Abstracts tagged "Safety"

Abstract Number: 1647 • 2016 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 Studies over 8 Years
Jürgen Wollenhaupt¹, Joel Silverfield², Eun Bong Lee³, Ketti Terry⁴, Kenneth Kwok⁵, Staci Abramsky⁵, Min Wang⁵, Chudy Nduaka⁶, Ryan DeMasi⁵ and Lisy 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, New York, NY, ⁶Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. The objective of this analysis was to report tofacitinib safety and tolerability…
Abstract Number: 2595 • 2016 ACR/ARHP Annual Meeting
Real World Results from a Post-Approval Safety Surveillance of Tofacitinib (Xeljanz): Over 3 Year Results from an Ongoing US-Based Rheumatoid Arthritis Registry
Arthur F. Kavanaugh¹, Jamie Geier², Clifton Bingham III³, Connie Chen², George W. Reed^4,5, Katherine C. Saunders⁴, Yan Chen⁶, Andrew Koenig⁶, Laura Cappelli⁷, Jeffrey D. Greenberg^4,8 and Joel M. Kremer⁹, ¹University of California, San Diego School of Medicine, LaJolla, CA, ²Pfizer, Inc., New York, NY, ³Johns Hopkins University, Baltimore, MD, ⁴Corrona, LLC, Southborough, MA, ⁵University of Massachusetts Medical School, Worcester, MA, ⁶Pfizer, Inc., Collegeville, PA, ⁷Medicine/Rheumatology, Johns Hopkins University, Baltimore, MD, ⁸NYU School of Medicine, New York, NY, ⁹Albany Medical College and the Center for Rheumatology, Albany, NY
Background/Purpose: An interim analysis of a prospective observational 3+ year study, embedded within the US Corrona Rheumatoid Arthritis (RA) registry (14 years and ongoing), was…
Abstract Number: 2609 • 2016 ACR/ARHP Annual Meeting
The Effectiveness of Zoster Vaccine in RA Patients Subsequently Treated up to 19 Months with Tofacitinib
Kevin L Winthrop¹, Ann Wouters², Ernest H. Choy^3,4, Chudy Nduaka², Staci Abramsky², Pinaki Biswas², Lisy Wang⁵, Jennifer Hodge², Irina Lazariciu⁶, Koshika Soma², Christopher F Mojcik² and William F.C Rigby⁷, ¹Oregon Health and Sciences University, Portland, OR, ²Pfizer Inc, New York, NY, ³CREATE Center, Division of Infection and Immunity, Cardiff University School of Medicine, Cardiff, Great Britain, ⁴CREATE Center, Division of Infection and Immunity,, Cardiff University, Cardiff, United Kingdom, ⁵Pfizer Inc, Groton, CT, ⁶Quintiles, Saint-Laurent, QC, Canada, ⁷Geisel School of Medicine at Dartmouth, Lebanon, NH
Background/Purpose: Rheumatoid arthritis (RA) patients are at increased risk for herpes zoster (HZ), and vaccination is recommended in patients over the age of 50 years,…
Abstract Number: 1639 • 2015 ACR/ARHP Annual Meeting
Clinical Outcomes for Rheumatoid Arthritis Patients Receiving Tofacitinib Monotherapy in the Open-Label Long-Term Extension over 6 Years
Roy Fleischmann¹, Yusuf Yazici², Jürgen Wollenhaupt³, Lisy Wang⁴, Anna Maniccia⁵, Kenneth Kwok⁴, Liza Takiya⁵ and Ronald van Vollenhoven⁶, ¹Rheumatology, Metroplex Clinical Research Center, Dallas, TX, ²New York University Hospital for Joint Diseases, New York, NY, ³Teaching Hospital of the University of Hamburg, Schoen-Klinik Hamburg-Eilbek, Hamburg, Germany, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, New York, NY, ⁶The Karolinska Institute, Stockholm, Sweden
Background/Purpose: Treatment options delivering sustained efficacy when given as monotherapy in RA are limited.1 Tofacitinib is an oral Janus kinase inhibitor for the treatment of…
Abstract Number: 1839 • 2015 ACR/ARHP Annual Meeting
Safety and Immunogenicity of Quadrivalent Human Papilloma Virus (qHPV) Vaccine (Gardasil®) in Systemic Lupus Erythematous (SLE), Phase I Trial Completion
J. Patricia Dhar^1,2, Lynnette Essenmacher³, Renee Dhar⁴, Ardella Magee⁵, Joel Ager⁶ and Robert Sokol⁷, ¹Internal Medicine, Wayne State University, Detroit, MI, ²Internal Medicine, Central Michigan University College of Medicine, Saginaw, MI, ³Wayne State University School of Medicine, Detroit, MI, ⁴CMED medical student, Central Michigan University College of Medicine, Mt. Pleasant, MI, ⁵Clinical and Translational Research Center, Wayne State University, Detroit, MI, ⁶Family Medicine, Wayne State University School of Medicine, Detroit, MI, ⁷Department of Obstetrics & Gynecology, Wayne State University School of Medicine, Detroit, MI
Background/Purpose: Women with SLE are at increased risk for HPV-related cervical disease. The qHPV vaccine immunizes and is protective against HPV types that cause the…
Abstract Number: 2311 • 2015 ACR/ARHP Annual Meeting
Safety of Pregabalin for Treatment of Fibromyalgia Is Comparable Between Subjects with Moderate or Severe Baseline Widespread Pain
Andrew Clair¹ and Birol Emir², ¹Pfizer Inc, New York, NY, ²Primary Care Business Unit, Pfizer Global Research and Development, New York, NY
Background/Purpose: Pregabalin has demonstrated efficacy and safety for the treatment of pain associated with fibromyalgia (FM) and is approved by the US Food and Drug…
Abstract Number: 3000 • 2015 ACR/ARHP Annual Meeting
Intrinsic Gene Expression Subset Predicts Improvement in Systemic Sclerosis Patients during Dasatinib (SprycelTM) Therapy
Viktor Martyanov¹, Jonathan Goldin², Kim Hyun³, Oumar Sy⁴, Wendy Hayes⁴, Shuyan Du⁴, Michael Whitfield¹ and John Varga⁵, ¹Department of Genetics, Geisel School of Medicine at Dartmouth, Hanover, NH, ²David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, ³Radiology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, ⁴Bristol-Myers Squibb, Princeton, NJ, ⁵Division of Rheumatology, Northwestern University, Feinberg School of Medicine, Chicago, IL
Background/Purpose: Intrinsic gene expression subsets are molecular pathway-driven subtypes of systemic sclerosis (SSc) that have been reproduced across multiple cohorts of SSc patients. The goal…
Abstract Number: 3134 • 2015 ACR/ARHP Annual Meeting
Safety and Tolerability of Pirfenidone in Patients with Systemic Sclerosis Interstitial Lung Disease
Dinesh Khanna¹, Carlo Albera², Aryeh Fischer³, James R. Seibold⁴, Nader A. Khalidi⁵, Ganesh Raghu⁶, Lorinda Chung⁷, Elena Schiopu¹, Dan Chen⁸ and Eduard Gorina⁹, ¹University of Michigan, Ann Arbor, MI, ²University of Turin, Turin, Italy, ³National Jewish Health and University of Colorado, Denver, CO, ⁴Scleroderma Research Consultants LLC, Litchfield, CT, ⁵McMaster University, Hamilton, ON, Canada, ⁶University of Washington, Seattle, WA, ⁷Division of Immunology and Rheumatology, Stanford University School of Medicine, Stanford, CA, ⁸Jazz Pharmaceuticals (formerly of InterMune), Palo Alto, CA, ⁹Formerly of InterMune, Brisbane, CA
Background/Purpose: Interstitial lung disease (ILD) is a common and serious complication of systemic sclerosis (SSc). Pirfenidone, a novel antifibrotic agent, has been shown to be…
Abstract Number: 718 • 2014 ACR/ARHP Annual Meeting
Safety of Gardasil® Vaccine in Systemic Lupus Erythematosu, Trial Update
J. Patricia Dhar^1,2, Lynnette Essenmacher³, Renee Dhar^4,5, Ardella Magee⁶, Harpreet Sagar², Malini Venkatram⁷ and Robert Sokol⁸, ¹Internal Medicine, Central Michigan University College of Medicine, Saginaw, MI, ²Internal Medicine/Rheumatology, Wayne State University, Detroit, MI, ³Wayne State University, Detroit, MI, ⁴Clinical Research Center, Wayne State University, Detroit, MI, ⁵CMED medical student,, Central Michigan University College of Medicine, Mount Pleasant, MI, ⁶Clinical Research Center, Wayne State University, Detroit, MI, ⁷Division of Rheumatology, Wayne State University, Detroit, MI, ⁸Obstetrics and Gynecology, Wayne State University, Detroit, MI
Background/Purpose: Cervical neoplasia is increased in women with SLE presumably due to cervical infection with oncogenic Human Papillomavirus (HPV) types which persist in an immunosuppressed…
Abstract Number: 1565 • 2013 ACR/ARHP Annual Meeting
RNA-Sequencing Confirms Clinical Safety Of Herpes Zoster Vaccine
Christopher J. Lessard^1,2, Indra Adrianto³, Joel M. Guthridge⁴, John A. Ice³, Graham B. Wiley³, Stuart B. Glenn³, Judith A. James^1,2, Joan T. Merrill¹, Patrick M. Gaffney¹, Courtney G. Montgomery³, Kathy L. Sivils^1,5 and Eliza Chakravarty³, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²College of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, ³Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁵University of Oklahoma Health Sciences Center, Oklahoma City, OK
Background/Purpose: SLE patients have increased risk of Herpes Zoster (HZ). A live-attenuated vaccine is available for healthy persons > 50 years old, but its safety…
Abstract Number: 2835 • 2013 ACR/ARHP Annual Meeting
Safety Of Gardasil® Vaccine In Systemic Lupus Erythematosus
J. Patricia Dhar¹, Lynnette Essenmacher², Renee Dhar³, Ardella Magee⁴, Joel Ager⁵, Malini Venkatram¹, Harpreet Sagar¹ and Robert Sokol⁶, ¹Internal Medicine/Rheumatology, Wayne State University, Detroit, MI, ²Wayne State University, Detroit, MI, ³Department of Clinical and Translational Research, Wayne State University, Detroit, MI, ⁴Clinical Research Center, Wayne State University, Detroit, MI, ⁵Family Medicine Department, Wayne State University, Detroit, MI, ⁶Obstetrics and Gynecology, Wayne State University, Detroit, MI
Background/Purpose: Cervical neoplasia is increased in women with SLE presumably due to cervical infection with oncogenic Human Papillomavirus (HPV) types which persist in an immunosuppressed…
Abstract Number: 1606 • 2013 ACR/ARHP Annual Meeting
Overview Of The Safety Of Epratuzumab In Systemic Lupus Erythematosus
Daniel J. Wallace¹, Josep Ordi-Ros², C. Michael Neuwelt³, Kenneth Kalunian⁴, Michelle A. Petri⁵, Slawomir Jeka⁶, Ronald F. van Vollenhoven⁷, Brian Kilgallen⁸, Sabine Bongardt⁹, Caroline Gordon¹⁰ and Vibeke Strand¹¹, ¹Cedars-Sinai Medical Center, Los Angeles, CA, ²Internal Medicine, Vall De Hebron General Hospt, Barcelona, Spain, ³East Bay Rheumatology Research Institute, San Leandro, CA, ⁴UCSD School of Medicine, La Jolla, CA, ⁵Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ⁶2nd University Hospital in Bydgoszcz Medical College of Nicolaus Copernicus University, Bydgoszcz, Poland, ⁷Clinical Trials Unit Department of Rheumatology, The Karolinska Institute, Stockholm, Sweden, ⁸UCB Pharma, Raleigh, NC, ⁹UCB Pharma, Brussels, Belgium, ¹⁰Rheumatology Research Group (East Wing), School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom, ¹¹Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA
Background/Purpose: The efficacy and safety of epratuzumab, a monoclonal antibody targeting CD22, has been evaluated in patients with moderate-to-severe systemic lupus erythematosus (SLE). A pooled…
Abstract Number: 627 • 2012 ACR/ARHP Annual Meeting
Zostavax Vaccine Is Safe in Lupus Patients with Low Disease Activity
Eliza F. Chakarvarty¹, Joel M. Guthridge², Joan T. Merrill³, Abigail Cogman², Tiny Powe¹, Virginia C. Roberts⁴ and Judith A. James⁵, ¹Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, CA, ²Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ³Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Arthritis Immunology, OMRF, Oklahoma City, OK, ⁵Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: The Zostavax vaccine was FDA approved in 2006 for the prevention of herpes zoster in healthy adults over age 50. Because it is…
Abstract Number: 150 • 2012 ACR/ARHP Annual Meeting
Ulodesine (BCX4208) Long-Term Safety When Added to Allopurinol in the Chronic Management of Gout: A Phase 2 24-Week Blinded Safety Extension and Vaccine Challenge Study
Alan S. Hollister¹, Andreas Maetzel¹, Michael A. Becker², Robert Terkeltaub³, David Fitz-Patrick⁴, Valerie Smith⁵ and William P. Sheridan⁶, ¹Development, BioCryst Pharmaceuticals, Inc., Durham, NC, ²Medicine, University of Chicago, Chicago, IL, ³Medicine-Rheumatology, VA Medical Ctr/University of California San Diego, San Diego, CA, ⁴East-West Medical Research Institute, Honolulu, HI, ⁵Pharpoint Research, Inc., Durham, NC, ⁶BioCryst Pharmaceuticals, Inc., Durham, NC
Background/Purpose: A majority of gout patients treated with 300 mg/d allopurinol do not reach the therapeutic goal range serum uric acid concentration (sUA) of 4…

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