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. 2010;12(2):R35.
doi: 10.1186/ar2944. Epub 2010 Mar 2.

The loss of health status in rheumatoid arthritis and the effect of biologic therapy: a longitudinal observational study

Affiliations

The loss of health status in rheumatoid arthritis and the effect of biologic therapy: a longitudinal observational study

Frederick Wolfe et al. Arthritis Res Ther. 2010.

Abstract

Introduction: The long-term course of rheumatoid arthritis (RA) in terms of health status is not well understood, nor is the degree of effectiveness of biologic therapy in the community. We modeled the progression of loss of health status, and measured incremental costs and effectiveness of biologic therapy in the community.

Methods: We studied change in function and health status in 18,485 RA patients (135,731 observations) at six-month intervals for up to 11 years, including a group of 4,911 patients (59,630 observations) who switched to biologic therapy from non-biologic therapy. We measured the SF-36 Physical Component (PCS) and Mental Component (MCS) Summary scales, the EQ-5D health utility scale, and the Health Assessment Questionnaire (HAQ) disability scale; and we calculated treatment and direct medical costs.

Results: RA onset caused an immediate and substantial reduction in physical but not mental health status. Thereafter, the progression of dysfunction in RA was very slow (HAQ 0.016 units and PCS -0.125 units annually), only slightly worse than the age and sex-adjusted US population. We estimated biologic treatment to improve HAQ by 0.29 units, PCS by 5.3 units, and EQ-5D by 0.05 units over a 10-year period. The estimated incremental 10-year total direct medical cost for this benefit was $159,140.

Conclusions: Biologic therapy retards RA progression, but its effect is far less than is seen in clinical trials. In the community, cost-effectiveness is substantially less than that estimated from clinical trial data. The study results represent the incremental benefit of adding biologic therapy to optimum non-biologic therapy.

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Figures

Figure 1
Figure 1
The change in health status over the lifetime course of RA. The change in health status over the lifetime course of 18,485 RA patients for PCS (upper left), MCS (upper right), EQ-5D (lower left), and HAQ (lower right). The dashed lines for PCS, MCS, and EQ-5D represent age and sex adjusted population normative data. See methods for details. HAQ, Health Assessment Questionnaire; PCS, SF-36 Physical Component Summary; MCS, SF-36 Mental Component Summary.
Figure 2
Figure 2
Changes in HAQ and PCS in patients treated with biologic therapy. Changes in HAQ and PCS in patients who started a biologic therapy at time 0. Horizontal graphs at y-axis represent curves of the distribution of values for HAQ (above) and PCS (below) at time 0. Annual cost is the annual cost calculated for the 10-year duration before and the 10-year duration after the start of biologic therapy. HAQ, Health Assessment Questionnaire; PCS, SF-36 Physical Component Summary; MCS, SF-36 Mental Component Summary.

Comment in

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