Abstracts Archive - Page 1550 of 2607 - ACR Meeting Abstracts

Abstract Number: 2441 • 2017 ACR/ARHP Annual Meeting
A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate
Hiroaki Matsuno^1,2, Masato Tomomitsu³, Atsushi Hagino³, Seonghye Shin⁴, Jiyoon Lee⁴ and Yeong Wook Song^5,6, ¹Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ²Institute of Medical Science, Tokyo Medical University, Tokyo, Japan, ³Mochida Pharmaceutical Co.,Ltd., Tokyo, Japan, ⁴Clinical Development, LG Chem, Ltd., Seoul, Korea, Republic of (South), ⁵Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Seoul National University, Seoul, Korea, Republic of (South), ⁶Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Medical Research Center, Seoul National University, Seoul, Korea, Republic of (South)
Background/Purpose: LBEC0101 has been developed as a biosimilar to the etanercept reference product (ETN-RP). This study was to evaluate the similarities between LBEC0101 and ETN-RP…
Abstract Number: 2442 • 2017 ACR/ARHP Annual Meeting
Biosimilar Candidate BI 695501 and Adalimumab Reference Product Have Similar Efficacy and Safety in Patients with Moderately-to-Severely Active Rheumatoid Arthritis (RA): 1-Year Results from a Phase III Study
Stanley B Cohen¹, Alberto Alonso-Ruiz², Piotr A. Klimiuk³, Eric Lee⁴, Nuala Peter⁵, Niklas Czeloth⁵ and Girish Jayadeva⁵, ¹Metroplex Clinical Research Center, Dallas, TX, ²Hospital de Cruces, Barakaldo, Spain, ³Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, ⁴Inland Rheumatology, Upland, CA, ⁵Boehringer Ingelheim, Ingelheim a.R., Germany
Background/Purpose: Clinical equivalence has been shown for BI 695501 and the adalimumab reference product (RP) through similar ACR20 response at Weeks (wks) 12 and 24…
Abstract Number: 2443 • 2017 ACR/ARHP Annual Meeting
Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects
Julia Jauch-Lembach¹, Andrej Skerjanec¹, Halimuniyazi Haliduola¹, Nicole Hass¹, Oliver von Richter¹, Rainard Fuhr² and Thomas Koernicke², ¹Hexal AG, Holzkirchen, Germany, ²PAREXEL International GmbH, Berlin, Germany
Background/Purpose: GP2017 is a proposed adalimumab biosimilar that has been shown to be similar to reference adalimumab at an analytical and preclinical level. The aim…
Abstract Number: 2444 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Safety of CT-P13 in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis: Observational Study in Republic of Korea
Dong-Wook Kim¹, Tae-Hwan Kim², Seong Ryul Kwon³, Eun Young Lee⁴, Chang-Nam Son⁵, Yun Sung Kim⁶, Soung Hun Kim⁷, Yong-Beom Park⁸, Jin-Wuk Hur⁹, Hye-Soon Lee¹⁰, Sang Joon Lee¹¹ and Jee Hye Suh¹², ¹Inje University Busan Paik Hospital, Busan, Korea, Republic of (South), ²Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ³Inha University Hospital, Incheon, Korea, Republic of (South), ⁴Seoul National University College of Medicine, Seoul, Korea, Republic of (South), ⁵Keimyung University Dongsan Medial Center, Daegu, Korea, Republic of (South), ⁶Chosun University Hospital, Gwangju, Korea, Republic of (South), ⁷Gwangmyeong Saeum Hospital, Gyeonggi-do, Korea, Republic of (South), ⁸Yonsei University Severance Hospital, Seoul, Korea, Republic of (South), ⁹Eulji University Seoul Hospital, Seoul, Korea, Republic of (South), ¹⁰Hanyang University Guri Hospital, Gyeonggi-do, Korea, Republic of (South), ¹¹CELLTRION, Inc., Incheon, Korea, Republic of (South), ¹²CELLTRION.Inc, Incheon, Korea, Republic of (South)
Background/Purpose: CT-P13 is approved as a biosimilar of innovator infliximab for marketing in 81 countries. After approval, observational study has been conducted in Republic of…
Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks
Seung-Cheol Shim¹, Ljubinka Bozic Majstorovic², Alfredo Berrocal Kasay³, Elias Chalouhi El-Khouri⁴, Fedra Irazoque-Palazuelos⁵, Francisco Cons Molina⁶, Francisco G. Medina-Rodriguez⁷, Pedro Miranda⁸, Pavel Shesternya⁹, Jose Chavez Corrales¹⁰, Piotr Wiland¹¹, Slawomir Jeka¹², Olena Garmish¹³, Pawel Hrycaj¹⁴, Natalia Fomina¹⁵, Won Park¹⁶, Chang-Hee Suh¹⁷, Sang-Joon Lee¹⁸, Sung Young Lee¹⁹ and Dae-Hyun Yoo²⁰, ¹Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), 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, ⁷Rheumatology, LaSalle University, Mexico City, Mexico, ⁸Centro De Estudios Reumatológicos, Santiago, Chile, ⁹Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁰Clinica San Borja, Lima, Peru, ¹¹Department and Clinic of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, ¹²2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ¹³Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, ¹⁴Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ¹⁵Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, ¹⁶Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ¹⁷Ajou University School of Medicine, Suwon, Korea, Republic of (South), ¹⁸CELLTRION, Inc., Incheon, Korea, Republic of (South), ¹⁹Clinical Planning Department, CELLTRION, Inc., Incheon, Korea, Republic of (South), ²⁰Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South)
Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…
Abstract Number: 2446 • 2017 ACR/ARHP Annual Meeting
Minimal and Comparable Radiographic Progression By Disease Activity States in Patients with Rheumatoid Arthritis Who Continued SB5 or Reference Adalimumab and Who Switched to SB5
Michael Weinblatt¹, Asta Baranauskaite², Jeehoon Ghil³, Soo Yeon Cheong³ and Evelyn Hong³, ¹Brigham and Women’s Hospital, Boston, MA, ²Lithuanian University of Health Sciences, Kaunas, Lithuania, ³Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)
Background/Purpose : SB5 is a biologic agent developed as a biosimilar of the reference adalimumab (ADL). One year results including radiographic progression from the phase…
Abstract Number: 2447 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Tolerability of Benepali in Rheumatoid Arthritis Patients Switched from Enbrel
Sarah Dyball¹, Victoria Hoskins², Sharon Christy-Kilner² and Sahena Haque³, ¹Rheumatology, University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom, ²University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom, ³Rheumatology department, University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom
Background/Purpose: Benepali, the etanercept biosimilar, is licenced in the UK for rheumatoid arthritis (RA) and costs less than Enbrel. This study aimed to evaluate the…
Abstract Number: 2448 • 2017 ACR/ARHP Annual Meeting
Increased Cumulative Exposure to Tumor Necrosis Factor Inhibitors Reduces Radiographic Progression in US Veterans with Rheumatoid Arthritis in Real World Clinical Practice
Grant Cannon¹, Alan R. Erickson², Chia-Chen Teng, MS¹, Tina Huynh¹, Sally W. Wade³, Bradley S. Stolshek⁴, David Collier⁵, Alex Mutebi⁶ and Brian C. Sauer, PhD¹, ¹Salt Lake City VA Medical Center and University of Utah, Salt Lake City, UT, ²Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, ³Wade Outcomes Research and Consulting, Salt Lake City, UT, ⁴Amgen, Inc., Thousand Oaks, CA, ⁵Amgen Inc., Thousand Oaks, CA, ⁶Global Health Economics, Amgen Inc., Thousand Oaks, CA
Background/Purpose: While tumor necrosis factor inhibitors (TNFi) have been proven to reduce progression of structural joint damage in rheumatoid arthritis (RA) in randomized clinical…
Abstract Number: 2449 • 2017 ACR/ARHP Annual Meeting
Comparative Effectiveness of Tocilizumab (TCZ) Monotherapy with Tumor Necrosis Factor Inhibitors (TNFi) in Combination with Varying Doses of Methotrexate (MTX) in Patients with Rheumatoid Arthritis
Leslie R Harrold¹, George W. Reed¹, Jennie Best², Steve Zlotnick², Gioia Persuitte³ and Joel Kremer⁴, ¹University of Massachusetts Medical School, Worcester, MA, ²Genentech, Inc., South San Francisco, CA, ³Corrona, LLC, Southborough, MA, ⁴Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Clinical studies have shown that the efficacy of TCZ monotherapy (TCZ mono) is superior to that of TNFi monotherapy and comparable to that of…
Abstract Number: 2450 • 2017 ACR/ARHP Annual Meeting
Comparative Effectiveness of Abatacept Versus TNFi in Patients with RA Who Are CCP+ in the United States Corrona Registry
Leslie R Harrold¹, Heather J. Litman², SE Connolly³, E Alemao³, K Price³, S Kelly³, Sabrina Rebello⁴, W Hua² and Joel Kremer⁵, ¹University of Massachusetts, Worcester, MA, ²Corrona, Southborough, MA, ³Bristol-Myers Squibb, Princeton, NJ, ⁴Corrona, LLC, Southborough, MA, ⁵Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Anti-cyclic citrullinated peptide positivity (CCP+) is associated with a better response to abatacept than anti-CCP negativity in patients with RA1,2; however, there are no…
Abstract Number: 2451 • 2017 ACR/ARHP Annual Meeting
Rapid Onset of Response Observed with Certolizumab Pegol in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Efficacy and Safety Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study
Liqi Bi¹, Yuhui Li², Lan He³, Huji Xu⁴, Jieruo Gu⁵, Guochun Wang⁶, Zhiyi Zhang⁷, Yi Liu⁸, Marion Boehnlein⁹, Jochen Dunkel⁹, Jing Shao¹⁰, Kristina Harris¹¹ and Zhanguo Li¹², ¹China-Japan Union Hospital of Jilin University*, Changchun, China, ²Peking University People’s Hospital*, Beijing, China, ³The First Affiliated Hospital of Xi’an Jiaotong University, Xi'an, China, ⁴Shanghai Changzheng Hospital, Shanghai, China, ⁵Sun Yat-sen University – The Third Affiliated Hospital, Guangzhou, China, ⁶China-Japan Friendship Hospital, Beijing, China, ⁷The First Affiliated Hospital of Harbin Medical University, Harbin, China, ⁸West China Hospital, Sichuan University, Chengdu, China, ⁹UCB Pharma, Monheim, Germany, ¹⁰UCB Pharma, Tokyo, Japan, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Peking University People's Hospital, Beijing, China
Background/Purpose: There are unmet needs for patients (pts) suffering from rheumatoid arthritis (RA) in China, where a limited number of anti-TNFs are available.1, 2 Certolizumab…
Abstract Number: 2452 • 2017 ACR/ARHP Annual Meeting
In Real-World Clinical Practice, Patients Switching from IV to SC Abatacept Maintain Clinical Efficacy after Switch
Rieke Alten¹, HM Lorenz², X Mariette³, H Nüßlein⁴, M Galeazzi⁵, F Navarro⁶, M Chartier⁷, J Heitzmann⁸, C Rauch⁹ and M Le Bars⁷, ¹Schlosspark-Klinik University Medicine, Berlin, Germany, ²University Hospital, Heidelberg, Germany, ³Université Paris-Sud, Paris, France, ⁴University of Erlangen-Nuremberg, Nuremberg, Germany, ⁵University of Siena, Siena, Italy, ⁶Hospital Universitario Virgen Macarena, Seville, Spain, ⁷Bristol-Myers Squibb, Rueil-Malmaison, France, ⁸Excelya, Boulogne-Billancourt, France, ⁹Bristol-Myers Squibb, Munich, Germany
Background/Purpose: Patients (pts) with RA may be able to switch from IV to SC abatacept with no loss of efficacy or safety concerns, but data…
Abstract Number: 2453 • 2017 ACR/ARHP Annual Meeting
Methotrexate Discontinuation from Combination Therapy with Adalimumab Is Not Associated with Inferior Outcomes at 6 Months
Dimitrios A. Pappas¹, Chitra Karki¹, Ying Shan¹, Jessica L. Suboticki², Jenny Griffith³ and Joel Kremer⁴, ¹Corrona, LLC, Southborough, MA, ²AbbVie Inc., Mettawa, IL, ³AbbVie Inc., North Chicago, IL, ⁴Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Methotrexate is frequently administered in combination with biologics for the therapy of Rheumatoid Arthritis (RA) as it leads to superior outcomes compared to biologic…
Abstract Number: 2454 • 2017 ACR/ARHP Annual Meeting
Real-World Consistency of Response to Adalimumab over Time in Patients with Rheumatoid Arthritis: Results from the Corrona Registry
Dimitrios A. Pappas^1,2, George W. Reed^2,3, Chitra Karki⁴, Jenny Griffith⁵, Martha Skup⁵, Vishvas Garg⁵ and Joel Kremer^2,6, ¹Columbia University, New York, NY, ²Corrona LLC, Southborough, MA, ³UMass Medical School, Worcester, MA, ⁴Corrona, LLC, Southborough, MA, ⁵AbbVie Inc., North Chicago, IL, ⁶Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Adalimumab (ADA) was approved in the US in 2002 for rheumatoid arthritis (RA), and subsequently approved for the management of other inflammatory diseases such…
Abstract Number: 2455 • 2017 ACR/ARHP Annual Meeting
Efficacy of Etanercept in Elderly Patients with Rheumatoid Arthritis
Christopher J. Edwards¹, Katherine Roshak², Jack F Bukowski³, Ronald Pedersen⁴, Mazhar Thakur⁵, Lisa Marshall² and Heather Jones², ¹University Hospital Southampton, Southampton, United Kingdom, ²Inflammation & Immunology Global Medical Affairs, Pfizer, Collegeville, PA, ³Clinical Affairs, Pfizer, Collegeville, PA, ⁴Department of Biostatistics, Pfizer, Collegeville, PA, ⁵Pfizer Ltd, Sandwich, United Kingdom
Background/Purpose: Ageing is associated with declining immune cell function and age-related comorbidities.1,2 In the US, the prevalence of rheumatoid arthritis (RA) is ~2% in individuals…

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