Abstracts tagged "clinical trial"

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…
Abstract Number: 1338 • ACR Convergence 2021
Bimekizumab in Patients with Psoriatic Arthritis: 3-Year Results for Overall and Tumor Necrosis Factor Inhibitor (TNFi)-Naïve Populations from a Phase 2b Open-Label Extension Study
Philip Mease¹, Atul Deodhar², Joseph Merola³, Iain McInnes⁴, Deepak Assudani⁵, Rajan Bajracharya⁵, Jason Coarse⁶, Barbara Ink⁷ and Georg Schett⁸, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Oregon Health & Science University, Portland, OR, ³Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁴University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁵UCB Pharma, Slough, United Kingdom, ⁶UCB Pharma, Raleigh, NC, ⁷UCB Celltech, Slough, UK, Slough, United Kingdom, ⁸Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, and has demonstrated clinical improvements in joint and skin outcomes…
Abstract Number: 1687 • ACR Convergence 2021
Integrated Laboratory Abnormality Profiles of Upadacitinib with up to 4.5 Years of Exposure in Patients with Rheumatoid Arthritis Treated in a Phase 3 Clinical Trial
Christina Charles-Schoeman¹, Jon Giles², Nancy Lane³, Ernest Choy⁴, Dan Furst⁵, Jiri Vencovsky⁶, Anthony Wilson⁷, Gerd Burmester⁸, Tim Shaw⁹, Yanna Song¹⁰, Heidi Camp¹⁰, Nasser Khan¹⁰, Jillian Yee¹⁰, Samuel Anyanwu¹⁰ and Iain McInnes¹¹, ¹Department of Medicine, University of California, Los Angeles, Los Angeles, CA, ²Columbia University Irving Medical Center, Division of Rheumatology, New York, NY, ³University of California Davis, Hillsborough, CA, ⁴CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, ⁵University of California Los Angeles, Los Angeles, CA, ⁶Institute of Rheumatology, Prague, Czech Republic, ⁷Center for Arthritis Research, Conway Institute, University College Dublin, Dublin, Ireland, ⁸Charité University Medicine Berlin, Berlin, Germany, ⁹AbbVie Inc., North Chicago, ¹⁰AbbVie Inc., North Chicago, IL, ¹¹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). The safety and efficacy of UPA has been…
Abstract Number: 1746 • ACR Convergence 2021
Baricitinib Decreases Anti-dsDNA and IgG Antibodies in Adults with Systemic Lupus Erythematosus from a Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial
Thomas Dörner¹, Ronald Van Vollenhaven², Andrea Doria³, Bochao Jia⁴, Damiano Fantini⁴, Jorge Ross Terres⁴, Maria Silk⁵, Stephanie de Bono⁴, Peter Fischer⁶ and Daniel Wallace⁷, ¹Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ²University Medical Center, Amsterdam, Netherlands, ³University of Padova, Padova, Italy, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Carmel, IN, ⁶Eli Lilly and Company, North Easton, MA, ⁷Cedars-Sinai, Los Angeles, CA
Background/Purpose: Baricitinib (BARI), an oral, selective Janus kinase (JAK)1 and JAK2 inhibitor, improved disease activity in adults with systemic lupus erythematosus (SLE) receiving standard background…
Abstract Number: 1805 • ACR Convergence 2021
Low Rates of Radiographic Progression with 2 Years of Guselkumab (TREMFYA®), a Selective Inhibitor of the Interleukin-23p19 Subunit: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Proton Rahman⁴, Alexa Kollmeier⁵, Xie Xu⁶, Yusang Jiang⁶, Shihong Sheng⁶, May Shawi⁷, Soumya Chakravarty⁸, Frederic Lavie⁹ and Désirée van der Heijde¹⁰, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁴Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁹Janssen Global Services, LLC, Horsham, PA, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Guselkumab (GUS), an IL-23p19-subunit inhibitor, is efficacious in treating patients (pts) with psoriasis and psoriatic arthritis (PsA). In the Phase 3, double-blind, placebo (PBO)-controlled…
Abstract Number: L09 • ACR Convergence 2020
A Phase 2a Randomized, Double-blind, Placebo-controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis (NOVESA)
Dinesh Khanna¹, Christopher Denton², Daniel Furst³, Maureen Mayes⁴, Marco Matucci-Cerinic⁵, Vanessa Smith⁶, Dick de Vries⁷, Liesbeth Deberdt⁸, Pieter‑Jan Stiers⁸, Niyati Prasad⁸ and Sohail Ahmed⁹, ¹University of Michigan, Ann Arbor, MI, ²Royal Free Hospital, University College London, London, United Kingdom, ³David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁴University of Texas Health Science Center at Houston, Houston, TX, ⁵Università degli Studi di Firenze, Firenze, Italy, ⁶Ghent University Hospital, Ghent, Belgium, ⁷Galapagos BV, Leiden, Netherlands, ⁸Galapagos NV, Mechelen, Belgium, ⁹Ahmed Science Medicine, Basel, Switzerland
Background/Purpose: There is a high unmet need for systemic sclerosis (SSc) treatments. Ziritaxestat (ziri; GLPG1690) is an autotaxin inhibitor with a novel mechanism of action.…
Abstract Number: L10 • ACR Convergence 2020
Targeting Plasmacytoid Dendritic Cells Improves Cutaneous Lupus Erythematosus Skin Lesions and Reduces Type I Interferon Levels: Results of a Phase 1 Study of VIB7734
Victoria Werth¹, Jodi Karnell², William Rees², Nanette Mittereder³, Li Yan², Yanping Wu³, Jorn Drappa², Gabor Illei² and John Ratchford², ¹University of Pennsylvania, Philadelphia, PA, ²Viela Bio, Gaithersburg, MD, ³Viela Bio, Gaithersburg
Background/Purpose: Plasmacytoid dendritic cells (pDCs) secrete large amounts of type I interferon (IFN) and other cytokines upon activation. pDCs migrate to sites of active disease…

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