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司库奇尤单抗可快速持久缓解强直性脊柱炎患者的疼痛和疲劳症状,无论基线 C 反应蛋白水平或既往肿瘤坏死因子抑制剂治疗如何:来自 MEASURE 2 研究的 2 年数据。

Secukinumab provides rapid and persistent relief in pain and fatigue symptoms in patients with ankylosing spondylitis irrespective of baseline C-reactive protein levels or prior tumour necrosis factor inhibitor therapy: 2-year data from the MEASURE 2 study.

机构信息

Oregon Health and Science University, Portland, OR, USA.

Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK.

出版信息

Clin Exp Rheumatol. 2019 Mar-Apr;37(2):260-269. Epub 2018 Jul 19.

Abstract

OBJECTIVES

To evaluate improvement in pain and fatigue in ankylosing spondylitis (AS) patients treated with secukinumab over 2 years (MEASURE 2 study).

METHODS

Patients with active AS were randomised to receive secukinumab 150 mg, 75 mg, or placebo weekly until Week 4, and every 4 weeks thereafter. This post hoc analysis included assessment of spinal and nocturnal back pain, FACIT-Fatigue, and association between pain and either FACIT-Fatigue or ASQoL item 5 (sleep quality) for the approved secukinumab 150 mg dose in the overall population, and stratified by baseline high-sensitivity C-reactive protein (hsCRP) levels (normal [<5 mg/L] or elevated [≥5 mg/L]) or prior TNF inhibitor therapy status (TNFi-naïve or inadequate response [TNFi-IR]).

RESULTS

Secukinumab-treated patients reported rapid improvement in pain and fatigue scores in overall population by Weeks 1 and 4, respectively; this trend of improvement was also observed irrespective of baseline hsCRP levels or prior TNFi therapy. Mean change at Week 16 in spinal/nocturnal pain (secukinumab vs. placebo) for the subgroups were -34.6/-30.2 vs. -16.6/-10.0, p<0.05/0.01 (normal hsCRP); -26.7/-31.6 vs. -7.8/-9.3, p<0.001/0.0001 (elevated hsCRP); -33.2/-35.4 vs. -13.2/-14.9, both p<0.0001 (TNFi-naïve); and -22.5/-22.8 vs. -9.4/-4.0, p=0.06/p<0.01 (TNFi-IR). FACIT-Fatigue was 7.1 vs. 3.3, p=0.15 (normal hsCRP); 8.7 vs. 3.6, p<0.05 (elevated hsCRP); 10.0 vs. 5.2, p<0.05 (TNFi-naïve); and 5.7 vs. 0.5, p=0.06 (TNFi-IR). These improvements were sustained or further improved through Week 104.

CONCLUSIONS

Secukinumab provides rapid and sustained relief of pain and fatigue over 2 years in patients with AS regardless of baseline hsCRP levels and prior TNFi therapy.

摘要

目的

评估司库奇尤单抗治疗强直性脊柱炎(AS)患者在 2 年内疼痛和疲劳改善情况(MEASURE 2 研究)。

方法

活动期 AS 患者被随机分配接受司库奇尤单抗 150mg、75mg 或安慰剂治疗,每周一次直至第 4 周,此后每 4 周一次。本事后分析纳入了评估脊柱和夜间背痛、FACIT-Fatigue 以及疼痛与 FACIT-Fatigue 或 ASQoL 项目 5(睡眠质量)之间相关性的分析,这些分析适用于总体人群中批准的司库奇尤单抗 150mg 剂量,以及根据基线高敏 C 反应蛋白(hsCRP)水平(正常[<5mg/L]或升高[≥5mg/L])或既往 TNF 抑制剂治疗状态(TNFi-初治或治疗应答不足[TNFi-IR])进行分层。

结果

在总体人群中,司库奇尤单抗治疗的患者在第 1 周和第 4 周分别报告了疼痛和疲劳评分的快速改善;这种改善趋势也与基线 hsCRP 水平或既往 TNFi 治疗无关。第 16 周时脊柱/夜间疼痛的平均变化(司库奇尤单抗 vs. 安慰剂)在亚组中分别为-34.6/-30.2 vs. -16.6/-10.0,p<0.05/0.01(正常 hsCRP);-26.7/-31.6 vs. -7.8/-9.3,p<0.001/0.0001(升高的 hsCRP);-33.2/-35.4 vs. -13.2/-14.9,均 p<0.0001(TNFi-初治);-22.5/-22.8 vs. -9.4/-4.0,p=0.06/p<0.01(TNFi-IR)。FACIT-Fatigue 为 7.1 vs. 3.3,p=0.15(正常 hsCRP);8.7 vs. 3.6,p<0.05(升高的 hsCRP);10.0 vs. 5.2,p<0.05(TNFi-初治);和 5.7 vs. 0.5,p=0.06(TNFi-IR)。这些改善在第 104 周时仍然持续或进一步改善。

结论

无论基线 hsCRP 水平和既往 TNFi 治疗如何,司库奇尤单抗均能在 2 年内快速持续缓解 AS 患者的疼痛和疲劳。

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