ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • Abstract Number: 0290 • ACR Convergence 2024

    Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program

    Mark Lebwohl1, Richard Warren2, Shinichi Imafuku3, Jerry Bagel4, April W. Armstrong5, Thierry Passeron6, Subhashis Banerjee7, Renata M. Kisa8, Matthew J. Colombo7, Thomas Scharnitz8, Kim Hoyt8, Diamant Thaçi9 and Andrew Blauvelt10, 1Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 2Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 3Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, 4Psoriasis Treatment Center of New Jersey, East Windsor, 5University of California Los Angeles, Los Angeles, 6Université Côte d’Azur, University Hospital of Nice, Nice, France, 7Bristol Myers Squibb, Princeton, NJ, 8Bristol Myers Squibb, Princeton, 9Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, 10Oregon Medical Research Center, Portland, OR

    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: 1137 • ACR Convergence 2024

    Deucravacitinib, an Oral,Selective,Allosteric Tyrosine Kinase 2 Inhibitor, in Patients WithModerate to Severe Scalp Psoriasis: Efficacy and Safety Results of a Phase 3b/4, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial (PSORIATYK SCALP)

    Kristina Callis Duffin1, Christopher E. M. Griffiths2, Matthias Hoffmann3, Andrew Blauvelt4, Eugene Balagula5, Andrew Napoli5, Ying-Ming Jou5, Rachel Dyme5, Virginia Hala5, andreas pinter6 and Mark Lebwohl7, 1University of Utah, Salt Lake City, 2Dermatology Centre, University of Manchester, Manchester, and King’s College Hospital and King’s College London, London, United Kingdom, 3Private Practice, Witten, Germany, 4Oregon Medical Research Center, Portland, OR, 5Bristol Myers Squibb, Princeton, 6University Hospital of the Goethe University, Frankfurt am Main, Frankfurt, Germany, 7Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

    Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US, EU, and other countries for treatment of adults with…
  • Abstract Number: 1552 • ACR Convergence 2024

    Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinibin Patients with Active SLE in the Phase 2 PAISLEY Trial

    Ronald Van Vollenhoven1, Joseph Merola2, Kathryn H. Dao3, Piotr Leszczynski4, Marilyn Pike5, Samantha Pomponi6, Coburn Hobar6, Matthew J. Colombo6, Ravi Koti6, Subhashis Banerjee6, Thomas Wegman7 and Eric Morand8, 1Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, 2UT Southwestern Medical Center, Newton, MA, 3Department of Internal Medicine, Division of Rheumatology, The University of Texas Southwestern Medical Center, Dallas, 4Department of Internal Medicine, Poznań University of Medical Sciences, Poznań, Poland, 5Rheumatology, MedPharm Consulting, Inc., Raleigh, NC, 6Bristol Myers Squibb, Princeton, NJ, 7Bristol Myers Squibb, Beaver Falls, PA, 8School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia

    Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of moderate to severe plaque…
  • Abstract Number: 1988 • ACR Convergence 2024

    A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

    Marta Cossu1, Carolina Bobadilla Mendez2, Amanda Jackson3, Eugene Myshkin4, Grace Liu5, Edwin Lam6, Ulf H. Beier2, Kathleen Weisel2, Brittney Scott2, Jocelyn H. Leu6, Sheng Gao2 and Dessislava Dimitrova2, 1Janssen Pharmaceutical Research and Development, a Johnson & Johnson company, Leiden, Netherlands, 2Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, 3Janssen Research & Development, LLC, La Jolla, CA, 4Janssen Research & Development, LLC, a Johnson & Johnson company, Cambridge, MA, 5Janssen Research & Development, LLC, a Johnson & Johnson company, Raritan, NJ, 6Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA

    Background/Purpose: Nipocalimab is a human IgG1 monoclonal antibody targeting the neonatal Fc receptor (FcRn) that selectively reduces IgG levels without impacting antigen presentation, T- and…
  • 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: 0298 • ACR Convergence 2024

    RAY121, a Novel Recycling Monoclonal Antibody Against Complement C1s: Safety, Pharmacokinetic and Pharmacodynamic Data from a Phase 1a First in Human Clinical Trial in Healthy Adults

    Miwa Haranaka1, Akinori Yamada2, Saki Takahashi2, Keisuke Gotanda2, Sonoko Nakano-Kanatani2, Nana Uemura2, Kensuke Ohnishi2, Masanobu Nishidate2, Ichio Ohnami2 and Megumi Kai3, 1Souseikai Hakata Clinic, Fukuoka, Japan, 2Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, 3Oita University, Oita, Japan

    Background/Purpose: Complement C1s is one of the major components of the classical complement pathway (CP), and the abnormal activation of CP is implicated in several…
  • Abstract Number: 1375 • ACR Convergence 2024

    Effects of Training with Blood Flow Restriction on Muscle Strength in Women with Rheumatoid Arthritis: A Randomized Clinical Trial

    Leonardo dos Santos1, Rafaela Santo2, Thiago Ramis1, André Mallmann3, Daniel Moraes3, Lucas Dória4, Stephanie Pilotti3, Gabriel Grave3, Nicole Bueno3, Anderson Silveira3, Cristian Santos1, Rafael Chakr1, Odirlei Monticielo1, Claiton Brenol1 and Ricardo Xavier5, 1Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil, 2Health Research and Innovation Science Centre, Klaipeda University, Klaipeda, Lithuania, Porto Alegre, Rio Grande do Sul, Brazil, 3Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil, 4Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil, 5Universidade Federal do Rio Grande do Sul, Porto Alegre/RS, Rio Grande do Sul, Brazil

    Background/Purpose: Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that often leads to decreased muscle strength and muscle mass. High intensity resistance training (HIRT), using…
  • Abstract Number: 1553 • ACR Convergence 2024

    Safety, Pharmacokinetics, Clinical Efficacy and Exploratory Biomarker Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Enpatoran in Active Systemic and Cutaneous Lupus Erythematosus (SLE/CLE)

    Torsten Witte1, Ruth Fernandez Ruiz2, Nadezda Abramova3, Dominika Weinelt3, Flavie Moreau4, Lena Klopp-Schulze5, Jamie Shaw6, Deborah Denis7 and Joerg Wenzel8, 1Dept of Immunology and Rheumatology, Hannover, Germany, 2Global Clinical Development, EMD Serono, Billerica, MA, 3Global Patient Safety, the healthcare business of Merck KGaA, Darmstadt, Germany, 4Global Biostatistics, EMD Serono, Billerica, MA, 5Quantitative Pharmacology, the healthcare business of Merck KGaA, Darmstadt, Germany, 6Companion Diagnostics and Biomarker Strategy, EMD Serono, Billerica, MA, 7EMD Serono, Rockland, MA, 8Department of Dermatology and Allergy, University Hospital of Bonn, Bonn, Germany

    Background/Purpose: Enpatoran, a highly selective, potent and reversible dual toll-like receptor 7/8 (TLR7/8) inhibitor, targets key innate and adaptive immune processes involved in the pathogenesis…
  • Abstract Number: 2023 • ACR Convergence 2024

    A PEGylated Mammalian Uricase Suitable for Intramuscular Administration to Patients with Refractory Chronic Gout

    Frank Fan1, Riyong Liu1 and Yu Wang2, 1Chongqing PegBio Biopharm Co.,Ltd., Chongqing, China (People's Republic), 2Hangzhou Grand Biologic Pharmaceutical, Inc., Hangzhou, China (People's Republic)

    Background/Purpose: For patients with refractory chronic gout, i.e., those who have frequent gout flares and/or persistent tophi despite treatment with the highest tolerable doses of…
  • Abstract Number: 2357 • ACR Convergence 2024

    Longitudinal Evaluation of Neutrophil-to-Lymphocyte Ratio in Guselkumab-Treated Patients with Psoriatic Disease and Levels of Systemic Inflammation Associated with Elevated Cardiovascular Risk: Post-hoc Analysis of 4 Phase 3, Randomized, Controlled Studies

    Joseph Merola1, Alexis Ogdie2, Arthur Kavanaugh3, Evan Leibowitz4, Emmanouil Rampakakis5, Ryan Funk6, Francois Nantel7, Frederic Lavie8, Katelyn Rowland9 and Enrique R. Soriano10, 1UT Southwestern Medical Center, Newton, MA, 2Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 3University of California San Diego, La Jolla, CA, 4Janssen Scientific Affairs, LLC, Fair Lawn, NJ, 5McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, 6Johnson & Johnson Innovative Medicine, Long Grove, IL, 7Nantel MedSci Consult, Montreal, QC, Canada, 8Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 9Janssen Pharmaceuticals, Horsham, PA, 10Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

    Background/Purpose: Psoriatic disease (PsD) is associated with an increased risk of cardiovascular (CV) disease. Neutrophil-to-lymphocyte ratio (NLR) is a biomarker of systemic inflammation; NLR ≥2.5…
  • Abstract Number: 0303 • ACR Convergence 2024

    Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER-2

    Laura K. Ferris1, Jerry Bagel2, Yu-Huei Huang3, Andrew E. Pink4, Stephen K. Tyring5, Georgios Kokolakis6, Amy M. DeLozier7, Daniel Kakaley8, Shu Li9, Yaung-Kaung Shen10, Takayuki Ota7 and Robert Bissonnette11, 1University of Pittsburgh, Pittsburgh, PA, 2Psoriasis Treatment Center of Central NJ, East Windsor, NJ, 3Chang Gung Memorial Hospital and Chang Gung University, Linkou, Taoyuan City, Taiwan (Republic of China), 4NHS Foundation Trust Great Maze Pond, London, United Kingdom, 5Center for Clinical Studies, Webster, TX, 6Psoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, 7Janssen Research & Development, LLC, San Diego, CA, 8Janssen Scientific Affairs, LLC, Horsham, PA, 9Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, 10Janssen Research & Development, LLC, Spring House, PA, 11Innovaderm Research, Montreal, QC, Canada

    Background/Purpose: JNJ-77242113, a targeted oral peptide, inhibits IL-23 signaling by binding the IL-23 receptor. At all doses, JNJ-77242113 showed superior efficacy at Week 16 versus…
  • Abstract Number: 1392 • ACR Convergence 2024

    Safety and Efficacy of Upadacitinib (UPA) in Japanese Patients with Rheumatoid Arthritis (RA) and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-SUNRISE Study

    Hideto Kameda1, Tsutomu Takeuchi2, Kunihiro Yamaoka3, Motohiro Oribe4, Mitsuhiro Kawano5, Masayuki Yokoyama6, Yuko Konishi6, Sumi Chonan6, Sara Penn7, Heidi S Camp7 and Yoshiya Tanaka8, 1Toho University, Tokyo, Japan, 2Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, 3Kitasato University School of Medicine, Kanagawa, Japan, 4Oribe Clinic of Rheumatism and Medicine, Oita, Japan, 5Kanazawa Medical University, Ishikawa, Japan, 6AbbVie GK, Tokyo, Japan, 7AbbVie, North Chicago, IL, 8Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan

    Background/Purpose: To evaluate the efficacy and safety of UPA in Japanese RA patients (pts) up to 5 yrs in a long term extension (LTE) of…
  • Abstract Number: 1554 • ACR Convergence 2024

    Belimumab Increases SLE Responder Index-4 Response Rates versus Placebo in Early Active Systemic Lupus Erythematosus: A Large Integrated Analysis of Belimumab Trials

    Karen Costenbader1, Joan Merrill2, Marta Mosca3, Holly Quasny4, Christine Henning5, Steven Bloom6, Julia Harris6, Ciara O’Shea7, Tatsuya Atsumi8 and Ronald van Vollenhoven9, 1Brigham and Women’s Hospital, Division of Rheumatology, Inflammation and Immunity, Harvard Medical School, Boston, MA, 2Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Program, Oklahoma City, OK, 3University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, 4GSK, Clinical Sciences, Durham, NC, 5GSK, Global Medical Affairs, Durham, NC, 6GSK, Immunology Biostatistics, Brentford, United Kingdom, 7GSK, Rheumatology, Global Medical Affairs, Dublin, Ireland, 8Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, 9Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands

    Background/Purpose: There are benefits of early treatment for autoimmune diseases; however, data are not available for patients (pts) with SLE as there is no definition…
  • 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: 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…
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