• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

替西罗莫司在老年患者中的疗效和安全性:两项随机 III 期临床试验(reSURFACE 1 和 reSURFACE 2)的 244 周汇总分析。

Efficacy and Safety of Tildrakizumab in Older Patients: Pooled Analyses of Two Randomized Phase III Clinical Trials (reSURFACE 1 and reSURFACE 2) Through 244 Weeks.

机构信息

Department of Dermatology, Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands.

Almirall R&D, Barcelona, Spain.

出版信息

Acta Derm Venereol. 2023 Oct 25;103:adv17752. doi: 10.2340/actadv.v103.17752.

DOI:10.2340/actadv.v103.17752
PMID:37877618
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10614651/
Abstract

The evidence on treating older patients with psoriasis with modern biologics is scarce. This study compared the efficacy and safety of tildrakizumab among younger and older patients with psoriasis (< 65/≥ 65 years) in a post hoc analysis of 2 phase III trials (reSURFACE1/2, n = 1,862). Tildrakizumab 100 mg/200 mg was administered at weeks 0/4/every 12 weeks thereafter. At week 28, patients with ≥ 75% improvement in baseline Psoriasis Area and Severity Index (PASI75) in reSURFACE1 were re-randomized to the same tildrakizumab dose or placebo; in reSURFACE2, PASI75 responders to 200 mg were re-randomized to tildrakizumab 100 mg or 200 mg; PASI75 responders to 100 mg maintained their dose. At weeks 64/52 (reSURFACE1/2), PASI50 responders entered an extension period (weeks 256/244). Outcomes were proportion of patients with PASI < 3, Dermatology Life Quality Index (DLQI) 0/1, comorbidities, comedication, and side-effects. The proportion of patients with a PASI < 3 was similar and maintained (tildrakizumab 100 mg and 200 mg, week 244: 83.3% and 84.1%/92.3% and 100.0%); DLQI 0/1 proportions at week 52 were 66.8% and 72.0%/68.3% and 81.3%. Comorbidity and comedication were more common in older patients. The safety profile of tildrakizumab appeared favourable in both groups. Tildrakizumab in patients ≥ 65 years appears effective and safe in long-term psoriasis management. These findings might assist treatment selection and overcome treatment reluctance.

摘要

针对老年银屑病患者使用现代生物制剂的证据有限。本研究通过对两项 III 期临床试验(reSURFACE1/2,n=1862)的事后分析,比较了 tildrakizumab 在年轻和老年银屑病患者(<65/≥65 岁)中的疗效和安全性。tildrakizumab 100 mg/200 mg 分别在第 0/4 周和之后每 12 周给药一次。在第 28 周,reSURFACE1 中基线银屑病面积和严重性指数(PASI75)改善≥75%的患者被重新随机分配至相同剂量的 tildrakizumab 或安慰剂;在 reSURFACE2 中,200 mg 应答者被重新随机分配至 tildrakizumab 100 mg 或 200 mg;100 mg 应答者维持其剂量。在第 64/52 周(reSURFACE1/2),PASI50 应答者进入扩展期(第 256/244 周)。结局为 PASI<3、皮肤病生活质量指数(DLQI)0/1、合并症、伴随药物治疗和副作用的患者比例。PASI<3 的患者比例相似且维持(tildrakizumab 100 mg 和 200 mg,第 244 周:83.3%和 84.1%/92.3%和 100.0%;DLQI 0/1 比例,第 52 周:66.8%和 72.0%/68.3%和 81.3%)。老年患者合并症和伴随药物治疗更为常见。tildrakizumab 的安全性特征在两组中均表现良好。tildrakizumab 对≥65 岁的患者在长期银屑病管理中有效且安全。这些发现可能有助于治疗选择并克服治疗犹豫。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/0baf415cebc7/ActaDV-103-17752-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/c82202001bcd/ActaDV-103-17752-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/ff233c58f007/ActaDV-103-17752-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/0baf415cebc7/ActaDV-103-17752-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/c82202001bcd/ActaDV-103-17752-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/ff233c58f007/ActaDV-103-17752-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e44/10614651/0baf415cebc7/ActaDV-103-17752-g003.jpg

相似文献

1
Efficacy and Safety of Tildrakizumab in Older Patients: Pooled Analyses of Two Randomized Phase III Clinical Trials (reSURFACE 1 and reSURFACE 2) Through 244 Weeks.替西罗莫司在老年患者中的疗效和安全性:两项随机 III 期临床试验(reSURFACE 1 和 reSURFACE 2)的 244 周汇总分析。
Acta Derm Venereol. 2023 Oct 25;103:adv17752. doi: 10.2340/actadv.v103.17752.
2
Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks.替拉珠单抗治疗中重度银屑病的长期疗效和安全性:两项随机III期临床试验(reSURFACE 1和reSURFACE 2)长达148周的汇总分析
Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18.
3
Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: Long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2).替西罗莫司治疗银屑病的疗效、药物存活率和安全性在合并和不合并代谢综合征的患者中相当:来自 2 项 3 期随机对照研究(reSURFACE 1 和 reSURFACE 2)的长期结果。
J Am Acad Dermatol. 2021 Feb;84(2):398-407. doi: 10.1016/j.jaad.2020.09.047. Epub 2020 Sep 19.
4
Long-term efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 5-year extension of a phase 3 study (reSURFACE 1).替西罗莫司乳膏治疗中度至重度斑块状银屑病日本患者的 5 年长期疗效和安全性:一项 3 期研究(reSURFACE 1)的 5 年扩展研究结果。
J Dermatol. 2021 Jun;48(6):844-852. doi: 10.1111/1346-8138.15763. Epub 2021 Feb 1.
5
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.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。
J Eur Acad Dermatol Venereol. 2019 Dec;33(12):2305-2312. doi: 10.1111/jdv.15862. Epub 2019 Sep 11.
6
Efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 64-week phase 3 study (reSURFACE 1).替西罗莫司单抗治疗中度至重度斑块状银屑病日本患者的疗效和安全性:一项 64 周 3 期研究(reSURFACE 1)的结果。
J Dermatol. 2021 Jun;48(6):853-863. doi: 10.1111/1346-8138.15789. Epub 2021 Feb 25.
7
Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2).在第 28 周有应答的中重度斑块状银屑病患者中,替度鲁单抗的 5 年疗效和安全性:两项随机 III 期临床试验(reSURFACE 1 和 reSURFACE 2)的汇总分析。
Br J Dermatol. 2021 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4.
8
Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials.替西单抗与安慰剂或依那西普治疗慢性斑块型银屑病(reSURFACE 1 和 reSURFACE 2):两项随机对照、3 期临床试验的结果。
Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5. Epub 2017 Jun 6.
9
Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies.替拉珠单抗用于斑块状银屑病连续给药、治疗中断、剂量调整及从依那西普转换治疗的疗效和安全性:III期研究结果
Br J Dermatol. 2020 Jun;182(6):1359-1368. doi: 10.1111/bjd.18484. Epub 2019 Nov 19.
10
Tildrakizumab efficacy and safety in patients with psoriasis and concomitant metabolic syndrome: post hoc analysis of 5-year data from reSURFACE 1 and reSURFACE 2.替西罗莫司治疗斑块状银屑病和代谢综合征患者的疗效和安全性:RE-SURFACE 1 和 RE-SURFACE 2 研究 5 年数据的事后分析。
J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1774-1783. doi: 10.1111/jdv.18167. Epub 2022 Jun 25.

引用本文的文献

1
Optimizing Psoriasis Treatment with Tildrakizumab: Current Evidence and Expert Recommendations for Treatment Individualization in Clinical Practice.使用替拉珠单抗优化银屑病治疗:临床实践中治疗个体化的当前证据和专家建议
Dermatol Ther (Heidelb). 2025 Sep 11. doi: 10.1007/s13555-025-01538-4.
2
Effectiveness and Safety of Tildrakizumab in Elderly and Frail Elderly Psoriatic Patients Up to 2 years.替拉珠单抗治疗老年及体弱老年银屑病患者长达2年的有效性和安全性
Psoriasis (Auckl). 2025 Aug 4;15:339-350. doi: 10.2147/PTT.S525256. eCollection 2025.
3
Real-World Study of Tildrakizumab Survival in Psoriasis: Impact of Arthritis, Hypertension, and Prior Biologic Use.

本文引用的文献

1
Real-world effectiveness and safety of tildrakizumab in long-term treatment of plaque psoriasis: Results from the non-interventional, prospective, multicentre study TILOT.在斑块状银屑病的长期治疗中,替拉珠单抗的真实世界疗效和安全性:来自非干预性、前瞻性、多中心研究 TILOT 的结果。
J Eur Acad Dermatol Venereol. 2023 Jan;37(1):85-92. doi: 10.1111/jdv.18572. Epub 2022 Sep 23.
2
Safety Assessment of Conventional and Biological Systemic Therapy in Older Adults with Psoriasis, a Real-world Multicentre Cohort Study.老年人银屑病常规和生物系统治疗的安全性评估:一项真实世界多中心队列研究。
Acta Derm Venereol. 2022 Oct 31;102:adv00805. doi: 10.2340/actadv.v102.2412.
3
银屑病中替拉珠单抗生存情况的真实世界研究:关节炎、高血压及既往生物制剂使用情况的影响
Life (Basel). 2025 May 15;15(5):789. doi: 10.3390/life15050789.
Drug Survival, Safety, and Effectiveness of Biologics in Older Patients with Psoriasis: A Comparison with Younger Patients-A BioCAPTURE Registry Study.
生物制剂在老年银屑病患者中的生存、安全性和有效性:与年轻患者的比较——一项 BioCAPTURE 登记研究。
Drugs Aging. 2022 Sep;39(9):715-727. doi: 10.1007/s40266-022-00961-y. Epub 2022 Jul 21.
4
Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients.抗 IL-23p19 生物制剂特诺雅(Tildrakizumab)治疗银屑病的有效性和安全性:一项真实世界、前瞻性非选择患者队列研究结果。
Dermatology. 2022;238(4):615-619. doi: 10.1159/000519924. Epub 2021 Nov 12.
5
Anti-interleukin-23 for psoriasis in elderly patients: guselkumab, risankizumab and tildrakizumab in real-world practice.老年银屑病患者的抗白细胞介素-23 治疗:真实世界中 Guselkumab、Risankizumab 和 Tildrakizumab 的应用。
Clin Exp Dermatol. 2022 Mar;47(3):561-567. doi: 10.1111/ced.14979. Epub 2021 Nov 17.
6
Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2).在第 28 周有应答的中重度斑块状银屑病患者中,替度鲁单抗的 5 年疗效和安全性:两项随机 III 期临床试验(reSURFACE 1 和 reSURFACE 2)的汇总分析。
Br J Dermatol. 2021 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4.
7
Quality of life, treatment goals, preferences and satisfaction in older adults with psoriasis: a patient survey comparing age groups.老年银屑病患者的生活质量、治疗目标、偏好及满意度:一项比较年龄组的患者调查
Br J Dermatol. 2021 Apr;184(4):759-762. doi: 10.1111/bjd.19665. Epub 2020 Dec 30.
8
Elderly patients with psoriasis: long-term efficacy and safety of modern treatments.老年银屑病患者:现代治疗的长期疗效和安全性。
J Dermatolog Treat. 2022 May;33(3):1339-1342. doi: 10.1080/09546634.2020.1809623. Epub 2020 Aug 20.
9
The risk of respiratory tract infections and symptoms in psoriasis patients treated with interleukin 17 pathway-inhibiting biologics: A meta-estimate of pivotal trials relevant to decision making during the COVID-19 pandemic.接受白细胞介素17通路抑制生物制剂治疗的银屑病患者发生呼吸道感染和症状的风险:对COVID-19大流行期间决策相关关键试验的荟萃估计。
J Am Acad Dermatol. 2020 Aug;83(2):677-679. doi: 10.1016/j.jaad.2020.05.035. Epub 2020 May 19.
10
Dermatology Life Quality Index (DLQI) score bands are applicable to DLQI-Relevant (DLQI-R) scoring.皮肤病生活质量指数(DLQI)评分范围适用于与DLQI相关(DLQI-R)的评分。
J Eur Acad Dermatol Venereol. 2020 Sep;34(9):e484-e486. doi: 10.1111/jdv.16398. Epub 2020 May 12.