Deodhar Atul, Mease Philip, Marzo-Ortega Helena, Hunter Theresa, Sandoval David, Kronbergs Andris, Lauzon Steven, Leung Ann, Navarro-Compán Victoria
Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, 3181 Sam Jackson Park Rd, Portland, OR, 97239, USA.
Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.
BMC Rheumatol. 2021 Sep 25;5(1):50. doi: 10.1186/s41927-021-00218-y.
Patients with non-radiographic axial spondyloarthritis experience negative impacts on sleep, work productivity, and activity impairment. Ixekizumab, a monoclonal antibody selectively targeting interleukin-17A, has shown efficacy in treating the signs and symptoms of non-radiographic axial spondyloarthritis. This analysis evaluated the effect of ixekizumab treatment on sleep, work productivity, and activity impairment in patients with non-radiographic axial spondyloarthritis.
COAST-X ( NCT02757352 ) was a 52-week, phase 3, multicenter, randomised placebo-controlled trial evaluating 80-mg ixekizumab every 2 weeks and every 4 weeks in patients with active non-radiographic axial spondyloarthritis. Sleep disturbance was measured with the Jenkins Sleep Evaluation Questionnaire (JSEQ) and analysed using mixed-effects models for repeated measures. Work productivity and activity impairment were measured using the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis and analysed using analysis of covariance. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work; activity impairment was assessed regardless of work status.
Overall, patients treated with both dosing regimens of ixekizumab reported numerically greater improvements in sleep than placebo through Week 52. At Weeks 16 and 52, patients treated with ixekizumab every 4 weeks had significantly greater improvements in presenteeism (p = 0.007 and p = 0.003, respectively) and overall work impairment (p = 0.014 and p = 0.005, respectively) and numeric improvements in absenteeism than placebo. Patients treated with ixekizumab every 2 weeks had numerically greater improvements in absenteeism, presenteeism, and overall work impairment than placebo. Both dosing regimens of ixekizumab were associated with significantly greater improvements in activity impairment than placebo (ixekizumab every 4 weeks: p = 0.003 at Week 16 and p = 0.004 at Week 52; ixekizumab every 2 weeks: p = 0.007 at Week 16 and p = 0.006 at Week 52).
Treatment with ixekizumab improved sleep, work productivity, and activity impairment in patients with nr-axSpA. Improvements in presenteeism and overall work impairment were sustained and consistent in the patients treated with ixekizumab every 4 weeks from Week 16 to Week 52. Improvements in activity impairment were sustained and consistent in both ixekizumab-treated groups from Week 16 to Week 52.
NCT02757352 , May 2, 2016.
非放射学中轴型脊柱关节炎患者在睡眠、工作效率和活动功能受限方面受到负面影响。司库奇尤单抗是一种选择性靶向白细胞介素-17A的单克隆抗体，已显示出对非放射学中轴型脊柱关节炎的体征和症状有治疗效果。本分析评估了司库奇尤单抗治疗对非放射学中轴型脊柱关节炎患者睡眠、工作效率和活动功能受限的影响。
COAST-X（NCT02757352）是一项为期52周的3期多中心随机安慰剂对照试验，评估每2周和每4周使用80mg司库奇尤单抗治疗活动性非放射学中轴型脊柱关节炎患者的效果。使用詹金斯睡眠评估问卷（JSEQ）测量睡眠障碍，并使用重复测量的混合效应模型进行分析。使用脊柱关节炎工作效率和活动功能受限问卷测量工作效率和活动功能受限，并使用协方差分析进行分析。对报告有带薪工作的患者评估旷工、出勤和总体工作受损情况；无论工作状态如何，均评估活动功能受限情况。
总体而言，接受两种司库奇尤单抗给药方案治疗的患者在第52周时报告的睡眠改善在数值上均高于安慰剂组。在第16周和第52周时，每4周接受司库奇尤单抗治疗的患者在出勤（分别为p = 0.007和p = 0.003）和总体工作受损（分别为p = 0.014和p = 0.005）方面的改善明显大于安慰剂组，旷工情况在数值上也有改善。每2周接受司库奇尤单抗治疗的患者在旷工、出勤和总体工作受损方面的改善在数值上高于安慰剂组。两种司库奇尤单抗给药方案均与活动功能受限方面明显大于安慰剂组的改善相关（每4周一次司库奇尤单抗：第16周时p = 0.003，第52周时p = 0.004；每2周一次司库奇尤单抗：第16周时p = 0.007，第52周时p = 0.006）。
司库奇尤单抗治疗改善了nr-axSpA患者的睡眠、工作效率和活动功能受限。从第16周至第52周，每4周接受司库奇尤单抗治疗的患者在出勤和总体工作受损方面的改善持续且一致。从第16周至第52周，两个司库奇尤单抗治疗组在活动功能受限方面的改善持续且一致。
NCT02757352，2016年5月2日。
