title: Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  Golimumab, administered subcutaneously every 4 weeks, has been shown to be effective in reducing the signs and symptoms of active psoriatic arthritis (PsA) through week 24 of the GO-REVEAL study. Herein we report 1-year clinical, radiographic, and safety findings.
  
  
  METHODS
  Adult patients with active PsA (≥3 swollen and ≥3 tender joints) were randomly assigned to receive subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks through week 20. At week 16, patients with <10% improvement from baseline in swollen and tender joint counts entered a blinded early escape phase, with placebo crossover to golimumab 50 mg, golimumab 50 mg increased to 100 mg, and golimumab 100 mg continued at 100 mg. Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24. Findings through 1 year are reported, including the second of 2 coprimary end points (i.e., change from baseline to week 24 in PsA-modified Sharp/van der Heijde score [SHS]).
  
  
  RESULTS
  A total of 405 patients were randomized: 113 to placebo and 146 each to the golimumab 50 mg and 100 mg groups. Mean changes in PsA-modified SHS from baseline to week 24 for the combined golimumab 50 mg and 100 mg group (-0.09) and the golimumab 50 mg group (-0.16) were significantly different versus placebo (0.27) (P = 0.015 and P = 0.011, respectively). Radiographic benefit was maintained through week 52 with golimumab. Clinical efficacy, including improvement in joint and skin responses and physical function, was maintained through 1 year. The frequency/types of adverse events were similar to those reported through week 24.
  
  
  CONCLUSIONS
  Treatment of PsA with golimumab inhibited structural damage progression and demonstrated continued clinical efficacy and safety through 1 year.
authors.affiliation: Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, 9500 Gilman Drive, Room A-112, La Jolla, CA 92093-0943, USA. akavanaugh@ucsd.edu
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
authors.forename: Iain B
authors.initials: IB
authors.lastname: McInnes
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
authors.forename: Gerald G
authors.initials: GG
authors.lastname: Krueger
authors.forename: Dafna D
authors.initials: DD
authors.lastname: Gladman
authors.forename: Juan
authors.initials: J
authors.lastname: Gómez-Reino
authors.forename: Kim
authors.initials: K
authors.lastname: Papp
authors.forename: Anna
authors.initials: A
authors.lastname: Baratelle
authors.forename: Weichun
authors.initials: W
authors.lastname: Xu
authors.forename: Surekha
authors.initials: S
authors.lastname: Mudivarthy
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
authors.forename: Zhenhua
authors.initials: Z
authors.lastname: Xu
authors.forename: Julie
authors.initials: J
authors.lastname: Zrubek
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*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D033023:Foot Joints / Q000000981:diagnostic imaging*; D050823:Hand Joints / Q000000981:diagnostic imaging*; D006801:Humans; D007279:Injections, Subcutaneous; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab