Abstract
BackgroundIt is recommended to optimise treatment as long as a predefined treatment target is not met, but should the aim be remission if patients are in low disease activity (LDA)? The aim of this study was to assess if, in patients with rheumatoid arthritis (RA) or patients with undifferentiated arthritis (UA) with Disease Activity Score (DAS) ≤ 2.4 (LDA), treatment intensification results in better functional ability.MethodsIn the IMPROVED study 610 patients with early RA or UA were treated with methotrexate + tapered high-dose prednisone. After 4 months, patients with DAS ≥ 1.6 were randomised to either of two treatment strategies. Patients with DAS < 1.6 tapered treatment. Over 5 years, patients with DAS ≥ 1.6 required treatment intensification, but protocol violations occurred, which allowed us to test the effect of treatment intensification regardless of subsequent DAS. A linear mixed model was used to test, in patients in LDA, the relationship between treatment intensification and functional ability (Health Assessment Questionnaire [HAQ]) over time.ResultsThe number of patients in LDA per visit ranged from 88 to 146. Per visit, 27–74% of the patients in LDA had treatment intensification. We found a statistically significant effect of treatment intensification on ΔHAQ, corrected for baseline HAQ, age, sex and treatment strategy (β = −0.085, 95% CI −0.13 to −0.044). When ΔDAS was added, the effect of treatment intensification was partly explained by ΔDAS, and the association with HAQ was no longer statistically significant (β = −0.022, 95% CI −0.060 to 0.016). When the interaction between treatment intensification and time in follow-up was added, a statistically significant interaction was found (β = 0.0098, 95% CI 0.0010 to 0.019), indicating lesser improvement in HAQ after treatment intensification if follow-up time increased.ConclusionsFor patients with early RA and patients with UA already in LDA, further treatment intensification aimed at DAS remission does not result in meaningful functional improvement.Trial registrationISRCTN, 11916566. Registered on 28 December 2006. EudraCT, 2006-006186-16. Registered on 16 July 2007.
Highlights
It is recommended to optimise treatment as long as a predefined treatment target is not met, but should the aim be remission if patients are in low disease activity (LDA)? The aim of this study was to assess if, in patients with rheumatoid arthritis (RA) or patients with undifferentiated arthritis (UA) with Disease Activity Score (DAS) ≤ 2.4 (LDA), treatment intensification results in better functional ability
Over a period of 5 years, both DAS and Health Assessment Questionnaire (HAQ) showed statistically significant improvement across all patients included in the original study
The unadjusted model showed a larger effect (β for treatment intensification = −0.24, 95% CI −0.32 to −0.15; β for time = −0.005, 95% CI −0.012 to 0.0027; β for treatment intensification × time = 0.017, 95% CI 0.0075 to 0.027). In this observational secondary analysis of data from a randomised clinical trial, we assessed whether intensifying drug therapy in patients who are in LDA but not in remission results in a clinically meaningful improvement in physical functioning as measured by the HAQ
Summary
It is recommended to optimise treatment as long as a predefined treatment target is not met, but should the aim be remission if patients are in low disease activity (LDA)? The aim of this study was to assess if, in patients with rheumatoid arthritis (RA) or patients with undifferentiated arthritis (UA) with Disease Activity Score (DAS) ≤ 2.4 (LDA), treatment intensification results in better functional ability. International recommendations state that at least low disease activity (LDA; e.g., Disease Activity Score [DAS] ≤ 2.4), but preferably remission (e.g., DAS ≤ 1.6 or more stringent definitions), is the best treatment target when treating patients with RA [5]. In the present study we assessed whether aiming for remission and modifying or intensifying treatment in patients who are already in LDA results in further clinically relevant improvements in functional ability, regardless of a subsequent change in DAS
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