Abstracts tagged "safety and tofacitinib"

Abstract Number: 963 • 2018 ACR/ARHP Annual Meeting
Long-Term Safety of Tofacitinib up to 9.5 Years: A Comprehensive Integrated Analysis of the RA Clinical Development Program
Stanley Cohen¹, Yoshiya Tanaka², Xavier Mariette³, Jeffrey R. Curtis⁴, Eun Bong Lee⁵, Peter Nash⁶, Kevin Winthrop⁷, Christina Charles-Schoeman⁸, Lisy Wang⁹, Connie Chen¹⁰, Kenneth Kwok¹⁰, Pinaki Biswas¹⁰, Andrea Shapiro¹¹, Ann Madsen¹⁰ and Jürgen Wollenhaupt¹², ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Paris-Sud University, Le Kremlin Bicêtre, France, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Seoul National University, Seoul, Korea, Republic of (South), ⁶University of Queensland, Brisbane, Australia, ⁷Oregon Health and Science University, Portland, OR, ⁸University of California, Los Angeles, CA, ⁹Pfizer Inc, Groton, CT, ¹⁰Pfizer Inc, New York, NY, ¹¹Pfizer Inc, Peapack, NJ, ¹²Schön-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. Here, we report the largest integrated safety analysis of tofacitinib to date…
Abstract Number: 1519 • 2018 ACR/ARHP Annual Meeting
Patient Characteristics Associated with Discontinuation of Tofacitinib for the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 9.5 Years
Jeffrey R. Curtis¹, Jürgen Wollenhaupt², Katerina Chatzidionysiou³, Sander W. Tas⁴, Lisy Wang⁵, Harry Shi⁶, María Montoro⁷, Petra Neregård⁸, Palle Dahl⁹ and Vassilis Tsekouras¹⁰, ¹University of Alabama at Birmingham, Birmingham, AL, ²Schön Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ³Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ⁴Amsterdam Rheumatology and Immunology Center, Academic Medical Center, Amsterdam, Netherlands, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Inc, Madrid, Spain, ⁸Pfizer Inc, Stochholm, Sweden, ⁹Pfizer Inc, Ballerup, Denmark, ¹⁰Pfizer Inc, Athens, Greece
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We explored characteristics of patients (pts) who discontinued (d/c) open-label, long-term extension…
Abstract Number: 1526 • 2018 ACR/ARHP Annual Meeting
Baseline Characteristics and Outcomes in Patients with Anemia in Clinical Studies of Tofacitinib
Burkhard Moeller¹, Axel Finckh², Jose Maria Alvaro-Gracia³, Godehard Scholz¹, Daniel Aletaha⁴, Francesca Biondo⁵, Sander Strengholt⁶, Jose L Rivas⁷, Carol A Connell⁸ and Harry Shi⁹, ¹Inselspital-University Hospital, Bern, Switzerland, ²University Hospital of Geneva, Geneva, Switzerland, ³Hospital Universitario de La Princesa, Madrid, Spain, ⁴Medical University of Vienna, Vienna, Austria, ⁵Pfizer Inc, Rome, Italy, ⁶Pfizer Inc, Capelle aan den IJssel, Netherlands, ⁷Pfizer SLU, Madrid, Spain, ⁸Pfizer Inc, Groton, CT, ⁹Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. The purpose of this study is to describe the profile of patients…
Abstract Number: 1537 • 2018 ACR/ARHP Annual Meeting
Frequency and Duration of Early Non-Serious Adverse Events in Rheumatoid Arthritis Patients Treated with Tofacitinib 5 Mg Twice Daily As Monotherapy and Combination Therapy
Ara Dikranian¹, Jürgen Wollenhaupt², Valderilio F Azevedo³, Louis Bessette⁴, David Gold⁵, Jose L Rivas⁶, Harry Shi⁷, Lisy Wang⁸, John Woolcott⁷, Andrea Shapiro⁹ and Peter Nash¹⁰, ¹Cabrillo Center for Rheumatic Disease, San Diego, CA, ²Schön Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ³Universidade Federal do Paraná, Curitiba, Brazil, ⁴Laval University, Kirkland, QC, Canada, ⁵Pfizer Canada, Montreal, QC, Canada, ⁶Pfizer SLU, Madrid, Spain, ⁷Pfizer Inc, Collegeville, PA, ⁸Pfizer Inc, Groton, CT, ⁹Pfizer Inc, Peapack, NJ, ¹⁰University of Queensland, Brisbane, Australia
Background/Purpose: Tolerability remains ill-defined in clinical trials and most commonly refers to non-serious adverse events (AEs) that may impact patient (pt) satisfaction and adherence to…
Abstract Number: 1544 • 2018 ACR/ARHP Annual Meeting
Tofacitinib Safety and Efficacy in the Treatment of Rheumatoid Arthritis in a Central/Eastern European Subpopulation
Jiri Vencovsky¹, Janusz Badurski², Šárka Forejtová¹, Olga Lukáčová³, Mykola Stanislavchuk⁴, Daniela Yaneva-Bichovska⁵, Harry Shi⁶, Radu Vasilescu⁷, Tatjana Lukic⁸ and Martin Kabina⁹, ¹Institute of Rheumatology, Prague, Czech Republic, ²Centre of Osteoporosis and Osteoarticular Diseases, Bialystok, Poland, ³National Institute for Rheumatic Diseases, Piešťany, Slovakia, ⁴Vinnytsia Regional Clinical Hospital, Vinnytsia, Ukraine, ⁵Medical Centre Synexus, Sofia, Bulgaria, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Regional Medical Europe, Brussels, Belgium, ⁸Pfizer Inc, New York, NY, ⁹Pfizer Innovative Health, Prague, Czech Republic
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed tofacitinib safety and efficacy in the Central…
Abstract Number: 431 • 2017 ACR/ARHP Annual Meeting
Post-Marketing Surveillance of Tofacitinib in Japanese Patients with Rheumatoid Arthritis: An Interim Report of Safety Data
Tsuneyo Mimori¹, Masayoshi Harigai², Tatsuya Atsumi³, Masataka Kuwana⁴, Syuji Takei⁵, Naoto Tamura⁶, Takao Fujii⁷, Hiroaki Matsuno⁸, Shigeki Momohara⁹, Kazuhiko Yamamoto¹⁰, Takeshi Kokubo¹¹, Yutaka Endo¹¹, Naonobu Sugiyama¹¹, Tomohiro Hirose¹¹, Yosuke Morishima¹¹ and Noritoshi Yoshii¹¹, ¹Kyoto University, Kyoto, Japan, ²Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ³Hokkaido University, Sapporo, Japan, ⁴Nippon Medical School, Tokyo, Japan, ⁵Kagoshima University, Kagoshima, Japan, ⁶Juntendo University, Tokyo, Japan, ⁷Wakayama Medical University, Wakayama, Japan, ⁸Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ⁹Hakkeikai Inc Medical Institution, Shizuoka, Japan, ¹⁰University of Tokyo, Tokyo, Japan, ¹¹Pfizer Japan Inc, Tokyo, Japan
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Efficacy and safety of tofacitinib have been shown in patients…
Abstract Number: 616 • 2017 ACR/ARHP Annual Meeting
Integrated Safety Summary of Tofacitinib in Psoriatic Arthritis Clinical Studies
Gerd R. Burmester¹, Oliver FitzGerald², Kevin Winthrop³, Valderilio F Azevedo⁴, William F C Rigby⁵, Keith S Kanik⁶, Cunshan Wang⁶, Pinaki Biswas⁷, Thomas Jones⁸, Sujatha Menon⁶, Niki Palmetto⁷ and Ricardo Rojo⁶, ¹Charité - University Medicine Berlin, Berlin, Germany, ²Department of Rheumatology, St Vincent's University Hospital, Dublin, Ireland, ³Oregon Health & Science University, Portland, OR, ⁴Universidade Federal do Paraná, Curitiba, Brazil, ⁵Geisel School of Medicine at Dartmouth, Lebanon, NH, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, New York, NY, ⁸Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for psoriatic arthritis (PsA). We describe the safety profile of tofacitinib from integrated Phase (P)3…
Abstract Number: 617 • 2017 ACR/ARHP Annual Meeting
Comparing Tofacitinib Safety Profile in Patients with Psoriatic Arthritis in Clinical Studies with Real-World Data
Jeffrey R. Curtis¹, Huifeng Yun¹, Oliver FitzGerald², Kevin Winthrop³, Valderilio F Azevedo⁴, Gerd R. Burmester⁵, William F C Rigby⁶, Keith S Kanik⁷, Ricardo Rojo⁷, Sujatha Menon⁷, Cunshan Wang⁷, Pinaki Biswas⁸, Thijs Hendrikx⁹ and Niki Palmetto⁸, ¹University of Alabama at Birmingham, Birmingham, AL, ²Department of Rheumatology, St Vincent's University Hospital, Dublin, Ireland, ³Oregon Health & Science University, Portland, OR, ⁴Universidade Federal do Paraná, Curitiba, Brazil, ⁵Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, ⁶Geisel School of Medicine at Dartmouth, Lebanon, NH, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer Inc, New York, NY, ⁹Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of psoriatic arthritis (PsA). Two Phase 3 studies have been completed (NCT01877668;…
Abstract Number: 1602 • 2016 ACR/ARHP Annual Meeting
Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 8 Years
Janet Pope¹, Edward Keystone², Shahin Jamal³, Lisy Wang⁴, Lara Fallon⁵, John Woolcott⁵, Irina Lazariciu⁶ and Boulos Haraoui⁷, ¹Western University, London, ON, Canada, ²Mount Sinai Hospital, Toronto, ON, Canada, ³University of British Columbia, Vancouver, BC, Canada, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Canada, Montreal, QC, Canada, ⁶Quintiles, Saint-Laurent, QC, Canada, ⁷Institut de Rhumatologie de Montréal, Montreal, QC, Canada
Background/Purpose: Tofacitinib is an oral JAK inhibitor for the treatment of RA. Open-label, long-term extension (LTE) studies enrolled tofacitinib-treated patients (pts) to evaluate safety and…
Abstract Number: 2143 • 2015 ACR/ARHP Annual Meeting
A Safety Analysis of Tofacitinib 5mg Twice Daily Administered As Monotherapy or in Combination with Background Conventional Synthetic Dmards in a Phase 3 Rheumatoid Arthritis Population
Alan J Kivitz¹, Boulos Haraoui², Jeffrey Kaine³, Vanessa Castellano⁴, Eustratios Bananis⁴, Carol A Connell⁵, Elaine Hoffman⁵ and Liza Takiya⁶, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Institut de Rhumatologie de Montréal, Montréal, QC, Canada, ³Sarasota Arthritis Research Center, Sarasota, FL, ⁴Pfizer Inc, Collegeville, PA, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, New York, NY
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). In Phase 3 (P3) studies, tofacitinib demonstrated safety and efficacy…
Abstract Number: 2416 • 2015 ACR/ARHP Annual Meeting
Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Pediatric Patients from Six to Less Than Eighteen Years of Age with Juvenile Idiopathic Arthritis
Hermine I. Brunner¹, Nicolino Ruperto², Nikolay Tzaribachev³, Zbigniew Zuber⁴, Elena Koskova⁵, Ivan Foeldvari⁶, Eizbieta Smolewska⁷, Gerd Horneff⁸, Charles Mebus⁹, Umberto Conte¹⁰, Rong Wang⁹, Christine Alvey⁹, Manisha Lamba⁹, Anasuya Hazra¹¹, Daniel Lovell¹² and Alberto Martini¹³, ¹Pediatric Rheumatology Collaborative Study Group, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Istituto G. Gaslini, Pediatria II, PRINTO, Genoa, Italy, ³Pediatric Rheumatology, Bad Bramstedt, Germany, ⁴St Louis Children’s Hospital ODS Rheumatology and Neurology, Krakow, Poland, ⁵Institute of Rheumatic Diseases, Piestany, Slovakia, ⁶Hamburger Zentrum für Kinder-und Jugendrheumatologie, Hamburg, Germany, ⁷Department of Pediatric Cardiology and Rheumatology, Medical University of Lodz, Lodz, Poland, ⁸Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, ⁹Pfizer Inc, Groton, CT, ¹⁰Pfizer Inc, New York, NY, ¹¹Pfizer Inc, Collegeville, PA, ¹²Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ¹³Istituto G. Gaslini, Pediatria II, PRINTO, and University of Genoa, Genoa, Italy
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of adult patients with rheumatoid arthritis (RA). We report the pharmacokinetics (PK), safety and…
Abstract Number: 849 • 2014 ACR/ARHP Annual Meeting
Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Safety and Efficacy in Open-Label, Long-Term Extension up to 6 Years
J. Wollenhaupt¹, J. Silverfield², E.B. Lee³, S.P. Wood⁴, K. Terry⁴, H. Nakamura⁵, K. Kwok⁶, A. Anisfeld⁶, C. Nduaka⁴, R. Riese⁴ and L. Wang⁴, 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, Tokyo, Japan, ⁶Pfizer Inc, New York, NY
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we report tofacitinib safety, tolerability, and durability of response…
Abstract Number: 508 • 2014 ACR/ARHP Annual Meeting
Relationship Between NK Cell Count and Important Safety Events in Rheumatoid Arthritis Patients Treated with Tofacitinib
R. van Vollenhoven¹, Y. Tanaka², R. Riese³, M. Lamba³, T. Kawabata³, T. Hirose⁴, S. Toyoizumi⁴, A. Hazra³ and S. Krishnaswami³, ¹The Karolinska Institute, Stockholm, Sweden, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Pfizer Inc, Groton, CT, ⁴Pfizer Inc, Tokyo, Japan
Background/Purpose: Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Cytokines (e.g. interleukin [IL]-2, -4, -7, -15, -21) involved…

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