Abstracts tagged "Adverse events"

Abstract Number: 1516 • 2018 ACR/ARHP Annual Meeting
Infection Events in Japanese Patients with Rheumatoid Arthritis Treated with Tofacitinib: Interim All-Case Post-Marketing Surveillance
Naoto Tamura¹, Masataka Kuwana², Tatsuya Atsumi³, Syuji Takei⁴, Masayoshi Harigai⁵, Takao Fujii⁶, Hiroaki Matsuno⁷, Tsuneyo Mimori⁸, Shigeki Momohara⁹, Kazuhiko Yamamoto¹⁰, Yoshinari Takasaki¹¹, Kazuto Nomura¹², Yutaka Endo¹², Tomohiro Hirose¹², Yosuke Morishima¹², Naonobu Sugiyama¹², Noritoshi Yoshii¹² and Michiaki Takagi¹³, ¹Juntendo University, Tokyo, Japan, ²Nippon Medical School, Tokyo, Japan, ³Hokkaido University, Sapporo, Japan, ⁴Medical Center for Children, Kagoshima, Japan, ⁵Tokyo Women’s Medical University, Tokyo, Japan, ⁶Wakayama Medical University, Wakayama, Japan, ⁷Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ⁸Kyoto University, Kyoto, Japan, ⁹Hakkeikai Inc Medical Institution, Shizuoka, Japan, ¹⁰The University of Tokyo, Tokyo, Japan, ¹¹Juntendo Koshigaya Hospital, Juntendo University Faculty of Medicine, Saitama, Japan, ¹²Pfizer Japan Inc, Tokyo, Japan, ¹³Yamagata University Faculty of Medicine, Yamagata, Japan
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. Previously, the efficacy and safety of tofacitinib were demonstrated in patients (pts)…
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: 1529 • 2018 ACR/ARHP Annual Meeting
Long-Term, Real-World Safety of Adalimumab in Rheumatoid Arthritis
Leslie R. Harrold^1,2, Jenny Griffith³, Heather J Litman⁴, Bernice Gershenson¹, Syed Islam³, Christine J Barr², Dianlin Guo³, Patrick Zueger⁵, Jonathan Fay³ and Jeffrey Greenberg^2,6, ¹University of Massachusetts Medical School, Worcester, MA, ²Corrona, LLC, Waltham, MA, ³AbbVie, Inc., North Chicago, IL, ⁴Corrona LLC, Waltham, MA, ⁵AbbVie Inc., North Chicago, IL, ⁶New York University School of Medicine, New York, NY
Background/Purpose: The incidence of adverse events (AE) among rheumatology medication users has not been well documented in real-world disease registry datasets in the US. We…
Abstract Number: 2582 • 2018 ACR/ARHP Annual Meeting
Post-Marketing Safety of Secukinumab in Adult Patients with Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Cumulative Analysis across >96,000 Patient-Treatment Years Exposure
Atul A. Deodhar¹, Dafna D Gladman², Iain B. McInnes³, Filip van Den Bosch⁴, Abhijit Shete⁵, Ruquan You⁶, Samina Hussain⁷ and Jorge Safi⁸, ¹Oregon Health & Science University, Portland, OR, ²Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁴Rheumatology, Ghent University Hospital and VIB Ghent University, Gent, Belgium, ⁵Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland, ⁶Shanghai Novartis Trading Limited, Shanghai, China, ⁷Novartis Healthcare Private Limited, Hyderabad, India, ⁸Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ
Background/Purpose: Secukinumab, a fully human monoclonal IgG1 antibody that selectively neutralizes IL-17A, is currently approved in >75 countries for use in psoriasis /psoriatic arthritis and…
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: 2585 • 2018 ACR/ARHP Annual Meeting
Secukinumab Immunogenicity in Patients with Psoriatic Arthritis and Ankylosing Spondylitis during a 52-Week Treatment Period
Atul A. Deodhar¹, Dafna D Gladman², Iain B. McInnes³, Vibeke Strand⁴, Mengyuan Ren⁵, Sebastian Spindeldreher⁶, Luminita Pricop⁷, Brian Porter⁷, Jorge Safi⁷, Abhijit Shete⁸ and Gerard Bruin⁶, ¹Oregon Health & Science University, Portland, OR, ²Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁴Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁵Novartis Pharmaceuticals, Shanghai, China, ⁶Novartis Institutes for BioMedical Research, Basel, Switzerland, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, ⁸Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland
Background/Purpose: Secukinumab, a fully human monoclonal IgG1 antibody (mAb) that selectively targets IL-17A, is efficacious for the treatment of psoriasis, psoriatic arthritis (PsA) and ankylosing…
Abstract Number: 1539 • 2018 ACR/ARHP Annual Meeting
Safety of Methotrexate and Leflunomide Combination Therapy in the Treatment of Rheumatoid Arthritis
María Badilla¹, Nicia Moldenhauer², Diego Neira³, Luis Muñoz⁴ and Oscar Neira¹, ¹Rheumatology Section., Hospital del Salvador, Universidad de Chile., Santiago, Chile, ²Rheumatology Section, Hospital del Salvador, Universidad de Chile, Santiago, Chile, ³Internal Medicine Departament, Hospital del Salvador, Universidad de Chile, Santiago, Chile, ⁴Pharmacy Department, Hospital del Salvador, Santiago, Chile
Background/Purpose: Best treatment of Rheumatoid Arthritis (RA) requires to begin early, with a tight control, including nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, disease-modifying antirheumatic drugs (DMARDs)…
Abstract Number: 2604 • 2018 ACR/ARHP Annual Meeting
Incidence of Serious Gastrointestinal Events and Inflammatory Bowel Disease Among Tildrakizumab-Treated Patients with Moderate to Severe Plaque Psoriasis: Data from 3 Large Randomized Clinical Trials
Melinda Gooderham¹, Boni E. Elewski², David M. Pariser³, Howard Sofen⁴, Alan M Mendelsohn⁵, Nicole Cichanowitz⁶ and Qing Li⁶, ¹Probity Medical Research, and Skin Center for Dermatololgy, Waterloo, and Peterborough, ON, Canada, ²University of Alabama at Birmingham, Birmingham, AL, ³Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, ⁴Ronald Reagan UCLA Medical Center, Department of Medicine (Dermatology) UCLA, Los Angeles, CA, ⁵Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁶Merck & Co., Inc., Kenilworth, NJ
Background/Purpose: Tildrakizumab (TIL), a high-affinity, humanized, immunoglobulin G1κ, anti–interleukin-23p19 monoclonal antibody, has demonstrated efficacy in the treatment of chronic plaque psoriasis.1,2 Here, we evaluate the…
Abstract Number: 1542 • 2018 ACR/ARHP Annual Meeting
Real-World Data from a Post-Approval Safety Surveillance Study of Tofacitinib Vs Biologic Dmards and Conventional Synthetic Dmards: Five-Year Results from a US-Based Rheumatoid Arthritis Registry
Joel Kremer¹, Laura C. Cappelli², Carol J. Etzel³, Jeffrey Greenberg³, Jamie Geier⁴, Ann Madsen⁴, Connie Chen⁴, Alina Onofrei³, Christine J Barr³, Dimitrios A. Pappas³, Kimberly J Dandreo³, Andrea Shapiro⁵, Carol A Connell⁶ and Arthur Kavanaugh⁷, ¹Albany Medical College and the Center for Rheumatology, Albany, NY, ²Johns Hopkins University, Baltimore, MD, ³Corrona LLC, Waltham, MA, ⁴Pfizer Inc, New York, NY, ⁵Pfizer Inc, Peapack, NJ, ⁶Pfizer Inc, Groton, CT, ⁷University of California, San Diego School of Medicine, La Jolla, San Diego, CA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. A prospective observational 5-year study, embedded within the US Corrona RA registry,…
Abstract Number: 2723 • 2018 ACR/ARHP Annual Meeting
Patient Experience in ANCA-Associated Vasculitis Evolves over Time from Diagnosis and Both Benefits and Adverse Impacts Are Felt with Current Therapy
Peter Rutherford¹, Dieter Goette¹, James O`Donoghue² and Xierong Liu², ¹Medical Affairs, Vifor Pharma, Zurich, Switzerland, ²Elma Research, London, United Kingdom
Background/Purpose: ANCA-associated vasculitis (AAV) leads to both acute illness and a long-term condition in which the disease remits and relapses. Therapy is often complex and…
Abstract Number: 346 • 2018 ACR/ARHP Annual Meeting
Immune-Related Adverse Events: Development of a Pilot Immune-Related Adverse Events Clinic for Expedited and Effective Patient Care
Pankti Reid¹ and Reem Jan², ¹Internal Medicine, rheumatology, University of Chicago, Chicago, IL, ²Medicine, Rheumatology, University of Chicago, Chicago, IL
Background/Purpose: The growing use of cancer immunotherapy and checkpoint inhibitors has led to a steep rise in immune-related adverse events (irAEs). Despite expanding research efforts,…
Abstract Number: 1612 • 2018 ACR/ARHP Annual Meeting
Myocardial Infarctions Among Ankylosing Spondylitis Patients in a Large US Insurance Database
Maureen Dubreuil¹, Christine Peloquin², David T. Felson³ and Tuhina Neogi³, ¹Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston, MA, ²Clinical Epidemiology Unit, Boston University School of Medicine, Boston, MA, ³Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, MA
Background/Purpose: Risk of myocardial infarction (MI) is estimated to be increased up to 60% in ankylosing spondylitis (AS). Studies in patients with rheumatoid arthritis, psoriatic…
Abstract Number: 2724 • 2018 ACR/ARHP Annual Meeting
Variable Response to Induction Therapy and Significant Burden of Treatment Adverse Events over the First 12 Months in Incident ANCA-Associated Vasculitis (AAV) Patients – a Study of Routine Clinical Practice in the EU
Peter Rutherford¹, Dieter Goette¹, Melinda Stamm² and Xierong Liu², ¹Medical Affairs, Vifor Pharma, Zurich, Switzerland, ²Elma Research, London, United Kingdom
Background/Purpose: Aims of therapy in incident AAV patients include ensuring rapid diagnosis, assessment of comorbidity, disease activity, and vasculitis damage before commencing treatment with a…
Abstract Number: 350 • 2018 ACR/ARHP Annual Meeting
Clinical Correlates of Immune-Related Adverse Events for Patients with Melanoma Treated with Checkpoint Inhibitors and a Noted Significant Difference in Peripheral Lymphocyte Counts
Pankti Reid¹, Tara Chongsuwat², Anisha Dua³ and Jason Luke⁴, ¹Internal Medicine, rheumatology, University of Chicago, Chicago, IL, ²Oncology Research Coordinator, University of Chicago, Chicago, IL, ³Medicine, University of Chicago, Chicago, IL, ⁴Hematology Oncology, University of Chicago, Chicago, IL
Background/Purpose: Checkpoint immunotherapy has become the standard of care in treating advanced melanoma. These medications have been associated with immune-related adverse events (irAEs). Accurate methods…
Abstract Number: 1768 • 2018 ACR/ARHP Annual Meeting
Kidney Involvement, Poor Performance Status, and Higher Cumulative Dose of Glucocorticoid Are the Risk Factors of the Discontinuation of Immunosuppressant in Patients with Antineutrophil Cytoplasmic Antibody Associated Vasculitis
Takamasa Murosaki, Takeo Sato, Katsuya Nagatani and Seiji Minota, Department of Internal Medicine, Division of Rheumatology/Clinical Immunology, Jichi Medical University, Shimotsuke, Japan
Background/Purpose: The use of immunosuppressant (IS) with glucocorticoid is recommended as remission induction treatment for severe cases with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV).…

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