Research article

Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial

Vibeke Strand¹ , Philip Mease² , Gerd R Burmester³ , Enkeleida Nikaï⁴ , Geoffroy Coteur⁵ , Ronald van Vollenhoven⁶ , Bernard Combe⁷ , Edward C Keystone⁸ and Arthur Kavanaugh⁹

¹  Division of Immunology/Rheumatology, Stanford University School of Medicine, 306 Ramona Road, Palo Alto, CA, 94028, USA

²  Seattle Rheumatology Associates, 1101 Madison St # 1000, Seattle, WA, 98104, USA

³  Department of Rheumatology and Clinical Immunology, Charité - University Medicine, Humboldt University of Berlin, Unter den Linden 6, Berlin, D-10099, Germany

⁴  Life Sciences, Business & Decision, Rue Saint Lambert 141, 1200 Brussels, Belgium

⁵  Outcomes & Access - Immunology, UCB SA, Allée de la Recherche 60, B-1070, Brussels, Belgium

⁶  Rheumatology Unit, Karolinska Institute, SE-171 77, Stockholm, Sweden

⁷  Immuno-Rhumatologie, Hôpital Lapeyronie, Université Montpellier 1, Montpellier, F-34000, France

⁸  Rebecca MacDonald Centre for Arthritis & Autoimmune Disease, Mount Sinai Hospital, 60 Murray St., Room 2-006, Box 4, Toronto, Ontario, M5T 3L9, Canada

⁹  Division of Rheumatology, Allergy and Immunology, University of California in San Diego, 9500 Gilman Drive, Mail code 0943, La Jolla, CA, 92093, USA

author email corresponding author email

Arthritis Research & Therapy 2009, 11:R170doi:10.1186/ar2859

Published:	12 November 2009

Abstract

Introduction

The objective of this study was to assess the impact of certolizumab pegol (CZP) treatment on health-related quality of life (HRQoL), fatigue and other patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA).

Methods

Patients with active RA (N = 982) were randomized 2:2:1 to subcutaneous CZP (400 mg at weeks 0, 2 and 4; followed by CZP 200 mg or 400 mg) plus methotrexate (MTX) every other week, or placebo (PBO) plus MTX. PRO assessments included HRQoL, fatigue, physical function, arthritis pain and disease activity. Adjusted mean changes from baseline in all PROs were obtained using analysis of covariance (ANCOVA) applying last observation carried forward (LOCF) imputation. The proportion of patients achieving clinically meaningful improvements in each PRO was obtained using logistic regression and by applying non-responder imputation to missing values after rescue medication or withdrawal. The correlations between PRO responses and clinical responses were also assessed by tetrachoric correlation using non-responder imputation.

Results

Patients treated with CZP plus MTX reported significant (P < 0.001), clinically meaningful improvements in HRQoL at the first assessment (week 12); reductions in fatigue, disease activity and pain and improvements in physical function were reported at week 1. In particular, CZP-treated patients reported improvements in mental health. Mean changes from baseline in the SF-36 Mental Component Summary (MCS) at week 52 for CZP 200 mg and 400 mg plus MTX, and PBO plus MTX were 6.4, 6.4 and 2.1, respectively (P < 0.001). In addition, mental health and vitality scores in CZP-treated patients approached age- and gender-adjusted US population norms. Improvements in all PROs were sustained. Similar benefits were reported with both CZP doses. Changes in SF-36 MCS scores had the lowest correlation with disease activity scores (DAS28) and American College of Rheumatology 20% improvement (ACR20) response rates, while improvements in pain showed the highest correlation.

Conclusions

Treatment with CZP plus MTX resulted in rapid and sustained improvements in all PROs, indicating that the benefits of CZP extend beyond clinical efficacy endpoints into areas that are more relevant and meaningful for patients on a daily basis.

Trial Registration

ClinicalTrials.gov NCT00152386.