Abstract
Background:Subclinical synovitis has been confirmed to be associated with the subsequent bone erosion and flare in rheumatoid arthritis (RA) patients who have already achieved clinical remission. But whether intensive therapy can improve the subclinical synovitis and reduce flare remains controversial.Objectives:We designed an 1-year open-labelled, randomized and controlled clinical trial to elucidate if intensive therapy can improve the subclinical synovitis and reduce clinical relapse.Methods:RA patients in clinical remission/low disease activity (defined by DAS28-CRP<3.2), however with subclinical synovitis [power Doppler (PD)≥1 and/or gray scale (GS)≥2 on ultrasound] were randomized into either maintenance or intensive treatment group. The rate of relapse [defined by DAS28(CRP) increased by at least 0.6 and >3.2] in 12 months was taken as the primary outcome. The improvement of PD and GS synovitis at 3, 6, 9 and 12 months were taken as secondary outcomes.Results:108 patients with 54 in each group were enrolled. Patients in maintenance group were older [59.5(19.4-77.5) vs. 51.8 (22.1-73.0), p=0.009] with lower baseline PD score [0(0-4) vs. 1(0-11), p=0.021] than intensive treatment group. The relapse rate was significantly higher in maintenance group than in intensive group [24.1% (13/54) vs. 9.1% (5/54), p=0.039] in one year. The intensive therapy is the single independent protective factor for relapse [OR=0.284 (0.081-0.998), p=0.049]. For 26 patients in maintenance group and 38 in intensive group with PD score≥1, their age and baseline PD were comparable. The relapse rate was also higher in maintenance group than in intensive group, although the difference was statistically insignificant [23.1% (6/26) vs. 7.9% (3/38), p=0.164].Both maintain and intensive therapy could improve GS and PD scores (Table 1). However, at 12 month, both GS and PD score improvement were significantly better in intensive group than in maintenance group (Table 2).Table 1.The improvement of GS and PD scores at each follow up time point in the maintenance and intensive therapy group.Patients with GS≥2Patients with PD≥1Change of GS against baselinemaintenance group(n=54)Intensive group(n=54)PChange of PD against baselinemaintenance group (n=26)Intensive group(n=38)P3m1(-10-12)1(-11-13)0.8153m1(-4-3)1(-3-7)0.4996m1(-14-21)2(-14-19)0.3306m1(-7-4)1(-1-8)0.0999m3(-3-16)4(-2-26)0.2669m1(0-3)1.5(1-11)0.25612m2(-7-19)3.5(-4-26)0.04812m1(-2-2)1(-1-11)0.020Table 2.The improvement of GS and PD scores at each follow up time point between the maintenance and intensive therapy group.Patients with GS≥2Patients with PD≥1GSmaintenance group(n=54)P(against baseline)Intensive group(n=54)P(against baseline)PDmaintenance group (n=26)P(against baseline)Intensive group(n=38)P(against baseline)Baseline5(1−24)–5.5(0−28)–Baseline2(1−4)−1.5(1−11)−3m4(0−16)0.0315(0−28)0.2333m0(0−6)0.0061(0−10)0.0016m4(0−17)0.0254(0−17)0.0146m1(0−9)0.0060(0−4)<0.0019m2(0−21)<0.0012(0−12)<0.0019m0(0−2)0.0010(0−3)<0.00112m3(0−23)0.0022(0−11)<0.00112m0(0−6)0.0010(0−4)<0.001Conclusion:For RA patients who have already achieved treatment target, intensive therapy can alleviate the subclinical synovitis better than maintenance therapy and reduce the relapse.
Published Version
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