Abstracts tagged "Biologics"

Abstract Number: 3225 • 2016 ACR/ARHP Annual Meeting
Dual Cytokine Inhibition with ABT-122, a Tnf– and IL-17–Targeted Dual Variable Domain Immunoglobulin (DVD-Ig™): Results from a 24-Week Open-Label Extension Study in Patients with Rheumatoid Arthritis
Mark C. Genovese¹, Michael Weinblatt², Heikki T. Mansikka³, Paul M. Peloso³, Kun Chen³, Yihan Li³, John Liu³ and Robert J. Padley³, ¹Stanford University Medical Center, Palo Alto, CA, ²Brigham and Women’s Hospital, Boston, MA, ³AbbVie Inc., North Chicago, IL
Background/Purpose: ABT-122 is a dual variable domain immunoglobulin (DVD-Ig™) that targets human tumor necrosis factor-α (TNF-α) and interleukin-17A (IL-17A). The object was to investigate the…
Abstract Number: 607 • 2016 ACR/ARHP Annual Meeting
The Clinical Response to Biologic and Non-Biologic Disease Modifying Antirheumatic Drugs (DMARDs) According to Gender in a French-Canadian Population with Rheumatoid Arthritis (RA)
Sonia Lagacé¹, Louis Bessette^2,3, Louis Coupal⁴ and Denis Choquette⁴, ¹Medicine, Laval University, Quebec, QC, Canada, ²Rheumatology, Laval University, Québec, QC, Canada, ³Rhumatologie, CHU de Québec - Université Laval, Quebec, QC, Canada, ⁴Rheumatology, Institut de Recherche en Rhumatologie de Montréal (IRRM), Montréal, QC, Canada
Background/Purpose: Several studies have reported that women with RA had higher level of pain, disease activity and functional impairment compared to men. In addition, women…
Abstract Number: 1634 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Chang-Hee Suh¹, Alfredo Berrocal Kasay², Elias Chalouhi El-Khouri³, Pedro Miranda⁴, Ljubinka Bozic Majstorovic⁵, Slawomir Jeka⁶, Pawel Hrycaj⁷, Dmytro Rekalov⁸, Piotr Wiland⁹, Andreas Krause¹⁰, Istvan Szombati¹¹, Anna Mihailova¹², Ihor Hospodarskyy¹³, Mariusz Piotrowski¹⁴, Seong-Ryul Kwon¹⁵, Eun-Young Lee¹⁶, Dae-Hyun Yoo¹⁷, Won Park¹⁸, Seung-Cheol Shim¹⁹, Sang-Joon Lee²⁰ and Taek S. Kwon²⁰, ¹Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, ²ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, ³Clinica Internacional, Lima, Peru, ⁴Centro De Estudios Reumatológicos, Santiago, Chile, ⁵Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, ⁶Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, ⁷Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, ⁸Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, ⁹Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, ¹⁰Medical Centre for Rheumatology Berlin-Buch, Immanuel Krankenhaus Berlin, Berlin, Germany, ¹¹QUALICLINIC Kft., Budapest, Hungary, ¹²Orto clinic Ltd., Riga, Latvia, ¹³Ternopil State Medical University, Ternopil, Ukraine, ¹⁴Rheumatology and Connective Tissue Diseases, Medical University of Lublin, Poland, Lublin, Poland, ¹⁵Internal Medicine/Rheumatology, Inha University Hospital, Incheon, South Korea, ¹⁶Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, The Republic of, ¹⁷Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ¹⁸Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ¹⁹Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ²⁰CELLTRION, Inc., Incheon, South Korea
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Result from Phase 3…
Abstract Number: 2592 • 2016 ACR/ARHP Annual Meeting
The Impact of Biologic Therapy Introduction on Hip and Knee Replacement Among Rheumatoid Arthritis Patients: An Interrupted Time Series Analysis Using the Clinical Practice Research Datalink
Samuel Hawley¹, René Cordtz², Lene Dreyer³, Christopher J. Edwards⁴, Nigel K Arden⁵, Antonella Delmestri⁵, Cyrus Cooper^1,6, Andrew Judge⁵ and Daniel Prieto-Alhambra⁷, ¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, ²Dept. of Rheumatology/C, Copenhagen University Hospital Gentofte, Hellerup, Denmark, ³Internal Medicine - Rheumatology Section, Copenhagen University Hospital at Gentofte, Copenhagen, Denmark, ⁴University of Southampton, Southampton, United Kingdom, ⁵Oxford NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, ⁶Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom, ⁷Internal Medicine and Primary Care, URFOA-IMIM, Parc de Salut Mar; Idiap Jordi Gol i Gurina-Institut Català de la Salut; Oxford NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK, Barcelona, Spain
Background/Purpose: In several developed countries it has been observed that the incidence of orthopaedic surgery among rheumatoid arthritis (RA) patients has been in decline, despite…
Abstract Number: 609 • 2016 ACR/ARHP Annual Meeting
Economic Impact of Adalimumab Treatment in Japanese Patients with Rheumatoid Arthritis from the Anouveau Study (Clinicaltrial.gov: NCT01346488)
Yoshiya Tanaka¹, Kiyotaka Yamazaki², Ryo Nakajima², Shuichi Komatsu³, Naoki Agata⁴, Ataru Igarashi⁵, Toshiro Tango⁶ and Tsutomu Takeuchi⁷, ¹University of Occupational and Environmental Health, Kitakyushu, Japan, ²Post Marketing Study Group, Medical, AbbVie GK, Tokyo, Japan, ³Scientific Project Manager Group, Medical, AbbVie GK, Tokyo, Japan, ⁴Medical Communication, Medical, AbbVie GK, Tokyo, Japan, ⁵Department of Drug Policy & Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan, ⁶Center for Medical Statistics, Tokyo, Japan, ⁷Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan
Background/Purpose: Patients with Rheumatoid Arthritis (RA) experience loss of productivity such as missing their work and lowering their performance incurred by impaired physical functioning. Treatment…
Abstract Number: 1635 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Dae-Hyun Yoo¹, Ljubinka Bozic Majstorovic², Alfredo Berrocal Kasay³, Elias Chalouhi El-Khouri⁴, Fedra Irazoque-Palazuelos⁵, Francisco Cons Molina⁶, Pedro Miranda⁷, Pavel Shesternya⁸, Francisco G. Medina-Rodriguez⁹, Piotr Wiland¹⁰, Slawomir Jeka¹¹, Olena Garmish¹², Pawel Hrycaj¹³, Dmytro Rekalov¹⁴, Natalia Fomina¹⁵, Devy Zisman¹⁶, Yong-Beom Park¹⁷, Young Mo Kang¹⁸, Chang-Hee Suh¹⁹, Seung Cheol Shim²⁰, Sang Joon Lee²¹, Sung Young Lee²² and Won Park²³, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, ³ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, ⁴Clinica Internacional, Lima, Peru, ⁵Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, ⁶Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁷Centro De Estudios Reumatológicos, Santiago, Chile, ⁸State Budgetary Educational Institution of High Professional Education "Krasnoyarsk state medical university n.a. professor V.F.Voino-Yasenetsky" Ministry of Health of Russian Federation, Krasnoyarsk, Russian Federation, ⁹Biologics Especializados SA, Mexico City, Mexico, ¹⁰Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, ¹¹Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, ¹²Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, ¹³Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, ¹⁴Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, ¹⁵Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, ¹⁶The Lady Davis, Haifa, Israel, ¹⁷Dept of Internal Medicine, Severance Hospital, Seoul, Korea, The Republic of, ¹⁸Division of Rheumatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea, Republic of, ¹⁹Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, ²⁰Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ²¹CELLTRION, Inc., Incheon, South Korea, ²²Clinical Planning Department, CELLTRION, Inc., Incheon, South Korea, ²³Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea
Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Result from Phase 3 Randomized Controlled Trial over 24…
Abstract Number: 2610 • 2016 ACR/ARHP Annual Meeting
Immunogenicity Assessment of Biologics in Clinical Studies in Chronic Inflammatory Disease: A Systematic Review
Boris Gorovits¹, Daniel Baltrukonis², Indranil Bhattacharya³, Mary A Birchler⁴, Deborah Finco², Daniel Sikema⁴, Michael S Vincent⁵, Sadiq Lula⁶, Lisa Marshall⁷ and Timothy Hickling¹, ¹Pfizer, Andover, MA, ²Pfizer, Groton, CT, ³Clinical Pharmacology, Pfizer, Cambridge, MA, ⁴Clinical Immunology, Glaxo Smith Kline BioPharmaceuticals, Upper Merion, PA, ⁵Inflammation and Immunology Research Unit, Pfizer, Cambridge, MA, ⁶Envision Pharma Group, London, United Kingdom, ⁷Inflammation Global Medical Affairs, Pfizer, Collegeville, PA
Background/Purpose: A portion of patients without clinical response to anti-inflammatory biologics have been shown to develop anti-drug antibodies (ADA).1 ADA prevalence varies widely among biologics,…
Abstract Number: 610 • 2016 ACR/ARHP Annual Meeting
A Systematic Review and Meta-Analysis of Comparative Efficacy of Biologics in Treating Patients with Rheumatoid Arthritis: Assessment of Long-Term Radiographic Progression from Published Clinical Trials
Erin Murray¹, Yekaterina Butylkova¹, Alexandra Ellis¹, Martha Skup², Jasmina Kalabic³ and Vishvas Garg⁴, ¹Doctor Evidence, Santa Monica, CA, ²AbbVie Inc., North Chicago, IL, ³AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, ⁴AbbVie Inc, North Chicago, IL
Background/Purpose: Previously, several studies have meta-analyzed clinical, functional or structural efficacy of biologics in treating rheumatoid arthritis (RA) patients. However, the comparative efficacy of biologics…
Abstract Number: 1651 • 2016 ACR/ARHP Annual Meeting
A Case Series on Patients on Tofacitinib in Combination with a Biologic
Nashla Barroso¹ and Daniel E. Furst², ¹Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, ²David Geffen School of Medicine at UCLA, Los Angeles, CA
Background/Purpose: Although there have been significant advances in the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA). patients can experience a lack of or…
Abstract Number: 2631 • 2016 ACR/ARHP Annual Meeting
Trends and Factors Associated with Use of Biologic Agents As Monotherapy Among US Patients with Rheumatoid Arthritis
Chieh-I Chen¹, Wenhui Wei², Stuart Blackburn³, Emma Sullivan³ and James Piercy³, ¹Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ²Sanofi US, Inc., Bridgewater, NJ, ³Adelphi Real World, Manchester, United Kingdom
Background/Purpose: For patients with rheumatoid arthritis (RA) receiving a biologic disease-modifying antirheumatic drug (bDMARD), the current standard of care is to use the bDMARD concurrently…
Abstract Number: 624 • 2016 ACR/ARHP Annual Meeting
Association Between Methotrexate Use and Effects of Treatment with a Second Biologic Agent in Rheumatoid Arthritis
Yoshikazu Ogawa¹, Nobunori Takahashi², Toshihisa Kojima³ and Naoki Ishiguro⁴, ¹orthopedic surgery, Sakashita Hospital, Nakatsugawa, Japan, ²Nagoya Univ. Grad. Schl. of Med., Nagoya, Japan, ³Department of Orthopedic Surgery, Nagoya University Hospital, Nagoya, Japan, ⁴Nagoya University, Nagoya, Japan
Background/Purpose: In general, the concomitant use of methotrexate (MTX) and biologic disease-modifying antirheumatic drugs (bDMARDS) plays an important role in treating bio-naïve patients with rheumatoid…
Abstract Number: 1686 • 2016 ACR/ARHP Annual Meeting
Association of Early Skin Improvement with ACR Responses Among Biologic DMARD-Naive Psoriatic Arthritic Patients Treated with Ixekizumab
Diamant Thaci¹, Akimichi Morita², Julie Birt³, Chen-Yen Lin³, Catherine L. Shuler³ and Alice B. Gottlieb⁴, ¹Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany, ²Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ³Eli Lilly and Company, Indianapolis, IN, ⁴Tufts University School of Medicine, Boston, MA
Background/Purpose: Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A. In a phase 3 study, IXE was superior to placebo (PBO) in achieving…
Abstract Number: 2636 • 2016 ACR/ARHP Annual Meeting
No Strong Evidence Supporting Predictors for Successful Dose Reduction or Discontinuation of a Biologic in Rheumatoid Arthritis: A Systematic Review
L. Tweehuysen¹, C.H. van den Ende², F.M.M. Beeren², E.M.J. Been², F.H.J. van den Hoogen^3,4 and A.A. den Broeder³, ¹Sint Maartenskliniek, Nijmegen, Netherlands, ²Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ³Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ⁴Rheumatology, Radboudumc, Nijmegen, Netherlands
Background/Purpose: Tapering of biologics in rheumatoid arthritis (RA) is based on a trial-and-error disease activity guided strategy, because it is not known in advance which…
Abstract Number: 630 • 2016 ACR/ARHP Annual Meeting
Strategies for Biological Drug Quantification in Biological Drug Immune Responses
Michael Kruse Meyer^1,2, Marlene Andersen^1,3, Troels Vindbæk Stausbo⁴, Tue Bjerg Bennike^4,5, Grethe Neumann Andersen^1,6 and Allan Stensballe^3,4, ¹Department of Rheumatology, North Denmark Regional Hospital, Hjørring, Denmark, ²Laboratory for Medical Mass Spectrometry, Aalborg University, Aalborg, Denmark, ³Department of Health Science and Technology, Aalborg University, Aalborg, Denmark, ⁴Laboratory of Medical Mass Spectrometry, Aalborg University, Aalborg, Denmark, ⁵Research Unit for Molecular Diagnostic and Clinical Research, Harvard Medical School, Boston, MA, ⁶Center for Clinical Science, Aalborg University, Hjørring, Denmark
Background/Purpose: The development of the biological DMARDs has benefitted patients, who previously had no treatment options. Currently no method for stratifying patients to these drugs…
Abstract Number: 1687 • 2016 ACR/ARHP Annual Meeting
Effect of Concomitant Conventional Disease-Modifying Antirheumatic Drugs (DMARDs) on the Efficacy and Safety of Ixekizumab in Biologic DMARD-Naive Patients with Active Psoriatic Arthritis
Alice B. Gottlieb¹, Laura C. Coates², Catherine L. Shuler³, Chen-Yen Lin³, Susan R. Moriarty³, Chin H. Lee³ and Philip J Mease⁴, ¹Tufts University School of Medicine, Boston, MA, ²University of Leeds, Leeds, United Kingdom, ³Eli Lilly and Company, Indianapolis, IN, ⁴Rheumatology Research, Swedish Medical Center and University of Washington, Seattle, WA
Background/Purpose: PsA is a chronic immune-mediated inflammatory disease associated with psoriasis, peripheral arthritis, enthesitis, dactylitis, and spondylitis. Ixekizumab (IXE) is an IgG4 mAb that binds…

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