Peterfy Charles, Burmester Gerd R, Bykerk Vivian P, Combe Bernard G, DiCarlo Julie C, Furst Daniel E, Huizinga Tom W J, Wong Dennis A, Conaghan Philip G, Emery Paul
Spire Sciences, Inc., Boca Raton, Florida, USA.
Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
Ann Rheum Dis. 2016 Aug;75(8):1501-5. doi: 10.1136/annrheumdis-2015-208258. Epub 2016 Feb 10.
To assess structural damage progression with subcutaneous abatacept (ABA) in the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) trial following abrupt withdrawal of all rheumatoid arthritis (RA) medication in patients achieving Disease Activity Score (DAS)-defined remission or low disease activity.
Patients with early, active RA were randomised to ABA plus methotrexate (ABA/MTX) 125 mg/week, ABA 125 mg/week or MTX for 12 months. All RA treatments were withdrawn after 12 months in patients with DAS28 (C reactive protein (CRP)) <3.2. Adjusted mean changes from baseline in MRI-based synovitis, osteitis and erosion were calculated for the intention-to-treat population.
351 patients were randomised and treated: ABA/MTX (n=119), ABA (n=116) or MTX (n=116). Synovitis and osteitis improved, and progression of erosion was statistically less with ABA/MTX versus MTX at month 12 (-2.35 vs -0.68, -2.58 vs -0.68, 0.19 vs 1.53, respectively; p<0.01 for each) and month 18 (-1.34 vs -0.49 -2.03 vs 0.34, 0.13 vs 2.0, respectively; p<0.01 for erosion); ABA benefits were numerically intermediate to those for ABA/MTX and MTX.
Structural benefits with ABA/MTX or ABA may be maintained 6 months after withdrawal of all treatments in patients who have achieved remission or low disease activity.
NCT01142726; Results.
在评估极早期类风湿关节炎治疗(AVERT)试验中,对达到疾病活动评分(DAS)定义的缓解或低疾病活动度的患者突然停用所有类风湿关节炎(RA)药物后,评估皮下注射阿巴西普(ABA)对结构损伤进展的影响。
将早期活动性RA患者随机分为接受每周125mg ABA联合甲氨蝶呤(ABA/MTX)、每周125mg ABA或甲氨蝶呤治疗12个月。对于疾病活动度评分28(C反应蛋白(CRP))<3.2的患者,在12个月后停用所有RA治疗。计算意向性治疗人群基于MRI的滑膜炎、骨炎和骨侵蚀相对于基线的调整后平均变化。
351例患者被随机分组并接受治疗:ABA/MTX组(n = 119)、ABA组(n = 116)或甲氨蝶呤组(n = 116)。在第12个月时,ABA/MTX组与甲氨蝶呤组相比,滑膜炎和骨炎有所改善,骨侵蚀进展在统计学上更少(分别为-2.35对-0.68、-2.58对-0.68、0.19对1.53;每项p<0.01),在第18个月时也是如此(分别为-1.34对-0.49、-2.03对0.34、0.13对2.0;骨侵蚀p<0.01);ABA的益处数值介于ABA/MTX组和甲氨蝶呤组之间。
对于已达到缓解或低疾病活动度的患者,停用所有治疗6个月后,ABA/MTX或ABA对结构的益处可能得以维持。
NCT01142726;结果