathologic hallmark of IBM.…
Abstract Number: 2361 • ACR Convergence 2024
Assessment of Laboratory Parameter Changes in a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Highly Selective TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis
Arthur Kavanaugh¹, Elena Muensterman², Apinya Lertratanakul³, Ting Hong³, Jingjing Chen³, Peter Pothula⁴, Ejim Mark⁵ and Alan Kivitz⁶, ¹University of California San Diego, La Jolla, CA, ²Takeda Development Center Americas, Cambridge, MA, ³Takeda Development Center Americas, Inc., Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Zasocitinib (TAK-279) is an oral, highly selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that binds with high specificity to the Janus homology 2 domain…
Abstract Number: 2584 • ACR Convergence 2024
Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial
Philip Mease¹, Alan Kivitz², Elena Muensterman³, Apinya Lertratanakul⁴, Ting Hong⁴, Jingjing Chen⁴, Ejim Mark⁵ and Xenofon Baraliakos⁶, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Altoona Center for Clinical Research, Duncansville, PA, ³Takeda Development Center Americas, Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, MA, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is an oral, selective TYK2 inhibitor under investigation for the treatment of immune-mediated inflammatory diseases including psoriatic arthritis (PsA). In a phase…
Abstract Number: 0179 • ACR Convergence 2024
Bridging the Gap: Enhancing Diversity in Lupus Clinical Trials Through Investigator and Research Staff Engagement
Tessa Englund¹, Katherine Holben¹, Simone Frank², Khadeejatul-Kubraa Lawal¹, Julie Hsieh³, Christine Lee³ and Saira Sheikh¹, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²North Carolina Translational and Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³U.S. Food and Drug Administration, Silver Spring, MD
Background/Purpose: Lupus disproportionately affects diverse racial and ethnic minority populations, yet there is a significant disparity between those affected and those enrolled in clinical trials.…

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 CT on October 25. 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].