Rheumatology Advance Access originally published online on March 27, 2006
Rheumatology 2006 45(10):1238-1246; doi:10.1093/rheumatology/kel066
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Improved health-related quality of life for rheumatoid arthritis patients treated with abatacept who have inadequate response to anti-TNF therapy in a double-blind, placebo-controlled, multicentre randomized clinical trial
University Hospital Leuven, Belgium, 1QualityMetric, Lincoln, RI, 2Bristol-Myers Squibb, Princeton, NJ and 3Centre for Rheumatology Immunology and Arthritis, Fort Lauderdale, FL, USA.
Correspondence to: Prof. Dr R. Westhovens, UZ KU LeuvenDienst Reumatologie, Herestraat 49B-3000, Leuven, Belgium. E-mail: rene.westhovens{at}uz.kuleuven.ac.be
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Abstract |
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Objective. Rheumatoid arthritis (RA) patients who have inadequate response to anti-tumour necrosis factor (TNF) therapy currently have treatment options that are limited and less than optimal in their risk-to-benefit ratio. Abatacept provides a new generation of RA medications that has previously been demonstrated to have positive clinical outcomes with this population. The current study sought to demonstrate the efficacy of abatacept on quality of life (QoL) for RA patients with inadequate response to anti-TNF therapy.
Methods. Patients were entered into a double-blind, placebo-controlled, multicentre randomized clinical trial, with 258 patients randomized to abatacept + disease-modifying anti-rheumatic drugs (DMARDs) and 133 patients randomized to placebo + DMARDS. The QoL was measured with the Short Form Health Survey (SF-36), Health Assessment Questionnaire (HAQ) and fatigue visual analogue scale, and was analysed with basic (ANOVA, chi-square) and multigroup growth curve techniques to assess differential change over time.
Results. Treatment group QoL improved significantly more than placebo on the HAQ and fatigue indices, as well as seven of the eight SF-36 scales and SF-36 physical and mental summary scores. Improvement rate was faster for abatacept than for placebo on the QoL measures, and the improvements from abatacept related to normal levels of QoL on many domains.
Conclusion. Clinically relevant benefits of abatacept over placebo are discussed regarding improving QoL. Importantly, the larger rate of change for abatacept over placebo provides clinicians with a medication that can lead to meaningful changes in a patient's life within a few weeks, even when the patient previously failed anti-TNF therapy.
KEY WORDS: Rheumatoid arthritis, Anti-TNF therapy, Abatacept, Quality of life, Patient-reported outcomes
Submitted 14 September 2005;
revised version accepted 3 February 2006.
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