Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands.
F Hoffmann-La Roche, Basel, Switzerland.
Rheumatology (Oxford). 2018 Feb 1;57(2):309-317. doi: 10.1093/rheumatology/kex386.
To evaluate the progression of erosions and joint space narrowing (JSN) in feet and hands in the U-Act-Early trial.
In this trial, 317 newly diagnosed DMARD-naïve RA patients initiated randomly tocilizumab, or step-up MTX or a combination of the two. Radiographs were scored at baseline and after 52 and 104 weeks using the Sharp-van der Heijde erosion and JSN score. Between the strategy arms, changes from baseline and the proportions of patients without radiographic progression (change from baseline ≤0) were compared.
Mean changes from baseline in erosion and JSN scores for the whole study population were after 52 weeks 0.59 and 0.18 and after 104 weeks 0.70 and 0.50, respectively. For JSN, at both time points no differences in progression were found between strategies (P ⩾ 0.09). For erosions, the progression was significantly lower at week 104 in both tocilizumab arms when compared with the MTX arm ((p≤0.023). Less progression of erosions in the feet was found after 104 weeks in both tocilizumab arms (P ⩽ 0.046); this was not significant for the hands (P ⩾ 0.11). The proportion of patients without progression in erosions was higher in the tocilizumab arms at week 52 (tocilizumab plus MTX: 87%, P = 0.038; tocilizumab: 81%, P = 0.29) and 104 (tocilizumab plus MTX: 85%, P = 0.001; tocilizumab: 77%, P = 0.028), compared with the MTX arm (74 and 60%, respectively).
In DMARD-naïve early RA patients, initiating a tocilizumab-based treat-to-target strategy inhibits the progression of erosions, especially in the feet, more compared with initiation of a step-up MTX strategy.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01034137.
评估 U-Act-Early 试验中足和手部侵蚀和关节间隙狭窄（JSN）的进展情况。
在这项试验中，317 名新诊断的、未接受过 DMARD 治疗的 RA 患者被随机分配至托珠单抗组、逐步递增 MTX 组或二者联合治疗组。在基线时以及 52 周和 104 周时使用 Sharp-van der Heijde 侵蚀和 JSN 评分对 X 光片进行评分。比较不同策略组间的基线变化和无影像学进展（从基线的变化≤0）的患者比例。
在整个研究人群中，52 周时侵蚀和 JSN 评分的平均基线变化分别为 0.59 和 0.18，104 周时分别为 0.70 和 0.50。在 JSN 方面，在两个时间点，不同策略之间的进展均无差异（P ⩾ 0.09）。在侵蚀方面，与 MTX 组相比，在第 104 周时，托珠单抗组的进展明显较低（（p ⩽ 0.023）。在第 104 周时，托珠单抗组的足部侵蚀进展也较低（p ⩽ 0.046）；但手部无明显差异（p ⩾ 0.11）。在第 52 周时，托珠单抗组的侵蚀无进展患者比例高于 MTX 组（托珠单抗联合 MTX：87%，P = 0.038；托珠单抗：81%，P = 0.29），在第 104 周时（托珠单抗联合 MTX：85%，P = 0.001；托珠单抗：77%，P = 0.028），也高于 MTX 组（分别为 74%和 60%）。
在新诊断的早期 RA 患者中，与起始逐步递增 MTX 策略相比，起始基于托珠单抗的达标治疗策略可更有效地抑制侵蚀进展，特别是足部侵蚀进展。
ClinicalTrials.gov，https://clinicaltrials.gov，NCT01034137。
