MedicalResearch.com Interview with:
Atul A. Deodhar, MD, MRCP, FACP, FACR
Professor of Medicine
Division of Arthritis & Rheumatic Diseases
Medical Director, Rheumatology Clinics
Medical Director, Immunology Infusion Center
Oregon Health & Science University (OHSU)
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Phase 2, randomized, double-blind, placebo–controlled, multicenter trial was designed to evaluate the efficacy and safety of guselkumab (Tremfya®) compared with placebo in adults with active psoriatic arthritis, despite having received treatment with standard-of-care therapies, including anti-tumor necrosis factor (TNF)-alpha agents.
In an observed analysis presented at ACR 2017, more than 70 percent of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 56. Findings also showed that improvements in tender and swollen joints, skin clearance, pain and physical function, and patient-reported quality of life outcomes reported at week 24, were maintained through week 56 in patients receiving guselkumab maintenance therapy (subcutaneous injections every eight weeks).
MedicalResearch.com: What should readers take away from your report?
Response: The Phase 2 study results showed guselkumab was efficacious and well tolerated in the treatment of active psoriatic arthritis. Guselkumab is the first anti-interleukin (IL)-23 monoclonal antibody to demonstrate positive activity in the treatment of this complex immune-mediated inflammatory arthritis that involves the joints and the skin, which is an important and exciting finding for the rheumatology community and for patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Two Phase 3 studies have been initiated to evaluate the efficacy and safety of guselkumab in the treatment of adults with active psoriatic arthritis who may have been previously treated with anti-tumor necrosis factor (TNF) alpha therapies (DISCOVER-1), and in patients who have not received prior treatment with a biologic therapy (DISCOVER-2). Results from these studies will be highly anticipated in the future.
MedicalResearch.com: Is there anything else you would like to add?
Response: Guselkumab (Tremfya®) received FDA approval for the treatment of moderate to severe plaque psoriasis earlier this year, and with these promising results in the treatment of active psoriatic arthritis, it’s exciting to see the potential of this IL-23 targeted therapy for an immune-mediated disease where new therapeutic options are still needed for patients.
Disclosure: I have served as a scientific adviser and clinical study investigator for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, UCB
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ABSTRACT NUMBER: 2878
Efficacy and Safety Results of Guselkumab in Patients with Active Psoriatic Arthritis over 56 Weeks from a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study
Atul A. Deodhar1, Alice B Gottlieb2, Wolf-Henning Boehncke3, Bin Dong4, Yuhua Wang4, Yanli Zhuang4, William Barchuk5, Xie L. Xu5 and Elizabeth Hsia4, 1Division of Arthritis & Rheumatic Diseases OP09, Oregon Health & Science University, Portland, OR, 2Department of Dermatology, New York Medical College, Valhalla, NY, 3Geneva University Hospital and University of Geneva, Geneva, Switzerland, 4Janssen Research & Development, LLC, Spring House, PA, 5Janssen Research & Development, LLC, San Diego, CA
Meeting: 2017 ACR/ARHP Annual Meeting
Date of first publication: September 18, 2017
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