Article
Prediction of Remission and Low Disease Activity in DMARD-Refractory Patients with RA Treated with Golimumab
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Published: | September 1, 2015 |
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Introduction: EULAR recommendations for RA therapy suggest addition of a biologic only if poor prognostic factors such as high disease activity are present. However, low baseline disease activity is associated with better biologic treatment outcomes.
Objective: To develop a tool to predict remission/low disease activity (LDA) and aid in selection of patients for anti-TNF treatment.
Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA despite DMARD-therapy. Patients received 50-mg SC golimumab (GLM) once monthly for 6 months along with their background DMARDs. Predictors of DAS28-ESR LDA and remission at 6 months were evaluated with univariate/multivariable regression models and receiver operating characteristic (ROC) analyses. To assess the relationship between predicted disease states and observed amount of improvement, further analyses evaluated associations between final regression model’s predicted rate of remission and observed 6-month improvements in DAS28, Health Assessment Questionnaire (HAQ), and EurolQoL 5-Dimension (EQ-5D).
Results: The analysis included 3280 patients: 82.8% female, mean age 52.3 years, mean disease duration 7.6 years, mean baseline DAS28–ESR 5.97 (standard deviation=1.095). DAS28-ESR remission and LDA were achieved by 23.9% and 37.4% of patients, respectively, after 6 months of GLM-therapy. In multiple regression models, remission at 6 months was associated with male sex, absence of comorbidities, and lower age, HAQ, ESR, and TJC28. The final model included sex, comorbidities, age, HAQ, ESR, and TJC28 as continuous variables and had an area under the ROC curve of 0.71 to predict remission and LDA at 6 months. When CRP replaced ESR or SJC28 replaced TJC28, predictive ability was slightly reduced. Predicted remission rates ranged from 4% to 67% in females (figure) and from 7% to 76% in males. Patients who were predicted to be least likely to reach DAS28 remission (who also had the highest baseline disease activity) had the greatest improvements in DAS28, HAQ, and EQ-5D scores during 6 months of GLM treatment.
Figure1 [Fig. 1]
Conclusion: Baseline sex, age, ESR, HAQ, absence of comorbidities, and TJC28 were predictive of remission and LDA after 6 months of GLM treatment. Patients with lower likelihood of remission still experienced improvements in DAS28, HAQ, and EQ-5D during treatment.