Abstracts tagged "monoclonal antibodies"

Abstract Number: 1828 • 2015 ACR/ARHP Annual Meeting
Target Modulation of a Type I Interferon Gene Signature and Pharmacokinetics of Anifrolumab in a Phase IIb Study of Patients with Moderate to Severe Systemic Lupus Erythematosus
Philip Brohawn¹, Lingning Santiago², Chris Morehouse¹, Brandon Higgs¹, Gabor Illei¹ and Koustubh Ranade¹, ¹MedImmune, Gaithersburg, MD, ²MedImmune, Mountain View, CA
Background/Purpose: Anifrolumab is a fully human IgG1 monoclonal antibody directed against subunit 1 of the type I interferon receptor (IFNAR1). Anifrolumab blocks the binding of…
Abstract Number: 2058 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar Candidate (CT-P10) and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase I Randomized Controlled Trial over 72 Weeks
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Slawomir Jeka⁵, Fidencio Cons Molina⁶, Pawel Hrycaj⁷, Wolfgang Spieler⁸, Piotr Wiland⁹, Jan Brzezicki¹⁰, Eun Young Lee¹¹, Francisco G. Medina-Rodriguez¹², Pavel Shesternya¹³, Sebastiao Radominski¹⁴, Marina Stanislav¹⁵, Volodymyr Kovalenko¹⁶, Donghyuk Sheen¹⁷, Leysan Myasoutova¹⁸, Mie Jin Lim¹⁹, Jung-Yoon Choe²⁰, Taek S. Kwon²¹ and Sang Joon Lee²¹, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ³Department of Rheumatology, Ajou University Hospital, Suwon, South Korea, ⁴Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ⁵University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁶Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁷Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ⁸Osteologie und Rheumatologie, ZeFOR GmbH Zentrum für Forschung, Zerbst, Germany, ⁹Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ¹⁰Wojewodzki Szpital Zespolony w Elablagu, Elblag, Poland, ¹¹Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, ¹²Rheumatology, LaSalle University, Mexico City, Mexico, ¹³Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁴CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, ¹⁵Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia, ¹⁶Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine, ¹⁷Rheumatology, Eulji University Hospital, Daejeon, South Korea, ¹⁸City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, ¹⁹Division of Rheumatology, Departments of Internal Medicine, Inha University Hospital, Incheion, South Korea, ²⁰Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, South Korea, ²¹CELLTRION, Inc., Incheon, South Korea
Background/Purpose: CT-P10 is a biosimilar candidate of innovator rituximab (RTX). PK profile and clinical data up to week 24 has been reported at ACR 20131.…
Abstract Number: 2144 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis
Kim Papp¹, Alan Menter², Howard Sofen³, Stephen Tyring⁴, Jean-Philippe Lacour⁵, Beate Berner⁶, Nathan Bennett⁷, Stella Aslanyan⁷, Mary Flack⁷ and Paul Scholl⁷, ¹Probity Clinical Research, Waterloo, ON, Canada, ²Baylor Research Institute, Dallas, TX, ³Dermatology Research Associates, Los Angeles, CA, ⁴Center for Clinical Studies, Houston, TX, ⁵Dermatology Department, Hôpital de L’Archet, Nice, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ⁷Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT
Background/Purpose: IL-23 is essential for the differentiation and maintenance of Th17 cells in psoriasis and psoriatic arthritis (PsA). We assessed the efficacy and safety of…
Abstract Number: 2749 • 2015 ACR/ARHP Annual Meeting
A Phase 1 Study of FPA008, an Anti-Colony Stimulating Factor 1 Receptor (anti-CSF1R) Antibody in Patients (pts) with Rheumatoid Arthritis (RA): Preliminary Results
Lei Zhou¹, Robert Sikorski¹, Seema Rogers¹, Stefan Costin², Mariusz Korkosz³, Maria Jaraczewska-Baumann⁴, Péterfai Éva⁵, Bernadette Rojkovich⁶, Janos Bartalos⁷, Emma Masteller¹, Hong Xiang¹, Brian Wong¹ and Julie Hambleton¹, ¹Five Prime Therapeutics, Inc., South San Francisco, CA, ²PRA Heath Sciences, Berlin, Germany, ³Malopolskie Centrum Medyczne, The University Hospital in Krakow, Krakow, Poland, ⁴MedPolonia Sp. z o.o, Poznan, Poland, ⁵Drug Research Center, Balatonfüred, Hungary, ⁶Hospitaller Brothers of St. John of God, Budapest, Hungary, ⁷PRA Hungary Ltd, Budapest, Hungary
Background/Purpose: FPA008 is a humanized IgG4 anti-CSF1R antibody that blocks the binding of CSF1 and IL34 ligands to CSF1R, resulting in inhibition of the activation…
Abstract Number: 2853 • 2015 ACR/ARHP Annual Meeting
Secukinumab Improves Skin Symptoms and Physical Functioning Compared with Ustekinumab in Patients with Moderate to Severe Psoriasis with Concomitant Psoriatic Arthritis: Subanalysis of a Randomized, Double Blind, Parallel-Group, Active Comparator-Controlled Phase 3b Trial
Alice B. Gottlieb¹, Diamant Thaci², Andrew Blauvelt³, Marina Milutinovic⁴ and Shephard Mpofu⁴, ¹Tufts Medical Center and Tufts University School of Medicine, Boston, MA, ²Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany, ³Research Excellence & Personalized Patient Care, Oregon Medical Research Center, Portland, OR, ⁴Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Psoriatic arthritis (PsA) is a common comorbidity in patients (pts) with psoriasis. In the ongoing Phase 3b CLEAR study (NCT02074982), secukinumab, a fully human…
Abstract Number: 2883 • 2015 ACR/ARHP Annual Meeting
Relationship Between Improvements in Fatigue and Signs & Symptoms of Active Psoriatic: Arthritis a Sub-Analysis of a Phase 3 Study with Secukinumab
Laure Gossec¹, Tore K. Kvien², Philip G. Conaghan³, Mikkel Østergaard⁴, Juan D. Cañete⁵, C. Gaillez⁶, Shephard Mpofu⁶, Bintu Sherif⁷ and Steffen Jugl⁸, ¹Rheumatology Department, Paris 06 University,Hôpital Pitié Salpêtrière, Paris, France, ²Dept of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ³University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, United Kingdom, ⁴Center for Rheumatology and Spine Diseases, Glostrup Hospital, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet - Glostrup, University of Copenhagen, Denmark, Glostrup, Denmark, ⁵Rheumatology, Hospital Clinic and IDIBAPS, Barcelona, Spain, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷RTI Health Solutions, Durham, NC, ⁸BF I&D GPA, Health Economics and Outcomes Research, Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Fatigue is highly important to patients (pts) with psoriatic arthritis (PsA). Secukinumab, an anti-interleukin-17A monoclonal antibody, significantly improved the signs and symptoms of active…
Abstract Number: 3193 • 2015 ACR/ARHP Annual Meeting
Immunomodulatory and Antiviral Therapies in a Mouse Model of Chikungunya Viral Arthritis
Jonathan Miner¹, Lindsey Cook¹, Raeann Shimak², Julie Fox¹, Alissa Young¹, Kristen Monte², Subhajit Poddar², Michael Diamond¹ and Deborah Lenschow¹, ¹Department of Medicine, Washington University in Saint Louis School of Medicine, Saint Louis, MO, ²Washington University in Saint Louis School of Medicine, Saint Louis, MO
Background/Purpose: Chikungunya virus (CHIKV) is a rapidly emerging arthritogenic mosquito-borne alphavirus that has infected more than 1 million individuals in the Western Hemisphere since 2014. …
Abstract Number: 550 • 2014 ACR/ARHP Annual Meeting
Secukinumab, an Anti–Interleukin-17A Monoclonal Antibody, Improves Physical Function, Quality of Life and Work Productivity in Patients with Active Psoriatic Arthritis: Results from a Phase 3, Randomized, Controlled Trial
Vibeke Strand¹, Philip J. Mease², Iain B. McInnes³, Bruce Kirkham⁴, Arthur Kavanaugh⁵, Proton Rahman⁶, P. Nash⁷, Luminita Pricop⁸, Jiacheng Yuan⁹, Hanno Richards¹⁰ and Shephard Mpofu¹¹, ¹Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, ²Rheumatology Research, Swedish Medical Center, Seattle, WA, ³Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁴Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom, ⁵University of California San Diego, La Jolla, CA, ⁶Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁷Rheumatology Research Unit, Nambour Hospital, Sunshine Coast and Department of Medicine, University of Queensland, Queensland, Australia, ⁸Integrated Hospital Care (IHC) Franchise, Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁹Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁰Clinical Immunology / Dermatology, Novartis Pharma AG, Basel, Switzerland, ¹¹Novartis Pharma AG, Basel, Switzerland
Background/Purpose Psoriatic arthritis (PsA) has a significant adverse effect on patients’ health-related quality of life (HRQoL), affecting their physical and emotional functioning and psychological health.…
Abstract Number: 538 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Monoclonal Antibody to Interleukin-17A, Significantly Improves Physical Function and Quality of Life in Subjects with Active Ankylosing Spondylitis: Results of a Phase 3 Randomized, Placebo-Controlled Trial with Intravenous Loading and Subcutaneous Maintenance Dosing
Atul A. Deodhar¹, Dominique L. Baeten², Jürgen Braun³, Xenofon Baraliakos³, Joachim Sieper⁴, Maxime Dougados⁵, Paul Emery⁶, Brian Porter⁷, Ruvie Martin⁷, Shephard Mpofu⁸ and Hanno Richards⁹, ¹Oregon Health and Sciences University, Portland, OR, ²Department of Clinical Immunology and Rheumatology and Department of Experimental Immunology, Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands, ³Rheumazentrum Ruhrgebiet, Herne, Germany, ⁴Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Descartes University, Cochin Hospital, Paris, France, ⁶University of Leeds, Leeds, United Kingdom, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Pharma AG, Basel, Switzerland, ⁹Clinical Immunology / Dermatology, Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ankylosing spondylitis (AS) can have a profound negative effect on an individual's physical functioning, health status and quality of life (QoL), affecting the ability…
Abstract Number: 537 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Human Anti–Interleukin-17A Monoclonal Antibody, Significantly Reduces Psoriasis Burden in Patients with Psoriatic Arthritis: Results from a Phase 3 Randomized Controlled Trial
Alice B. Gottlieb¹, Philip J. Mease², Iain B. McInnes³, Bruce Kirkham⁴, Arthur Kavanaugh⁵, Proton Rahman⁶, Peter Nash⁷, Luminita Pricop⁸, Jiacheng Yuan⁹, Hanno Richards¹⁰ and Shephard Mpofu¹¹, ¹Tufts Medical Center, Boston, MA, ²Swedish Medical Center and University of Washington, Seattle, WA, ³University of Glasgow, Glasgow, United Kingdom, ⁴Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom, ⁵UCSD School of Medicine, La Jolla, CA, ⁶Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁷University of Queensland, Brisbane, Australia, ⁸Integrated Hospital Care (IHC) Franchise, Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁹Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁰Clinical Immunology / Dermatology, Novartis Pharma AG, Basel, Switzerland, ¹¹Novartis Pharma AG, Basel, Switzerland
Background/Purpose Reducing the burden of skin manifestations of psoriatic arthritis (PsA) is an important aspect of disease management. Secukinumab, a human anti–IL-17A monoclonal antibody, has…
Abstract Number: 536 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Monoclonal Antibody to Interleukin-17A, Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: Results of a Phase 3, Randomized, Placebo-Controlled Trial with Subcutaneous Loading and Maintenance Dosing
Joachim Sieper¹, Jürgen Braun², Xenofon Baraliakos², Dominique L. Baeten³, Maxime Dougados⁴, Paul Emery⁵, Atul A. Deodhar⁶, Brian Porter⁷, Mats Andersson⁸, Shephard Mpofu⁸ and Hanno Richards⁹, ¹Charité Universitätsmedizin Berlin, Berlin, Germany, ²Rheumazentrum Ruhrgebiet, Herne, Germany, ³Department of Clinical Immunology and Rheumatology and Department of Experimental Immunology, Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands, ⁴INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France., Paris, France, ⁵University of Leeds, Leeds, United Kingdom, ⁶Oregon Health and Sciences University, Portland, OR, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Pharma AG, Basel, Switzerland, ⁹Clinical Immunology / Dermatology, Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Previous data indicate that interleukin (IL)-17, a key pro-inflammatory cytokine, might play a role in the pathogenesis of ankylosing spondylitis (AS). We assessed the…
Abstract Number: L1 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis: 24-Week Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study Using Subcutaneous Dosing
Iain B. McInnes^1,2, Philip J. Mease³, Bruce Kirkham⁴, Arthur Kavanaugh⁵, Christopher T. Ritchlin⁶, Proton Rahman⁷, Désirée van der Heijde⁸, Robert B. M. Landewé⁹, Philip G. Conaghan¹⁰, Hanno Richards¹¹, Gregory Ligozio¹², Luminita Pricop¹³ and Shephard Mpofu¹⁴, ¹University of Glasgow, Glasgow, Scotland, ²University of Glasgow, Glasgow, United Kingdom, ³Swedish Medical Center and University of Washington, Seattle, WA, ⁴Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom, ⁵UC San Diego School of Medicine, La Jolla, CA, ⁶Allergy Immunology & Rheumatology, University of Rochester Medical Center, Rochester, NY, ⁷Memorial University, St John's, NF, Canada, ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹University of Amsterdam and Atrium Medical Center, Amsterdam, Netherlands, ¹⁰University of Leeds, Leeds, United Kingdom, ¹¹Clinical Immunology / Dermatology, Novartis Pharma AG, Basel, Switzerland, ¹²Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹³Integrated Hospital Care (IHC) Franchise, Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁴Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Secukinumab, a human anti–IL-17A monoclonal antibody, has shown efficacy in the treatment of psoriasis in phase 3 studies with subcutaneous (s.c.) dosing as well…
Abstract Number: 1492 • 2014 ACR/ARHP Annual Meeting
Safety and Tolerability of NNC01140006, an Anti-IL-21 Monoclonal Antibody, at Multiple s.c. Dose Levels in Patients with Rheumatoid Arthritis
Frank Wagner¹, Birte Skrumsager² and Sergey Fitilev³, ¹Charité Research Org GmbH, Berlin, Germany, ²Novo Nordisk A/S, Søborg, Denmark, ³Department of Clinical Pharmacology, Municipal Clinic #2, Moscow, Russia
Background/Purpose A phase 1, randomised, double-blind, placebo-controlled, dose-escalation trial was conducted to assess the safety and tolerability of the anti-IL-21-antibody NNC0114-0006, in patients with active…
Abstract Number: 989 • 2014 ACR/ARHP Annual Meeting
Fcgamma Receptor IIb Facilitates Rapid Internalisation of Rituximab (type 1 anti-CD20 antibody) in B Cells from Patients with RA and SLE and Contributes to Less Efficient B Cell Lysis Than Type 2 Anti-CD20 Antibodies, in Vitro
Venkat Reddy¹, Geraldine Cambridge², David A. Isenberg³, Mark Cragg⁴ and Maria J. Leandro², ¹Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom, ²Centre for Rheumatology, Department of Medicine, University College London, London, United Kingdom, ³Centre for Rheumatology Research, Rayne Building, 4th Floor, Centre for Rheumatology, Department of Medicine, University College London, London, United Kingdom, ⁴Antibody and Vaccine group, Cancer Sciences Unit, Faculty of Medicine, Southampton University, Southampton, United Kingdom
Background/Purpose Incomplete B-cell depletion using rituximab (RTX) is associated with poor clinical response in some individuals with RA and SLE, in particular. However, the precise…
Abstract Number: 953 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Human Anti–Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis and Inhibits Radiographic Progression: Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study
Philip J. Mease¹, Iain B. McInnes², Bruce Kirkham³, Arthur Kavanaugh⁴, Proton Rahman⁵, Désirée van der Heijde⁶, Robert Landewé⁷, Peter Nash⁸, Luminita Pricop⁹, Jiacheng Yuan¹⁰, Hanno Richards¹¹ and Shephard Mpofu¹², ¹Swedish Medical Center and University of Washington, Seattle, WA, ²University of Glasgow, Glasgow, United Kingdom, ³Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom, ⁴UCSD School of Medicine, La Jolla, CA, ⁵Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁶Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁷Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands, ⁸University of Queensland, Brisbane, Australia, ⁹Integrated Hospital Care (IHC) Franchise, Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁰Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹¹Clinical Immunology / Dermatology, Novartis Pharma AG, Basel, Switzerland, ¹²Novartis Pharma AG, Basel, Switzerland
Background/Purpose Secukinumab has demonstrated significant and rapid efficacy in the treatment of psoriasis in two phase 3 studies. We present the first randomized, multicenter, double-blind,…

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