Session Type: Abstract Submissions (ACR)
The TaSER study (NCT00920478) is an open label randomized clinical trial with blinded assessments of outcome. It was designed to test whether the efficacy of DAS28 driven treat-to-target DMARD strategies could be improved by the addition of regular musculoskeletal ultrasound (MSUS) disease activity assessment.
111 untreated early UA/RA patients (symptom duration <1 year) were randomized to step-up DMARD escalation strategies guided by either DAS28 alone (target = DAS28<3.2) or DAS28+MSUS assessment of a limited joint set (target = PD signal in ≤1 joint). In the MSUS group, ultrasound assessment was undertaken in patients in LDAS, or moderate DAS but with minimal synovitis (28SJC²1). The follow-up period was 18 months. In the first 3 months both groups received identical treatment. Thereafter, treatment was escalated whenever the appropriate target was not achieved; through the addition of new DMARDs, DMARD dose optimisation, and/or IA/IM steroid. The sequence of DMARD escalation was: MTX � MTX/SSZ/HCQ � scMTX/SSZ/HCQ � etanercept/scMTX/SSZ/HCQ.
Outcomes were assessed every 3 months by a metrologist who was blinded to randomization group. The primary clinical outcome was the mean improvement in DAS44. Secondary outcome measures included: mean improvement in ACR core set variables and DAS44 remission rate. Radiological outcomes included the MRI RAMRIS score and Total Sharp Score (results still to be analysed)
110 (99%) patients fulfilled 2010 ACR/EULAR RA classification criteria. Both groups were well matched for disease duration (median 4m), baseline DAS (4.4), ACPA+ve (60%) and HAQ (1.6 v 1.5). The DAS28 group contained a higher proportion of females (60% vs 78%, p 0.031). Both groups experienced significant improvements in DAS44 (mean change in DAS44 -2.51 [DAS28] vs -2.76 [MSUS]; 95%CI -0.84, 0.33; p 0.39) and HAQ (-0.79 v -1.06; 95%CI -0.57, 0.031: p0.08). The DAS28 group had a numerically higher rate of DAS44 remission after 3 months (43% v 33%; p=0.32). However, after 18 months, more patients in the MSUS groups had attained DAS44 remission (44% v 65%; p=0.046). There was no difference in DAS44, HAQ or ACR core set variables at any time point
Both groups exhibited similar, very robust improvements in clinical outcomes. MSUS disease activity assessment was not associated with improved clinical outcomes except a higher rate of DAS44 remission after 18 months.
Graph 1 – Mean change in DAS44 from baseline
Graph 2 – Proportion of patients achieving DAS44 remission (* p<0.05)
I. B. McInnes,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/targeting-ultrasound-remission-in-early-rheumatoid-arthritis-results-of-the-taser-study/