Background/Purpose: Treat-to-target (T2T) of remission strategies has been widely accepted as the standard of care for patients with Rheumatoid Arthritis (RA). In early RA, implementation of T2T in daily clinical practice has been shown to provide earlier clinical improvement.  However, the optimal treatment protocol is still not clear.

The objective of this study is to compare the effectiveness of two T2T strategies: a step up approach starting with methotrexate (MTX) monotherapy (cohort I) versus an initial combination approach (cohort II) starting with high dose of MTX, hydroxychloroquine (HCQ) and an optional intramuscular triamcinolone acetonide (TCA) injection in early RA patients.

Methods: Baseline demographics, clinical and patient-reported outcome measures and one-year follow-up data were used. A total number of 128 patients from cohort II were case-control matched with 128 patients from cohort I on gender, age and baseline disease activity. Twelve month follow-up data were available for 121 patients in both cohorts. The primary outcome was the proportion of patients having reached at least one DAS28 <2.6 (DAS28 remission) after 1 year. Secondary outcomes were time to achieve remission and mean-changes in DAS28 scores at 6 months and 1 year. Results were analyzed using chi-square tests for proportional differences, t-tests for mean differences and Kaplan-Meier survival analysis for between-group differences in time to achieve remission. The course over time was compared between groups by specifying a linear mixed model with strategy and time as fixed factors. An ante-dependence structure was used as a model for the covariance matrix, since it gave the best fit to the data. Post-hoc ANCOVA analyses were performed with baseline DAS28 score as a covariate.

Results: After one year of follow-up, remission was reached at least once in 77.3% of the patients in cohort II versus 71.9% in cohort I (p=0.391). Median time to first remission was 17 weeks in cohort II versus 27 weeks in cohort I (p=0.044). A significant time by strategy interaction was found. Post-hoc analysis revealed a significant difference between strategies at 6 months (p=0.04, mean difference = 0.295, 95% CI= 0.01 – 0.58) but not at 12 months (p=0.36, mean difference = 0.128, 95% CI= -0.14 – 0.4). 

Conclusion: In patients with early RA treated according to the T2T principles, the initial combination therapy with MTX and HCQ and optional TCA resulted in significantly quicker remission and lower disease activity at 6 months than the step up strategy starting with MTX monotherapy. At 12 months, no significant differences remained in mean DAS28 scores or the proportion of patients in remission.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/superiority-of-initial-combination-over-step-up-therapy-in-treatment-to-the-target-of-remission-in-daily-clinical-practice-in-early-rheumatoid-arthritis-patients-results-from-the-dream-registry/