Abstracts tagged "monoclonal antibodies"

Abstract Number: 009 • 2020 Pediatric Rheumatology Symposium
Emapalumab (Anti-Interferon-Gamma Monoclonal Antibody) in Patients with Macrophage Activation Syndrome (MAS) Complicating Systemic Juvenile Idiopathic Arthritis (sJIA)
Fabrizio De Benedetti¹, Paul Brogan ², Claudia Bracaglia ¹, Manuela Pardeo ¹, Giulia Marucci ¹, Emanuela Sacco ¹, Despina Eleftheriou ³, Charalampia Papadopoulou ³, Alexei Grom ⁴, Pierre Quartier ⁵, Rayfel Schneider ⁶, Philippe Jacqmin ⁷, Rikke Frederiksen ⁸, Maria Ballabio ⁹ and Cristina de Min ⁸, ¹Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy, ²UCL Institute of Child Health and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom, ³UCL Institute of Child Health, and Great Ormond Street Hospital NHS Foundation Trust, Section Head Infection, Immunology, and Rheumatology, London, United Kingdom, ⁴Cincinnati Children's Hospital Medical Center, Cincinnati, ⁵Paris-Descartes University, IMAGINE Institute, RAISE reference centre, Pediatric Immuno-Hematology and Rheumatology Unit, Necker hospital, Assistance Publique-Hôpitaux de Paris, Paris, France, ⁶The Hospital for Sick Children, Toronto, Canada, ⁷MnS Modelling and Simulation, Dinant, Belgium, ⁸Swedish Orphan Biovitrum AG (Sobi), Basel, Basel-Stadt, Switzerland, ⁹Swedish Orphan Biovitrum AG (Sobi), Basel, Switzerland
Background/Purpose: MAS is a severe complication of rheumatic diseases and occurs most frequently in patients with sJIA. Data from animal models and from observational studies…
Abstract Number: L13 • 2019 ACR/ARP Annual Meeting
Guselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study
Philip J. Mease¹, Proton Rahman ², Alice B. Gottlieb ³, Elizabeth Hsia ⁴, Alexa Kollmeier ⁵, Xie Xu ⁶, Ramanand Subramanian ⁵, Prasheen Agarwal ⁵, Shihong Sheng ⁵, Bei Zhou ⁵, Désirée van der Heijde ⁷ and Iain McInnes ⁸, ¹Swedish Medical Center and University of Washington, Seattle, Washington, ²Memorial University of Newfoundland, Newfoundland, Canada, ³Icahn School of Medicine at Mt Sinai, NY, NY, New York, New York, ⁴Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, Pennsylvania, ⁵Janssen Research & Development, LLC, Spring House, Pennsylvania, ⁶Janssen Research & Development, LLC, Spring House, ⁷Leiden University Medical Center, Leiden, Netherlands, ⁸Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Guselkumab (GUS), an anti-interleukin-23p19 monoclonal antibody, is approved for psoriasis (PsO). We assessed GUS efficacy and safety in DISCOVER-1 (ACR2019 Abstract ID697955) and DISCOVER-2,…
Abstract Number: 1525 • 2019 ACR/ARP Annual Meeting
Safety of Tildrakizumab in Psoriatic Arthritis: An Interim Analysis from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial
Christopher Ritchlin ¹, Vibeke Strand ², Rocco Ballerini ³, Richard C. Chou ⁴, Stephen Rozzo ³, Alan Mendelsohn³ and Arthur Kavanaugh ⁵, ¹Division of Allergy, Immunology and Rheumatology, Center for Musculoskeletal Research, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA, Rochester, NY, ²Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA, Palo Alto, CA, ³Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, ⁴University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA, Buffalo, NY, ⁵University of California, San Diego School of Medicine, La Jolla, CA
Background/Purpose: Tildrakizumab (TIL) is an anti–interleukin-23p19 monoclonal antibody approved by the FDA for treatment of moderate-to-severe plaque psoriasis1,2 and is under investigation for treatment of…
Abstract Number: 1526 • 2019 ACR/ARP Annual Meeting
Efficacy and Safety of Tildrakizumab 100 Mg for Plaque Psoriasis in Patients Randomized to Treatment Continuation vs Treatment Withdrawal with Retreatment upon Relapse in a Phase 3 Study
Wendy Cantrell ¹, Patricia Lee ², Emil Tanghetti ³, Alan Mendelsohn⁴, Jeff Parno ⁴, Stephen Rozzo ⁴ and Wilson Liao ⁵, ¹Department of Dermatology, University of Alabama Birmingham, Birmingham, AL, USA; Dermatology at the Whitaker Clinic, Birmingham, AL, USA, Birmingham, AL, ²Center for Clinical Studies, Webster, TX, USA, Webster, TX, ³Center for Dermatology and Laser Surgery, Sacramento, CA, USA, Sacramento, CA, ⁴Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, ⁵Department of Dermatology, University of California San Francisco, San Francisco, CA, USA, San Francisco, CA
Background/Purpose: We assessed residual plaque psoriasis in patients successfully treated with anti–interleukin-23p19 monoclonal antibody tildrakizumab (TIL) who interrupted treatment, relapsed, and were retreated vs continuously…
Abstract Number: 1527 • 2019 ACR/ARP Annual Meeting
Limited Changes in Hematological Parameters During Tildrakizumab Treatment: Post Hoc Analysis of Data from the Tildrakizumab Psoriasis Clinical Program
Holly Glover ¹, Kristine Kucera ², Alan Mendelsohn³, Jeff Parno ³, Stephen Rozzo ³, Frank Ferritto ⁴ and Renata Block ⁵, ¹Dermatology and Skin Cancer Surgery Center, McKinney, TX, USA, McKinney, TX, ²North Texas Dermatology, Richardson, TX, USA, Richardson, TX, ³Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, ⁴Polley Dermatology, Wilson, NC, USA, Wilson, NC, ⁵Pinski Dermatology & Cosmetic Surgery, Chicago, IL, USA, Chicago, IL
Background/Purpose: Tildrakizumab (TIL) is a high-affinity, anti–interleukin‐23p19 monoclonal antibody with demonstrated efficacy for the treatment of chronic plaque psoriasis in a phase 2b (P05495 [NCT01225731])…
Abstract Number: 2878 • 2019 ACR/ARP Annual Meeting
Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab, a High-Affinity Anti–Interleukin-23P19 Monoclonal Antibody, in Patients with Active Psoriatic Arthritis
Philip Mease¹, Saima Chohan ², Ferran J. García Fructuoso ³, Alice Gottlieb ⁴, Richard C. Chou ⁵, Alan Mendelsohn ⁶, Rocco Ballerini ⁶ and Michael E. Luggen ⁷, ¹Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, ²Arizona Arthritis and Rheumatology Research, PLLC, Phoenix, AZ, USA, Phoenix, AZ, ³Hospital CIMA Sanitas, Barcelona, Spain, Barcelona, Spain, ⁴Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York City, NY, ⁵University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA, Buffalo, NY, ⁶Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, ⁷Cincinnati Rheumatic Disease Study Group, Inc. and University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati, OH
Background/Purpose: Tildrakizumab (TIL), a high-affinity anti–interleukin-23p19 monoclonal antibody, is approved for moderate-to-severe plaque psoriasis treatment and is under investigation for PsA. This study evaluated the…
Abstract Number: 532 • 2019 ACR/ARP Annual Meeting
A Phase 2 Study of E6011, an Anti-Fractalkine Monoclonal Antibody, ㏌ Patients with Rheumatoid Arthritis Inadequately Responding to Biologics
Yoshiya Tanaka¹, Tsutomu Takeuchi ², Hisashi Yamanaka ³, Toshihiro Nanki ⁴, Hisanori Umehara ⁵, Nobuyuki Yasuda ⁶, Fumitoshi Tago ⁷, Yasumi Kitahara ⁸, Makoto Kawakubo ⁷, Hayato Hisaki ⁸, Seiichiro Hojo ⁸, Tetsu Kawano ⁶ and Toshio Imai ⁶, ¹University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ²Keio University School of Medicine, Tokyo, Japan, ³Sanno Medical Center, Minato-ku, Tokyo, Japan, ⁴Division of Rheumatology, Department of Internal Medicine, School of Medicine, Faculty of Medicine, Toho University, Tokyo, Japan, ⁵Nagahama City Hospital / Division of Rheumatology and Immunology, Nagahama, Japan, ⁶KAN Research Institute, Inc., Kobe, Japan, ⁷Eisai Co., Ltd., Tokyo, Japan, ⁸Eisai Co., Ltd., Bunkyo-ku, Japan
Background/Purpose: Fractalkine (CX3CL1, designated as FKN hereafter) is the sole member of the CX3C-chemokine which leads to dual actions, chemotaxis and cell adhesion for leukocytes…
Abstract Number: 1410 • 2019 ACR/ARP Annual Meeting
Cycling of Tumor Necrosis Factor-α (TNF-α) Inhibitors versus Switching to Different Μechanism of Αction in Rheumatoid Arthritis Patients with Inadequate Response to TNF-α Inhibitor: A Bayesian Network Meta-analysis
Alberto Migliore¹, Giuseppe Pompilio ², Davide Integlia ², Joe Zhuo ³ and Evo Alemao ⁴, ¹Unit of Rheumatology Ospedale S. Pietro Fatebenefratelli, Rome, Italy, ²Isheo Srl, Rome, Italy, ³Bristol-Myers Squibb, Princeton, NJ, ⁴Bristol-Myers Squibb, Princeton
Background/Purpose: TNF inhibitors are a common treatment for rheumatoid arthritis (RA), but there is no best practice for when a specific TNF inhibitor stops working1.…
Abstract Number: 1523 • 2019 ACR/ARP Annual Meeting
Impact of Body Weight on Efficacy of Tildrakizumab in Moderate-to-Severe Plaque Psoriasis
Alan Menter ¹, Zoe Draelos ², Jayme Heim ³, Jeff Parno ⁴, Alan Mendelsohn⁴, Stephen Rozzo ⁴ and Christopher Griffiths ⁵, ¹Division of Dermatology, Baylor Scott & White, and Texas A&M College of Medicine, Dallas, TX, USA, Dallas, TX, ²Dermatology Consulting Services, High Point, NC, USA, High Point, NC, ³West Michigan Dermatology, Holland, MI, USA, Holland, MI, ⁴Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, ⁵Centre for Dermatology Research, The University of Manchester, Manchester, UK, Manchester, United Kingdom
Background/Purpose: Tildrakizumab (TIL) is a high-affinity, anti–interleukin‐23p19 monoclonal antibody approved for the treatment of moderate-to-severe chronic plaque psoriasis. An inverse efficacy–body weight relationship has been…
Abstract Number: 1524 • 2019 ACR/ARP Annual Meeting
Tildrakizumab Efficacy on Psoriasis in Patients with Psoriatic Arthritis—An Analysis from a Phase 2 Study
Alice Gottlieb ¹, Ana-Maria Orbai ², Rocco Ballerini ³, Richard C. Chou ⁴, Stephen Rozzo ³, Alan Mendelsohn³ and Luis R. Espinoza ⁵, ¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York City, NY, ²Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ³Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, ⁴University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA, Buffalo, NY, ⁵Section of Rheumatology, LSU Health Sciences Center, New Orleans, LA, New Orleans, LA
Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody approved by the FDA to treat moderate-to-severe plaque psoriasis. A randomized, double-blind, multidose, placebo-controlled, phase 2b…
Abstract Number: L20 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of Subcutaneous Tanezumab for the Treatment of Osteoarthritis of the Hip or Knee
Thomas J. Schnitzer¹, Richard Easton², Shirley Pang³, Dennis Levinson⁴, Glenn Pixton⁵, Lars Viktrup⁶, Isabelle Davignon⁷, Mark T. Brown⁷, Kenneth M. Verburg⁷ and Christine R. West⁷, ¹Northwestern University, Chicago, IL, ²Michigan Orthopaedic & Spine Surgeons, Rochester Hills, MI, ³St. Jude Medical Center, Fullerton, CA, ⁴Chicago Clinical Research Institute, Chicago, IL, ⁵Pfizer, Inc., Morrisville, NC, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Pfizer, Inc., Groton, CT
Background/Purpose: Tanezumab is a humanized mAb that blocks nerve growth factor (NGF) and is in clinical development for chronic pain treatment. Tanezumab administered intravenously has…
Abstract Number: 1111 • 2018 ACR/ARHP Annual Meeting
CBS004, a Novel Monoclonal Antibody Against Bdca-2 Inhibits TLR-Induced Activation of Human pDC in Vitro and In Vivo. a Novel Therapeutic Target for Systemic Sclerosis
Clarissa Corinaldesi¹, Yasser M El-Sherbiny², Gemma Migneco³, Rebecca Ross¹, Steve Holmes⁴, Clive McKimmie⁵ and Francesco Del Galdo¹, ¹Leeds Biomedical Research Centre and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ²NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals, NHS Trust, Leeds, United Kingdom, ³Institute of Cancer and Pathology, University of Leeds, Leeds, United Kingdom, ⁴Capella Biosciences, LTD, London, United Kingdom, ⁵Virus Host Interactions Team, Section of Infection and Immunity, University of Leeds, Leeds, United Kingdom
Background/Purpose: Human plasmacytoid dendritic cells (pDCs) have been implicated in the pathogenesis of Systemic Sclerosis (SSc) through their ability to infiltrate the skin and secrete…
Abstract Number: 1574 • 2018 ACR/ARHP Annual Meeting
Autoantibodies Present in Saliva from Sjogren’s Syndrome and Non-Sjogren’s Sicca Patients Are Not Detectible in Serum
Kristi A. Koelsch^1,2,3, Joshua Cavett^3,4, Kenneth Smith³, Jacen Maier-Moore⁵, Astrid Rasmussen³, David M. Lewis⁶, Lida Radfar⁷, Biji T. Kurien^2,4,8, Judith A. James^3,9, Kathy L. Sivils¹⁰, A. Darise Farris¹¹ and R. Hal Scofield^2,11,12, ¹Section of Endocrinology and Diabetes, University of Oklahoma Health Sciences Center, Okalahoma City, OK, ²U.S. Department of Veterans Affairs Medical Center, Oklahoma City, OK, ³Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴College of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, ⁵Clinical Laboratory Science, University of Texas at El Paso, El Paso, TX, ⁶Department of Oral and Maxillofacial Pathology, University of Oklahoma College of Dentistry, Oklahoma City, OK, ⁷Department of Oral Diagnosis and Radiology, University of Oklahoma College of Dentistry, Oklahoma City, OK, ⁸Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁹University of Oklahoma Health Sciences Center, Oklahoma City, OK, ¹⁰Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma, OK, ¹¹Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ¹²Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Background/Purpose: There is evidence for B cell involvement in the pathogenesis of Sjögren’s syndrome by the presence of autoantigen-specific B cells. Autoantibodies toward Ro/SSA and…
Abstract Number: 2525 • 2018 ACR/ARHP Annual Meeting
Correlation Analysis between Sirukumab Exposure and Selected Safety Events Following Subcutaneous Administration Using Pooled Phase 3 Data in Rheumatoid Arthritis
Yan Xu¹, Yanli Zhuang¹, Chuanpu Hu¹, Benjamin Hsu², Zhenhua Xu¹, Amarnath Sharma¹ and Honghui Zhou¹, ¹Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, ²Immunology Clinical Development, Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: To characterize the exposure-response (ER) relationship between systemic exposure to sirukumab (an anti- interleukin-6 [IL-6] human monoclonal antibody) and the occurrence of selected safety…
Abstract Number: 2626 • 2018 ACR/ARHP Annual Meeting
Normalization of CRP Levels and Clinical Response to Ixekizumab in Patients with Psoriatic Arthritis: Results from the Spirit Studies
Bernard Combe¹, Paul Emery², Annelies Boonen³, Soyi Liu Leage⁴, Christophe Sapin⁴, Natalia Bello⁵ and Maxime Dougados⁶, ¹CHU, Montpellier University, Montpelier, France, Montpellier, France, ²Leeds Musculoskeletal Biomedical Research Unit, LTHT Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK, Leeds, United Kingdom, ³Division of Rheumatology, Maastricht University, School for Public Health and Primary Care, Maastricht University Medical Centre, The Netherlands, Maastricht, Netherlands, ⁴Lilly France, Neuilly sur Seine Cedex, France, Neuilly sur Seine Cedex, France, ⁵Eli Lilly and Company (Spain), Alcobendas, Spain, Alcobendas, Spain, ⁶Rheumatology Department, Cochin Hospital, AP-HP, Paris Descartes University, Paris, France, Paris, France
Background/Purpose: It is important to understand the association between early changes in inflammatory biomarkers and treatment response at later times after initiation of a biologic…

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