Kvien Tore K, Conaghan Philip G, Gossec Laure, Strand Vibeke, Østergaard Mikkel, Poddubnyy Denis, Williams Nicole, Porter Brian, Shete Abhijit, Gilloteau Isabelle, Deodhar Atul
Diakonhjemmet Hospital and University of Oslo, Oslo, Norway.
University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.
Arthritis Care Res (Hoboken). 2022 May;74(5):759-767. doi: 10.1002/acr.24517. Epub 2022 Mar 10.
To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in the MEASURE 1 study (up to 3 years) and the MEASURE 2 study (up to 2 years).
Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous) and MEASURE 2 (150 mg subcutaneous). Patients were naive to treatment with anti-tumor necrosis factor (anti-TNF-naive) therapy or had an inadequate response/intolerance to anti-TNF therapy (anti-TNF-IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored.
Significant improvements in FACIT-F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1) and week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F improvement ≥4; observed data) with secukinumab 150 mg than with placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in patients who were anti-TNF-naive (74.3% and 84.6%, respectively) and anti-TNF-IR (81.3% and 75.0%, respectively). Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including the Assessment of SpondyloArthritis international Society (ASAS) 20%/40% improvement, ASAS5/6 responses, the Ankylosing Spondylitis Disease Activity Score with C-reactive protein level, the Bath Ankylosing Spondylitis Disease Activity Index, and the Short Form 36 health questionnaire scores.
Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti-TNF exposure.
在MEASURE 1研究（长达3年）和MEASURE 2研究（长达2年）中，调查150 mg司库奇尤单抗对强直性脊柱炎（AS）患者疲劳的长期影响。
在MEASURE 1（10 mg/kg静脉注射[IV]，随后150 mg皮下注射）和MEASURE 2（150 mg皮下注射）研究中，将活动性AS患者随机分为司库奇尤单抗组或安慰剂组。患者既往未接受过抗肿瘤坏死因子（抗TNF）治疗（抗TNF初治）或对抗TNF治疗反应不足/不耐受（抗TNF-IR）。使用慢性病治疗功能评估-疲劳（FACIT-F）量表测量疲劳。探讨疲劳反应与基线特征以及临床/实验室变量之间的关系。
在两项研究中，与安慰剂相比，司库奇尤单抗在第16周时FACIT-F评分较基线均有显著改善（P<0.05）。改善持续至第156周（MEASURE 1）和第104周（MEASURE 2）。在MEASURE 1（P<0.05）和MEASURE 2（P<0.01）中，在第16周时，报告疲劳反应（FACIT-F改善≥4；观察数据）的患者使用150 mg司库奇尤单抗的显著多于使用安慰剂的患者。在第156周（MEASURE 1），75.6%接受司库奇尤单抗治疗的患者实现了疲劳反应，在第104周（MEASURE 2）这一比例为81.4%；在抗TNF初治患者（分别为74.3%和84.6%）和抗TNF-IR患者（分别为81.3%和75.0%）中，这些结果是一致的。基线特征并不能一致地预测疲劳改善情况。疲劳反应与多项临床指标的反应呈中度至高度相关，包括国际脊柱关节炎协会（ASAS）20%/40%改善、ASAS5/6反应、含C反应蛋白水平的强直性脊柱炎疾病活动评分、巴斯强直性脊柱炎疾病活动指数以及简明健康调查问卷3 SF-36评分。
无论既往是否接触过抗TNF，司库奇尤单抗均可在长达3年的时间里快速且持续地改善疲劳。
