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Rheumatology Advance Access originally published online on May 25, 2008
Rheumatology 2008 47(7):1073-1076; doi:10.1093/rheumatology/ken204
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Assessment of anti-TNF-{alpha} efficacy in rheumatoid arthritis: is 3 months sufficient?

J. M. Pocock1, J. C. Vasconcelos2 and A. J. K. Östör1

1Department of Rheumatology, Addenbrooke's Hospital and 2Department of Public Health and Primary Care, Centre for Applied Medical Statistics, University of Cambridge, Cambridge, UK.

Correspondence to: A. J. K. Östör, Rheumatology Clinical Research Unit, Box 194, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ, UK. E-mail: andrew.ostor{at}addenbrookes.nhs.uk


  Abstract

Objectives. The optimal therapeutic trial duration of anti-TNF-{alpha} therapy is currently unknown. The British Society for Rheumatology (BSR) guidance states that non-response at 3 months warrants re-evaluation of treatment and recommends not to persist beyond 6 months. The National Institute for Health and Clinical Excellence (NICE) specifies treatment continuation if response is achieved by 6 months, yet the European League against Rheumatism (EULAR) and the American College of Rheumatology (ACR) maintain a 3 month cut-off. No evidence exists to support a 6 month therapeutic trial over 3 months. Thus, we undertook a study to evaluate the proportion of patients who failed to meet NICE response criteria at 3 months but obtained this by 6 months, and to identify predictive factors for this.

Methods. Patients who commenced anti-TNF-{alpha} therapy for RA were studied, counting those who switched to a second or third agent separately for each instigation of therapy (n = 244). Response at 3 and 6 months was defined according to NICE criteria as a ≥1.2 reduction in Disease Activity Score (DAS28).

Results. Of the 189 patients with available 3 month DAS28 responses, 149 fulfilled response criteria. Of the 40 who failed, 27 continued treatment, of whom 21 were available for follow-up at 6 months. Out of the 21 patients, 12 (57%; 95% CI 36, 78) achieved a response at this time. This data set was too small to investigate predictors of response at 6 months.

Conclusions. A substantial proportion of patients who fail NICE response criteria at 3 months and continue on treatment to 6 months achieve a response. These results support a 6 month therapeutic trial over 3 months.

KEY WORDS: Rheumatoid arthritis, Anti-tumour necrosis factor, Therapeutic trial duration, The British Society for Rheumatology, National Institute for Health and Clinical Excellence, European League Against Rheumatism, Disease Activity Score, Response criteria, Biological therapies

Submitted 25 January 2008; revised version accepted 17 April 2008.
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