University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.
MetroHealth Medical Center and Case Western Reserve University School of Medicine, Cleveland, Ohio.
Arthritis Care Res (Hoboken). 2022 Mar;74(3):451-460. doi: 10.1002/acr.24482. Epub 2022 Jan 26.
To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active nonradiographic axial spondyloarthritis (SpA).
COAST-X was a randomized, controlled trial conducted in patients with nonradiographic axial SpA over 52 weeks. Participants were randomized at a ratio of 1:1:1 to receive 80 mg of ixekizumab subcutaneously every 4 weeks or 2 weeks or placebo for 52 weeks. Self-reported functioning and health end points included the Medical Outcomes Study Short Form 36 (SF-36) health survey, Assessment of Spondyloarthritis International Society (ASAS) health index, and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility descriptive system.
Compared to placebo, ixekizumab treatment resulted in improvement of SF-36 physical component summary scores from baseline, with a score of 4.7 improving to 8.9 with ixekizumab therapy every 4 weeks (P < 0.05) and a score of 9.3 with ixekizumab therapy every 2 weeks (P < 0.01); the greatest improvements were observed in the domains of physical functioning, role-physical, and bodily pain at weeks 16 and 52. A higher proportion of patients receiving ixekizumab therapy every 2 weeks reported ≥3 improvements based on the ASAS health index from baseline to weeks 16 and 52 (P < 0.05). Significantly more patients receiving ixekizumab every 4 weeks reported improvements in "good health status" on the ASAS health index (ASAS score of ≤5) at weeks 16 and 52 (P < 0.05). Patients receiving ixekizumab reported improvements on the EQ-5D-5L compared to those who received placebo at week 16 (0.11 versus 0.17 for patients receiving treatment every 4 weeks and 0.19 for patients receiving treatment every 2 weeks; P < 0.05), which remained consistent at week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen for patients who received ixekizumab therapy every 2 weeks or every 4 weeks.
In patients with nonradiographic axial SpA, therapy with ixekizumab was superior to placebo in the improvement of self-reported functioning and health at weeks 16 and 52.
评估依奇珠单抗对活动性非放射学中轴型脊柱关节炎（SpA）患者自我报告功能和健康状况的影响。
COAST-X 是一项在 52 周内对非放射学中轴型 SpA 患者进行的随机对照试验。参与者以 1:1:1 的比例随机分配，接受皮下注射 80mg 依奇珠单抗每 4 周、每 2 周或安慰剂治疗 52 周。自我报告的功能和健康终点包括医疗结局研究短表 36（SF-36）健康调查、脊柱关节炎国际协会（ASAS）健康指数和欧洲五维健康量表-5 级（EQ-5D-5L）健康效用描述系统。
与安慰剂相比，依奇珠单抗治疗可改善 SF-36 生理成分综合评分，从基线的 4.7 分提高至每 4 周治疗的 8.9 分（P<0.05）和每 2 周治疗的 9.3 分（P<0.01）；在第 16 周和第 52 周，观察到身体功能、角色身体和躯体疼痛等领域的改善最大。每 2 周接受依奇珠单抗治疗的患者，基于 ASAS 健康指数，从基线到第 16 周和第 52 周报告≥3 项改善的比例更高（P<0.05）。每 4 周接受依奇珠单抗治疗的患者，在第 16 周和第 52 周时，ASAS 健康指数中报告“健康状况良好”（ASAS 评分≤5）的患者比例显著增加（P<0.05）。与安慰剂组相比，接受依奇珠单抗治疗的患者在第 16 周（每 4 周治疗的患者为 0.11，每 2 周治疗的患者为 0.19；P<0.05）和第 52 周（每 4 周治疗的患者为 0.11，每 2 周治疗的患者为 0.17）在 EQ-5D-5L 上的报告有所改善，且在第 52 周时仍保持一致。对于每 2 周或每 4 周接受依奇珠单抗治疗的患者，基于依奇珠单抗剂量方案的反应没有临床意义上的差异。
在非放射学中轴型 SpA 患者中，与安慰剂相比，依奇珠单抗治疗在第 16 周和第 52 周时可改善自我报告的功能和健康状况。
