Rheumatology Advance Access originally published online on November 1, 2005
Rheumatology 2006 45(5):558-565; doi:10.1093/rheumatology/kei169
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Patients with stable long-standing rheumatoid arthritis continue to deteriorate despite intensified treatment with traditional disease modifying anti-rheumatic drugs—results of the British Rheumatoid Outcome Study Group randomized controlled clinical trial
Arc Epidemiology Unit and 1 Biostatistics Group, University of Manchester, Manchester M13 9PT, 2 Royal Cornwall NHS Trust, Truro, Cornwall TR1 3LJ, 3 University Hospital of North Staffordshire NHS Trust, Stoke-on-Trent ST4 7LN, 4 East Cheshire NHS Trust, Macclesfield, Cheshire SK10 3BL, 5 Cannock Hospital, Cannock, Staffordshire WS11 1BG and 6 Academic Rheumatology Unit, King's College Hospital, London WC2R 2LS, UK.
Correspondence to: D. P. M. Symmons, Arc Epidemiology Unit, Stopford Building, University of Manchester, Oxford Road, Manchester M13 9PT, UK. E-mail: deborah.symmons{at}man.ac.uk
Objective. Patients with rheumatoid arthritis (RA) should start treatment early with the aim of suppressing the inflammatory process completely. It is not known if this strategy should, or can, be continued in later disease.
Methods. In a multicentre, randomized, observer-blinded, controlled trial, 466 patients with established RA (>5 yr), on stable therapy for at least 6 months, were randomized to adequate symptom control/shared care setting (SCSC) or aggressive treatment/hospital setting (ATH). All were reviewed annually by a rheumatologist. The primary outcome after 3 yr was the Health Assessment Questionnaire (HAQ). Others included the OMERACT core set and the Disease Activity Score (DAS) 28.
Results. Three hundred and ninety-nine patients completed the trial. There was a significant deterioration in HAQ in both arms. Only the physician global score differed between the arms.
Conclusions. The trial showed no additional benefit of intensified treatment with traditional disease modifying anti-rheumatic drugs (DMARDs) in patients with stable, established RA. It proved hard to suppress C-reactive protein levels. Patients in the SCSC arm were able to initiate treatment changes when their symptoms deteriorated without frequent hospital assessment. Pending further evidence, the model of shared care with annual hospital review is as good as 4-monthly hospital review for these patients.
KEY WORDS: Randomised controlled trial, Traditional DMARDs, Rheumatoid arthritis, Aggressive therapy
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