Background The ongoing REMARCA study (Russian acronym: Russian InvEstigation of MethotrexAte and biologics in eaRly aCtive inflammatory Arthritis) included patients with early and established active RA, who did not use subcutaneous methotrexate (SC MTX) and/or biologics. The main goal of the study is an adaptation of “Treat to target” (T2T) recommendations for clinical practice.
Objectives The purpose of this part of REMARCA trial is to compare two regimens of escalation of the dose of SC MTX in pts with very early (duration of symptoms ≤6 months) and established RA.
Methods 191 patients (pts) with active severe RA (34 males, 157 females, 51,8% with very early RA, 80,1% RF(+), 81,2% anti-CCP(+), DAS28 5,52±1,12, SDAI 30,8±14,7, CDAI 27,3±12,5) were followed up for at least 12 months, among them 115 pts (18 males, 97 females, 60% with very early RA) were followed for 24 months. All patients received SC MTX as a fist-line therapy. We used two regimens of SC MTX dose escalation: 1) fast escalation – starting dose 15 mg/week increasing with increments of 5 mg every 1–2 week to achieve 20–30 mg/week in 4–6 weeks; 2) “slow” escalation (usual recommendations) - starting dose 10 mg/week increasing with increments of 2,5–5 mg every 2–4 week to achieve maximal dose in 8–12 weeks. Fast and “Slow” regimens were prescribed in random manner (with exception of pts who had signs of probable safety problems, such as liver, kidney disease etc., when “slow” regimen used). Use of oral steroids was limited to continuation of previously administered low doses (in 14,7% pts) and intra-articular injections (2 doses per 3 months). Therapy revision and initiation of biological DMARDs in combination with SC MTX (adalimumab, certolizumab, or abatacept), was made every 3 months (or more often if indicated) in order to reach T2T targets.
Results After 12 months, 73 (38,2%) pts achieved SDAI low disease activity (LDA) and 65 (34%) achieved SDAI remission. In the group followed up to 24 months, 45 (39%) and 49 (42,6%) achieved stable SDAI LDA or remission respectively. At 12 month 36,1% pts responded well to monotherapy with SC MTX, and 63,9% required a switch to a combination therapy with biologics. In the group followed up to 24 months the proportion of pts left on MTX monotherapy and switched to biologics was 32,2% and 67,8% resp. Fast escalation regimen used in 87 (45,5%) pts was associated with less need for biologic therapy (see table). When fast escalation used in pts with very early RA (n=47, 24,5%), monotherapy with SC MTX was sufficient in 68,1–66,7% of pts.
Conclusions Early administration of SC MTX with fast escalation of the dose leads to the achievement of T2T goals without need for combination with biological DMARDs in 2/3 of patients with severe active RA.
Acknowledgement Trial State registration number: 01201454666 (http://www.rosrid.ru/search)
Disclosure of Interest None declared