title: Patient-reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of a phase III, multicenter, randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To evaluate the effect of golimumab on physical function, health-related quality of life (HRQOL), and productivity in psoriatic arthritis (PsA).
  
  
  METHODS
  GO-REVEAL was a multicenter, randomized, placebo-controlled study. Adult patients with active PsA (n = 405) received golimumab (50 or 100 mg) or placebo every 4 weeks, with early escape at week 16 (placebo → 50 mg, 50 → 100 mg) or placebo crossover to golimumab 50 mg at week 24. Patient-reported outcomes included physical function (Health Assessment Questionnaire [HAQ] disability index [DI] score), HRQOL (36-item Short Form health survey [SF-36] mental component summary [MCS] and physical component summary [PCS] scores), and productivity (home/school/work). Clinical response was assessed using the 28-joint Disease Activity Score using the C-reactive protein level (DAS28-CRP) and the Psoriasis Area and Severity Index (PASI) score for arthritis and skin symptoms, respectively.
  
  
  RESULTS
  At week 24, golimumab-treated patients had significant mean improvements in HAQ DI (0.36), SF-36 (PCS 7.83, MCS 3.84), and productivity (2.24) scores compared with placebo (-0.01, 0.67, -0.60, and 0.08, respectively; P < 0.001 for all). Also, greater proportions of golimumab- than placebo-treated patients had clinically meaningful improvements in HAQ DI (≥0.30) and SF-36 PCS and MCS (≥5) scores at week 24 (P < 0.05). Also at week 24, improvements in DAS28-CRP scores were significantly but moderately correlated with improvements in HAQ DI, SF-36 PCS, and productivity scores. Correlations between these patient-reported outcomes and improvements in PASI, enthesitis, and dactylitis scores were very weak. Improvements in HAQ DI, SF-36, and productivity scores were similar among all groups by week 52 and week 104 when including placebo → golimumab crossover patients.
  
  
  CONCLUSIONS
  Golimumab-treated patients had significant improvements in physical function, HRQOL, and productivity through week 24; these improvements correlated with clinical improvement in signs and symptoms of peripheral arthritis and were sustained through 2 years.
authors.affiliation: University of California, San Diego, La Jolla.
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
authors.forename: Iain B
authors.initials: IB
authors.lastname: McInnes
authors.forename: Gerald G
authors.initials: GG
authors.lastname: Krueger
authors.forename: Dafna
authors.initials: D
authors.lastname: Gladman
authors.forename: Anna
authors.initials: A
authors.lastname: Beutler
authors.forename: Tim
authors.initials: T
authors.lastname: Gathany
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: Neeta
authors.initials: N
authors.lastname: Tandon
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D004526:Efficiency; D004651:Employment; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011788:Quality of Life; D020127:Recovery of Function; D057566:Self Report; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; C529000:golimumab