Biologicals Archives - Page 34 of 54

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: 1629 • ACR Convergence 2022
AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases
Shawn Morales, Jennifer Cross and Robert Huizinga, Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada
Background/Purpose: AUR200 targets both B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), which are key mediators in the pathogenesis of B cell-mediated autoimmune…
Abstract Number: 2031 • ACR Convergence 2022
Efficacy and Safety of Telitacicept in Primary Sjögren’s Syndrome: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial
Dong Xu¹, Shangzhu Zhang¹, Cibo Huang², Chenghui Huang³, Li Qin⁴, Xiaomei Li⁵, Meiqing Chen⁶, Xiumei Liu⁷, Yi Liu⁸, Zhijun Li⁹, Jiankang Hu¹⁰, Chunde Bao¹¹, wei Wei¹², Jing Tian¹³, Xinwang Duan¹⁴, Jianmin Fang¹⁵ and Xiaofeng Zeng¹⁶, ¹Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Beijing Hospital, Beijing, China, ³The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, ⁴Huzhou Third Municipal Hospital, Huzhou, China, ⁵Anhui Provincial Hospital, Hefei, China, ⁶The First Affiliated Hospital of Xiamen University, Xiamen, China, ⁷The First Hospital of Shanxi Medical University, Taiyuan, China, ⁸West China Hospital of Sichuan University, Chengdu, China, ⁹The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹⁰Jiangxi Pingxiang People’s Hospital, Shanghai, China, ¹¹Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China, ¹²Tianjin Medical University General Hospital, Tianjin, China, ¹³Second Xiangya Hospital of Central South University, Changsha, China, ¹⁴The Second Affiliated Hospital of Nanchang University, Nanchang, China, ¹⁵Shanghai Tongji Hospital, Shanghai, China, ¹⁶Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China
Background/Purpose: To evaluate the efficacy and safety of telitacicept in adult patients with primary Sjögren’s syndrome (pSS) in a phase II randomized double-blind placebo-controlled trial.Methods:…
Abstract Number: 2151 • ACR Convergence 2022
Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-week Randomized, Placebo-controlled Trial
Kurt de Vlam¹, Peter Taylor², Philip J Mease³, Paul Peloso⁴, Dieter Wetzel⁵, Nicolai Brun⁵, Brian Wiens⁶, Jan Brandt-Juergens⁷, Edit Drescher⁸, Eva Dokoupilova⁹, Anna Rowinska-Osuch¹⁰, Nadia Abdel- Kader Martin¹¹ and Frank Behrens¹², ¹University Hospitals Leuven, Leuven, Belgium, ²University of Oxford, Oxford, United Kingdom, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴ACELYRIN, Naples, FL, ⁵Affibody AB, Solna, Sweden, ⁶ACELYRIN, Inc., Los Angeles, CA, ⁷Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁸Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, ⁹Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, ¹⁰ETG Network, Warsaw, Poland, ¹¹Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, ¹²Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany
Background/Purpose: PsA is a chronic, inflammatory disease with multiple manifestations, with arthritis and skin involvement. Other areas of inflammation include enthesitis, dactylitis and nail involvement.…
Abstract Number: 0290 • ACR Convergence 2022
Evaluation of Treatment Discontinuation Due to Adverse Events, and the Effect of Cardiovascular Risk Factors or Type of JAK-inhibitors: An International Collaboration of Registries of Rheumatoid Arthritis Patients (the ‘JAK-pot‘ Study)
Kim Lauper¹, Romain Aymon², Denis Mongin², Sytske Anne Bergstra³, Denis Choquette⁴, Catalin Codreanu⁵, Ori Elkayam⁶, Kimme Hyrich⁷, Florenzo Iannone⁸, Nevsun Inanc⁹, Lianne Kearsley-Fleet¹⁰, Tore K. kvien¹¹, Eirik Kristianslund¹², Burkhard Leeb¹³, Galina Lukina¹⁴, Dan Nordstrom¹⁵, Karel Pavelka¹⁶, Manuel Pombo-Suarez¹⁷, Ziga Rotar¹⁸, Maria José Santos¹⁹, Delphine Courvoisier²⁰ and Axel Finckh²¹, ¹Geneva University Hospitals, Genéve, Switzerland, ²Geneva University Hospitals, Geneva, Switzerland, ³LUMC, Leiden, Netherlands, ⁴Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada, ⁵Center for Rheumatic Diseases, Bucharest, Romania, ⁶Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, ⁷The University of Manchester, Manchester, United Kingdom, ⁸School of Medicine University of Bari, Bari, Italy, ⁹Marmara University School of Medicine, Division of Rheumatology, Istanbul, Turkey, ¹⁰Centre for Epidemiology Versus Arthritis, University of Manchester, Manchester, United Kingdom, ¹¹Diakonhjemmet Hospital, Oslo, Norway, ¹²Diakonhjemmet Hospital, Division of Rheumatology and Research, Oslo, Norway, ¹³Bioreg, Stockerau, Austria, ¹⁴Federal state budgetary scientific institution �Research Institute of rheumatology named after V. A. Nasonova�, Moscow, Russia, ¹⁵Helsinki University Hospital, Helsinki, Finland, ¹⁶Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, Praha, Czech Republic, ¹⁷Hospital Clinico Universitario, Santiago de Compostela, Spain, ¹⁸University Medical Centre Ljubljana, Ljubljana, Slovenia, ¹⁹Hospital Garcia de Orta, Almada, Charneca da Caparica, Portugal, ²⁰University Hospitals of Geneva, Geneva, Switzerland, ²¹Geneva University Hospital, Geneve - Vesenaz, Switzerland

Background/Purpose: The "ORAL Surveillance" study1 suggests an increased risk of serious adverse events (AEs) with tofacitinib, a JAK-inhibitor (JAKi), compared to TNF-inhibitors (TNFi). Currently, there…
Abstract Number: 0367 • ACR Convergence 2022
Comparative Risk of COVID-19 Among Patients with Systemic Lupus Erythematosus According to Immunosuppressant Use
April Jorge¹, Baijun Zhou¹, yuqing zhang² and Hyon Choi³, ¹Massachusetts General Hospital, Boston, MA, ²Massachusetts General Hospital, Quincy, MA, ³MASSACHUSETTS GENERAL HOSPITAL, Lexington, MA
Background/Purpose: Patients with SLE are at increased risk of COVID-19 and its severe outcomes, in part due to the use of immunosuppressants. We sought to…
Abstract Number: 0512 • ACR Convergence 2022
Development of CARRA Biologic Consensus Treatment Plans for Management of Refractory Moderate Juvenile Dermatomyositis
Matthew Sherman¹, Hanna Kim² and Stacey Tarvin³, ¹Muscle Disease Unit, Laboratory of Muscle Stem Cells and Gene Regulation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH); Children’s National Hospital, Washington, DC, ²Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences; Juvenile Myositis Therapeutic and Translation Studies Unit, PTRB, NIAMS, NIH, Bethesda, MD, ³Riley Hospital for Children at Indiana University Health, Indianapolis, IN
Background/Purpose: There is a paucity of prospective clinical trials evaluating treatments for juvenile dermatomyositis (JDM). Consensus treatment plans (CTPs) are designed to facilitate comparative effectiveness…
Abstract Number: 0785 • ACR Convergence 2022
Humoral Immune Responses Following Four SARS-CoV-2 Vaccine Doses or COVID-19 Infection in Patients with Immune-Mediated Inflammatory Diseases on Immunosuppressive Therapy: A Prospective Cohort Study
Hilde Ørbo¹, Kristin Hammersbøen Bjørlykke², Joe Sexton¹, Anne Therese Tveter¹, Ingrid Jyssum¹, Ingrid Egeland Christensen¹, David Warren³, Tore K. Kvien¹, Adity Chopra⁴, Grete Birkeland Kro³, Jørgen Jahnsen², Ludvig A. Munthe³, Espen Haavardsholm¹, Gunnveig Grødeland³, Sella Aarrestad Provan¹, Kristin Kaasen Jørgensen², Silje Watterdal Syversen¹ and Guro Løvik Goll¹, ¹Diakonhjemmet Hospital, Oslo, Norway, ²Akershus University Hospital, Oslo, Norway, ³Oslo University Hospital, Oslo, Norway, ⁴Oslo University Hospital, Oslo, Oslo, Norway
Background/Purpose: Patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive therapy have impaired humoral immune responses to SARS-CoV-2 vaccination. This study aimed to assess serologic response…
Abstract Number: 0917 • ACR Convergence 2022
Fifty-two-week Results from a Phase 3, Randomized, Double-blind, Active-controlled Clinical Trial to Compare BAT1806/BIIB800, a Proposed Tocilizumab Biosimilar, with a Tocilizumab Reference Product in Subjects with Moderate to Severe RA with an Inadequate Response to Methotrexate
Xiaomei Leng¹, Piotr Leszczynski², Sławomir Jeka³, Shengyun Liu⁴, Huaxiang Liu⁵, Malgorzata Miakisz⁶, Jieruo Gu⁷, Lali Kilasonia⁸, Mykola Stanislavchuk⁹, Xiaolei Yang¹⁰, Yinbo Zhou¹¹, Qingfeng Dong¹¹, Marian Mitroiu¹², Janet Addison¹³ and Xiaofeng Zeng¹⁴, ¹Peking Union Medical College Hospital, Department of Rheumatology and Clinical Immunology, Beijing, China, ²Poznan University of Medical Sciences, Department of Rheumatology, Rehabilitation and Internal Medicine, Poznan, Poland, ³University Hospital No 2 in Bydgoszcz Collegium Medicum UMK, Clinic and Department of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁴First Affiliated Hospital of Zhengzhou University, Department of Rheumatology and Immunology, Zhengzhou, China, ⁵Qilu Hospital of Shandong University, Department of Rheumatology, Jinan, China, ⁶Twoja Przychodnia Centrum Medyczne, Internal Medicine and Rheumatology, Nowa Sól, Poland, ⁷The Third Affiliated Hospital of Sun Yat-sen University, Department of Rheumatology, Guangzhou, China, ⁸Tbilisi Heart and Vascular Clinic Ltd, Rheumatology, Tbilisi, Georgia, ⁹National Pirogov Memorial Medical University, Internal Medicine, Vinnytsia, Ukraine, ¹⁰Bio-Thera Solutions, Ltd., Research and Development, Guangzhou, China, ¹¹Bio-Thera Solutions Ltd, Research and Development, Guangzhou, China, ¹²Biogen International GmbH, Evidence Generation Biosimilars, Baar, Switzerland, ¹³Biogen Idec Ltd, Maidenhead, United Kingdom, ¹⁴Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China
Background/Purpose: BAT1806 (also referred to as BIIB800) is a proposed biosimilar to tocilizumab reference product (TCZ). Results of this Phase 3, randomized, double-blind, active-controlled trial…
Abstract Number: 1073 • ACR Convergence 2022
Analysis of Clinical Outcomes in ANCA-associated Vasculitis Treated with Rituximab: Eighty Years a Single Center Experience in Japan
Soko Kawashima¹, Mitsumasa Kishimoto², Yoshinori Komagata³ and Shinya kaname⁴, ¹Kyorin University, Mitaka Tokyo, Japan, ²Kyorin University School of Medicine, Yokohama, Japan, ³Kyorin University School of Medicine, Tokyo, Japan, ⁴Kyorin University, Tokyo, Japan
Background/Purpose: Contrary to many Western countries, MPO-ANCA-associated vasculitis (MPO-AAV) is dominant in Japan. The therapeutic response to rituximab (RTX) may differ. Therefore, we conducted a…
Abstract Number: 1424 • ACR Convergence 2022
Cost-Effectiveness of a Progressive Spacing of Tocilizumab or Abatacept in Patients with Rheumatoid Arthritis in Sustained Remission: A Medico-Economic Analysis of the ToLEDo Trial
Joanna KEDRA¹, Lina El Houari¹, Florence Tubach¹, Benjamin granger¹ and Bruno Fautrel², ¹Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, PEPITES, F75013, Paris, France, Paris, France, ²Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France
Background/Purpose: Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) progressive tapering is a real opportunity in people living with rheumatoid arthritis (RA) having achieved remission both from…
Abstract Number: 1652 • ACR Convergence 2022
Long-term Safety and Efficacy of Anifrolumab in Adult Patients with Systemic Lupus Erythematosus: A Multicenter, Randomized, Double-blind, Placebo-controlled 3-year TULIP Extension Study
Kenneth C. Kalunian¹, Richard A. Furie², Eric F. Morand³, Ian N. Bruce⁴, Susan Manzi⁵, Yoshiya Tanaka⁶, Kevin Winthrop⁷, Gabriel Abreu⁸, Ihor Hupka⁹, Lijin Zhang¹⁰, Shanti Werther¹¹, Micki Hultquist¹², Raj Tummala¹⁰ and Catharina Lindholm¹¹, ¹UC San Diego, La Jolla, CA, ²Northwell Health, Great Neck, NY, ³Monash University, Melbourne, Australia, ⁴The University of Manchester, Manchester, United Kingdom, ⁵Allegheny Health Network, Pittsburgh, PA, ⁶University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁷Oregon Health & Science University, Portland, OR, ⁸AstraZeneca, Mölndal, Sweden, ⁹AstraZeneca, Warsaw, Poland, ¹⁰AstraZeneca, Gaithersburg, MD, ¹¹AstraZeneca, Gothenburg, Sweden, ¹²AstraZeneca, Bethesda, MD
Background/Purpose: Anifrolumab is a fully human IgG1 κ monoclonal antibody that binds to the type I IFN receptor and inhibits type I IFN signaling.1 In…
Abstract Number: 2056 • ACR Convergence 2022
Long Term Safety and Effectiveness of Belimumab Therapy in Patient with SLE: A Single Center Retrospective Analysis
Takehiro Nakai¹, Sho Fukui², Takahiro Asano³, Futoshi Iwata⁴, Hiroki Ozawa⁵, Satoshi Kawaai⁴, Yukihiko Ikeda¹, Hiromichi Tamaki¹, Mitsumasa Kishimoto⁶, Kenichi YAMAGUCHI⁷ and Masato Okada¹, ¹St. Luke's International Hospital, Tokyo, Japan, ²Kyorin University Hospital, Tokyo, Japan, ³St. Luke's International Hospital, Chuo City Tokyo, Japan, ⁴St. Luke's International Hospital, Chuo-ku, Tokyo, Japan, ⁵Immuno-Rheumatology Center, St.Luke's International Hospital, Tokyo, Japan, ⁶Kyorin University School of Medicine, Yokohama, Japan, ⁷St.Luke's International Hospital, Tokyo, Japan
Background/Purpose: Many clinicians use belimumab as a maintenance therapy of SLE, but there is scarce data on belimumab drug retention rate and safety/effectiveness profile in…
Abstract Number: 2152 • ACR Convergence 2022
Depression and Other Neurological Disorders Are Associated with Biologic DMARD Failure in Psoriatic Arthritis
Nicoletta Luciano¹, Elisa Barone², Enrico Brunetta¹, Maria De Santis³, Angela Ceribelli⁴, Marta Caprioli⁵, Giacomo Maria Guidelli¹, Arianna Sonaglia¹, Daniela Renna⁶, Francesca Motta⁷, Natasa Isailovic⁷, Matteo Vecellio³ and Carlo Selmi⁸, ¹IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Rozzano, Italy, ²IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Rozzano (MI), Lombardia, Italy, ³Humanitas University, IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Pieve Emanuele, Italy, ⁴Humanitas Research Hospital, Humanitas University, Rozzano (MI) Italy, Borgo San Giacomo, Italy, ⁵IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Pavia, Italy, ⁶IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Milano, Italy, ⁷Humanitas University, IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Rozzano (MI), Italy, ⁸Humanitas University, IRCCS Humanitas Research Hospital, Rheumatology and Clinical Immunology, Rozzano, Italy
Background/Purpose: The management of patients with psoriasis and psoriatic artrhitis (PsA) has been recently enriched and has thus become more challenging by the wide armamentarium…
Abstract Number: 0076 • ACR Convergence 2022
Real World Rheumatology Practice of Biologic Monotherapy for the Treatment of Patients with Rheumatoid Arthritis: A Four-year Cohort Study Using a National Claims Database
Ko-Jen Li¹, Kuo-Cherh Huang², Chia-Cheng Lin³ and Chia-Li Chang², ¹National Taiwan University Hospital, Taipei, Taiwan, ²Taipei Medical University, Taipei, Taiwan, ³Chugai Pharma Taiwan Ltd., Taipei, Taiwan
Background/Purpose: There is a growing concern over the rise of polypharmacy, arguably one of the most pressing prescribing challenges. The option of biologic monotherapy is…

Abstracts tagged "Biologicals"

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

AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases

Efficacy and Safety of Telitacicept in Primary Sjögren’s Syndrome: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial

Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-week Randomized, Placebo-controlled Trial

Evaluation of Treatment Discontinuation Due to Adverse Events, and the Effect of Cardiovascular Risk Factors or Type of JAK-inhibitors: An International Collaboration of Registries of Rheumatoid Arthritis Patients (the ‘JAK-pot‘ Study)

Comparative Risk of COVID-19 Among Patients with Systemic Lupus Erythematosus According to Immunosuppressant Use

Development of CARRA Biologic Consensus Treatment Plans for Management of Refractory Moderate Juvenile Dermatomyositis

Humoral Immune Responses Following Four SARS-CoV-2 Vaccine Doses or COVID-19 Infection in Patients with Immune-Mediated Inflammatory Diseases on Immunosuppressive Therapy: A Prospective Cohort Study

Fifty-two-week Results from a Phase 3, Randomized, Double-blind, Active-controlled Clinical Trial to Compare BAT1806/BIIB800, a Proposed Tocilizumab Biosimilar, with a Tocilizumab Reference Product in Subjects with Moderate to Severe RA with an Inadequate Response to Methotrexate

Analysis of Clinical Outcomes in ANCA-associated Vasculitis Treated with Rituximab: Eighty Years a Single Center Experience in Japan

Cost-Effectiveness of a Progressive Spacing of Tocilizumab or Abatacept in Patients with Rheumatoid Arthritis in Sustained Remission: A Medico-Economic Analysis of the ToLEDo Trial

Long-term Safety and Efficacy of Anifrolumab in Adult Patients with Systemic Lupus Erythematosus: A Multicenter, Randomized, Double-blind, Placebo-controlled 3-year TULIP Extension Study

Long Term Safety and Effectiveness of Belimumab Therapy in Patient with SLE: A Single Center Retrospective Analysis

Depression and Other Neurological Disorders Are Associated with Biologic DMARD Failure in Psoriatic Arthritis

Real World Rheumatology Practice of Biologic Monotherapy for the Treatment of Patients with Rheumatoid Arthritis: A Four-year Cohort Study Using a National Claims Database