依奇珠单抗在中度银屑病患者中持续 4 年具有高疗效和良好的安全性：来自 UNCOVER-3 研究的结果。
Ixekizumab sustains high level of efficacy and favourable safety profile over 4 years in patients with moderate psoriasis: results from UNCOVER-3 study.
机构信息
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Medical College of Wisconsin, Milwaukee, WI, USA.
出版信息
J Eur Acad Dermatol Venereol. 2020 Feb;34(2):301-309. doi: 10.1111/jdv.15921. Epub 2019 Nov 7.
BACKGROUND
Psoriasis, a chronic disease usually requires long-term disease management.
OBJECTIVE
This study evaluates the efficacy and safety of recommended ixekizumab (IXE) dose over 4 years (204 weeks) from UNCOVER-3 study.
METHODS
UNCOVER-3 was a randomised, double-blind, multicenter, phase 3 study wherein patients with moderate-to-severe plaque psoriasis received placebo, IXE 80 mg every 2 weeks (Q2W), IXE 80 mg every 4 weeks (Q4W) (both IXE groups had 160 mg starting dose) or etanercept 50 mg twice weekly. At week 12, all patients switched to IXE Q4W dose for the long-term extension (264 weeks). After week 60 and at investigator's discretion, patients could receive dose adjustment to IXE Q2W. The efficacy endpoints at week 204 were percentage of patients achieving PASI 75/90/100, sPGA score of 1 or 0, and those achieving PSSI = 0, NAPSI = 0 and PPASI 100. Efficacy data were summarised through 204 weeks using as-observed, multiple imputation (MI) and modified non-responder imputation (mNRI) methods.
RESULTS
The proportion of patients achieving PASI 75/90/100 at week 204 using mNRI method were 82.8%, 66.4% and 48.3%, respectively. Using as-observed and MI methods, 98.2% and 94.8% patients achieved PASI 75, 87.8% and 73.3% achieved PASI 90, and 67.1% and 52.7% achieved PASI 100 response, respectively, at week 204. The response rates for sPGA (0, 1) were 88.7%, 76.2% and 68.5% and for sPGA (0) were 68.9%, 54.6% and 49.7% using as-observed, MI and mNRI methods, respectively. Similar trends were observed with NAPSI = 0, PSSI = 0, PPASI 100 and itch NRS = 0. There were no new safety concerns through year 4.
CONCLUSIONS
This study demonstrated sustained high-efficacy response through 4 years of continuous treatment with ixekizumab in patients with moderate-to-severe plaque psoriasis. The safety profile remained consistent with prior findings, with no new or unexpected safety concerns.
背景
银屑病是一种慢性疾病，通常需要长期疾病管理。
目的
本研究评估了 UNCOVER-3 研究中推荐的依奇珠单抗（IXE）剂量在 4 年（204 周）内的疗效和安全性。
方法
UNCOVER-3 是一项随机、双盲、多中心、III 期研究，其中中重度斑块状银屑病患者接受安慰剂、IXE 80mg 每 2 周（Q2W）、IXE 80mg 每 4 周（Q4W）（IXE 两组均有 160mg 的起始剂量）或依那西普 50mg 每周 2 次。在第 12 周，所有患者均转换为 IXE Q4W 剂量进行长期扩展（264 周）。在第 60 周和根据研究者的判断，患者可以接受 IXE Q2W 的剂量调整。第 204 周的主要疗效终点是达到 PASI 75/90/100、sPGA 评分 1 或 0，以及达到 PSSI=0、NAPSI=0 和 PPASI 100 的患者比例。使用观测值、多重插补（MI）和改良无应答插补（mNRI）方法在第 204 周汇总疗效数据。
结果
使用 mNRI 方法，第 204 周达到 PASI 75/90/100 的患者比例分别为 82.8%、66.4%和 48.3%。使用观测值和 MI 方法，第 204 周分别有 98.2%和 94.8%的患者达到 PASI 75，87.8%和 73.3%的患者达到 PASI 90，67.1%和 52.7%的患者达到 PASI 100 反应。使用观测值、MI 和 mNRI 方法，sPGA（0、1）的应答率分别为 88.7%、76.2%和 68.5%，sPGA（0）的应答率分别为 68.9%、54.6%和 49.7%。NAPSI=0、PSSI=0、PPASI 100 和瘙痒 NRS=0 也观察到类似的趋势。在第 4 年没有出现新的安全性问题。
结论
这项研究表明，在中重度斑块状银屑病患者中，连续 4 年接受依奇珠单抗治疗可保持持续的高疗效反应。安全性特征与先前的发现一致，没有新的或意外的安全性问题。
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