Abstracts tagged "treatment and safety"

Abstract Number: 2461 • 2018 ACR/ARHP Annual Meeting
Analysis of Severe Adverse Drug Reactions to Disease Modifying Drugs in an Inception Rheumatoid Arthritis Cohort
Zulema Rosales Rosado^1,2, Judit Font Urgelles¹, Pia Mercedes Lois¹, Cristina Vadillo Font¹, Dalifer Freites Núñez², Isabel Hernández-Rodríguez¹, Juan A Jover Jover¹ and Lydia A Alcazar², ¹Rheumatology, Hospital Clínico San Carlos, Madrid, Spain, ²Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain
Background/Purpose: There is a well-known risk of developing adverse drug reactions (ADR) in rheumatic patients due, mainly, to the Disease Modifying Drugs (DMARD) widely used.…
Abstract Number: 2522 • 2018 ACR/ARHP Annual Meeting
Biosimilar BI 695501 and Adalimumab Reference Product (RP) Have Similar Efficacy and Safety in Patients (pts) with Moderately-to-Severely Active Rheumatoid Arthritis (RA): Long-Term Results from a Phase IIIb Extension Study (VOLTAIRE®-RAext)
Stanley Cohen¹, Niklas Czeloth², Eric Lee³, Piotr A. Klimiuk⁴, Nuala Peter⁵ and Girish Jayadeva², ¹Metroplex Clinical Research Center, Dallas, TX, ²Boehringer Ingelheim, Ingelheim a.R., Germany, Ingelheim, Germany, ³Inland Rheumatology, Upland, CA, ⁴Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, ⁵Boehringer Ingelheim, Biberach a.d.R., Germany, Ingelheim a.R., Germany
Background/Purpose: Clinical equivalence of BI 695501 to the adalimumab RP has been shown in pts with moderately-to-severely active RA in the Phase III VOLTAIRE®-RA study…
Abstract Number: 465 • 2014 ACR/ARHP Annual Meeting
18-Month Worldwide Post-Marketing Surveillance Experience of Tofacitinib
S. Cohen¹, Jeffrey R. Curtis², Roy Fleischmann¹ and Y. Chen³, ¹Metroplex Clinical Research Center, Dallas, TX, ²University of Alabama, Birmingham, AL, ³Pfizer Inc, Collegeville, PA
Background/Purpose: Post-marketing surveillance is an important part of monitoring adverse events (AEs) following the approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor…
Abstract Number: 2644 • 2013 ACR/ARHP Annual Meeting
Phase IB/Iia Study On Intravenous Administration Of Expanded Allogeneic Adipose-Derived Mesenchymal Stem Cells In Refractory Rheumatoid Arthritis Patients
JM Alvaro-Gracia¹, Juan A. Jover², Rosario Garcia-Vicuña³, Luis Carreño⁴, Alberto Alonso⁵, Sara Marsal⁶, Francisco J. Blanco⁷, Víctor M. Martínez-Taboada⁸, Peter C. Taylor⁹, Federico Díaz-González¹⁰ and Lydia Dorrego¹¹, ¹Unidad de Terapias Biológicas. Servicio de Reumatología, Hospital Universitario de La Princesa, Madrid, Spain, ²Rheumatology, Hospital Clínico San Carlos, Madrid, Spain, ³Rheumatology, Hospital Universitario de La Princesa. IIS La Princesa, Madrid, Spain, ⁴Rheumatology, Gregorio Marañón Hospital, Madrid, Spain, ⁵Hospital de Cruces, Bilbao, Spain, ⁶Rheumatology Research Group, Vall d'Hebron Hospital Research Institute, Barcelona, Spain, ⁷INIBIC-Hospital Universitario A Coruña. Rheumatology Division. Genomic Group, A Coruña, Spain, ⁸Rheumatology, Hospital Universitario Marqués de Valdecilla. IFIMAV., Santander, Spain, ⁹NDORMS, Botnar Research Centre, University of Oxford, Oxford, United Kingdom, ¹⁰Hospital Universitario de Canarias, La Laguna. Tenerife, Spain, ¹¹TiGenix, Tres Cantos, Spain
Background/Purpose: Expanded adipose-derived stem cells (eASCs) are shown to have immune-modulatory effects both in vitro and in animal models of arthritis. eASCs are currently under…
Abstract Number: 2321 • 2013 ACR/ARHP Annual Meeting
Long-Term Safety and Efficacy Of Certolizumab Pegol In Combination With Methotrexate In The Treatment Of Rheumatoid Arthritis: 5-Year Results From a 24-Week Randomized Controlled Trial and Open-Label Extension Study
Josef S. Smolen¹, Ronald van Vollenhoven², Arthur Kavanaugh³, Vibeke Strand⁴, Jiri Vencovsky⁵, Michael H. Schiff⁶, Robert Landewé⁷, Boulos Haraoui⁸, Susan Walker⁹ and Désirée van der Heijde¹⁰, ¹Medical University of Vienna and Hietzing Hospital, Vienna, Austria, ²Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden, ³Division of Rheumatology Allergy and Immunology, University of California San Diego, San Diego, CA, ⁴Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, ⁵Institute of Rheumatology, Department of Clinical and Experimental Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, ⁶Rheumatology Division, University of Colorado, Denver, CO, ⁷Academic Medical Center Amsterdam & Atrium Medical Center, Heerlen, Netherlands, ⁸Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada, ⁹UCB Pharma, Raleigh, NC, ¹⁰Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: In the RAPID2 randomized controlled trial (RCT; NCT00160602), certolizumab pegol (CZP) +MTX every 2 weeks (Q2W) improved signs and symptoms of rheumatoid arthritis (RA)…
Abstract Number: 2485 • 2012 ACR/ARHP Annual Meeting
Tofacitinib, an Oral Janus Kinase Inhibitor: Analyses of Efficacy and Safety of 10 versus 5mg Twice Daily in a Pooled Phase 3 and Long-Term Extension Rheumatoid Arthritis Population
S. Cohen¹, S. Krishnaswami², B. Benda³, R. Riese², M.G. Boy⁴, D. Gruben⁴, G. Wallenstein⁵, C. A. Mebus⁴, S. H. Zwillich² and J. D. Bradley⁶, ¹Metroplex Clinical Research Centre, Dallas, TX, ²Pfizer Inc., Groton, CT, ³Clinical Development & Medical Affairs, Pfizer Inc., Collegeville, PA, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, New York, NY, ⁶Worldwide Pharmaceutical Development, Pfizer Inc., Groton, CT
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy for RA. Phase (P) 3 studies demonstrated…
Abstract Number: 1282 • 2012 ACR/ARHP Annual Meeting
Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Open-Label, Long-Term Extension Safety and Efficacy up to 48 Months
Jurgen Wollenhaupt¹, Joel C. Silverfield², Eun Bong Lee³, Susan P. Wood⁴, Koshika Soma⁵, Lisy Wang⁴, Hiroyuki Nakamura⁶, Yoshihiro Komuro⁶, Chudi I. Nduaka⁴, David Gruben⁴, Birgitta Benda⁷, Samuel H. Zwillich⁵, Richard Riese⁴ and John D. Bradley⁴, ¹Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ²Healthpoint Medical Group, Tampa, FL, ³Seoul National University, Seoul, South Korea, ⁴Pfizer Inc., Groton, CT, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Japan Inc., Tokyo, Japan, ⁷Pfizer Inc., Collegeville, PA
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy in RA. Here we report the safety…

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