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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT00265096.

© 2013 The Authors. Arthritis Care & Research is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Figures

Figure 1

Proportions of patients achieving a clinically meaningful change from baseline in Health Assessment Questionnaire (HAQ) disability index (DI; ≥0.30) and 36-item Short Form health survey physical component summary (PCS; ≥5) and mental component summary (MCS; ≥5) scores at weeks 14, 24, 52, and 104. At weeks 52 and 104, all patients initially randomized to placebo were receiving golimumab (50 or 100 mg), and some patients initially randomized to golimumab 50 mg were receiving golimumab 100 mg.

Figure 2

Relationships between improvements in physical component summary (PCS) and mental component summary (MCS) scores of the 36-item Short Form health survey (SF-36) and the impact of disease on productivity and achievement (+) or nonachievement (−) of an American College of Rheumatology ≥20% improvement criteria (ACR20) and Psoriasis Area and Severity Index ≥75% improvement (PASI75) response criteria at week 24.