Rheumazentrum Herne, Herne, Germany.
Charité Universitätsmedizin Berlin, Berlin, Germany.
Arthritis Res Ther. 2019 Jun 7;21(1):142. doi: 10.1186/s13075-019-1911-1.
The aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS).
Baseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31-743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640-819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs.
A total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant.
Secukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs.
本研究旨在比较接受司库奇尤单抗治疗长达 2 年的强直性脊柱炎（AS）患者与接受 NSAIDs 治疗的生物初治患者（ENRADAS）的影像学进展。
采用 mSASSS 由两位读者独立评估基线和 2 年时的颈椎和腰椎侧位片，读者对影像学的时间顺序和队列不了解。主要终点是无影像学进展患者的比例（从基线到第 2 年 mSASSS 变化≤0）。主要分析集包括基线（≤第 30 天）和基线后第 31-743 天的影像学检查患者。进行了敏感性分析，以评估以下两种队列之间比较的稳健性：敏感性分析集 1 包括所有基线（≤第 30 天）和第 2 年（第 640-819 天）影像学检查患者；敏感性分析集 2 包括所有基线和基线后（>第 30 天）影像学检查患者。
MEASURE 1 队列中共有 168 例（84%）患者和 ENRADAS 队列中共有 69 例（57%）患者符合主要分析集标准。在 2 年期间，主要分析中 mSASSS 的 LS（SE）从基线的平均变化在 MEASURE 1 组中为 0.55（0.139），在 ENRADAS 组中为 0.89（0.216）（p=0.1852）。在主要分析和敏感性分析中，基线时 mSASSS 的平均变化在 MEASURE 1 组中均低于 ENRADAS 组。在所有影像学进展的无进展患者比例方面，司库奇尤单抗治疗组始终高于恩瑞达治疗组（从基线到第 2 年 mSASSS 的变化≤0、≤0.5、≤1 和≤2），但差异无统计学意义。
与接受 NSAIDs 治疗的生物初治患者相比，接受司库奇尤单抗治疗的患者在 2 年内影像学进展的非进展患者比例更高，mSASSS 变化更低，但差异无统计学意义。
