RESEARCH - Assessment of anti-TNF efficacy in RA: is 3 month sufficient?

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Rheumatology Advance Access published online on May 25, 2008

Rheumatology, doi:10.1093/rheumatology/ken204

Assessment of anti-TNF- 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.

Abstract

Objectives. The optimal therapeutic trial duration of anti-TNF-

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- 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.

http://rheumatology.oxfordjournals.org/cgi/content/abstract/ken204v1?papetoc

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