替度鲁单抗治疗中重度银屑病的疗效和对生活质量的影响：两项随机对照试验的汇总分析。
Tildrakizumab efficacy and impact on quality of life up to 52 weeks in patients with moderate-to-severe psoriasis: a pooled analysis of two randomized controlled trials.
机构信息
Oregon Medical Research Center, Portland, OR, USA.
Department of Medicine (Dermatology), UCLA, Los Angeles, CA, USA.
出版信息
J Eur Acad Dermatol Venereol. 2019 Dec;33(12):2305-2312. doi: 10.1111/jdv.15862. Epub 2019 Sep 11.
BACKGROUND
Two randomized controlled trials (reSURFACE 1 and 2) have demonstrated the effectiveness of tildrakizumab, a high-affinity, humanized, IgG1κ, anti-interleukin-23 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in the first 28 weeks.
OBJECTIVES
To examine the efficacy of tildrakizumab and its impact on quality of life (QoL) in patients with different levels of week-28 Psoriasis Area and Severity Index (PASI) improvement.
METHODS
Patients treated with tildrakizumab 100 mg or 200 mg from baseline to week 28 were pooled from reSURFACE 1 and reSURFACE 2 and classified into five mutually exclusive week-28 PASI improvement groups for each dose: PASI 0-49, 50-74, 75-89, 90-99 and 100. Mean PASI improvement and Dermatology Life Quality Index (DLQI) 0/1 over time were examined for each group.
RESULTS
Of 1156 patients, 575 were in the 100-mg and 578 in the 200-mg cohorts, respectively. At week 28, 8.3%, 14.3%, 23.8%, 30.4% and 23.1% in the 100-mg and 4.0%, 18.1%, 19.6%, 29.1% and 29.3% in the 200-mg cohort achieved PASI < 50, 50-74, 75-89, 90-99 and 100, respectively. Patients with PASI < 50 at week 28 could be identified as early as week 8, and those with week-28 PASI ≥ 90 had approximately 50% PASI improvement by week 4. Among patients achieving PASI > 50 at week 28 who continued the same dose of tildrakizumab to week 52, mean PASI improvement was maintained or improved over time. Similar results were observed for both doses. Higher proportions of patients achieved DLQI 0/1 in higher week-28 PASI groups, and DLQI 0/1 was maintained or improved to week 52. However, not all patients with PASI 100 had DLQI 0/1.
CONCLUSION
Patients unlikely to respond to tildrakizumab could be identified by week 8, and those likely to achieve a PASI ≥ 90 response could be identified as early as week 4. Week-28 PASI improvement level correlated with QoL improvement.
背景
两项随机对照试验（reSURFACE 1 和 2）已经证明了替拉珠单抗的有效性，替拉珠单抗是一种高亲和力的人源化 IgG1κ 抗白细胞介素-23 单克隆抗体，可用于治疗前 28 周的中度至重度斑块状银屑病。
目的
检查替拉珠单抗的疗效及其对不同水平第 28 周银屑病面积和严重程度指数（PASI）改善患者生活质量（QoL）的影响。
方法
从 reSURFACE 1 和 reSURFACE 2 中筛选出从基线到第 28 周接受替拉珠单抗 100mg 或 200mg 治疗的患者，并将其分为五个相互排斥的第 28 周 PASI 改善组，每组剂量分别为：PASI 0-49、50-74、75-89、90-99 和 100。检查每个组随时间推移的平均 PASI 改善和皮肤病生活质量指数（DLQI）0/1。
结果
在 1156 名患者中，分别有 575 名患者接受了 100mg 剂量，578 名患者接受了 200mg 剂量。在第 28 周时，100mg 组中分别有 8.3%、14.3%、23.8%、30.4%和 23.1%的患者，200mg 组中分别有 4.0%、18.1%、19.6%、29.1%和 29.3%的患者达到 PASI<50、50-74、75-89、90-99 和 100。第 28 周 PASI<50 的患者早在第 8 周就可以被识别出来，第 28 周 PASI≥90 的患者在第 4 周时大约有 50%的 PASI 改善。在第 28 周达到 PASI>50 的患者中，继续使用相同剂量的替拉珠单抗至第 52 周时，平均 PASI 改善得到维持或随时间改善。两种剂量均观察到相似的结果。在第 28 周 PASI 较高的患者中，有更高比例的患者达到 DLQI 0/1，且 DLQI 0/1 可维持或改善至第 52 周。然而，并非所有 PASI 为 100 的患者都有 DLQI 0/1。
结论
到第 8 周可以识别出不太可能对替拉珠单抗有反应的患者，而到第 4 周可以识别出可能有 PASI≥90 反应的患者。第 28 周 PASI 改善水平与 QoL 改善相关。
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