ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: L05 • ACR Convergence 2024

    Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115, a Novel PEGylated Uricase, in Participants with Elevated Urate Levels

    Christian Schwabe1, Orit Cohen Barak2, Alexandra Cole3, Hadar Reuveni2, Liron Shelev2, Liora Blinder-Haddad2 and Nicola Dalbeth4, 1NZCR, Auckland, New Zealand, 2Protalix Ltd, Karmiel, Israel, 3NZCR, Christchurch, New Zealand, 4University of Auckland, Auckland, New Zealand

    Background/Purpose: PEGylated uricases have already demonstrated therapeutic modality in the treatment of refractory gout patients. PRX-115 is a recombinant homotetrameric uricase enzyme, produced from Candida…
  • Abstract Number: L09 • ACR Convergence 2024

    Efficacy and Safety of Tofacitinib in Patients with Active Systemic Juvenile Idiopathic Arthritis

    Hermine Brunner1, Caifeng Li2, Kogie Chinniah3, Yosef Uziel4, Olga Synoverska5, Sujata Sawhney6, Inmaculada Calvo Penades7, Ingrid Clara Louw8, Meiping Lu9, Pooja Nikunj Patel10, Pamela F. Weiss11, Cheng Chang12, Ivana Vranic13, Shixue Liu14, Annette Diehl15, Jose L. Rivas16, Carol A. Connell17, Gary G. Koch18, Alberto Martini19, Daniel J. Lovell1, Nicolino Ruperto20 and the PRINTO and PRCSG investigators, 1Cincinnati Children’s Hospital Medical Center, and University of Cincinnati, Cincinnati, OH, 2Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Bejing, China, 3Department of Paediatrics and Child Health, University of Kwa-Zulu, and Enhancing Care Foundation, Durban, South Africa, 4Pedriatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center and Israel Tel Aviv University School of Medicine, Kfar Saba, Israel, 5Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine, 6Sir Ganga Ram Hospital, New Delhi, India, 7Hospital Universitario y Politécnico La Fe, Valencia, Spain, 8Panorama Medical Centre, Cape Town, South Africa, 9Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China, 10Ann & Robert H. Lurie Children’s Hospital of Chicago; Northwestern University School of Medicine, Chicago, IL, 11Division of Rheumatology, Children's Hospital of Philadelphia, and University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, 12Pfizer Inc, New York, NY, 13Pfizer Ltd, Tadworth, United Kingdom, 14Pfizer Inc, Shanghai, China, 15Pfizer Inc, Collegeville, PA, 16Pfizer SLU, Madrid, Spain, 17Pfizer Inc, Groton, CT, 18University of North Carolina at Chapel Hill, Chapel Hill, NC, 19University of Genoa, Genoa, Italy, 20Università Milano Bicocca, Milano, and IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy

    Background/Purpose: Tofacitinib (TOF) has been shown to be efficacious in the treatment of polyarticular course JIA, including systemic JIA (sJIA) without active systemic features. Here…
  • Abstract Number: L10 • ACR Convergence 2024

    Neuroimmune Modulation in Adults with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological or Targeted Synthetic DMARDs: Results at 12 and 24 Weeks from a Randomized, Sham-Controlled, Double-Blind Pivotal Study

    John Tesser1, Joshua June2, Pendleton Wickersham3, Jane Box4, Guillermo Valenzuela5, Angela Crowley6, Nikila Kumar7, Norman Gaylis8, Gordan Lam9, David Ridley10, Gineth Paola Pinto-Patarroyo11 and David Chernoff12, 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2Great Lakes Center of Rheumatology, Lansing, MI, 3Arthritis Associates PA, San Antonio, TX, 4DJL Clinical Research, PLLC, Charlotte, NC, 5Guillermo Valenzuela MD PA/ IRIS Rheumatology, Plantation, FL, 6Illinois Bone and Joint Institute - Hinsdale Orthopaedics, Hinsdale, IL, 7Arizona Arthritis & Rheumatology Associates, Scottsdale, AZ, 8Arthritis & Rheumatic Disease Specialties, Aventura, FL, 9Arthritis & Osteoporosis Consults of the Carolinas, Charlotte, NC, 10St. Paul Rheumatology, Eagan, MN, 11Annapolis Rheumatology, Fairfax, VA, 12SetPoint Medical, Sausalito, CA

    Background/Purpose: In this study, we evaluated the safety and efficacy of an implantable, cervical vagus nerve stimulation device for treatment of RA. Methods: This randomized,…
  • Abstract Number: L16 • ACR Convergence 2024

    Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial

    Megan Clowse1, David Isenberg2, Joan Merrill3, Thomas Dörner4, Michelle Petri5, Edward Vital6, Eric Morand7, Teri Jimenez8, Stephen Brookes9, Janine Gaiha-Rohrbach10, Christophe Martin11, Annette Nelde12 and Christian Stach13, 1Division of Rheumatology and Immunology, Duke University, Durham, NC, 2Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, 3Oklahoma Medical Research Foundation, Oklahoma City, OK, 4Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, 5Johns Hopkins University School of Medicine, Baltimore, MD, 6Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, 7Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, 8UCB, Raleigh, NC, 9Biogen, Maidenhead, United Kingdom, 10Biogen, Cambridge, MA, 11UCB, Slough, United Kingdom, 12Biogen, Baar, Switzerland, 13UCB, Monheim am Rhein, Germany

    Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
  • Abstract Number: 0003 • ACR Convergence 2024

    CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases

    Máire F. Quigley1, Jennifer S. Michaelson1, Jeffrey Jones1, Farrukh T. Awan2, Geoffrey P. Shouse3, Yue Zhang1, Todd Shearer1, Judy Inumerable1, Irina M. Shapiro1, Patrick A. Baeuerle1 and Stephen Wax1, 1Cullinan Therapeutics, Inc., Cambridge, 2UT Southwestern Medical Center, Dallas, 3City of Hope Comprehensive Cancer Center, Duarte

    Background/Purpose: CD19-directed CAR T cell therapy has been reported to induce profound B cell depletion and deep clinical responses, including drug-free remission, in patients with…
  • Abstract Number: 0500 • ACR Convergence 2024

    An Update on the Integrated Safety Analysis of Filgotinib in Patients with Moderate to Severe Active Rheumatoid Arthritis over a Median of 4.3 Years

    Kevin Winthrop1, Daniel Aletaha2, Roberto Caporali3, Yoshiya Tanaka4, Tsutomu Takeuchi5, Vikas Modgill6, Edmund V. Ekoka Omoruyi7, Dick de Vries8, Katrien Van Beneden9, Jacques-Eric Gottenberg10 and Gerd Burmester11, 1School of Medicine, Oregon Health and Science University, Portland, OR, 2Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria, 3Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, 4Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, 5Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, 6Medical Safety, Galapagos NV, Mechelen, Belgium, 7Biostatistics, Galapagos NV, Mechelen, Belgium, 8Clinical Development, Galapagos BV, Leiden, Netherlands, 9Medical Affairs, Galapagos NV, Mechelen, Belgium, 10Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, 11Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany

    Background/Purpose: The oral Janus kinase 1-preferential inhibitor filgotinib (FIL) is approved at doses of 100 mg (FIL100) and 200 mg (FIL200) for the treatment of…
  • Abstract Number: 0658 • ACR Convergence 2024

    Zetomipzomib (KZR-616), a First-in-Class Selective Immunoproteasome Inhibitor, Demonstrated Improvements in SLE/LN Disease Measures and Biomarkers in Patients with Highly Active SLE or Nephrotic Range Proteinuria in the Open-label Phase 1b/2 MISSION Study

    Richard Furie1, Amit Saxena2, Samir Parikh3, Richard Leff4, Lucas Bohnett5, Kathryn Ray6, Brian Tuch4, Janet Anderl4, Jennifer Whang4 and Kiruthi Palaniswamy7, 1Northwell Health, Manhasset, NY, 2NYU School of Medicine, New York, NY, 3Ohio State University, Columbus, OH, 4Kezar Life Sciences, South San Francisco, CA, 5Kezar Life Sciences, El Cajon, 6Kezar Life Sciences, Mill Valley, CA, 7Kezar Life Sciences, Inc, South San Francisco, CA

    Background/Purpose: Zetomipzomib is a selective inhibitor of the immunoproteasome with anti-inflammatory and immunomodulatory potential without evidence of immunosuppression to date. The MISSION study (NCT03393013), a…
  • Abstract Number: 0792 • ACR Convergence 2024

    Radiographic and Pain Outcomes from a Phase 3 Trial (OA-07) Evaluating the Efficacy and Safety of Repeat Lorecivivint Injections over 3 Years in Subjects with Knee OA

    Yusuf Yazici1, Jeyanesh Tambiah2, Christopher Swearingen3 and Timothy McAlindon4, 1NYU Grossman School of Medicine, La Jolla, CA, 2Biosplice Therapeutics Inc., San Diego, CA, 3Biosplice Therapeutics, Inc, San Diego, CA, 4University of Massachusets, Worchester, MA

    Background/Purpose: Knee OA has unmet need for safe and efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate inflammatory…
  • Abstract Number: 1367 • ACR Convergence 2024

    Maintained Improvement of Disease Activity and Patient-reported Outcomes (PROs) with Filgotinib in Patients with Rheumatoid Arthritis (RA) in the Real World: Up to 2-year Interim Data from FILOSOPHY

    James Galloway1, Jérôme Avouac2, Gerd Burmester3, Roberto Caporali4, Thomas P.A. Debray5, Katrien Van Beneden6, Neil Betteridge7, Susana Romero Yuste8, Monia Zignani5, Patrick Verschueren9 and Karen Bevers10, 1Centre for Rheumatic Diseases, King's College London, London, United Kingdom, 2Rheumatology A Department, Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, 3Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 4Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, 5Alfasigma S.p.A., Bologna, Italy, 6Medical Affairs, Galapagos NV, Mechelen, Belgium, 7Neil Betteridge Associates, Lonodn, United Kingdom, 8Department of Rheumatology, University Hospital Complex of Pontevedra, Pontevedra, Spain, 9Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, 10Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands

    Background/Purpose: FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies of filgotinib in patients with RA. This interim analysis evaluated effectiveness and…
  • 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…
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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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