Abstracts tagged "Biologics"

Abstract Number: 94 • 2014 ACR/ARHP Annual Meeting
Possible Effects of Medicare-Only Insurance Coverage on the Use of Biologics in Patients with RA
Marcia Genta, Dallas Arthritis Center, Dallas, TX
Background/Purpose: Biologics, a relatively new widely used class of medication that can substantially improve the course of RA, are expensive and their use is not…
Abstract Number: 2472 • 2014 ACR/ARHP Annual Meeting
The First, Multicenter, Double-Blind, Randomized, Parallel-Group Study of Certolizumab Pegol in Early Rheumatoid Arthritis Demonstrates Inhibition of Joint Damage Progression
Tatsuya Atsumi¹, Kazuhiko Yamamoto², Tsutomu Takeuchi³, Hisashi Yamanaka⁴, Naoki Ishiguro⁵, Yoshiya Tanaka⁶, Katsumi Eguchi⁷, Akira Watanabe⁸, Hideki Origasa⁹, Toshiharu Shoji¹⁰, Osamu Togo¹¹, Toshiyuki Okada¹², Désirée M. van der Heijde¹³, Nobuyuki Miyasaka¹⁴ and Takao Koike^15,16, ¹Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, ²Department of Allergy and Rheumatology, The University of Tokyo, Tokyo, Japan, ³Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Kitakyushu, Japan, ⁴Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ⁵Department of orthopedics, Nagoya University Graduate School and Faculty of Medicine, Nagoya, Japan, ⁶The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ⁷Department of Rheumatology, Sasebo City General Hospital, Nagasaki, Japan, ⁸Division of Rheumatology, Department of Internal Medicine, School of Medicine, Tohoku University, Tokyo, Japan, ⁹Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Japan, ¹⁰Department of Clinical Research and Development, UCB Pharma, Tokyo, Japan, ¹¹Biometrics Group, UCB Pharma, Tokyo, Japan, ¹²Astellas Pharma Inc, Tokyo, Japan, ¹³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ¹⁴Department of Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan, ¹⁵NTT Sapporo Medical Center, Sapporo, Japan, ¹⁶Hokkaido University Graduate School of Medicine, Sapporo, Japan
Background/Purpose The efficacy and safety of certolizumab pegol (CZP)+methotrexate (MTX) therapy compared to MTX alone, in Japanese MTX-naïve early rheumatoid arthritis (RA) patients (pts) with…
Abstract Number: 1556 • 2014 ACR/ARHP Annual Meeting
Integrated Safety of Ustekinumab in Psoriatic Arthritis: 2 Year Follow-up from the Psoriatic Arthritis Clinical Development Program
Arthur Kavanaugh¹, Iain B. McInnes², Christopher T. Ritchlin³, Proton Rahman⁴, Lluís Puig Sanz⁵, Alice B. Gottlieb⁶, Michael Song⁷, Bruce Randazzo⁷, Shu Li⁷, Yin You⁷ and Alan M. Mendelsohn⁸, ¹University of California San Diego, La Jolla, CA, ²University of Glasgow, Glasgow, United Kingdom, ³Allergy Immunology & Rheumatology, University of Rochester Medical Center, Rochester, NY, ⁴Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁵Dermatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, ⁶Tufts Medical Center, Boston, MA, ⁷Janssen Research & Development, LLC., Spring House, PA, ⁸Immunology, Janssen Research & Development, LLC., Spring House, PA
Background/Purpose: To report the safety of ustekinumab(UST) from the psoriatic arthritis (PsA)development program. Methods: Safety data through up to 2yrs of follow-up were pooled from…
Abstract Number: 1040 • 2014 ACR/ARHP Annual Meeting
Dysregulated Serum Interleukin 16 Concentration Associated with Clinical Disease Activity in Patients with Rheumatoid Arthritis Is Efficiently Corrected By Immunological Intervention
Atsuko Murota¹, Katsuya Suzuki¹, Yoshiaki Kassai², Takahiro Miyazaki³, Rimpei Morita⁴, Akihiko Yoshimura⁴ and Tsutomu Takeuchi¹, ¹Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ²Takeda Pharmaceutical Company, Fujisawa, Japan, ³Inflammation Drug Discovery Unit, Takeda Pharmaceutical Company Limited, Kanagawa, Japan, ⁴Department of Microbiology and Immunology, Keio University School of Medicine, Tokyo, Japan
Background/Purpose: IL-16 is a chemoattractant factor that evokes massive infiltration of mononuclear cells in the synovial tissue in patients rheumatoid arthritis (RA). IL-16 concentrations are…
Abstract Number: 57 • 2014 ACR/ARHP Annual Meeting
Risk of Hospitalized Infection in a Psoriasis/Psoriatic Arthritis Cohort
Kevin L. Winthrop¹, Lang Chen², John Baddley², Allison Taylor³, Benjamin Chan⁴, Huifeng Yun⁵, Sarah Siegel⁶ and Jeffrey R. Curtis⁷, ¹Dept of Infectious Disease, Oregon Health & Science University, Portland, OR, ²Medicine, University of Alabama at Birmingham, Birmingham, AL, ³Clinical Immunology/Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ⁴Oregon Health and Science University, Portland, OR, ⁵Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, AL, ⁶Oregon Health & Science University, Portland, OR, ⁷The University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Psoriasis (PsO)/Psoriatic arthritis (PsA) often requires treatment with systemic immunosuppressive agents, some of which may increase hospitalized infection risk. Few population-based studies to date…
Abstract Number: 2467 • 2014 ACR/ARHP Annual Meeting
Effectiveness and Safety of Tocilizumab in Biologics NaÃ¯ve RA Patients – Interim Analysis of PMS for Investigating Success in Achieving Clinical and Functional Remission and Sustaining Efficacy with Tocilizumab in Biologics-NaÃ¯ve RA Patients Study
Naoki Ishiguro¹, Tatsuya Atsumi², Masayoshi Harigai³, Tsuneyo Mimori⁴, Norihiro Nishimoto⁵, Takayuki Sumida⁶, Tsutomu Takeuchi⁷, Yoshiya Tanaka⁸, Nobuhiro Takagi⁹, Kunihiko Tanaka¹⁰ and Hisashi Yamanaka¹¹, ¹Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, ²Medicine II School of Medicine, Hokkaido University, Sapporo, Japan, ³Department of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, ⁴Dept of Rheum & Clinical Immunology, Kyoto Univ Grad Schl of Med, Kyoto, Japan, ⁵Department of Molecular Regulation for Intractable Diseases, Institute of Medical Science, Tokyo Medical University, Osaka, Japan, ⁶Dept Internal Medicine, Univ of Tsukuba/Inst Clin Med, Tsukuba City, Japan, ⁷Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan, ⁸First Dept of Internal Med, U Occupa & Environ Hlth, Kitakyushu, Japan, ⁹Medical Science, Chugai Pharmaceutical, Tokyo, Japan, ¹⁰Pharmacovigilance, Chugai Pharmaceutical, Tokyo, Japan, ¹¹Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan
Background/Purpose: The all-patient PMS study of tocilizumab (TCZ) followed 7901 RA patients for 28 wks. That study (hereafter, PMS7901) showed patients with a high probability…
Abstract Number: 1527 • 2014 ACR/ARHP Annual Meeting
Efficacy of Biologic Treatments in Early Active Rheumatoid Arthritis: An Indirect Comparison
Laura Sawyer¹, Stacey Chang¹, Alex Diamantopoulos² and Fred Dejonckheere³, ¹Symmetron Limited, London, United Kingdom, ²Symmetron Limited, Herts, United Kingdom, ³F. Hoffmann-La Roche, Basel, Switzerland
Background/Purpose: To date, no head-to-head trials have been conducted comparing the efficacy of biologic treatments for early active rheumatoid arthritis (ERA). Here, we evaluated the…
Abstract Number: 941 • 2014 ACR/ARHP Annual Meeting
Biologic De-Escalation in Rheumatoid Arthritis: Cost Savings and Clinical Success
Tarun S. Sharma¹, Lyudmila Kirillova², Andrea Berger³ and Eric D. Newman⁴, ¹Rheumatology, Geisinger Medical Center, Danville, PA, ²Rheumatology, Geisinger Health System, Danville, PA, ³Center for Health Research, Geisinger Health System, Danville, PA, ⁴Department of Rheumatology, Geisinger Health System, Danville, PA
Background/Purpose: Economic considerations and clinical risks of prolonged biologic use in Rheumatoid Arthritis (RA) have emerged as concerns. In this study, we measured the clinical…
Abstract Number: L2 • 2014 ACR/ARHP Annual Meeting
A Comparison of Three Treatment Strategies in Recent Onset DMARD Naïve Juvenile Idiopathic Arthritis: 3-Months Results of the BeSt for Kids-Study
Petra C.E. Hissink Muller^1,2, D.M.C. Brinkman^1,3, Dieneke Schonenberg⁴, Yvonne Koopman-Keemink⁵, J. Merlijn Van den Berg⁶, W.P. Bekkering⁷, Marion van Rossum^8,9, Lisette WA van Suijlekom-Smit¹⁰, Cornelia F. Allaart¹¹ and Rebecca ten Cate¹, ¹Pediatric Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²Pediatric Rheumatology, Reade, Amsterdam, Netherlands, ³Pediatric Rheumatology, Rijnland Hospital, Leiderdorp, Netherlands, ⁴Department of Pediatric Rheumatology and Immunology, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands, ⁵Pediatrics, Haga ziekenhuis, The Hague, Netherlands, ⁶Pediatric Hematology, Immunology and Infectious diseases, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands, ⁷Pediatric Physiotherapy, Leiden University Medical Center, Leiden, Netherlands, ⁸Pediatric Rheumatology Immunology, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands, ⁹Reade, Amsterdam, Netherlands, ¹⁰Pediatric Rheumatology, Sophia Children's Hospital Erasmus Medical Center, Rotterdam, Netherlands, ¹¹Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: BeSt for Kids compares 3 Disease Modifying Anti Rheumatic Drug (DMARD) strategies in juvenile idiopathic arthritis (JIA) patients, for time to inactive disease, time…
Abstract Number: 2397 • 2014 ACR/ARHP Annual Meeting
Improvement of Fatigue in Patients with Rheumatoid Arthritis Treated with Biologics: Relationship with Sleep Disorders, Depression and Clinical Efficacy. a Prospective, Multicenter Study
Marlène Genty¹, Marie Kostine², Elodie Ardouin³, Bernard Combe⁴ and Cédric Lukas⁵, ¹RHEUMATOLOGY, CHU LAPEYRONIE, MONTPELLIER, France, ²Rheumatology, CHU Pellegrin, Bordeaux, France, ³Rheumatology, Limoges University Hospital, Limoges, France, ⁴Immuno-Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ⁵Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France
Background/Purpose The functional burden of disease in Rheumatoid arthritis (RA) patients, mainly caused by inflamed joints, is often worsened by extra-articular manifestations, among which asthenia remains…
Abstract Number: 1525 • 2014 ACR/ARHP Annual Meeting
Cumulative Clinical Â Response in Â RheumatoidÂ Arthritis Patients with Â Rituximab Repeated Courses after Failure to TumorÂ Necrosis Factor Inhibitors in RoutineÂ Clinical Practice Â
Catalin Codreanu¹, Ruxandra Ionescu², Ioan Ancuta³, Corina Mogosan⁴, Simona Rednic⁵, Paulina Ciurea⁶, Maria Suta⁷, Magda Parvu⁸, Andra Balanescu², Mihai Bojinca³, Dan Nemes⁹, Codrina Ancuta¹⁰ and Elena Rezus¹¹, ¹5 Thomas Masaryk Street, 'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, ²Rheumatology, Sfanta Maria Clinical Hospital, UMF Carol Davila, Bucharest, Romania, ³Internal Medicine and Rheumatology, Carol Davila University of Medicine and Pharmacy & Cantacuzino Hospital, Bucharest, Romania, ⁴'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, ⁵Rheumatology, University of Medicine and Pharmacy, Cluj-Napoca, Romania, ⁶Clinical County Hospital,Craiova, Craiova, Romania, ⁷317 Tomis Str. , Bl. 4A, ap. 3, Constanta Municipal Hospital, Constanta, Romania, ⁸Rheumatology, Colentina Clinical Hospital, Bucuresti, Romania, ⁹Rehabilitation and Rheumatology, ”Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania, ¹⁰G.T.Popa Center for Biomedical Research, Iasi, Romania, ¹¹Rheumatology, Recovering Clinical Hospital, Iasi, Romania
Background/Purpose The concept of achieving tight control of rheumatoid arthritis (RA) and treating to target has been well established. It focuses on early diagnosis, aggressive…
Abstract Number: 933 • 2014 ACR/ARHP Annual Meeting
A Multi-Center, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab in Pediatric Patients with Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy: Week 48 Results
Hermine I. Brunner¹, Nicolino Ruperto², N Tzaribachev³, Gerd Horneff⁴, Carine Wouters⁵, Violeta Vladislava Panaviene⁶, Vyacheslav Chasnyk⁷, Carlos Abud-Mendoza⁸, Ruben Cuttica⁹, Andreas Reiff¹⁰, M Maldonado-Velázquez¹, Nadina Rubio-Pérez¹¹, Rik Joos¹², V Keltsev¹³, Evgeny Nasonov¹⁴, Daniel Kingsbury¹⁵, M Bandeira¹⁶, Earl Silverman¹⁷, F Weller-Heinemann¹¹, A van Royen-Kerkhof¹⁸, Alan M. Mendelsohn¹⁹, Lilianne Kim²⁰, Daniel Lovell²¹ and A Martini²², ¹PRCSG, Cincinnati, OH, ²Pediatria II,, Istituto Giannina Gaslini, Genoa, Italy, ³PRINTO & PRCSG, Bramstedt, Germany, ⁴Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany, ⁵Pediatric Rheumatology, University Hosp Gasthuisberg, Leuven, Belgium, ⁶Istituto Giannina Gaslini, Genoa, Italy, ⁷Litovskaya Str., 2, Novartis Pharma, Saint-Peterburg, Russia, ⁸Unidad de Investigaciones Reumatológicas, Hospital Central & Facultad de Medicina, Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, ⁹Tilcara 3023, Hospital de Ninos Pedro de Elizalde, Capital Federal, Argentina, ¹⁰Children’s Hospital of Los Angeles, Los Angeles, CA, ¹¹PRINTO, Genoa, Italy, ¹²UZ Gent, Gent, Belgium, ¹³Paediatric Rheumatology International Trials Organisation–IRCCS [PRINTO], Genoa, Italy, ¹⁴State Institute of Rheumatology of RAMS, Moscow, Russia, ¹⁵Pediatric Rheumatology, Randall Children's Hospital at Legacy Emanuel, Portland, OR, ¹⁶Pediatrics, Hospital Infantil Pequeno Príncipe, Curitiba, Brazil, ¹⁷Division of Rheumatology, Hosp for Sick Children, Toronto, ON, Canada, ¹⁸Department of Pediatric Immunology & Rheumatology, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, Netherlands, ¹⁹Immunology, Janssen Research & Development, LLC., Spring House, PA, ²⁰Janssen Research & Development, LLC., Spring House, PA, ²¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati, Cincinnati, OH, ²²Istituto Gaslini-PRINTO, Genova, Italy
Background/Purpose: To assess efficacy and safety of SC golimumab (GLM) in polyarticular pediatric juvenile idiopathic arthritis pts (aged 2 to
Abstract Number: 324 • 2013 ACR/ARHP Annual Meeting
Long-Term Safety Of Ustekinumab: 5 Years Of Follow-Up From The Psoriasis Clinical Development Program Including Patients With Psoriatic Arthritis
Kim Papp¹, Christopher E.M Griffiths², Kenneth B. Gordon³, Mark Lebwohl⁴, Philippe O. Szapary⁵, Yasmine Wasfi⁵, Daphne Chan⁵, Yaung-Kaung Shen⁵, Vincent Ho⁶, Pierre-Dominique Ghislain⁷, Bruce Strober⁸ and Kristian Reich⁹, ¹Probity Research, Waterloo, ON, Canada, ²Dermatology Centre, University of Manchester, Manchester, United Kingdom, ³Feinberg School of Medicine, Northwestern University, Chicago, IL, ⁴Mount Sinai Medical Center, New York, NY, ⁵Janssen Research & Development, LLC., Spring House, PA, ⁶University of British Columbia, Vancouver, BC, Canada, ⁷7. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain,, Brussels, Belgium, ⁸University of Connecticut, Farmington, CT, ⁹SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany
Background/Purpose: Ustekinumab(UST) is approved for moderate-to-severe psoriasis (PsO), and is currently in Phase 3 development for psoriatic arthritis (PsA). We report the long-term safety experience…
Abstract Number: 2325 • 2013 ACR/ARHP Annual Meeting
Final 5-Year Safety and Efficacy Results Of a Phase 3, Randomized, Placebo-Controlled Trial Of Golimumab In Patients With Active Rheumatoid Arthritis Despite Previous Anti-Tumor Necrosis Factor Therapy
Josef S. Smolen¹, Jonathan Kay², Robert Landewé³, Eric L. Matteson⁴, Norman B. Gaylis⁵, Jürgen Wollenhaupt⁶, Frederick T. Murphy⁷, Chenglong Han⁸, Timothy A. Gathany⁸, Stephen Xu⁹, Yiying Zhou¹⁰, Elizabeth C. Hsia⁹ and Mittie K. Doyle⁹, ¹Division of Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria, ²Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, ³Clinical Immunology & Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center, Heerlen, Netherlands, ⁴Rheumatology, Mayo Clinic, Rochester, MN, ⁵Arthritis & Rheumatic Disease Specialties, Aventura, FL, ⁶Schön Klinik Hamburg-Eilbek, Hamburg, Germany, ⁷Altoona Ctr for Clinical Research, Duncansville, PA, ⁸Janssen Global Services, LLC., Malvern, PA, ⁹Janssen Research & Development, LLC., Spring House, PA, ¹⁰Biostatistics, Janssen Research & Development, LLC., Spring House, PA
Background/Purpose: GO-AFTER was the first multicenter, randomized, placebo (PBO)-controlled trial of the safety/efficacy of an anti-TNFα agent, GLM, in pts with active RA despite prior…
Abstract Number: 1534 • 2013 ACR/ARHP Annual Meeting
Safety and Efficacy Of Golimumab, a Human Anti-Tumor Necrosis Factor Monoclonal Antibody Injected Subcutaneously Every 4 Weeks, In Chinese Patients With Active Ankylosing Spondylitis: 1-Year Results Of a Phase 3, Randomized, Placebo-Controlled Study
Chunde Bao¹, Feng Huang², Muhammad Asim Khan³, Kaiyin Fei⁴, Zhong Wu⁴, Yanli Zhuang⁴, Timothy A. Gathany⁵, Chenglong Han⁵ and Elizabeth C. Hsia⁴, ¹Shanghai Institute of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, ²Dept of Rheumatology, Chinese PLA General Hospital, Beijing, China, ³Medicine/ Rheumatology, Case Western Reserve University Hospital, Cleveland, OH, ⁴Janssen Research & Development, LLC., Spring House, PA, ⁵Janssen Global Services, LLC., Malvern, PA
Background/Purpose: A multicenter, randomized, placebo (PBO)-controlled study of golimumab (GLM) was performed in Chinese pts with ankylosing spondylitis (AS). To assess efficacy and safety of…

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