Abstracts tagged "Biologicals"

Abstract Number: 1421 • ACR Convergence 2022
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of a Proposed Tocilizumab Biosimilar (MSB11456) versus US‑licensed Tocilizumab: Results of a Randomized, Double-blind, Parallel‑group, Single‑intravenous Dose Study in Healthy Adults (APTURA II)
Monika Tomaszewska-Kiecana¹, Martin Ullmann², Emmanuelle Vincent², Corinne Petit-frere², Joëlle Monnet³ and Andras Illes², ¹Biokinetica S.A., Jozefow, Poland, ²Fresenius Kabi SwissBioSim, Eysins, Switzerland, ³Fresenius Kabi Swiss BioSim, Eysins, Switzerland
Background/Purpose: Tocilizumab is a biologic anti-interleukin-6 receptor monoclonal immunoglobin G1 antibody indicated for treating inflammatory diseases, including RA, and cytokine release syndrome. MSB11456 is a…
Abstract Number: 1605 • ACR Convergence 2022
Profound Anticoagulant Effects of Initial Antirheumatic Treatments in Early Rheumatoid Arthritis Patients; A NORD-STAR Spin-off Study
Bas Dijkshoorn¹, Daisy Vedder¹, Anna Rudin², Dan Nordstrom³, Bjorn Gudbjornsson⁴, Kristina Lend⁵, Till Uhlig⁶, Espen Haavardsholm⁶, Gerdur Maria Grondal⁷, Merete L Hetland⁸, Marte Heiberg⁶, Mikkel Østergaard⁹, Kim Horslev-Petersen¹⁰, Jon Lampa¹¹, Ronald van Vollenhoven¹², Aleksandra antovic¹³ and Michael Nurmohamed¹⁴, ¹Reade Rheumatology Center, Amsterdam, Netherlands, ²Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy of University of Gothenburg, Gothenburg, Sweden, ³Helsinki University Hospital, Helsinki, Finland, ⁴Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland, ⁵The Karolinska Institute, Stockholm, Sweden, ⁶Diakonhjemmet Hospital, Oslo, Norway, ⁷Landspitali University Hospital, Centre for Rheumatology Research, Reykjavik, Iceland, ⁸Rigshospitalet, Glostrup, Denmark, ⁹Rigshospitalet, University of Copenhagen, Glostrup, Denmark, ¹⁰Danish Hospital for Rheumatic Diseases, Haderslev, Denmark, ¹¹Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden, ¹²Amsterdam University Medical Centers, Amsterdam, Netherlands, ¹³Karolinska Institute, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, ¹⁴Amsterdam University Medical Center, Kortenhoef, Netherlands
Background/Purpose: Patients with rheumatoid arthritis (RA) are at an increased risk of venous thromboembolism. Thus far, there have not been any comparative studies investigating the…
Abstract Number: 2006 • ACR Convergence 2022
Healthcare Resource Utilization and Economic Burden of Patients with Adequate and Inadequate Responses to Advanced Therapies for Rheumatoid Arthritis in Japan
Kei Ikeda¹, Yuko Kaneko², Jayeshkumar Patel³, Toru Yamazaki⁴, Siran Fang³, Tsujita Yuki⁴ and Yutaka Kawahito⁵, ¹Chiba University Hospital, Chiba, Japan, ²Keio University School of Medicine, Tokyo, Japan, ³AbbVie, Inc., North Chicago, IL, ⁴AbbVie GK, Tokyo, Japan, ⁵Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan, Kyoto, Kyoto, Japan
Background/Purpose: Substantial numbers of patients with RA receiving advanced therapies including biologics, biosimilars, and Janus kinase inhibitors do not achieve ACR50 responses and lack of…
Abstract Number: 2142 • ACR Convergence 2022
Strong Correlation Between Short- vs Long-form Composite Measures of Psoriatic Arthritis Disease Activity in a TNFi-IR Population Treated with Guselkumab: Data from the Phase 3b COSMOS Trial
William Tillett¹, Laura Coates², Mohamed Sharaf³, Marlies Neuhold⁴, Elke Theander⁵, Paul Bergmans⁶, May Shawi⁷, Michelle Perate⁸, Christine Contré⁹ and Philip Helliwell¹⁰, ¹Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, ³Johnson & Johnson, Middle East FZ LLC, Dubai, United Arab Emirates, ⁴Takeda Europe & Canada Business Unit (EUCAN) Medical Affairs, Zurich, Switzerland; formerly at Janssen Scientific Affairs, LLC, Zug, Switzerland, ⁵Formerly at Janssen Scientific Affairs, LLC, Solna, Sweden, ⁶Formerly at Janssen, Breda, Netherlands, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Janssen Scientific Affairs, LLC, Horsham, PA, ⁹Formerly at Janssen Scientific Affairs, LLC, Issy-les-Moulineaux, France, Issy-les-Moulineaux, France, ¹⁰Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
Background/Purpose: Accurate assessment of psoriatic arthritis (PsA) disease activity in clinical practice requires a feasible, continuous, multidimensional composite instrument to assess key domains of this…
Abstract Number: 0267 • ACR Convergence 2022
Cancer Risk with Biologic and Targeted Synthetic DMARDs in Patients with Rheumatic Diseases and Previous Malignancy: Results from the BIOBADASER Register
Juan Molina¹, Fernando Sanchez-Alonso², Cristina Bohorquez³, Cesar Diaz-Torne⁴, Carolina Perez-Garcia⁵, Juan Maria Blanco-Madrigal⁶, Paloma Vela-Casampere⁷, José María Älvaro-Gracia¹ and Isabel Castrejon⁸, ¹Hospital General Universitario Gregorio Marañón, Madrid, Spain, ²Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain, ³University Hospital Príncipe de Asturias, Immune System Diseases-Rheumatology Service, Alcalá de Henares, Madrid, Spain, ⁴Department of Rheumatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, ⁵Department of Rheumatology, Hospital del Mar, Barcelona, Spain, ⁶Department of Rheumatology, Hospital de Basurto, Bilbao, Spain, ⁷Hospital General Universitario Alicante, Alicante, Spain, ⁸Hospital Universitario Gregorio Marañón, Madrid, Spain
Background/Purpose: To investigate the occurrence and relative risk of incident malignancy in patients with rheumatic diseases and previous malignancy treated with biologic and targeted synthetic…
Abstract Number: 0360 • ACR Convergence 2022
Longitudinal Variation of Proteomic Biomarkers That Correlate with Efficacy Endpoints: Results from a Phase 3 Trial of Anifrolumab in Moderate to Severe Systemic Lupus Erythematosus
Mark Lazarus¹, Paul Newcombe¹, Richard A. Furie², Philip Brohawn³, Wendy White³, Dominic Sinibaldi³, Nicola Ferrari¹, Raj Tummala³, Hussein Al-Mossawi¹, Edward Vital⁴, Eric F. Morand⁵, Daniel Muthas⁶ and Madhu Ramaswamy³, ¹AstraZeneca, Cambridge, United Kingdom, ²Northwell Health, Great Neck, NY, ³AstraZeneca, Gaithersburg, MD, ⁴University of Leeds, Leeds, England, United Kingdom, ⁵Monash University, Melbourne, Australia, ⁶AstraZeneca, Gothenburg, Sweden
Background/Purpose: Phase 2/3 clinical trials in patients with moderate to severe SLE have demonstrated that anifrolumab, a monoclonal antibody blocking IFNAR1, produced better clinical outcomes…
Abstract Number: 0485 • ACR Convergence 2022
Assessing the Effectiveness of Tocilizumab in Newly Diagnosed Giant Cell Arteritis versus Refractory/recurrent Giant Cell Arteritis in Clinical Practice
Julio Sánchez-Martín¹, Javier Loricera², Clara Moriano³, Santos Castañeda⁴, F. Javier Narváez⁵, Vicente Aldasoro⁶, Olga Maiz⁷, Rafael Melero⁸, Juan Ignacio Villa Blanco⁹, Paloma Vela-Casasempere¹⁰, Susana Romero Yuste¹¹, José Luis Callejas¹², Eugenio De Miguel¹³, Eva Galíndez-Agirregoikoa¹⁴, Francisca Sivera¹⁵, Jesus Fernandez¹⁶, Carles Galisteo¹⁷, Ivan Ferraz Amaro¹⁸, Lara Sánchez-Bilbao¹, Monica Calderon-Goercke¹⁹, Miguel Ángel González-Gay²⁰ and Ricardo Blanco², ¹Hospital Universitario Marqués de Valdecilla, Santander, Spain, ²Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ³Complejo Asistencial Universitario de León, León, Spain, ⁴Division of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain, ⁵Rheumatology Department, Hospital Universitario de Bellvitge, Barcelona, Spain, ⁶Hospital Universitario de Navarra, Pamplona, Spain, ⁷Hospital Universitario de Donostia, San Sebastián, Spain, ⁸Complexo Hospitalario Universitario de Vigo, Vigo, Spain, ⁹Sierrallana Hospital, Torrelavega, Spain, ¹⁰Hospital General Universitario Alicante, Alicante, Spain, ¹¹Complexo Hospitalario Universitario, Pontevedra, Spain, ¹²Hospital San Cecilio, Granada, Spain, ¹³Hospital Universitario La Paz, Madrid, Spain, ¹⁴Basurto University Hospital, Bilbao, Spain, ¹⁵Hospital Universitario de Elda, San Vicente del Raspeig, Spain, ¹⁶Hospital de La Coruña, La Coruña, Spain, ¹⁷Hospital Parc Tauli,, Sabadel, Spain, ¹⁸Division of Rheumatology. Hospital Universitario de Canarias. Spain., Santa Cruz de Tenerife, Spain, ¹⁹Hospital de Sierrallana, Torrelavega, Spain, ²⁰Department of Medicine and Psychiatry, Universidad de Cantabria; Rheumatology Division, Hospital Universitario Marqués de Valdecilla; Research group on genetic epidemiology and atherosclerosis in systemic diseases and in metabolic diseases of the musculoskeletal system, IDIVAL, Santander, Spain. Cardiovascular Pathophysiology and Genomics Research Unit, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Background/Purpose: Tocilizumab (TCZ) is the only biologic drug approved in giant cell arteritis (GCA), based in two clinical trials (CT) (1,2). CT included selected patients…
Abstract Number: 0784 • ACR Convergence 2022
Breakthrough SARS-CoV-2 Infections in Immune Mediated Disease Patients Undergoing B Cell Depleting Therapy: A Retrospective Cohort Analysis
Cassandra Calabrese¹, Elizabeth Kirchner², M. Elaine Husni³, Brandon Moss², Anthony Fernandez², Yuxuan Jin³ and Leonard Calabrese³, ¹Cleveland Clinic Foundation, Cleveland Heights, OH, ²Cleveland Clinic Foundation, Cleveland, OH, ³Cleveland Clinic, Cleveland, OH
Background/Purpose: Immunocompromised patients with immune mediated inflammatory diseases (IMIDs) undergoing therapy with B cell depleting agents (BCDT) are among the most vulnerable to severe COVID-19…
Abstract Number: 0916 • ACR Convergence 2022
Should RA Patients with Controlled Disease Taper Methotrexate from Targeted Therapy or Continue It? Risk Differences in Sustaining Remission from a Systematic Review and Meta-analysis
Charis Meng, Diviya Rajesh, Bridget Jivanelli, Deanna Jannat-Khah, DrPH, MSPH and Vivian Bykerk, Hospital for Special Surgery, New York, NY
Background/Purpose: Patients with RA often struggle with side effects of methotrexate (MTX). ACR guidelines conditionally recommend the tapering of MTX before tapering biologic (b)DMARDs, but…
Abstract Number: 1072 • ACR Convergence 2022
Efficacy and Safety Assessment of a Rituximab Biosimilar in Patients with Granulomatosis with Polyangiitis (GPA)
Adil Vural¹, Komal Mushtaq¹, Chao Zhang¹, Mahmoud Alwakeel¹, Vickie Sayles¹, Kristine Duly², Carol Langford¹ and Rula Hajj-Ali³, ¹Cleveland Clinic, Cleveland, OH, ²Cleveland Clinic, Fairview Park, OH, ³Cleveland Clinic, Hunting Valley, OH
Background/Purpose: A biosimilar is a medication that is highly similar to a biologic agent that is already approved by a regulatory organization. Considering the share…
Abstract Number: 1423 • ACR Convergence 2022
Long-Term Treatment with Golimumab Is a Safe Treatment Option Regardless of Risk Factors in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting
Regan Arendse¹, Proton Rahman², Philip Baer³, Derek Haaland⁴, Dalton Sholter⁵, Odalis Asin-Milan⁶, Meagan Rachich⁷, Emmanouil Rampakakis⁸, A. Marilise Marrache⁹ and Allen J. Lehman¹⁰, ¹Community Rheumatology Care, Saskatoon, Canada, ²Memorial University, St. John's, NL, Canada, ³Baer Weinberg MPC, Scarborough, ON, Canada, ⁴The Waterside Clinic, Oro Medonte, ON, Canada, ⁵University of Alberta, Edmonton, AB, Canada, ⁶Janssen Canada, Laval, QC, Canada, ⁷Janssen Inc., Guelph, ON, Canada, ⁸McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁹Janssen Inc., Dollard-des-Ormeaux, QC, Canada, ¹⁰Janssen Inc., Toronto, ON, Canada
Background/Purpose: Golimumab (GLM), a tumor necrosis factor inhibitor (TNFi), has demonstrated efficacy and a favorable safety profile in inflammatory rheumatic diseases. Recent safety studies with…
Abstract Number: 1624 • ACR Convergence 2022
Blocking IL-1, IL-33 and IL-36 Signaling with the Anti-IL1RAP Antibody mCAN10 Ameliorates Inflammation and Fibrosis in Preclinical Models of Systemic Sclerosis
Caitriona Grönberg¹, Sara Rattik¹, Meik Kunz², Thoung Trinh-Minh³, Cuong Tran-Manh³, Xiang Zhou³, Petter Skoog¹, David Liberg¹ and Jörg Distler³, ¹Cantargia AB, LUND, Sweden, ²Friedrich-Alexander University (FAU) Erlangen-Nuremberg, Erlangen, Germany, ³Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and University Hospital Erlangen, Erlangen, Germany
Background/Purpose: The IL-1 receptor accessory protein (IL1RAP) is a co-receptor required for signaling through the IL-1, IL-33, and IL-36 receptors. IL1RAP-dependent signaling has been implicated…
Abstract Number: 2008 • ACR Convergence 2022
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs
Alan Kivitz¹, Liangwei Wang², Ilias Alevizos², Michele Gunsior², Judith Falloon² and Gabor Illei³, ¹Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ²Horizon Therapeutics, Gaithersburg, MD, ³Horizon Therapeutics, Rockville, MD
Background/Purpose: Dazodalibep (DAZ), a non-antibody biologic antagonist of CD40L, led to higher/durable response rates vs. placebo (PBO) in a double-blind, Phase 1b trial of patients…
Abstract Number: 2145 • ACR Convergence 2022
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials
Lars Erik¹, Kim Papp², Douglas White³, Cecilia Asnal⁴, Wenjing Lu⁵, Ahmed Soliman⁵, Byron Padilla⁶, Michael Chen⁵ and Andrew Ostor⁷, ¹Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark, ²K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ³Rheumatology Department, Waikato Hospital, and Waikato Clinical School, University of Auckland, Hamilton, New Zealand, ⁴Hospital Alemán, Buenos Aires, Argentina, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc., Waukegan, IL, ⁷Cabrini Hospital, Monash University & Emeritus Research, Melbourne, Australia
Background/Purpose: PsA is a chronic, systemic inflammatory disease with a variety of clinical manifestations including arthritis, enthesitis, and dactylitis and is associated with skin and…
Abstract Number: L19 • ACR Convergence 2021
Secukinumab in Giant Cell Arteritis: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial
Nils Venhoff¹, Wolfgang Schmidt², Raoul Bergner³, Jürgen Rech⁴, Leonore Unger⁵, Hans-Peter Tony⁶, Meryl Mendelson⁷, Christian Sieder⁸, Meron Maricos⁸ and Jens Thiel⁹, ¹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany, ²Immanuel Krankenhaus Berlin, Medical Center for Rheumatology Berlin-Buch, Lindenberger Weg 19, 13125 Berlin, Germany, Berlin, Germany, ³Medizinische Klinik A, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany, ⁴Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, ⁵Medical Department 1, Städtisches Klinikum Dresden, Dresden, Germany, ⁶Department of Medicine 2, Rheumatology and Clinical Immunology Oberduerrbachertstr. 697080, Wuerzburg, Germany, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Pharma GmbH, Nuremberg, Germany, ⁹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany; Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
Background/Purpose: Little is known about glucocorticoid-sparing agents in giant cell arteritis (GCA) except for IL-6 inhibition. Secukinumab (SEC) has shown significant improvements in the signs…

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