title: Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study).
abstract: OBJECTIVE
  Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).
  
  
  METHODS
  Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs).
  
  
  RESULTS
  126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8-69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8-72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1-0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate).
  
  
  CONCLUSIONS
  Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years.
  
  
  BACKGROUND
  NCT00265096.
authors.affiliation: Division of Rheumatology, Allergy, Immunology, University of California, San Diego, La Jolla, California, USA.
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
authors.affiliation: Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, UK.
authors.forename: Iain B
authors.initials: IB
authors.lastname: McInnes
authors.affiliation: Department of Rheumatology, Swedish Medical Center, University of Washington, Seattle, Washington, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
authors.affiliation: Department of Dermatology, University of Utah, Salt Lake City, Utah, USA.
authors.forename: Gerald G
authors.initials: GG
authors.lastname: Krueger
authors.affiliation: Toronto Western Research Institute, Toronto, Ontario, Canada.
authors.forename: Dafna
authors.initials: D
authors.lastname: Gladman
authors.affiliation: Director of Imaging Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
authors.affiliation: Department of Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
authors.forename: Yiying
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Department of Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
authors.forename: Jiandong
authors.initials: J
authors.lastname: Lu
authors.affiliation: Biologics Clinical Pharmacology, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
authors.forename: Jocelyn H
authors.initials: JH
authors.lastname: Leu
authors.affiliation: Department of Immunology, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
authors.forename: Neil
authors.initials: N
authors.lastname: Goldstein
authors.affiliation: Department of Immunology, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Beutler
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011859:Radiography; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate
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