ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 1472 • ACR Convergence 2024

    Achievement of Low Disease Activity/Remission in Guselkumab-Treated Patients with Moderately-Highly Active Psoriatic Arthritis Regardless of Baseline Characteristics: Pooled Post-Hoc Analysis of Two Phase 3/Randomized Studies

    Philip Mease1, Alice Gottlieb2, Iain McInnes3, Natalie J. Shiff4, Anthony Todd5, Emmanouil Rampakakis6, Francois Nantel7, Jenna Parrett5, Frederic Lavie8 and Proton Rahman9, 1Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, 2Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, 3University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, 4Janssen Scientific Affairs, LLC / University of Saskatchewan, Adjunct, Community Health and Epidemiology, Horsham, PA, 5Janssen Scientific Affairs, LLC, Horsham, PA, 6McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, 7Nantel Medsci Consult, Montreal, QC, Canada, 8Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 9Memorial University of Newfoundland, Faculty of Medicine, Division of Rheumatology, St. John's, Canada

    Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated multidomain efficacy (swollen/tender joints, psoriasis, enthesitis and dactylitis) in patients (pts) with active PsA in…
  • Abstract Number: 1734 • ACR Convergence 2024

    Safety and Efficacy Data from a Phase I Trial of Umbilical Lining-Derived Stem Cells (ULSC) in Adult Dermatomyositis/Polymyositis

    Michael R Bubb`1, Eileen Handberg1, Rafael Gonzalez2, Blas Betancourt1, J. Nicole Bostick1, Sarah Long1, Keith March1 and Carl Pepine1, 1University of Florida, Gainesville, FL, 2Restem, LLC, Corona, CA

    Background/Purpose: Mesenchymal stem/stromal cells are self-renewing, multi-potent stromal cells which act as modulators of immune responses. Umbilical cord-derived mesenchymal stromal cells, a classification of cells…
  • Abstract Number: 2047 • ACR Convergence 2024

    Safety in Patients with Latent Tuberculosis Who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease

    Luis Puig1, Tsen-Fang Tsai2, Enrique R. Soriano3, Tina Bhutani4, Megan Miller5, Alexa P. Kollmeier5, Shu Li5, Yin You5, Melissa Petrick5, Hewei Li6, Hetal Patel7, Frederic Lavie8, Melinda Gooderham9, Angela Londoño10, Mark Lebwohl11 and Peter Nash12, 1Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, 2National Taiwan University Hospital, Taipei, Taiwan (Republic of China), 3Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, 4University of California San Francisco Medical Center, San Francisco, CA, 5Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, 6Janssen Pharmaceutical, Hopewell Township, NJ, 7Pharmaceutical Companies of Johnson & Johnson, Naperville, IL, 8Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 9SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada, 10CES University, Medellín, Colombia, 11Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 12School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia

    Background/Purpose: Certain psoriatic disease treatments, including TNF-α inhibitors (TNFi), increase risk of latent tuberculosis infection (LTBI) activation.1,2 Current treatment guidelines recommend TB screening before initiating…
  • Abstract Number: 2348 • ACR Convergence 2024

    Bimekizumab Efficacy and Safety Through 4 Years in Moderate to Severe Plaque Psoriasis: Long-Term Results from a Phase 3 Study and Open-Label Extension

    Diamant Thaçi1, Luis Puig2, Joseph F. Merola3, Denis Jullien4, Antonio Costanzo5, Maggie Wang6, Delphine Deherder7, José M. López Pinto8 and Mark Lebwohl9, 1Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, 2Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, 3UT Southwestern Medical Center, Dallas, TX, 4Department of Dermatology, Hôpital Edouard Herriot, Hospices Civils de Lyon, University of Lyon, Lyon, France, 5Department of Dermatology, Humanitas Clinical and Research Centre, IRCCS, Rozzano, Milan, Italy, 6UCB Pharma, Morrisville, NC, 7UCB Pharma, Braine-l'Alleud, Belgium, 8UCB Pharma, Madrid, Spain, 9Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

    Background/Purpose: Clinical improvements through Week 152, with no unexpected safety findings, were previously reported with bimekizumab (BKZ) in the BE SURE phase 3 trial and…
  • Abstract Number: 2581 • ACR Convergence 2024

    Vunakizumab in Patients with Active Psoriatic Arthritis: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study

    Hejian Zou1, Weiguo Wan2, Yu Xue1, Lingyun Sun3, Ning Zhang4, Haiying Chen5, Xiaofei Shi6, Shengyun Liu7, Lin Chen8, Xinmei Ma9, Hua Wei10, Zhenyu Jiang11, Xiaomei Li12, Hongtao Fan13, Hongbin Li14, Jingyang Li15, Rui Wu16, Guixiu Shi17, Jing Zhu18, Xiaodan Kong19, Yuewu Lu20, Xiaojing Cui21, Qianning Zheng21, Xiaoyan Bai22 and Guangchao Dong21, 1Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China, Shanghai, China (People's Republic), 2Huashan Hospital, Fudan University, Shanghai, China (People's Republic), 3Dept of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing Univ Medical School, Nanjing, CN, Nanjing, China (People's Republic), 4Shengjing Hospital Affiliated to China Medical University, Shenyang, China (People's Republic), 5The Third Hospital of Hebei Medical University, Shijiazhuang, China (People's Republic), 6The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China (People's Republic), 7The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (People's Republic), 8Jilin Province People's Hospital, Changchun, China (People's Republic), 9Zaozhuang Municipal Hospital, Zaozhuang, China (People's Republic), 10Subei People's Hospital of Jiangsu Province, Yangzhou, China (People's Republic), 11The First Hospital of Jilin University, Changchun, China (People's Republic), 12The First Affiliated Hospital of the University of Science and Technology of China, Hefei, China (People's Republic), 13The First People's Hospital of Yunnan Province, Kunming, China (People's Republic), 14Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China (People's Republic), 15Zhuzhou Central Hospital, Zhuzhou, China (People's Republic), 16The Tirst Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China (People's Republic), 17The First Affilated Hospital of Xiamen University, Xiamen, China (People's Republic), 18Sichuan Provincial People's Hospital, Chengdu, China (People's Republic), 19The Second Affiliated Hospital of Dalian Medical University, Dalian, China (People's Republic), 20BeiJing Chao-Yang Hospital, Capital Medical University, Beijing, China, 21Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China (People's Republic), 22Jiangsu Hengrui Pharmaceuticals Co., Ltd., Beijing, China

    Background/Purpose: Patients with psoriasis often develop psoriatic arthritis (PsA), a chronic systemic inflammatory disease with a severe clinical burden that impairs quality of life. In…
  • Abstract Number: 0018 • ACR Convergence 2024

    Preclinical Analysisof CB-010, an Allogeneic anti-CD19CAR-T Cell Therapywith a PD-1 Knockout, for the Treatment of Patients with Refractory Systemic Lupus Erythematosus (SLE)

    Elizabeth Garner, George Kwong, Tristan W Fowler, Heinrich Kufeldt, Brian Kerfs, Julie Kim, Art Aviles, Lynne Alexander, Franco Davi, Chris Holland, Jean-Yves Maziere, Ashraf Garrett, Mara Bryan, Linh Chu, Sarbani Bhaduri, Michele Gerber, Elaine Alambra, Justin Skoble, Tom Kochy, Tonia Nesheiwat, Socorro Portella, Enrique Zudaire and Steven B Kanner, Caribou Biosciences, Berkeley, CA

    Background/Purpose: Autologous CD19-directed CAR-T cell therapy has been shown to eradicate aberrant B cells leading to durable clinical responses in SLE patients (Müller 2024; Wang 2024). However, autologous CAR-T cell…
  • Abstract Number: 0502 • ACR Convergence 2024

    Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study

    Gerd Burmester1, Jakub Trefler2, Artur Racewicz3, Janusz Jaworski4, Agnieszka Zielińska5, Marek Krogulec6, Sławomir Jeka7, Rafał Wojciechowski8, Katarzyna Kolossa9, Anna Dudek10, Magdalena Krajewska-Włodarczyk11, Paweł Hrycaj12, Piotr Adrian Klimiuk13, SungHyun Kim14, JeeHye Suh14, GoEun Yang14, Yunah Kim14, YooBin Jung14, JiWoo Hong14 and Josef Smolen15, 1Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 2REUMA RESEARCH, Wrocław, Poland, 3Zdrowie Osteo-Medic, Warszawa, Poland, 4Reumatika-Centrum Reumatologii, Warszawa, Poland, 5MICS Centrum Medyczne Warszawa, Warszawa, Poland, 6NZOZ Lecznica MAK - MED, Nadarzyn, Poland, 7MICS Centrum Medyczne, Polska, Poland, 8Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, PL, Bydgoszcz, Poland, 9MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland, 10Centrum Medyczne Amed, Warszawa, Poland, 11University of Warmia and Mazury, Clinic of Rheumatology, Olsztyn, Poland, 12Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł, Poznań, Poland, 13Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, 14Celltrion, Inc., Incheon, Republic of Korea, 15Medical University of Vienna, Vienna, Austria

    Background/Purpose: The therapeutic equivalence of CT-P47 (a proposed biosimilar to reference tocilizumab [ref-tocilizumab]) was demonstrated in patients with moderate to severe RA through disease activity…
  • Abstract Number: 0659 • ACR Convergence 2024

    Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial

    Richard Furie1, Jorge A. Ross Terres2, Elsa Martins3, Imran Hassan4, Thomas Schindler3, Jay Garg5, William F. Pendergraft III6, Ana Malvar7 and Brad Rovin8, 1Northwell Health, Manhasset, NY, 2Genentech, Inc,, San Francisco, 3F. Hoffmann-La Roche Ltd, Basel, Switzerland, 4Hoffmann-La Roche Ltd, Mississauga, Canada, 5Genentech, Inc., South San Francisco, CA, 6Genentech, Inc., Chapel Hill, NC, 7Organización Médica de Investigación, Buenos Aires, Argentina, 8The Ohio State University, Columbus, OH

    Background/Purpose: Lupus nephritis (LN) is the most common severe organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, placebo-controlled, Phase II NOBILITY trial (NCT02550652) demonstrated…
  • Abstract Number: 0823 • ACR Convergence 2024

    A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis

    Carol Langford1, Nader Khalidi2, Jason Springer3, Marcia Friedman4, Bernhard Hellmich5, Christian Pagnoux6, Natasha Dehghan7, Ora Singer8, Curry Koening9, Yih Chang Lin10, Paul Monach11, Larry Moreland12, Aurore Fifi-Mah13, Oliver Flossmann14, Lindsy Forbess15, Peter Lanyon16, Eamonn Molloy17, Ulrich Specks18, Robert Spiera19, Elaine Yacyshyn20, Carol McAlear21, Cristina Burroughs10, Rachel Jones22, Rennie Rhee21, Rula A. Hajj-Ali23, Kenneth Warrington18, David Cuthbertson10, Jeffrey Krischer10, David Jayne22 and Peter Merkel21, and the Vasculitis Clinical Research Consortium and the European Vasculitis Society, 1Cleveland Clinic, Moreland Hills, OH, 2McMaster University, Hamilton, ON, Canada, 3Vanderbilt University Medical Center, Franklin, TN, 4Oregon Health and Science University, Portland, OR, 5Medius Kliniken, Kirchheim unter Teck, Germany, 6Mount Sinai Hospital, Toronto, ON, Canada, 7University of British Columbia - Vancouver, Vancouver, BC, Canada, 8University of Michigan, Huntington Woods, MI, 9University of Texas Dell Medical School, Austin, TX, 10University of South Florida, Tampa, FL, 11VA Boston Healthcare System, Boston, MA, 12University of Colorado, Denver, CO, 13University of Calgary, Calgary, AB, Canada, 14Royal Berkshire Hospital, Reading, United Kingdom, 15Cedars-Sinai Medical Center, Los Angeles, CA, 16University of Nottingham, Nottingham, United Kingdom, 17St Vincent's University Hospital, Dublin, Ireland, 18Mayo Clinic, Rochester, MN, 19Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, 20University of Alberta, Edmonton, AB, Canada, 21University of Pennsylvania, Philadelphia, PA, 22University of Cambridge, Cambridge, United Kingdom, 23Cleveland Clinic, Cleveland, OH

    Background/Purpose: Granulomatosis with polyangiitis (GPA) is a small-vessel vasculitis associated with frequent relapses. Following encouraging results from an open-label study, a randomized, double-blind, placebo-controlled trial…
  • Abstract Number: 1376 • ACR Convergence 2024

    Comparison of the Efficacy of DMARDs in Phase 3 Trials of Different Populations Used in FDA Approvals for Rheumatoid Arthritis Since 2010

    Catherine Emanuel1 and Ajay Aggarwal2, 1Aclaris Therapeutics Inc., St Louis, MO, 2Aclaris Therapeutics, Inc., Wellesley, MA

    Background/Purpose: Varying mechanisms of action are required to address the needs of rheumatoid arthritis patients with different levels of severity. Since 2010, all new FDA…
  • Abstract Number: 1473 • ACR Convergence 2024

    Patient-Reported Symptoms Improved with Stringent Control of Swollen Joints in Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab

    M. Elaine Husni1, Philip Mease2, Dafna Gladman3, Barbara Ink4, Jérémy Lambert5, Patrick Healy6 and Laure Gossec7, 1Cleveland Clinic, Cleveland, OH, 2Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, 3University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 4UCB Pharma, Slough, United Kingdom, 5UCB Pharma, Colombes, France, 6UCB Pharma, Morrisville, NC, 7Sorbonne Université, Paris, France

    Background/Purpose: PsA is characterized by joint and skin inflammation, and associated with debilitating symptoms of pain and fatigue.1 Previous research has shown that pain and…
  • 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…
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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.

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