ACR Meeting Abstracts

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  • Abstract Number: 2558 • 2018 ACR/ARHP Annual Meeting

    Efficacy and Safety Outcomes in Patients with Axial Spondyloarthritis Treated with Certolizumab Pegol: Results from the 48-Week Run-in Part of a Withdrawal Study (NCT02505542)

    Robert B.M. Landewé1, Désirée van der Heijde2, Maxime Dougados3, Xenofon Baraliakos4, Filip van Den Bosch5, Bengt Hoepken6, Karen Thomas6 and Lianne S. Gensler7, 1Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam and Zuyderland MC, Heerlen, Netherlands, 2Leiden University Medical Centre, Leiden, Netherlands, 3Rheumatology B Department, Paris-Descartes University and Cochin Hospital, Paris, France, 4Ruhr-University Bochum, Herne, Germany, 5Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium, 6UCB Pharma, Monheim, Germany, 7University of California, San Francisco, CA

    Background/Purpose: C-OPTIMISE is the first trial to evaluate whether certolizumab pegol (CZP) can be reduced/discontinued in patients with radiographic(r)-axSpA/ankylosing spondylitis (AS) and non-radiographic(nr)-axSpA achieving sustained…
  • Abstract Number: 2559 • 2018 ACR/ARHP Annual Meeting

    Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis and Previous Inadequate Response to TNF Inhibitors: Two-Year Follow-up from a Phase 3 Study

    Ana-Maria Orbai1, Amanda M. Gellett2, Lisa Kerr2 and Arnaud Constantin3, 1Johns Hopkins University School of Medicine, Baltimore, MD, 2Eli Lilly and Company, Indianapolis, IN, 3Hopital Pierre-Paul Riquet, Toulouse, France

    Background/Purpose: Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets IL-17A, was superior to placebo (PBO) at Week (Wk) 24 for treating PsA signs and…
  • Abstract Number: 2560 • 2018 ACR/ARHP Annual Meeting

    Efficacy of Guselkumab in Psoriasis Patients with Self-Reported Psoriatic Arthritis with Involvement of the Scalp, Nails, Hands, and Feet: A Pooled Analysis from 2 Pivotal Phase 3 Psoriasis Studies

    Ana-Maria Orbai1, Soumya D Chakravarty2, Yin You3, Shelly Kafka4, Chetan S Karyekar4 and Joseph F. Merola5, 1Johns Hopkins University School of Medicine, Baltimore, MD, 2Janssen Scientific Affairs, LLC/Drexel U School of Medicine, Horsham/Phila, PA, 3Janssen Research & Development, LLC, Spring House, PA, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5Brigham and Women's Hospital and Harvard Medical School, Boston, MA

       Background/Purpose: VOYAGE 1 & 2 were the pivotal Ph3 GUS trials for plaque PsO.1,2 Here we compare efficacy of GUS vs PBO & adalimumab (ADA)…
  • Abstract Number: 2561 • 2018 ACR/ARHP Annual Meeting

    Rapid and Sustained Improvements in Patient-Reported Signs and Symptoms with Ixekizumab in Biologic-Naive and TNF-Inadequate Responder Patients with Psoriatic Arthritis

    Ana-Maria Orbai1, Dafna D Gladman2, Julie Birt3, Amanda M. Gellett3, Chen-Yen Lin3 and Tore Kvien4, 1Johns Hopkins University School of Medicine, Baltimore, MD, 2University of Toronto, Toronto, ON, Canada, 3Eli Lilly and Company, Indianapolis, IN, 4Diakonhjemmet Hospital, Oslo, Norway

    Background/Purpose: Ixekizumab (IXE), a high-affinity mAb that selectively targets IL-17A, has shown improvements up to Week (Wk) 24 across several domains of PsA (including ACR20)…
  • Abstract Number: 2562 • 2018 ACR/ARHP Annual Meeting

    Secukinumab Improves Grappa-Omeract Core Domains of Psoriatic Arthritis

    Ana-Maria Orbai1, Iain B. McInnes2, Laura C. Coates3, M. Elaine Husni4, Dafna D Gladman5, Laure Gossec6, Luminita Pricop7, Olivier Chambenoit8, Xiangyi Meng8 and Philip J. Mease9, 1Johns Hopkins University School of Medicine, Baltimore, MD, 2University of Glasgow, Glasgow, United Kingdom, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 4Cleveland Clinic, Cleveland, OH, 5Toronto Western Research Institute and University of Toronto, Toronto, ON, Canada, 6Université Pierre et Marie Curie and Hôpital Pitié-Salpêtrière, Paris, France, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, 9Swedish Medical Center and University of Washington, Seattle, WA

    Background/Purpose: Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has demonstrated efficacy for patients with psoriatic arthritis (PsA) in multiple phase 3 clinical…
  • Abstract Number: 2563 • 2018 ACR/ARHP Annual Meeting

    Efficacy and Safety of a Potent and Highly Selective Oral Tyrosine Kinase 2 Inhibitor, BMS-986165, in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase II, Randomized, Placebo-Controlled Trial

    Kim A Papp1, Kenneth B. Gordon2, Diamant Thaçi3, Akimichi Morita4, Melinda Gooderham5, Peter Foley6,7,8, Ihab G. Girgis9, Sudeep Kundu9 and Subhashis Banerjee9, 1Clinical Research and Probity Medical Research, Waterloo, ON, Canada, 2Medical College of Wisconsin, Milwaukee, WI, 3University of Luebeck, Luebeck, Germany, 4Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 5SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, ON, Canada, 6The University of Melbourne, Melbourne, Australia, 7St Vincent’s Hospital Melbourne & Probity Medical Research, Melbourne, Australia, 8Skin & Cancer Foundation Inc, Melbourne, Australia, 9Bristol-Myers Squibb, Princeton, NJ

    Background/Purpose: BMS-986165, a potent and highly selective oral tyrosine kinase 2 inhibitor, inhibits signal transducer and activator of transcription (STAT)-dependent signalling pathways of interleukin-23 and…
  • Abstract Number: 2564 • 2018 ACR/ARHP Annual Meeting

    Secukinumab Efficacy in Psoriatic Arthritis: Individual Patient Meta-Analysis of Four Phase 3 Trials in 2049 Patients

    Alice B Gottlieb1, Philip J. Mease2, Bruce Kirkham3, Peter Nash4, Alejandro Balsa5, Bernard Combe6, Juergen Rech7, Ruvie Martin8, Gregory Ligozio8, Ken Abrams8 and Luminita Pricop9, 1Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY, 2Swedish Medical Center and University of Washington, Seattle, WA, 3Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom, 4University of Queensland, Brisbane, Australia, 5Rheumatology, Hospital La Paz - IdiPAZ, Madrid, Spain, 6Rheumatology, CHU Montpellier, Montpellier University, Montpellier, France, 7Universitätsklinikum Erlangen, Erlangen, Germany, 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, 9Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ

    Background/Purpose: Secukinumab provided rapid, significant and sustained improvement in the signs and symptoms of psoriatic arthritis (PsA) in multiple Phase 3 studies.1-4 Herein, we report…
  • Abstract Number: 2565 • 2018 ACR/ARHP Annual Meeting

    Safety and Efficacy of Tofacitinib, an Oral Janus Kinase Inhibitor, up to 36 Months in Patients with Active Psoriatic Arthritis: Data from the Third Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study

    Peter Nash1, Laura C. Coates2, Alan J. Kivitz3, Philip J. Mease4, Dafna D Gladman5, Jose A Covarrubias-Cobos6, Dona Fleishaker7, Cunshan Wang7, Elizabeth Kudlacz7, Sujatha Menon7, Lara Fallon8, Thijs Hendrikx9 and Keith S Kanik7, 1University of Queensland, Brisbane, Australia, 2University of Oxford, Oxford, United Kingdom, 3Altoona Center for Clinical Research, Duncansville, PA, 4Swedish Medical Center and University of Washington, Seattle, WA, 5Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 6Unidad Reumatologica Las Americas S.C.P, Mérida, Yucatan, Mexico, 7Pfizer Inc, Groton, CT, 8Pfizer Canada, Montreal, QC, Canada, 9Pfizer Inc, Collegeville, PA

    Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). We report the safety, tolerability, and efficacy of tofacitinib in…
  • Abstract Number: 2566 • 2018 ACR/ARHP Annual Meeting

    Impact of Guselkumab Versus Placebo and Adalimumab on Patient Reported Outcomes in Patients with and without Psoriatic Arthritis in a Phase 3 Pivotal Psoriasis Study

    Luis Puig1, Chenglong Han2, Ronald Vender3, Michael Song2, Yin You2, Yaung-Kaung Shen2 and Peter Foley4, 1Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona Medical School, Barcelona, Spain, 2Janssen Research & Development, LLC, Spring House, PA, 3McMaster University, Hamilton, ON, Canada, 4University of Melbourne, St. Vincent’s Hospital, Melbourne and Skin & Cancer Foundation Inc., Carlton, Australia

    Background/Purpose: VOYAGE 2 is a phase 3 double-blind, placebo/active comparator-controlled trial comparing guselkumab (GUS) with placebo (PBO) and adalimumab (ADA) in patients (pts) with moderate-to-severe…
  • Abstract Number: 2567 • 2018 ACR/ARHP Annual Meeting

    Clinically Meaningful Improvement in Skin and Nail Psoriasis in Bio-Naïve Active Psoriatic Arthritis Patients Treated with Intravenous Golimumab: Results through Week 24 from a Phase 3 Study

    M. Elaine Husni1, Philip J. Mease2, Soumya D Chakravarty3, Shelly Kafka4, Diane D. Harrison5, Dennis Parenti4, Lilianne Kim5, Kim Hung Lo5, Elizabeth C Hsia6 and Arthur Kavanaugh7, 1Cleveland Clinic, Cleveland, OH, 2Swedish Medical Center & U of Wash School of Medicine, Seattle, WA, 3Janssen Scientific Affairs, LLC/Drexel U School of Medicine, Horsham/Phila, PA, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5Janssen Research & Development, LLC, Spring House, PA, 6Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, PA, 7UCSD, San Diego, CA

    Background/Purpose: GO-VIBRANT was a Phase 3 trial of intravenous (IV) golimumab (GLM) in adult patients (pts) w/active psoriatic arthritis (PsA). To evaluate improvement in skin,…
  • Abstract Number: 2568 • 2018 ACR/ARHP Annual Meeting

    Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial

    Philip J. Mease1, Arthur Kavanaugh2, Andreas Reimold3, Hasan Tahir4, Juergen Rech5, Stephen Hall6, Piet Geusens7, Pellet Pascale8, Evie Maria Delicha9, Luminita Pricop10 and Shephard Mpofu9, 1Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, 2University of California, San Diego, School of Medicine, La Jolla, CA, 3Hospital of Southern Norway, Kristiansand, Norway, 4Rheumatology, Barts Health NHS Trust, London, United Kingdom, 5Universitätsklinikum Erlangen, Erlangen, Germany, 6Monash University,, Melbourne, Australia, 7University of Hasselt, Belgium and Maastricht University Hospital, Maastricht, Netherlands, 8Novartis Pharma AG, basel, Switzerland, 9Novartis Pharma AG, Basel, Switzerland, 10Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ

    Background/Purpose: Secukinumab (SEC), a fully human monoclonal IgG1 antibody, provided rapid and significant improvements in all key clinical domains of psoriatic arthritis (PsA) in the…
  • Abstract Number: 2569 • 2018 ACR/ARHP Annual Meeting

    Association of Enthesitis with Achievement of Normal Quality of Life and Clinical Response in Patients with Non-Radiographic Axial Spondyloarthritis Treated with Adalimumab

    Philip J. Mease1, Filip van Den Bosch2, Uta Kiltz3, Patrick Zueger4, Kun Chen4, Meijing Wu4 and Jaclyn K. Anderson4, 1Swedish Medical Center and University of Washington, Seattle, WA, 2Ghent University, Ghent, Belgium, 3Rheumazentrum Ruhrgebiet, Herne, Germany, 4AbbVie Inc., North Chicago, IL

    Background/Purpose: Enthesitis, a key pathology in non-radiographic axial spondyloarthritis (nr-axSpA), has been difficult to treat with conventional therapies and may take longer to resolve than…
  • Abstract Number: 2570 • 2018 ACR/ARHP Annual Meeting

    Probability of Achieving Low Disease Activity or Remission in Subjects with Active Psa Treated with Apremilast

    Philip J. Mease1, Frank Behrens2, Dafna D Gladman3, Arthur Kavanaugh4, Michele Brunori5, Lichen Teng5, Benoit Guerette5, Rubén Queiro6 and Alexis Ogdie7, 1Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, 2Division of Rheumatology, Goethe University and Fraunhofer IME-TMP, Frankfurt, Germany, 3Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 4University of California, San Diego, School of Medicine, La Jolla, CA, 5Celgene Corporation, Summit, NJ, 6Rheum-Derm Unit, Hospital Universitario Central de Asturias, Oviedo, Spain, 7University of Pennsylvania, Philadelphia, PA

    Background/Purpose: The ability to predict responses to apremilast (APR) could impact treatment decisions. This post-hoc analysis was conducted to (1) assess the predictive values of…
  • Abstract Number: 2571 • 2018 ACR/ARHP Annual Meeting

    Adalimumab Serum Concentration Fails to Predict Achievement of Sustained Remission or Absence of Flare for Patients with Non-Radiographic Axial Spondyloarthritis

    Nisha Kwantra1, Marina Magrey2, Philip J. Mease3, Joachim Sieper4, Robert B.M. Landewé5, Xin Wang6, Apinya Lertratanakul1, Jaclyn K. Anderson1 and Nael Mostafa1, 1AbbVie Inc., North Chicago, IL, 2Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland, OH, 3Swedish Medical Center and University of Washington, Seattle, WA, 4University Clinic Benjamin Franklin, Berlin, Germany, 5Amsterdam Rheumatology & Clinical Immunology Center and Zuyderland Medical Center, Amsterdam; Heerlen, Netherlands, 6AbbVie, North Chicago, IL

    Background/Purpose: In patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA) in the ABILITY-3 study who achieved sustained remission with adalimumab (ADA), continued ADA therapy was…
  • Abstract Number: 2572 • 2018 ACR/ARHP Annual Meeting

    Predictors for Use of Secukinumab 300mg over 150mg in Psoriatic Arthritis: A Meta-Analysis of Four Phase 3 Trials By Machine Learning

    Luminita Pricop1, Corine Gaillez2, Gregory Ligozio3, Xuan Zhu3 and David James3, 1Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, 2Novartis Pharma AG, Basel, Switzerland, 3Novartis Pharmaceuticals Corporation, East Hanover, NJ

    Background/Purpose: Subcutaneous secukinumab 150mg and 300mg are approved doses for the treatment of psoriatic arthritis (PsA) with the higher dose recommended for patients with anti-TNF inadequate…
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