ACR Meeting Abstracts

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Abstracts tagged "infliximab and rheumatoid arthritis (RA)"

  • Abstract Number: 548 • 2019 ACR/ARP Annual Meeting

    Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial

    Rene Westhovens1, Piotr Wiland 2, Marek Zawadzki 3, Delina Ivanova 4, Alfredo Berrocal 5, Elias Chalouhi 6, Éva Balázs 7, Sergii Shevchuk 8, Larisa Eliseeva 9, Mykola Stanislavchuk 10, Roman Yatsyshyn 11, SangJoon Lee 12, SungHyun Kim 12, NooRi Han 13, YooBin Jung 13 and DaeHyun Yoo 14, 1University Hospitals, Leuven, Belgium, 2Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, 3Medical Univeristy, Dpt of Rheumatology, Wroclaw, Wroclaw, Poland, 4Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, 5Cayetano Heredia University, Lima, Peru, 6Clinica Internacional Sede Lima, Lima, Peru, 7Dr. Bugyi István Hospital, Szentes, Hungary, 8Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov, Vinnytsia, Ukraine, 9Siberian State Medical University of Roszdrav, Tomsk, Russia, 10National Pirogov Memorial Medical University, Vinnytsya, Vinnytsia, Ukraine, 11Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine, 12Celltrion Inc., Incheon, Republic of Korea, 13Celltrion, Inc., Incheon, Republic of Korea, 14Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea

    Background/Purpose: Efficacy and safety of a new subcutaneous (SC) formulation (CT-P13 SC) were evaluated up to Week 30. The phase I/III randomized controlled trial in…
  • Abstract Number: 1403 • 2019 ACR/ARP Annual Meeting

    CDAI Analysis of Dose Escalation in a Trial of Infliximab for Rheumatoid Arthritis

    John Tesser1, Shawn Black 2, Rongshuang Lin 3, Wayne Langholff 3, Jonathan Uy 4 and Shelly Kafka 4, 1Arizona Arthritis and Rheumatology Associate, Phoenix, AZ, 2Janssen Scientific Affairs, LLC, Horsham, RI, 3Janssen Research & Development, LLC, Spring House, PA, 4Janssen Scientific Affairs, LLC, Horsham, PA

    Background/Purpose: In the START (Safety Trial for Rheumatoid Arthritis with Remicade Therapy) trial, patients (pts) with active rheumatoid arthritis (RA) received placebo (PBO), or infliximab…
  • Abstract Number: 2490 • 2018 ACR/ARHP Annual Meeting

    Real World Evidence Describing Infliximab Utilization Patterns in Rheumatoid Arthritis Patients in Community Rheumatology Practices in the United States: Implications for Cost Efficiencies?

    Sergio Schwartzman1, Dennis Parenti2, Shawn Black2, Stephen Xu3, Wayne Langholff3 and Shelly Kafka2, 1Weill Cornell Medical College, New York, NY, 2Janssen Scientific Affairs, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose: AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is an ongoing prospective Phase 4 comparator study designed to provide…
  • Abstract Number: 2514 • 2018 ACR/ARHP Annual Meeting

    Development of a Subcutaneous Formulation of CT-P13 (Infliximab): Maintenance Subcutaneous Administration May Elicit Lower Immunogenicity Compared to Intravenous Treatment

    Dae-Hyun Yoo1, René Westhovens2, S. Ben-Horin3, W. Reinisch4, S. Schreiber5, B.D. Ye6, Sang-Joon Lee7, J.H. Suh7 and M.R. Kim7, 1Department of Rheumatology, Hospital for Rheumatic Diseases Hanyang University, Seoul, Korea, Republic of (South), 2Rheumatology, University Hospital KU Leuven, Leuven, Belgium, 3University of Tel Aviv Sheba Medical Center, Tel-Hashomer, Israel, 4Medical University of Vienna, Vienna, Austria, 5University Hospital Schleswig-Holstein, Kiel, Germany, 6Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of (South), 7CELLTRION, Inc., Incheon, Korea, Republic of (South)

    Background/Purpose: Intravenous (IV) use of CT-P13, an infliximab (INX) biosimilar, has resulted in comparable efficacy, safety and immunogenicity as innovator INX in various indications including…
  • Abstract Number: 2521 • 2018 ACR/ARHP Annual Meeting

    A Randomized, Double-Blind Phase III Study Comparing the Efficacy, Safety and Immunogenicity of PF-06438179/GP1111 (Ixifi™), an Infliximab Biosimilar, and Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Active RA: Results from Week 54 to Week 78

    Stanley Cohen1, Alan J. Kivitz2, Michael Tee3, Carol Cronenberger4, Min Zhang5, Sarah Hackley6, Karl Schumacher7 and Muhammad I. Rehman8, 1Metroplex Clinical Research Center, LLC, Dallas, TX, 2Altoona Center for Clinical Research, Duncansville, PA, 3Department of Medicine, Medical Center Manila and University of the Philippines, Manila, Philippines, 4Pfizer Inc, Collegeville, PA, 5Pfizer Inc, La Jolla, CA, 6Pfizer Ltd, Sandwich, United Kingdom, 7Global Clinical Development, Biopharmaceuticals, Sandoz Biopharmaceuticals, Holzkirchen, Germany, 8Pfizer Inc, Andover, MA

    Background/Purpose: PF-06438179/GP1111 (IFX-PF) is an infliximab (IFX) biosimilar for the treatment of immune-mediated inflammatory diseases, including RA. This randomized, double-blind, comparative clinical study evaluated the…
  • Abstract Number: 1057 • 2017 ACR/ARHP Annual Meeting

    Budgetary Impact Analysis of Real-World Dosing Patterns in Matched Cohorts of Rheumatoid Arthritis Patients Treated with Infliximab or Golimumab Intravenous Anti-TNF Medications

    Lorie A. Ellis1, Elisabetta Malangone-Monaco2, Helen Varker2, Diana Stetsovsky3, Maureen Kubacki4, Raphael J. DeHoratius5 and Shelly Kafka4, 1Janssen HECOR Immunology, Horsham, PA, 2Truven Health Analytics, Bethesda, MD, 3Truven Health Analytics, Philadelphia, PA, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5Janssen Scientific Affairs, LLC/Sidney Kimmel School of Medicine, Thomas Jefferson University, Horsham/Philadelphia, PA

    Background/Purpose: Infliximab (IFX) is more frequently selected than golimumab for intravenous use (GLM-IV) in patients with Rheumatoid Arthritis (RA) but differences in dosing and administration…
  • Abstract Number: 1471 • 2017 ACR/ARHP Annual Meeting

    Flare Incidence and Predictive Factors in a Population of Patients with Rheumatoid Arthritis Under Optimised Treatment with Adalimumab and Infliximab

    Amara Pieren1, Dora Pascual-Salcedo2, Pilar Aguado3, Gema Bonilla4, Eugenio De Miguel5, Irene Monjo6, Laura Nuño3, Diana Peiteado3, Alejandro Villalba3, Enrique Moral Coro4, C. Tornero7, Patricia Bogas4, Alejandro Balsa3 and Chamaida Plasencia-Rodriguez4, 1Rheumatologyº, Hospital La Paz, Madrid, Spain, 2Immuno-Rheumatology Research group, La Paz University Hospital, Madrid, Spain, 3Rheumatology, La Paz University Hospital, Madrid, Spain, 4Hospital Universitario La Paz, Madrid, Spain, 5Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, 6Internal Medicine, Hospital Universitario La Paz, MADRID, Spain, 7Rheumatology, Rheumatology. La Paz University Hospital, Spain., Madrid, Spain

    Background/Purpose:Anti-TNF has drastically changed the prognostic of the RA,carrying an important healthcare expense.This is why,optimisation seems a successful strategy that should not be linked to…
  • Abstract Number: 2798 • 2017 ACR/ARHP Annual Meeting

    A Randomized, Double-Blind Study Comparing PF-06438179/GP1111, a Potential Infliximab Biosimilar, and Infliximab, Both in Combination with MTX, As Treatment for Patients with Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Therapy

    Stanley B Cohen1, Rieke Alten2, Hideto Kameda3, Muhammad I. Rehman4, Karl Schumacher5, Susanne Schmitt5, Steven Y. Hua6 and K. Lea Sewell7, 1Metroplex Clinical Research Center, Dallas, TX, 2Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, 3Division of Rheumatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan, 4Pfizer Inc, Andover, MA, 5Global Clinical Development, Biopharmaceuticals, Hexal AG, Holzkirchen, Germany, 6Pfizer Inc, San Diego, CA, 7Biosimilars Development, Pfizer Inc, Cambridge, MA

    Background/Purpose: This double-blind, randomized study evaluated efficacy, safety and immunogenicity of PF‑06438179/GP1111, a potential infliximab biosimilar, vs infliximab sourced from the EU (infliximab-EU) in patients…
  • Abstract Number: 713 • 2016 ACR/ARHP Annual Meeting

    Predictors of Treatment Retention Among Patients with Rheumatoid Arthritis or Ankylosing Spondylitis Treated with Remicade® (Infliximab) for Long-Term in Canadian Real-World

    Michael Starr1, Edward Keystone2, Rafat Faraawi3, Louis Bessette4, Boulos Haraoui5, Wojciech Olszynski6, John Kelsall7, Raman Joshi8, Andrew Chow9, Algis Jovaisas10, J Carter Thorne11, Emmanouil Rampakakis12, Eliofotisti Psaradellis13, Marilise Marrache14, Brendan Osborne15, Karina Maslova16, Francois Nantel17, Allen J Lehman16 and Cathy Tkaczyk15, 1Rheumatology, Mcgill University, Pointe-Claire,, QC, Canada, 2Mt. Sinai Hospital, University of Toronto, Toronto, ON, Canada, 3McMaster University, Hamilton, ON, Canada, 4Rheumatology, CHUL de Quebec, Quebec, QC, Canada, 5Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada, 6103 Midtown Professional Center, Rheumatology Associates of Saskatoon, Saskatoon, SK, Canada, 7Mary Pack Arthritis Centre, Vancouver, Vancouver, BC, Canada, 8William Osler Health Centre-Brampton Civic Hospital, Brampton, ON, Canada, 9Credit Valley Rheumatology, Mississauga, ON, Canada, 10Capital North Therapeutics & Research, Ottawa, ON, Canada, 11Southlake Regional Health Centre, Newmarket, ON, Canada, 12JSS Medical Research, St-Laurent, QC, Canada, 13JSS Medical Research, Montreal, QC, Canada, 14Medical Affairs, Janssen Inc, Toronto, ON, Canada, 15Medical Affairs, Janssen Inc., Toronto, ON, Canada, 16Janssen Inc., Toronto, ON, Canada, 1719 Green belt Dr, Janssen Inc., Toronto, ON, Canada

    Background/Purpose: Remission has become a target to achieve in rheumatic diseases and it also could be linked to treatment retention. The aim of this analysis…
  • Abstract Number: 2472 • 2016 ACR/ARHP Annual Meeting

    Early DAS28 Drop Is a Predictor for Clinical Response to Anti-TNF Agents in Patients with Rheumatoid Arthritis: An Observational Study of a Real Life Inception Cohort

    Ana C.M. Ribeiro1, Karina Bonfiglioli2, Renata Miossi2, Carla G.S. Saad1, Julio C. B. Moraes3, Mariana G Waisberg1, Fernando Henrique Carlos de Souza1, Nadia E Aikawa4, Leandro L. do Prado1, Michelle Lopes1, Luciana Seguro1 and Eloisa Bonfá3, 1Rheumatology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, 2Rheumatology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil, 3Rheumatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, 4Pediatric Rheumatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

    Background/Purpose:  Predictors of rheumatoid arthritis (RA) response to anti-TNF agents have been described. Except for certolizumab, the value of interim analysis before 24 weeks of…
  • Abstract Number: 2590 • 2016 ACR/ARHP Annual Meeting

    The Efficacy of Additional Immunoadsorption on the Modulation of Disease Activity in Patients with Severe Rheumatoid Arthritis

    Xiaodan Kong1, Changyan Liu1, Dongyuan Cui1 and Qi Zhang2, 1Department of Rheumatology, The second Hospital of Dalian Medical University, Dalian, China, 2Department of Rheumatology, The second Hospital of Dalian Medical University, Dalian, Cocos (Keeling) Islands

    Background/Purpose:  Immunoadsorption been used in patients with severe refractory rheumatoid arthritis (RA) was first reported in 1994, and the efficacy is promising. However, the subset…
  • Abstract Number: 2596 • 2016 ACR/ARHP Annual Meeting

    Comparable Safety and Immunogenicity and Sustained Efficacy after Transition to SB2 (An Infliximab Biosimilar) Vs Ongoing Reference Infliximab (Remicade®) in Patients with Rheumatoid Arthritis: Results of Phase III Transition Study

    Josef S. Smolen1, Jung-Yoon Choe2, Nenad Prodanovic3, Jaroslaw Niebrzydowski4, Ivan Staykov5, Eva Dokoupilova6, Asta Baranauskaite7, Roman Yatsyshyn8, Mevludin Mekic9, Wieslawa Porawska10, Hana Ciferska11, Krystyna Jedrychowicz-Rosiak12, Agnieszka Zielinska13, Jasmine Choi14 and Young Hee Rho14, 1Medical University of Vienna, Vienna, Austria, 2Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, South Korea, 3Clinical Center Banja Luka, Banja Luka, Bosnia, 4Medica Pro Familia, Gdynia, Poland, 5MHAT "Dr. Ivan Seliminski", AD, Sliven, Bulgaria, 6MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic, 7Lithuanian University of Health Sciences, Kaunas, Lithuania, 8SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk, Ukraine, 9University Clinic Centre Sarajevo, Sarajevo, Bosnia, 10Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, 11Revmatologicky ustav, Praha 2, Czech Republic, 12MCBK S.C., Grodzisk Mazowiecki, Poland, 13Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland, 14Samsung Bioepis Co., Ltd., Incheon, South Korea

    Background/Purpose: SB2 is approved by the European Medicines Agency as a biosimilar of the reference infliximab (INF). The 30-week and 54-week results of Phase III…
  • Abstract Number: 2640 • 2016 ACR/ARHP Annual Meeting

    Can GP88 (Progranulin) be Used to Predict the Efficacy of Infliximab?

    Masao Sato1, Masao Takemura2, Yasuko Yamamoto3 and Kuniaki Saito4, 1Rheumatology, Matsunami General Hospital, Gifu, Japan, 2Advanced Diagnostic System Research Laboratory, Fujita Health University, Toyoake, Japan, 3Disease Control and Prevention, Fujita Health University, Toyoake, Japan, 4Disease Control and Prevention, Fjita Health University, Aichi, Japan

    Background/Purpose:   GP88 (progranulin; PGRN) is a glycoprotein with a molecular weight of approximately 88,000 Da and is thought to play an important role in…
  • Abstract Number: 62 • 2016 ACR/ARHP Annual Meeting

    Increased Frequency of Anti-Drug Antibodies in Patients Carrying Compatible IgG1 Allotypes and  Treated with Anti-TNF Antibodies

    Antonio Gonzalez1, Rosario Lopez-Rodriguez1, Ana Martinez2, Chamaida Plasencia-Rodriguez2, Andrea Jochems2, Dora Pascual-Salcedo2 and Alejandro Balsa2, 1Instituto Investigacion Sanitaria-Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, 2Instituto de Investigación Hospital Universitario La Paz (IDIPAZ), Madrid, Spain

    Background/Purpose:  One of the causes of insufficient response to biological drugs is the production of anti-drug antibodies (ADA) (1). These antibodies can decrease the effectiveness…
  • Abstract Number: 1221 • 2015 ACR/ARHP Annual Meeting

    Characteristics and Outcomes of RA Patients Who Start Biosimilar Infliximab in South Korea

    Yoon-Kyoung Sung1, Soo-Kyung Cho1, Soyoung Won2, Chan-Bum Choi3, So-Young Bang4, Seung-Jae Hong5, Hyoun-Ah Kim6, Eunmi Koh7, Hye-Soon Lee8, Chang-Hee Suh9, Dae-Hyun Yoo10, Sang-Cheol Bae1 and BIOPSY investigators, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, 2Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, 3Hanyang University Hospital for Rheumatic Diseases, Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, 4Hanyang University Guri Hospital, Guri, South Korea, 5Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, South Korea, 6Ajou University Hospital, Suwon, South Korea, 7Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, 8Department of Rheumatology, Hanyang University Guri Hospital, Guri, South Korea, 9Department of Rheumatology, Ajou University Hospital, Suwon, South Korea, 10Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea

    Background/Purpose: Recently biosimilar infliximab was approved in South Korea and it has been commonly used for rheumatoid arthritis (RA) patients who are resistant to conventional…
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