在随机 3 期临床试验中，依奇珠单抗治疗可迅速改善与健康相关的生活质量和瘙痒：UNCOVER-2 和 UNCOVER-3 的结果。
Rapid improvements in health-related quality of life and itch with ixekizumab treatment in randomized phase 3 trials: results from UNCOVER-2 and UNCOVER-3.
机构信息
Central Dermatology, St Louis, MO, USA.
Oregon Medical Research Center, Portland, OR, USA.
出版信息
J Eur Acad Dermatol Venereol. 2017 Sep;31(9):1483-1490. doi: 10.1111/jdv.14211. Epub 2017 Jun 28.
BACKGROUND
Patients with moderate-to-severe psoriasis report impaired health-related quality of life (HRQoL).
OBJECTIVE
To assess speed of onset of ixekizumab-induced clinically relevant improvement in HRQoL.
METHODS
This post hoc analysis used pooled data from patients randomized in UNCOVER-2 and UNCOVER-3, and treated with 80 mg ixekizumab every 2 weeks (IXEQ2W), 80 mg ixekizumab every 4 weeks (IXEQ4W), 50 mg etanercept (ETN) twice weekly or placebo (PBO) for 12 weeks. HRQoL and pruritus were assessed using the Dermatology Life Quality Index (DLQI) and Itch Numeric Rating Scale (NRS), respectively. Minimally clinical important differences (MCID) in DLQI and Itch NRS were defined as ≥5-point and ≥4-point improvements from baseline, respectively. Time to response from randomization was estimated using Kaplan-Meier methodology and the log-rank test. Hazard ratios between treatments were calculated using a Cox proportional hazards regression model adjusting for studies.
RESULTS
A total of 2570 patients were included: 361 PBO; 740 ETN; 733 IXEQ4W and 736 IXEQ2W. Significantly greater differences in time to DLQI ≥5 point or Itch NRS ≥4 point improvement for IXEQ2W or IXEQ4W compared with ETN and PBO (P < 0.001) were observed. The median time when 50% of patients reached a ≥5-point reduction in DLQI was shorter for ixekizumab-treated patients (2 weeks, both schedules) compared with ETN- (4 weeks) or PBO-treated (>12 weeks) patients. Likewise, the median time when 50% of patients reached a ≥4-point reduction in Itch NRS was shorter for ixekizumab-treated patients (2 weeks, both schedules) compared with ETN- (8 weeks) or PBO-treated (>12 weeks) patients. Significantly more ixekizumab-treated patients were likely to achieve MCIDs in DLQI or itch reduction compared with ETN or PBO after 12 weeks of treatment.
CONCLUSION
Ixekizumab-treated patients achieved more rapid improvements both in HRQoL and itch compared with patients treated with ETN and PBO.
背景
中重度斑块状银屑病患者报告其健康相关生活质量（HRQoL）受损。
目的
评估依奇珠单抗诱导 HRQoL 临床相关改善的起效速度。
方法
本事后分析采用了来自 UNCOVER-2 和 UNCOVER-3 随机化的患者汇总数据，这些患者接受了 80mg 依奇珠单抗每 2 周（IXEQ2W）、80mg 依奇珠单抗每 4 周（IXEQ4W）、50mg 依那西普每周两次或安慰剂（PBO）治疗 12 周。使用皮肤病生活质量指数（DLQI）和瘙痒数字评分量表（NRS）分别评估 HRQoL 和瘙痒。DLQI 和瘙痒 NRS 的最小临床重要差异（MCID）分别定义为与基线相比≥5 分和≥4 分的改善。使用 Kaplan-Meier 方法和对数秩检验估计从随机分组到应答的时间。使用 Cox 比例风险回归模型调整研究因素，计算治疗之间的风险比。
结果
共纳入 2570 例患者：361 例 PBO；740 例 ETN；733 例 IXEQ4W 和 736 例 IXEQ2W。与 ETN 和 PBO 相比，IXEQ2W 或 IXEQ4W 治疗在达到 DLQI≥5 分或瘙痒 NRS≥4 分改善的时间上有显著差异（P<0.001）。达到 DLQI 降低≥5 分的 50%患者的中位数时间更短，为接受依奇珠单抗治疗的患者（2 周，两种方案），而接受依那西普（4 周）或 PBO 治疗的患者（>12 周）。同样，达到瘙痒 NRS 降低≥4 分的 50%患者的中位数时间更短，为接受依奇珠单抗治疗的患者（2 周，两种方案），而接受依那西普（8 周）或 PBO 治疗的患者（>12 周）。与 ETN 或 PBO 相比，接受依奇珠单抗治疗的患者在 12 周治疗后更有可能达到 DLQI 或瘙痒缓解的 MCID。
结论
与接受依那西普和 PBO 治疗的患者相比，接受依奇珠单抗治疗的患者在 HRQoL 和瘙痒方面的改善速度更快。
Zotero 插件