Background Treat-to-target therapy (T2T) is recommended in the treatment of rheumatoid arthritis (RA), but appears not yet fully implemented in daily practice.
Objectives To evaluate adherence to a T2T strategy and to determine the rheumatologist's opinion about the study protocol steps, suppression of RA and performance of disease activity score (DAS).
Methods During 10 year follow-up rheumatologists in 20 clinics treated 508 early RA patients enrolled in the BeSt study as part of their daily outpatient practice. The protocol required treatment adjustments based on 3-monthly DAS measurements, with treatment intensification aiming to achieve low disease activity (DAS ≤2.4) and tapering and discontinuation steps when the target was met and sustained. Rheumatologists filled in questionnaires about satisfaction with level of RA suppression, agreement with the next protocol step and the DAS as representation of disease activity. We checked adherence to the treatment protocol over time and investigated if questionnaire responses and hypothetical conditions (see results) where rheumatologists might disagree with the DAS were associated with protocol violations, using generalized estimating equations.
Results Protocol adherence decreased over time from almost 100% in year 1 to ±60% per visit in year 10, with an average of 79% per visit over 10 years. Rheumatologists mostly agreed with DAS (80-90% of visits over time), and were satisfied with treatment steps in the protocol (75-90% over time) and the level of RA suppression (85-90% over time). Although even then the protocol was mostly followed, the odds for PV increased when the rheumatologist felt the DAS underestimated (Odds Ratio, OR 2.1, 95% confidence interval, CI 1.7-2.5) or overestimated (OR 2.0, 95% CI 1.7-2.3) true disease activity, when the rheumatologist disagreed with the study protocol (OR 2.5, 95% CI 2.1-2.9) or was dissatisfied with the level of RA suppression (OR 1.4, 95% CI 1.2-1.6). The odds for PV were also higher in some specific conditions: when swollen joint count (SJC) was ≤1 and erythrocyte sedimentation rate (ESR) was ≥28 (OR 1.3, 95% CI 1.1-1.5), or when the visual analogue scale of global health of the patient (VASpt) was ≥20 millimetre (mm) higher than the VAS of the physician (VASph) (OR 1.3, 95%CI 1.2-1.5). Other specified conditions as SJC ≤1 and tender joint count ≥2, or SJC ≤1 and VASpt ≥20 mm, or VASph ≥20 mm higher than the VASpt, did not increase the risk of PV.
Conclusions Rheumatologists adhered well to the treat-to-target strategy of the BeSt protocol, although over time adherence decreased. This may be because in later years, physicians started taking part in the study who had not taken part in designing the protocol. Rheumatologists mostly agreed with how the DAS represented disease activity and with the treatment protocol steps, and were satisfied with the level of RA suppression. However, when they did not agree or were dissatisfied, protocol deviation was more likely. These results prove the feasibility of DAS targeted treatment, steering at low disease activity: rheumatologists feel the DAS performs well in estimating disease activity and are willing to comply with DAS steered therapy adjustments.
Disclosure of Interest I. Markusse: None declared, L. Dirven: None declared, H. Han: None declared, K. Ronday: None declared, P. Kerstens: None declared, W. Lems: None declared, T. Huizinga: None declared, C. Allaart Grant/research support: The study was designed by the investigators and supported by a government grant from the Dutch Insurance Companies, with additional funding from Schering-Plough B.V. and Janssen B.V. Data collection, trial management, data analysis and preparation of the manuscript were performed by the authors.
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