Abstracts Archive - Page 1458 of 2425 - ACR Meeting Abstracts

Abstract Number: 604 • 2016 ACR/ARHP Annual Meeting
Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study
Michael Weinblatt¹, Asta Baranauskaite², Jaroslaw Niebrzydowski³, Eva Dokoupilova⁴, Agnieszka Zielinska⁵, Karina Sitek-Ziolkowska⁶, Janusz Jaworski⁷, Artur Racewicz⁸, Margarita Pileckyte², Krystyna Jedrychowicz-Rosiak⁹, Vyacheslav Zhdan¹⁰, Soo Yeon Cheong¹¹ and Jeehoon Ghil¹¹, ¹Brigham and Women’s Hospital, Boston, MA, ²Lithuanian University of Health Sciences, Kaunas, Lithuania, ³Medica Pro Familia, Gdynia, Poland, ⁴MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic, ⁵Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland, ⁶Medica pro Familia, Katowice, Poland, ⁷Reumatika Centrum Reumatologi, Warszawa, Poland, ⁸Zdrowie Osteo- Medic s.c, Bialystok, Poland, ⁹Przychodnia Neuromedyka, Zyrardów, Poland, ¹⁰M.V.Sklifosovskyi Poltava Regional Clinical Hospital, Poltava, Ukraine, ¹¹Samsung Bioepis Co., Ltd., Incheon, South Korea
Background/Purpose: SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 24-week results of the phase III study have been reported.1 Efficacy,…
Abstract Number: 605 • 2016 ACR/ARHP Annual Meeting
Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects
Jan Hillson¹, Tim Mant², Tanmoy Ganguly³, William Avery³, Molly Rosano³, Carolyn Huntenburg³, Donna Palmer⁴, Siddesh Darne⁴, Borislava Pavlova⁴, Jennifer Doralt⁴, Russell Reeve⁵, Niti Goel⁵, Doris Weilert⁵, Paul Rhyne⁶, John Caminis⁴ and James Roach³, ¹Clinical Research, Momenta Pharmaceuticals, Inc., Cambridge, MA, ²Quintiles Drug Research Unit at Guy's Hospital, London, London, United Kingdom, ³Momenta Pharmaceuticals, Inc., Cambridge, MA, ⁴Shire, Cambridge, MA, ⁵Quintiles, Inc., Durham, NC, ⁶Q2 Solutions, Marietta, GA
Background/Purpose: 324 healthy volunteers were randomized 1:1:1 to receive a single 40 mg dose of M923, US-sourced reference adalimumab, or EU-sourced reference adalimumab by subcutaneous…
Abstract Number: 606 • 2016 ACR/ARHP Annual Meeting
A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (AbbVie) in Healthy Adult Subjects
Kenneth Bahrt¹, Joannes Reijers², Marlous Dillingh², Claudia Rehrig¹ and Jacobus Burggraaf³, ¹Oncobiologics Inc, Cranbury, NJ, ²Centre for Human Drug Research, Leiden, Netherlands, ³Centre for Human Drug Research, Leiden,, Netherlands
ONS-3010 is being developed as a biosimilar candidate of Humira® (Adalimumab), a full-length recombinant human IgG1 monoclonal antibody specific for TNFα. This study evaluated the b,…
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: 608 • 2016 ACR/ARHP Annual Meeting
Initial Intensive Therapy of Adalimumab and Methotrexate Is Associated with Long-Term Structural Remission and Low Disease Activity after Adalimumab Discontinuation Is Maintained up to 3 Years in Japanese Patients: Hopeful-3 Study
Yoshiya Tanaka¹, Hisashi Yamanaka², Naoki Ishiguro³, Nobuyuki Miyasaka⁴, Katsuyoshi Kawana⁵, Naoki Agata⁵ and Tsutomu Takeuchi⁶, ¹University of Occupational and Environmental Health, Kitakyushu, Japan, ²Tokyo Women's Medical University, Tokyo, Japan, ³Department of Orthopedic Surgery, Nagoya University, Graduate School & Faculty of Medicine, Nagoya, Japan, ⁴Tokyo Medical and Dental University, Tokyo, Japan, ⁵Abbvie GK, Tokyo, Japan, ⁶Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan
Background/Purpose: Methods: Of 172 patients enrolled, 135 (ADA continuation, n=61; ADA discontinuation, n=74) with DAS28–CRP at both week 52 (start of HOPEFUL-2) and week 208…
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: 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: 611 • 2016 ACR/ARHP Annual Meeting
Analysis of a German Subpopulation with Active Rheumatoid Arthritis Treated with Golimumab As Add-on Therapy to Disease-Modifying Antirheumatic Drugs
Hendrik Schulze-Koops¹, Jürgen Wollenhaupt², Marita Winnemöller³, Ines Klaudius³ and Helena Löffler³, ¹Division of Rheumatology, Division of Rheumatology and Clinical Immunology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany, ²Schön Klinik Hamburg-Eilbek, Hamburg, Germany, ³Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany
Background/Purpose: In previous clinical studies the human monoclonal TNFα-antibody golimumab (GLM) showed a good clinical response and a favorable benefit:risk profile in the treatment of…
Abstract Number: 612 • 2016 ACR/ARHP Annual Meeting
Long-Term Sustainability of TNF-Blocker Injection Spacing in Rheumatoid Arthritis: Results of a 3-Year Long-Term Observational Follow-up of a Tapering randomised Controlled Trial
Johanna Sigaux¹, Florian Bailly^2,3, Frédérique Gandjbakhch^1,3, Violaine Foltz^1,3, Florence Tubach^4,5, Laure Gossec^1,6 and Bruno Fautrel^1,7, ¹Rheumatology, Pitié Salpêtrière Hospital, Paris, France, ²rheumatology, Pitié Salpêtrière Hospital, paris, France, ³Sorbonne Universités, UPMC Univ Paris 06, Paris, France, Paris, France, ⁴Aix-Marseille University, Marseille, France, ⁵Université Pierre et Marie Curie (UPMC)-Paris 6; APHP, Pitié Salpêtrière Hospital, Département Biostatistics and Public health, Pharmacoepidémiology center (Cephepi), 7501875013, Paris, France ;, Paris, France, ⁶Sorbonne Universités, UPMC University Paris 06, Paris, France, Paris, France, ⁷GRC08, Sorbonne Universités, UPMC Univ Paris 06, Paris, France, Paris, France
Background/Purpose: Tapering of TNF blockers (TNFb) in rheumatoid arthritis (RA) patients in sustained remission is feasible in short-term randomized controlled trials (RCT). Less data are…
Abstract Number: 613 • 2016 ACR/ARHP Annual Meeting
Immunogenicity of Anti-TNF Therapies in Patients with Inflammatory Rheumatic Diseases and Secondary Failure: A Multicentre Study of 570 Patients
Alejandro Balsa¹, Raimon Sanmarti², José Rosas³, Susana Gomez Castro⁴, Ana Cabez⁴, Victor Martin⁴ and María Montoro⁴, ¹Rheumatology, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain, ²Rheumatology Department, Hospital Clínic de Barcelona, Barcelona, Spain, ³Rheumatology, Hospital Marina Baixa, Villajoyosa (Alicante), Spain, ⁴Pfizer, Madrid, Spain
Abstract Immunogenicity of anti-TNF therapies in Patients with inflammatory rheumatic Diseases and secondary failure: a multicentre study of 570 patients. Background/Purpose: The treatment of…
Abstract Number: 614 • 2016 ACR/ARHP Annual Meeting
Canadian Study of Outcomes in Adalimumab (HUMIRA®) Patients with Support for Adherence – Results from the Companion Study
Sebastien Gerega¹, Brad Millson¹, Louis Bessette², John Marshall³, Gerald Lebovic^4,5, Michael Sung¹, Driss Oraichi¹, Sandra Gazel⁶, Tania Gaetano⁶, Martin Latour⁶ and Marie-Claude Laliberté⁶, ¹IMS Brogan, Kirkland, QC, Canada, ²Centre Hospitalier de l'Université Laval, Quebec, QC, Canada, ³Department of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada, ⁴Applied Health Research Centre, St. Michael’s Hospital, Toronto, ON, Canada, ⁵Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada, ⁶AbbVie, Inc., St.Laurent, QC, Canada
Background/Purpose: Adalimumab (ADA) is a TNF-alpha inhibitor indicated for use in various inflammatory autoimmune diseases including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis…
Abstract Number: 615 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetic Similarity of ABP 710 Relative to Infliximab: Results from a Randomized, Single-Blind, Single-Dose, Parallel Group Study in Healthy Subjects
Primal Kaur¹, Vincent Chow², Nan Zhang³ and Eswar Krishnan⁴, ¹Amgen, Thousand Oaks, CA, ²Clinical Pharmacology, Amgen, Inc., Thousand Oaks, CA, ³Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁴Biosimilars, Amgen, Inc, Thousand Oaks, CA
Background/Purpose: Methods: Results: Pharmacokinetics: A total of 49 subjects received ABP 710 and 50 subjects received infliximab. Following a single dose, the adjusted…
Abstract Number: 616 • 2016 ACR/ARHP Annual Meeting
ABP 501 Long-Term Safety/Efficacy: Interim Results from an Open-Label Extension Study
Stanley Cohen¹, Jose L. Pablos², Nan Zhang³, Warren Rizzo⁴, Gerhard Muller⁵, Devi Padmanaban⁶, Alan Kivitz⁷, Alan K. Matsumoto⁸ and Primal Kaur⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Grupo de Enfermedades Inflamatorias y Autoinmunes, Instituto de Investigación Hospital 12 de Octubre (i+12), Madrid, Spain, ³Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁴Advanced Arthritis Care & Research, Scottsdale, AZ, ⁵Dept of Nephrology and Rheumatogy, University Medical Center Göttingen, Göttingen, NIEDERSACHSEN, Germany, ⁶Biosimilars, Amgen, Thousand Oaks, CA, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Rheumatology, Arthritis & Rheumatism Associate, Wheaton, MD, ⁹Amgen, Thousand Oaks, CA
Background/Purpose: This was a single-arm OLE of the parent study; the objective was to assess long-term safety and efficacy of ABP 501. The study…
Abstract Number: 617 • 2016 ACR/ARHP Annual Meeting
Therapy in Patients with Rheumatoid Arthritis (RA) with Inadequate Response to Tumor Necrosis Factor Alpha Inhibitors (TNFi): A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs
Maria A. Lopez-Olivo¹, Aliza Matusevich^2,3 and Maria Suarez-Almazor⁴, ¹Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine,The University of Texas MD Anderson Cancer Center, Houston, Texas, USA,, Houston, TX, ²General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³The University of Texas, School of Public Health, Houston, TX, ⁴Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA., Houston, TX
Background/Purpose: Up to one-third of the patients who receive TNFi lose responsiveness over time. Options available to these patients include treatment with an alternative TNFi…
Abstract Number: 618 • 2016 ACR/ARHP Annual Meeting
Do Canadian Rheumatologists Actually Treat to Target Once a Biologic Has Been Initiated? an Analysis from a Prospective, Observational Registry
Philip Baer¹, Andrew Chow², Michael Starr³, Boulos Haraoui⁴, Regan Arendse⁵, Michelle Teo⁶, Emmanouil Rampakakis⁷, Eliofotisti Psaradellis⁸, Allen J Lehman⁹, Francois Nantel¹⁰, Brendan Osborne¹¹, Cathy Tkaczyk¹¹ and Karina Maslova⁹, ¹Independent Rheumatology Practice, Scarborough, ON, Canada, ²Credit Valley Rheumatology, Mississauga, ON, Canada, ³Rheumatology, Mcgill University, Pointe-Claire,, QC, Canada, ⁴University of Montreal, Montreal, QC, Canada, ⁵University of Saskatchewan, Saskatoon, SK, Canada, ⁶Balfour Medical Clinic, Penticton, BC, Canada, ⁷JSS Medical Research, St-Laurent, QC, Canada, ⁸JSS Medical Research, Montreal, QC, Canada, ⁹Janssen Inc., Toronto, ON, Canada, ¹⁰19 Green belt Dr, Janssen Inc., Toronto, ON, Canada, ¹¹Medical Affairs, Janssen Inc., Toronto, ON, Canada
Background/Purpose: Methods: Results: After 6 months of treatment, 46% of patients had achieved treatment target of remission or low DA, and 54% were…

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