Abstracts tagged "clinical trial"

Abstract Number: 0920 • ACR Convergence 2021
Influence of Baseline Demographics on Improvements in Disease Activity Measures in Patients with Ankylosing Spondylitis Receiving Upadacitinib: A Post Hoc Subgroup Analysis
Filip Van den Bosch¹, Denis Poddubnyy², Jayne Stigler³, Andrew Ostor⁴, Salvatore D'Angelo⁵, Victoria Navarro-Compán⁶, In-Ho Song³, Tianming Gao³, Fabiana Ganz³ and Lianne Gensler⁷, ¹Dept. of Rheumatology - Ghent University Hospital, Ghent, Belgium, Ghent, Belgium, ²Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany, ³AbbVie Inc., North Chicago, IL, ⁴Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁵Rheumatology Institute of Lucania (IReL) – Rheumatology Department of Lucania, “San Carlo” Hospital of Potenza and “Madonna delle Grazie” Hospital of Matera, Potenza, Italy, ⁶Rheumatology service, Hospital Universitario La Paz-IdiPaz, Madrid, Spain, ⁷Department of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, has demonstrated efficacy and safety through 14 weeks in the SELECT-AXIS 1 study in biologic disease-modifying antirheumatic…
Abstract Number: 1331 • ACR Convergence 2021
Guselkumab (TREMFYA®) Improves Anemia in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Randomized Controlled Clinical Trials
Arthur Kavanaugh¹, Yan Liu², Proton Rahman³, Philip Mease⁴, Laure Gossec⁵, Xie Xu², Elizabeth Hsia², May Shawi⁶, Chenglong Han², Marlies Neuhold⁷ and Atul Deodhar⁸, ¹University of California San Diego, La Jolla, CA, ²Janssen Research & Development, LLC, Spring House, PA, ³Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁵Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁶Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁷Janssen-Cilag, Zug, Switzerland, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Anemia related to systemic inflammation can be an important feature of psoriatic arthritis (PsA). Hemoglobin (Hgb) levels have been shown to be inversely related…
Abstract Number: 1614 • ACR Convergence 2021
Preliminary Results from a Pilot Feasibility and Acceptability Trial of Resilience Coaching for Adolescent Chronic Musculoskeletal Pain
Sabrina Gmuca¹, Pamela Weiss¹, Mackenzie McGill¹, Maitry Sonagra², David D. Sherry¹, Peter Cronholm³, Jeffrey S. Gerber¹, Tonya M. Palermo⁴, Jami F. Young¹ and Abby R. Rosenberg⁴, ¹Children's Hospital of Philadelphia, Philadelphia, PA, ²Children's Hospital of Philadelphia, Cherry Hill, NJ, ³University of Pennsylvania, Philadelphia, PA, ⁴Seattle Children's Hospital, Seattle, WA
Background/Purpose: Chronic musculoskeletal pain (CMP) affects up to 40% of youth and is associated with physical disability and psychological distress. Resilience coaching interventions, such as…
Abstract Number: 1740 • ACR Convergence 2021
Efficacy of Anifrolumab in Patients with SLE Previously Treated with Biologics: Post Hoc Analysis of Data from 2 Phase 3 Trials
Richard Furie¹, Eric Morand², Kenneth Kalunian³, Konstantina Psachoulia⁴, Emmanuelle Maho⁵, Catharina Lindholm⁶ and Raj Tummala⁴, ¹Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ²Monash University, Melbourne, Australia, ³University of California, La Jolla, CA, ⁴BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁵BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Background/Purpose: In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab, a type I IFN receptor mAb, improved disease activity in patients with SLE.1,2 We investigated…
Abstract Number: 1802 • ACR Convergence 2021
Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials
Xenofon Baraliakos¹, Atul Deodhar², Roberto Ranza³, Simona Rednic⁴, Francesco Ciccia⁵, Fabiana Ganz⁶, Tianming Gao⁶, Apinya Lertratanakul⁶, In-Ho Song⁶, Andrew Ostor⁷ and Laura Coates⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²Oregon Health & Science University, Portland, OR, ³Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, ⁴Emergency Clinical County Hospital, Rheumatology and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania, ⁵University of Campania “Luigi Vanvitelli", Naples, Italy, ⁶Abbvie Inc., North Chicago, IL, ⁷Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
Background/Purpose: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor…
Abstract Number: 0441 • ACR Convergence 2021
A Randomized, Double-blind, Placebo-controlled Study of Arimoclomol in Patients with Inclusion Body Myositis
Pedro Machado¹, Richard Barohn², Michael McDermott³, Thomas Blaetter⁴, Tom Lloyd⁵, Aziz Shaibani⁶, Miriam Freimer⁷, Anthony Amato⁸, Emma Ciafaloni³, Sarah Jones⁹, Tahseen Mozaffar¹⁰, Summer Gibson¹¹, Matthew Wicklund¹², Todd Levine¹³, Claus Sundgreen⁴, Tim Carstensen⁴, Karen Bonefeld⁴, Anders Jørgensen⁴, Karina Phonekeo⁴, Andrew Heim¹⁴, Laura Herbelin¹⁴, Michael Hanna¹⁵ and Mazen Dimachkie¹⁴, ¹Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ²University of Missouri - Columbia, Columbia, MO, ³University of Rochester, Rochester, NY, ⁴Orphazyme A/S, Copenhagen, Denmark, ⁵Johns Hopkins University, Baltimore, MD, ⁶Nerve and Musle Center, Houston, TX, ⁷Ohio State University, Columbus, OH, ⁸Brigham and Women's Hospital, Boston, MA, ⁹University of Virginia, Charlottesville, VA, ¹⁰University of California Irvine, Irvine, CA, ¹¹University of Utah, Salt Lake City, UT, ¹²University of Colorado, Denver, CO, ¹³Phoenix Neurological Associates, Phoenix, AZ, ¹⁴University of Kansas Medical Center, Kansas City, KS, ¹⁵University College London, London, United Kingdom
Background/Purpose: Inclusion body myositis (IBM) is the most common idiopathic inflammatory myopathy occurring in patients over the age of 45 years. Since immune suppression has…
Abstract Number: 0926 • ACR Convergence 2021
Predictors of 1-Year Treatment Response Among Upadacitinib-Treated Patients with Ankylosing Spondylitis: A Post Hoc Analysis
Marina Magrey¹, Sofia Ramiro², Marcelo Medeiros Pinheiro³, Tianming Gao⁴, Fabiana Ganz⁴, In-Ho Song⁴, Ana Biljan⁵, Nigil Haroon⁶ and Martin Rudwaleit⁷, ¹Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH, ²Leiden University Medical Center, Leiden, Netherlands, ³Universidade Federal de São Paulo, São Paulo, Brazil, ⁴AbbVie Inc., North Chicago, IL, ⁵Abbvie Inc., Chicago, IL, ⁶Division of Rheumatology, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada, ⁷University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany
Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase inhibitor that has demonstrated efficacy and safety among patients with ankylosing spondylitis (AS) in the phase 2/3…
Abstract Number: 1332 • ACR Convergence 2021
Validation of the PROMIS-29 Profile in Patients with Active Psoriatic Arthritis Using Data from a Phase 3, Randomized, Placebo-Controlled Study Evaluating Guselkumab (TREMFYA®)
Ana-Maria Orbai¹, Laura Coates², Atul Deodhar³, Christopher Ritchlin⁴, Alexa Kollmeier⁵, Marlies Neuhold⁶, Yi-Hsuan Liu⁷, Yan Liu⁷ and Chenglong Han⁷, ¹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen-Cilag, Zug, Switzerland, ⁷Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: It is important to assess symptoms of pain, fatigue, anxiety, depression, sleep disturbance, and impaired physical function in patients (pts) with psoriatic arthritis (PsA),…
Abstract Number: 1680 • ACR Convergence 2021
Impact of Race on the Efficacy and Safety of Tofacitinib in Patients with RA: A Post Hoc Analysis of Phase 2, 3, and 3b/4 Clinical Trials
Grace Wright¹, Eduardo Mysler², Yi-Hsing Chen³, Cassandra Kinch⁴, Arne Yndestad⁵, Kenneth Kwok⁶, Mary Jane Cadatal⁷, Rebecca Germino⁸ and Alexis Ogdie⁹, ¹Grace C Wright MD PC, and Association of Women in Rheumatology, New York, NY, ²Organización Médica de Investigación, Buenos Aires, Argentina, ³Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), ⁴Pfizer Canada ULC, Kirkland, QC, Canada, ⁵Pfizer Inc, Oslo, Norway, ⁶Pfizer Inc, New York, NY, ⁷Pfizer Inc, Manila, Philippines, ⁸Pfizer Inc, Groton, CT, ⁹Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: While racial disparities in clinical outcomes for RA patients (pts) receiving bDMARDs or csDMARDs have been described,1 there remains a paucity of data on…
Abstract Number: 1741 • ACR Convergence 2021
Anifrolumab Results in Favorable Responses Regardless of SLE Disease Duration: Post Hoc Analysis of Data from 2 Phase 3 Trials
Kenneth Kalunian¹, Maria Dall'Era², Richard Furie³, Eric Morand⁴, Konstantina Psachoulia⁵, Emmanuelle Maho⁶, Catharina Lindholm⁷ and Raj Tummala⁵, ¹University of California, La Jolla, CA, ²University of California San Francisco, San Francisco, CA, ³Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁴Monash University, Melbourne, Australia, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁷BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Background/Purpose: In 2 phase 3 trials, TULIP-1 and TULIP-2, anifrolumab, a type I IFN receptor mAb, improved disease activity in patients with SLE.1,2 Here, we…
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…

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