Patient reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of the GO-REVEAL trial

Kavanaugh, A., McInnes, I. B. , Krueger, G. G., Gladman, D., Beutler, A., Gathany, T., Mack, M., Tandon, N., Han, C. and Mease, P. (2013) Patient reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of the GO-REVEAL trial. Arthritis Care and Research, NA-NA. (doi: 10.1002/acr.22044) (PMID:23666608) (PMCID:PMC4282022)

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McInnes, Professor Iain
• Authors: Kavanaugh, A., McInnes, I. B., Krueger, G. G., Gladman, D., Beutler, A., Gathany, T., Mack, M., Tandon, N., Han, C., and Mease, P.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity
• Journal Name: Arthritis Care and Research
• Publisher: John Wiley & Sons, Inc.
• ISSN: 2151-464X
• ISSN (Online): 2151-4658
• Copyright Holders: Copyright © 2013 The Authors
• First Published: First published in Arthritis Care and Research 65(10):1666-1673
• Publisher Policy: Reproduced under a Creative Commons License