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Identifying patients with rheumatoid arthritis with moderate disease activity at risk of significant radiographic progression despite methotrexate treatment.

ABSTRACT: To determine the baseline factors predictive of significant radiographic progression (SRP) in patients with moderately active rheumatoid arthritis (RA) despite receiving methotrexate (MTX).Patients from the MTX arm of the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) trial with sustained moderate RA (defined as ?3.2 mean disease activity score in 28 joints ?5.1 during the last 6?months of the first year) were analysed for SRP (mTSS >3.0 overall) after 2 and 3?years. Baseline predictors for SRP were identified by univariate and multivariate analyses. All variables shown to be significantly associated with SRP were categorised based on clinically relevant cut-offs and tertiles and were included in a matrix risk model.228 patients were assigned MTX treatment, 210 patients were in the radiographic intention-to-treat population, and 96 of these had sustained moderate RA. SRP occurred in 25 (26%) and 33 (34%) patients after 2 and 3?years of MTX treatment, respectively. Univariate and multivariate analyses found that C reactive protein (CRP) and rheumatoid factor (RF) positivity at baseline were predictive of SRP after 2 and 3?years (p<0.05 for all). The matrix risk model showed that RF positivity and CRP levels >40?mg/L at baseline were significantly associated with SRP after 2 (p<0.05 for both; R(2)=0.24) and 3?years (p<0.05 for both; R(2)=0.22). The baseline erosion score was not found to be predictive of SRP.Patients with sustained moderate RA despite receiving MTX treatment are at risk of SRP, with both RF positivity and high CRP levels shown to be predictive of this.

SUBMITTER: Fautrel B

PROVIDER: S-EPMC4613151 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Identifying patients with rheumatoid arthritis with moderate disease activity at risk of significant radiographic progression despite methotrexate treatment.

Fautrel B B Nab H W HW Brault Y Y Gallo G G

RMD open 20150728 1

<h4>Objectives</h4>To determine the baseline factors predictive of significant radiographic progression (SRP) in patients with moderately active rheumatoid arthritis (RA) despite receiving methotrexate (MTX).<h4>Methods</h4>Patients from the MTX arm of the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) trial with sustained moderate RA (defined as ≥3.2 mean disease activity score in 28 joints ≤5.1 during the last 6 months of the first year) were analysed for SRP ( ...[more]

PMID: 26509051

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Project description:OBJECTIVE:Progressive rheumatoid arthritis (RA) is responsible for joint damage causing disabilities, but there is no agreement on which disease measures best predict radiographic progression. We aimed to determine which disease activity measures, including the disease activity score, the modified disease activity score in 28 joints with C-reactive protein testing (M-DAS28-CRP), the Clinical Disease Activity Index, and the Health Assessment Questionnaire Disability Index, at baseline and 3 months best predicted rapid radiographic progression (RRP) in patients with early RA. METHODS:Data were used from PREMIER, a 2-year, multicenter, double-blind, active comparator controlled study with methotrexate (MTX)-naïve patients with RA and active disease for less than 3 years. Treatments included adalimumab plus oral MTX, adalimumab, or oral MTX. Only patients in the MTX arm were analyzed in this study. RRP was defined as a change in the modified total Sharp score of less than 3.5 at month 12. The logistic regression analysis assessed the impact of measures at baseline and 3 months on RRP at 12 months. Best cutoff points of the M-DAS28-CRP were also estimated by using area under the receiver operating characteristic curve. RESULTS:A total of 149 patients were included (female patients: n = 113 [75.8%]; positive rheumatoid factor: n = 127 [85.2%]; mean [SD] age: 52.9 [13.3] years; mean [SD] disease duration: 0.8 [0.9] year; mean [SD] M-DAS28-CRP: 6.3 [0.9]). After adjusting for potential confounders, only the M-DAS28-CRP at baseline (adjusted odds ratio [AOR] = 3.29; 95% confidence interval [CI]: 1.70-6.36) and 3 months (AOR = 2.56; 95% CI: 1.43-4.56) strongly predicted RRP at 12 months. M-DAS28-CRP of 4.5 and 2.6 at baseline and 3 months, respectively, maximized positive and negative predictive values for prediction of RRP. CONCLUSION:The M-DAS28-CRP was a stronger predictor at baseline and 3 months for RRP compared with other disease activity measures. Removing tender joint count and patient global assessment from the DAS28-CRP improves prediction of RRP.

Project description:OBJECTIVES:Methotrexate is considered to be first-line therapy for rheumatoid arthritis (RA). However, a substantial proportion of treated patients do not achieve the desired goals of therapy. This analysis aimed to identify predictors of insufficient response to methotrexate in patients with early RA. METHODS:The Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab (OPTIMA) and PREMIER studies in patients with RA for <1?and <3 years, respectively, examined the efficacy of methotrexate and adalimumab in methotrexate-naive patients. This post hoc analysis included patients for whom initial methotrexate monotherapy was not successful after 6 months. Candidate predictors of insufficient response and clinically relevant radiographic progression (CRRP) included demographics, baseline disease characteristics and time-averaged disease variables over a 12-week interval. In OPTIMA, adalimumab was added to therapy after insufficient treatment response; in PREMIER, initial methotrexate therapy was continued; clinical, functional and radiologic outcomes were assessed after 1?year. RESULTS:Baseline 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)) and time-averaged DAS28(CRP) over 4, 8 and 12 weeks were the strongest predictors of insufficient response to methotrexate and CRRP. Addition of adalimumab to methotrexate therapy was associated with better clinical, functional and radiographic outcomes after 1?year compared with continuing on methotrexate monotherapy. CONCLUSIONS:In patients with early RA, baseline disease characteristics and early disease activity can predict response to methotrexate treatment and radiographic progression at 6 months. The addition of adalimumab at 6 months after methotrexate failure is associated with improved outcomes. These results support treatment-to-target strategies and timely adaptation of therapy in patients with early RA. TRIAL REGISTRATION NUMBER:NCT00420927, NCT00195663; Post-results.

Dataset Information

Identifying patients with rheumatoid arthritis with moderate disease activity at risk of significant radiographic progression despite methotrexate treatment.

Publications

Identifying patients with rheumatoid arthritis with moderate disease activity at risk of significant radiographic progression despite methotrexate treatment.

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