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Criteria for TNF-Targeted Therapy in Rheumatoid Arthritis

Estimates of the Number of Patients Potentially Eligible

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Abstract

Tumour necrosis factor (TNF) antagonists or blocking agents represent a major advance in the treatment of rheumatoid arthritis (RA), but their use raises economic concerns because of the high drug cost. Population-based patient registers with clinical data allow the estimation of the proportion of patients with RA who are eligible for TNF antagonist therapy according to recent consensus statements on TNF-targeted therapy.

Data were derived from a representative county-based (500 000 population) register of patients with RA. Of 894 patients aged between 18 and 70 years, 636 (71%) [females 80%, mean (SD) age 53.6 (12.2) years and mean (SD) disease duration 12.2 (9.3) years] had a clinical and radiographic examination. The eligibility for TNF-targeted therapy was estimated from the following criteria: (i) previous or current therapy with at least one disease-modifying antirheumatic agent (DMARD); and (ii) active disease. Disease activity criteria were set to 28-swollen joint count (28-SJC) ≥6, 28-tender joint count ≥6, and erythrocyte sedimentation rate (ESR) ≥28 mm/hour or C-reactive protein (CRP) ≥20 mg/L. Sensitivity analyses were performed varying some of these disease activity parameters.

Of the 636 patients, as many as 526 (83%) had previously or were currently using DMARDs and 98 (15%) fulfilled both the DMARD and activity criteria, thus being the maximum number of patients considered for TNF-targeted therapy. If the most stringent criteria were used (ever DMARD, 28-SJC ≥12 and ESR ≥50 mm/hour or CRP ≥40 mg/L) only 15 of the 626 (2%) would be candidates for TNF-targeted therapy. In a population of 1 million, assuming a prevalence of 2000 patients with RA under the age of 70 years, the number of candidates for TNF-targeted therapy would be 40 to 300, depending on the disease activity criteria. Stringent ESR and CRP criteria would lead to a major reduction in the number of eligible patients. These utilisation data imply annual drug costs in the range of $US480 000 to $US3 600 000 for TNF antagonists for RA per 1 million population. Further economic evaluations are needed to determine for which groups such treatment is warranted from a health economics perspective.

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Acknowledgements

We thank the research nurses Ingerid Müller and Catherine Planke for assistance with the data collection, research secretary Kirsten Mossin for keeping the Oslo RA register updated and medical student Espen Haavardsholm for data entry. Till Uhlig, MD was at the time of the study financially supported by the Research Council of Norway.

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Authors and Affiliations

  1. Oslo City Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, N-0319, Oslo, Norway

    Tore K. Kvien & Till Uhlig

  2. Institute of Public Health, Health Economics Research Unit, University of Southern Denmark, Odense, Denmark

    Ivar Sønbø Kristiansen

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  1. Tore K. Kvien
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  2. Till Uhlig
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  3. Ivar Sønbø Kristiansen
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Correspondence to Tore K. Kvien.

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Kvien, T.K., Uhlig, T. & Kristiansen, I.S. Criteria for TNF-Targeted Therapy in Rheumatoid Arthritis. Drugs 61, 1711–1720 (2001). https://doi.org/10.2165/00003495-200161120-00003

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