Abstracts tagged "Biologicals"

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…
Abstract Number: L07 • ACR Convergence 2021
Depletion of KLRG1+ T Cells in a First-in-human Clinical Trial of ABC008 in Inclusion Body Myositis (IBM)
Niti Goel¹, Dulce Soler-Ferran², Monette Coutreau², Jorge Escobar³, Kate Courtemanche², Merrilee Needham⁴ and Steven Greenberg⁵, ¹Abcuro, Inc.; Duke University, Durham, NC, ²Abcuro, Inc., Newton, MA, ³Abcuro, Inc., Hayward, CA, ⁴Perron Institute, Murdoch University, Perth, Australia, ⁵Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose: Inclusion body myositis (IBM), a relentlessly progressive autoimmune skeletal muscle disease, has no effective available pharmacological therapy. A prominent feature of IBM on microscopy…
Abstract Number: L12 • ACR Convergence 2021
Neither Add-on nor Withdrawal of Methotrexate Impacts Efficacy of IL12/23 Inhibition in Active PsA: Data from a Multicenter Investigator-initiated Randomized Placebo-controlled Clinical Trial on Arthritis, Dactylitis, Enthesitis, Psoriasis, QoL and Function
Michaela Koehm¹, Tanja Rossmanith², Ann Christina Foldenauer², Eva Herrmann³, Herbert Kellner⁴, Uta Kiltz⁵, Jürgen Rech⁶, Gerd Burmester⁷, David Kofler⁸, Jan Brandt-Jürgens⁹, Christin Jonetzko¹⁰, Harald Burkhardt¹ and Frank Behrens¹, ¹Rheumatology Goethe-University Frankfurt and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany, ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany, ³Institute for Biostatistics and Mathematical Modeling, Goethe-Universität Frankfurt, Frankfurt, Germany, ⁴Praxis Prof. Dr. Kellner, München, Germany, ⁵Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, ⁷Charite Universitaetsmedizin Berlin, Germany and DRFZ, Berlin, Germany, ⁸Universitätsklinikum Köln, Med. Klinik I f. Innere Medizin Immunologische Ambulanz, Köln, Germany, ⁹Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz, Berlin, Germany, ¹⁰Fraunhofer Insitute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany
Background/Purpose: Methotrexate (MTX) is often used as first-line DMARD-therapy in active psoriatic arthritis (PsA). Randomized clinical trials usually require treatment failure or intolerance of csDMARD/MTX…
Abstract Number: L18 • ACR Convergence 2021
Humoral and Cellular Immune Responses to a Second Dose of COVID-19 Vaccine BNT162b2 in People Receiving Methotrexate or Targeted Immunosuppression: A Cohort Study
Satveer K Mahil¹, Katie Bechman², Antony Raharja¹, Clara Domingo-Vila³, David Baudry¹, Matt Brown², Andrew Cope², Tejus Dasandi¹, Hataf Khan⁴, Thomas Lechmere⁴, Michael Malim⁴, Freya Meynell¹, Emily Pollock³, Kamila Sychowska³, Jonathan Barker¹, Sam Norton⁵, James Galloway², Katie Doores⁴, Timothy Tree³ and Catherine Smith¹, ¹St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, ²Centre for Rheumatic Diseases, King's College London, London, ³Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom, ⁴Department of Infectious Diseases, School of Immunology & Microbial Sciences, King's College London, London, United Kingdom, ⁵Psychology Department, Institute for Psychiatry Psychology & Neuroscience, King’s College London, London
Background/Purpose: COVID-19 vaccines have robust immunogenicity in the general population. Data on individuals with immune-mediated inflammatory diseases who are taking immunosuppressants remains limited. Our cohort…
Abstract Number: 0432 • ACR Convergence 2021
Anti-IL5 Therapy in Eosinophilic Granulomatosis with Polyangiitis (EGPA): A Longitudinal Follow-up Study ≥ 24months
Allyson Egan¹, Pasupathy Sivasothy², Lisa Willcocks², Rachel Jones², Marcos Martinez Del Pero³ and David R.W. Jayne⁴, ¹Vasculitis and Lupus Centre, Cambridge University Hospital, University of Cambridge, London, United Kingdom, ²Vasculitis and Lupus Centre, Department of Medicine, Cambridge University Hospital, Cambridge, United Kingdom, ³Vasculitis and Lupus Centre, Cambridge University Hospital, Cambridge, United Kingdom, ⁴University of Cambridge, Cambridge, United Kingdom
Background/Purpose: In the randomized, placebo-controlled MIRRA trial for relapsing and refractory eosinophilic granulomatosis with polyangiitis (EGPA), adjuvant therapy with 300mg anti-IL5 mAB Mepolizumab [MEPO] for…

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