Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial

Abstract

ObjectivesTo compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis.MethodsIn a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression.Results281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively −2.39 (95% CI −4.77 to −0.00) and −1.67 (95% CI −3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM.ConclusionsTreatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.Trial registration numberISRCTN26791028.

Effects of psychosocial factors on monitoring treatment effect in newly diagnosed rheumatoid arthritis patients over time: response data from the tREACH study

“…If sustained remission (DAS < 1.6 at two consecutive visits) was achieved, medication was tapered according to protocol. Detailed information on the medication scheme can be found in the original tREACH paper (6).…”

“…Fifteen-month follow-up data were used from the tREACH cohort, for which a detailed description of the inclusion criteria and protocol can be found in the original tREACH paper (6). In brief, patients with early arthritis (duration of complaints < 1 year) and a high risk of developing persistent arthritis [score > 6 points on the Visser model (14)] were eligible.…”

“…This target has been proposed in guidelines as remission or low disease activity, which is commonly measured in clinical practice by composite scores such as the Disease Activity Score (DAS) and the Disease Activity Score based on 28-joint count (DAS28) (4). Recently published studies show that with this regimen a response rate of 40-80% can be reached within 1 year (5,6). Several patient and disease characteristics, such as baseline disease activity (7,8), age (7,9), and gender (7)(8)(9), have been reported that may explain part of the variability in response rates.…”

Rheumatoid Arthritis in the 21st Century: Treatment Patterns and Disease Activity States

“…Data based on the multicenter treatment in the Rotterdam Early Arthritis Cohort (tREACH) have also shown lower DAS in patients using initial triple combination DMARD therapy compared to initial methotrexate monotherapy 14 . Treatment goals were attained faster and maintained with 40% fewer treatment intensifications in the combination DMARD group.…”

Cost-effectiveness of Biological Disease-modifying Antirheumatic Drugs for the Treatment of Rheumatoid Arthritis: Implications for Clinical Practice

“…Progressive erosive disease with disabling joint malformations has now become a rare event due to a change in treatment strategies, i.e., early and intensive treatment combined with a treat-to-target strategy 4 . However, since up to 40% of patients still fail to show an adequate response taking conventional DMARD alone 5 , the additive success should be attributed to the availability of bDMARD as well 3 . Moreover, when bDMARD were given as induction therapy, remission rates up to 80% were reported 6 .…”