Abstracts tagged "Psoriatic arthritis and safety"

Abstract Number: 1657 • 2018 ACR/ARHP Annual Meeting
The Effect of Guselkumab on Enthesitis: Results from a Phase 2 Study in Patients with Active Psoriatic Arthritis
Philip Helliwell¹, Alice B Gottlieb², Atul A. Deodhar³, Wolf-Henning Boehncke⁴, Dennis McGonagle¹, Xie L. Xu⁵, Stephen Xu⁵, Yuhua Wang⁵, Elizabeth C Hsia^5,6, Chetan S Karyekar⁵ and Philip J. Mease⁷, ¹U of Leeds, Leeds, United Kingdom, ²NY Medical College, Metropolitan Hospital, NY, NY, ³Oregon Health & Science U, Portland, OR, ⁴U of Geneva, Geneva, Switzerland, ⁵Janssen Research & Development, LLC, Spring House, PA, ⁶U Penn School of Medicine, Phila, PA, ⁷Swedish Medical Center & U of Wash, Seattle, WA
Background/Purpose: In a Phase 2 study, Guselkumab (GUS) was shown to be safe & effective in pts w/active PsA w/meaningful improvements in enthesitis. To evaluate…
Abstract Number: 605 • 2017 ACR/ARHP Annual Meeting
Ixekizumab Exhibits a Favorable Safety Profile during 24 Weeks of Treatment in Subjects with Active Psoriatic Arthritis: Integrated Safety Analysis of Two Randomized, Placebo Controlled, Phase III Clinical Trials
Philip J Mease¹, Gerd R. Burmester², Susan Moriarty³, Olivier Benichou³, Wen Xu³ and Peter Nash⁴, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, ³Eli Lilly and Company, Indianapolis, IN, ⁴University of Queensland, Brisbane, Australia
Background/Purpose: Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets IL-17A. The objective of this analysis is to report the integrated safety of…
Abstract Number: 624 • 2017 ACR/ARHP Annual Meeting
Ixekizumab Provides Sustained Improvement in Signs and Symptoms in Patients with Active Psoriatic Arthritis: Two Year Results from a Phase 3 Trial
Philip S. Helliwell¹, Eric Lespessailles², Catherine Shuler³, Lotus Mallbris³, Janelle Erickson³ and Roy Fleischmann⁴, ¹St. Luke's Hospital and University of Leeds, Bradford, United Kingdom, ²University Orleans, Orleans, France, ³Eli Lilly and Company, Indianapolis, IN, ⁴Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets IL-17A. In the SPIRIT-P1 phase 3 study (NCT01695239), IXE was superior to placebo…
Abstract Number: 2969 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis and Previous Inadequate Response to TNF Inhibitors: 52-Week Results from a Phase 3 Study
Mark C. Genovese¹, Bernard Combe², Joel Kremer³, David Adams⁴, Chin Lee⁴, Lisa Kerr⁴ and Peter Nash⁵, ¹Stanford University Medical Center, Palo Alto, CA, ²Rheumatology, CHU Lapeyronie and Montpellier University, Montpellier, France, ³St. Peter's Hospital, Albany, NY, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵University of Queensland, Brisbane, Australia
Background/Purpose: Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets interleukin-17A. In patients with active psoriatic arthritis (PsA) who had an inadequate response…
Abstract Number: 1726 • 2016 ACR/ARHP Annual Meeting
An Integrated Safety Data Analysis Across All Phase II and Phase III Clinical Programs for Ustekinumab in Psoriatic Arthritis, Crohn’s Disease, and Psoriasis
Lianne S. Gensler¹, Elizabeth C. Hsia², Christopher Gasink², Bruce Randazzo², Dennis Parenti³, Steve Fakharzadeh³, Kehzen L. Tang² and Soumya Chakravarty³, ¹Medicine/Rheumatology, UCSF, San Francisco, CA, ²Janssen Research & Development, LLC, Spring House, PA, ³Janssen Scientific Affairs, LLC, Horsham, PA
Background/Objective:Therapeutic decisions are based on efficacy, but clinicians need to consider medication safety in this process. Here, we report ustekinumab (UST) integrated safety data in…
Abstract Number: 1704 • 2016 ACR/ARHP Annual Meeting
Consistent Safety and Tolerability of Secukinumab over Long-Term Exposure in Patients with Active Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses
Philip J Mease¹, Iain B McInnes², Kristian Reich³, Mats Andersson⁴, Aiyang Tao⁵, Todd Fox⁴ and Chetan Karyekar⁵, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²University of Glasgow, Glasgow, Great Britain, ³Dermatologikum Hamburg and Georg-August-University Göttingen, Hamburg, Germany, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Pooled safety data from the psoriasis (PsO) and psoriatic arthritis (PsA) clinical trial programs of secukinumab (SEC), through approximately 1 year, have been reported…
Abstract Number: 2840 • 2015 ACR/ARHP Annual Meeting
Long-Term (104 Week) Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials
Philip J. Mease¹, Adewale O. Adebajo², Dafna D. Gladman³, Juan J. Gomez-Reino⁴, Stephen Hall⁵, Arthur Kavanaugh⁶, Eric Lespessailles⁷, Georg A. Schett⁸, Kamal Shah⁹, Lichen Teng⁹ and Jürgen Wollenhaupt¹⁰, ¹Clinical Professor, University of Washington School of Medicine, Seattle, WA, ²University of Sheffield, Sheffield, United Kingdom, ³Toronto Western Research Institute, Toronto, ON, Canada, ⁴Rheumatology, Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, ⁵Monash University, Melbourne, Australia, ⁶University of California, San Diego School of Medicine, LaJolla, CA, ⁷University of Orléans, Orléans, France, ⁸University of Erlangen-Nuremberg, Erlangen, Germany, ⁹Celgene Corporation, Warren, NJ, ¹⁰Schön Klinik Hamburg Eilbek, Hamburg, Germany
Background/Purpose: Apremilast (APR), a phosphodiesterase 4 inhibitor, helps regulate the immune responses in psoriatic arthritis (PsA). PALACE 1-3 compared APR efficacy/safety with placebo in patients…
Abstract Number: 2866 • 2015 ACR/ARHP Annual Meeting
Effectiveness and Safety of Golimumab in the Treatment of Psoriatic Arthritis over a 12 Month Period
Proton Rahman¹, Michel Zummer², William G Bensen³, Isabelle Fortin⁴, Dalton Sholter⁵, Milton F. Baker⁶, Regan Arendse⁷, Eliofotisti Psaradellis⁸, Emmanouil Rampakakis⁹, Francois Nantel¹⁰, Allen J Lehman¹⁰, Cathy Tkaczyk¹¹, Karina Maslova¹⁰ and Brendan Osborne¹¹, ¹Medicine, Memorial University, St John's, NF, Canada, ²Rheumatology, Hôpital Maisonneuve-Rosemont and University of Montreal, Montreal, QC, Canada, ³St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, ⁴Centre de Rhumatologie de l'Est du Québec, Rimouski, QC, Canada, ⁵Rheumatology Associates, Edmonton, AB, Canada, ⁶VIHA, Victoria, BC, Canada, ⁷University of Saskatchewan, Saskatoon, SK, Canada, ⁸JSS Medical Research, Montreal, QC, Canada, ⁹JSS Medical Research, St-Laurent, QC, Canada, ¹⁰Janssen Inc., Toronto, ON, Canada, ¹¹Medical Affairs, Janssen Inc., Toronto, ON, Canada
Background/Purpose: The efficacy and tolerability of golimumab (GLM) in patients with psoriatic arthritis (PsA) has been demonstrated in several controlled clinical trials. Longitudinal observational studies…
Abstract Number: 2886 • 2015 ACR/ARHP Annual Meeting
Secukinumab Safety and Tolerability in Patients with Active Psoriatic Arthritis and Psoriasis: Results from a Pooled Safety Analysis
Philip J. Mease¹, Iain B. McInnes², Alice B. Gottlieb³, Albert Widmer⁴, Luminita Pricop⁵ and Shephard Mpofu⁴, ¹Rheumatology Research, Swedish Medical Center, Seattle, WA, ²Immunology, Infection and Inflammation, University of Glasgow, Glasgow, United Kingdom, ³Dermatology, Tufts Medical Center, Boston, MA, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Integrated Hospital Care (IHC) Franchise, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Secukinumab, a fully human anti–interleukin-17A monoclonal antibody, has been shown to improve the signs and symptoms of psoriasis and psoriatic arthritis (PsA).1–3 Here, we…
Abstract Number: 1556 • 2014 ACR/ARHP Annual Meeting
Integrated Safety of Ustekinumab in Psoriatic Arthritis: 2 Year Follow-up from the Psoriatic Arthritis Clinical Development Program
Arthur Kavanaugh¹, Iain B. McInnes², Christopher T. Ritchlin³, Proton Rahman⁴, Lluís Puig Sanz⁵, Alice B. Gottlieb⁶, Michael Song⁷, Bruce Randazzo⁷, Shu Li⁷, Yin You⁷ and Alan M. Mendelsohn⁸, ¹University of California San Diego, La Jolla, CA, ²University of Glasgow, Glasgow, United Kingdom, ³Allergy Immunology & Rheumatology, University of Rochester Medical Center, Rochester, NY, ⁴Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁵Dermatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, ⁶Tufts Medical Center, Boston, MA, ⁷Janssen Research & Development, LLC., Spring House, PA, ⁸Immunology, Janssen Research & Development, LLC., Spring House, PA
Background/Purpose: To report the safety of ustekinumab(UST) from the psoriatic arthritis (PsA)development program. Methods: Safety data through up to 2yrs of follow-up were pooled from…
Abstract Number: 323 • 2013 ACR/ARHP Annual Meeting
Safety Of Ustekinumab From The Placebo-Controlled Periods Of Psoriatic Arthritis and Psoriasis Clinical Developmental Programs
Iain B. McInnes¹, Kim Papp², Lluis Puig³, Kristian Reich⁴, Christopher T. Ritchlin⁵, Bruce Strober⁶, Proton Rahman⁷, Arthur Kavanaugh⁸, Alan M. Mendelsohn⁹, Michael Song¹⁰, Daphne Chan¹⁰, Yaung-Kaung Shen¹⁰, Shu Li¹⁰ and Alice B. Gottlieb¹¹, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Probity Research, Waterloo, ON, Canada, ³Universitat Autònoma de Barcelona, Barcelona, Spain, ⁴SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany, ⁵Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, ⁶University of Connecticut, Farmington, CT, ⁷Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁸University of California, San Diego, La Jolla, CA, ⁹Immunology, Janssen Research & Development, LLC., Spring House, PA, ¹⁰Janssen Research & Development, LLC., Spring House, PA, ¹¹Tufts Medical Center, Boston, MA
Background/Purpose: To describe the short-term safety experience of UST during the double-blind, PBO-controlled portion of the PsA & PsO clinical developmental programs. Methods: Safety…
Abstract Number: 324 • 2013 ACR/ARHP Annual Meeting
Long-Term Safety Of Ustekinumab: 5 Years Of Follow-Up From The Psoriasis Clinical Development Program Including Patients With Psoriatic Arthritis
Kim Papp¹, Christopher E.M Griffiths², Kenneth B. Gordon³, Mark Lebwohl⁴, Philippe O. Szapary⁵, Yasmine Wasfi⁵, Daphne Chan⁵, Yaung-Kaung Shen⁵, Vincent Ho⁶, Pierre-Dominique Ghislain⁷, Bruce Strober⁸ and Kristian Reich⁹, ¹Probity Research, Waterloo, ON, Canada, ²Dermatology Centre, University of Manchester, Manchester, United Kingdom, ³Feinberg School of Medicine, Northwestern University, Chicago, IL, ⁴Mount Sinai Medical Center, New York, NY, ⁵Janssen Research & Development, LLC., Spring House, PA, ⁶University of British Columbia, Vancouver, BC, Canada, ⁷7. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain,, Brussels, Belgium, ⁸University of Connecticut, Farmington, CT, ⁹SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany
Background/Purpose: Ustekinumab(UST) is approved for moderate-to-severe psoriasis (PsO), and is currently in Phase 3 development for psoriatic arthritis (PsA). We report the long-term safety experience…
Abstract Number: 2218 • 2012 ACR/ARHP Annual Meeting
5 Year Safety, Efficacy, and Radiographic Data in Patients with Active Psoriatic Arthritis Treated with Golimumab: Results From the Long-Term Extension of a Randomized, Placebo-Controlled Study
Arthur Kavanaugh¹, Desiree M. van der Heijde², Iain B. McInnes³, Philip J. Mease⁴, Gerald G. Krueger⁵, Dafna D. Gladman⁶, Yiying Zhou⁷, J. D. Lu⁸, Zhenhua Xu⁹, Lenore Noonan¹⁰ and Anna Beutler⁹, ¹UCSD School of Medicine, La Jolla, CA, ²Dept of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ³University of Glasgow, Glasgow, United Kingdom, ⁴Rheumatology Research, Swedish Medical Center, Seattle, WA, ⁵School of Medicine, University of Utah, Salt Lake City, UT, ⁶Division of Rheumatology, Toronto Western Hospital and University of Toronto, Toronto, ON, Canada, ⁷Biostatistics, Janssen Research & Development, LLC., Spring House, PA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Research & Development, LLC., Spring House, PA, ¹⁰Immunology, Janssen Research & Development, LLC., Spring House, PA
5 year safety, efficacy, and radiographic data in patients with active psoriatic arthritis treated with golimumab: Results from the long-term extension of the randomized, placebo-controlled,…

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