Initial combination therapy versus step-up therapy in treatment to the target of remission in daily clinical practice in early rheumatoid arthritis patients: results from the DREAM registry

Abstract

BackgroundTreat to target (T2T) is widely accepted as the standard of care for patients with rheumatoid arthritis (RA) and has been shown to be more effective than traditional routine care. The objective of this study was to compare the effectiveness of two T2T strategies in patients with early RA: a step-up approach starting with methotrexate (MTX) monotherapy (cohort I) versus an initial disease-modifying antirheumatic drug combination approach (cohort II).MethodsA total 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 28-joint Disease Activity Score (DAS28) score <2.6 (remission) during 12 months of follow-up. Secondary outcomes were time until remission was achieved and mean DAS28 scores at 6- and 12-month follow-up.ResultsAfter 12 months 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 = 0.31). Median time until first remission was 17 weeks in cohort II versus 27 weeks in cohort I (P = 0.04). A significant time by strategy interaction was found in mean DAS28 scores. Post hoc analysis revealed a significant difference in mean DAS28 scores between both cohorts at 6 months (P = 0.04), but not at 12 months (P = 0.36).ConclusionsThe initial combination strategy resulted in a comparable remission rate after 1 year but a significantly shorter time until remission. At 6 months, mean DAS28 scores were lower in patients with initial combination treatment than in those with step-up therapy. At 12 months, no significant differences remained in mean DAS28 scores or the proportion of patients in remission.

Radiographic progression in early rheumatoid arthritis patients following initial combination versus step-up treat-to-target therapy in daily clinical practice: results from the DREAM registry

“…We also showed that while a T2T strategy with initial combination therapy was not superior to a T2T strategy with step-up therapy in the proportion of patients in remission at 12 months follow-up (77% versus 72%, respectively), the strategy with initial combination therapy did result in a significantly shorter time until remission. At 6 months, mean disease activity scores were lower in patients with initial combination therapy than in those with step-up therapy [6]. This is in line with clinical trials showing that initial combination therapy results in more rapid improvements in disease activity, daily functioning and quality of life than initial monotherapy [9,13,29,30].…”

“…This study used data from the ongoing DREAM T2T remission induction strategies I (initial step-up monotherapy) and II (initial combination therapy), two observational, multicenter strategies which were established in 2006 and 2012, respectively [5,6,27]. In both strategies, adults ≥18 years with a clinical diagnosis of RA and a disease duration (time from the diagnosis to the start of therapy) < 1 year were enrolled consecutively immediately after a clinical diagnosis of RA.…”

“…Patients in both strategies were treated according to a T2T strategy with protocolized treatment adjustments aiming at remission (DAS28 < 2.6), details of which have previously been published [5,6,27]. Briefly, the main differences between both strategies were; time moments of evaluation, and the medication that was started immediately after diagnosis (mono/step-up therapy versus combination therapy).…”

“…Prevention of structural damage is an important goal in the treatment of RA. In the last years, research has shown that early intensive treatment improves both the short-and long-term outcomes of RA [2][3][4][5][6]. The benefits of early use of (combinations of) disease modifying anti-rheumatic drugs (DMARDs) and biological agents [7][8][9][10][11][12], in combination with protocolled treatment aimed at a predefined goal (treat-to-target (T2T)) [13][14][15], has led to a change in traditional treatment paradigms.…”

“…The benefits of early use of (combinations of) disease modifying anti-rheumatic drugs (DMARDs) and biological agents [7][8][9][10][11][12], in combination with protocolled treatment aimed at a predefined goal (treat-to-target (T2T)) [13][14][15], has led to a change in traditional treatment paradigms. More specifically, early and intensive targeted treatment with DMARDs has been shown to lead to substantial reductions in disease activity [5,6] and radiologic damage in patients with early RA [8,13,[16][17][18][19][20][21].…”