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: 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: 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: 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,…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].