Ixekizumab for treatment of moderate to severe plaque psoriasis: real world clinical experience.

IF 2 Q3 Medicine
Federico Diotallevi, Anna Campanati, Giulia Radi, Elisa Molinelli, Annamaria Offidani
{"title":"Ixekizumab for treatment of moderate to severe plaque psoriasis: real world clinical experience.","authors":"Federico Diotallevi,&nbsp;Anna Campanati,&nbsp;Giulia Radi,&nbsp;Elisa Molinelli,&nbsp;Annamaria Offidani","doi":"10.23736/S0392-0488.18.06094-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Data concerning clinical experience in real world setting with ixekizumab for psoriasis are still exiguous. So, the aim of this report was to provide our experience in the use of ixekizumab in outpatient setting.</p><p><strong>Methods: </strong>Fifteen Caucasian individuals (10 male, 5 females; mean age: 58.1; range: 30-75 years) affected by moderate to severe plaque psoriasis (PASI≥10 and/or DLQI≥10 and/or BSA≥10) were treated with ixekizumab, following dosing regimen of technical data sheet and clinically evaluated after 4 weeks (T4) and 12 weeks (T12) after. At baseline median PASI was 16.3 (range: 10-30, SD=6.0). The median BSA was 21.3 (10-35, SD=7.0), the median PGA was 3.4 (2-6, SD=1.2), the median DLQI was 18.6 (14-25, SD=3.6), the median m-NAPSI was 42.0 (30-56, SD=13.11). The median absolute value of PASI, BSA, PGA, DLQI and m-NAPSI showed a statistically significant decrease (P<0.05) already after 4 weeks of treatment, in order to testify treatment effectiveness.</p><p><strong>Results: </strong>At T4, 93.3% of the patients reached PASI50, 6.9% reached PASI75; at T12, 100% of the patients reached PASI50, 80% reached PASI75, 13% reached PASI90 and 6.9% reached PASI100. One-third of observed patients reached MDA after 12 weeks of treatment. Injection site reactions were the only side effects occurring during the first 12 weeks of treatment.</p><p><strong>Conclusions: </strong>Our preliminary results seem to confirm the efficacy and safety profile provided through the UNCOVER pivotal trials (UNCOVER 1-3) although further larger observational studies are needed.</p>","PeriodicalId":49071,"journal":{"name":"Giornale Italiano Di Dermatologia E Venereologia","volume":"155 6","pages":"739-743"},"PeriodicalIF":2.0000,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"19","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Giornale Italiano Di Dermatologia E Venereologia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.23736/S0392-0488.18.06094-7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/11/9 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 19

Abstract

Background: Data concerning clinical experience in real world setting with ixekizumab for psoriasis are still exiguous. So, the aim of this report was to provide our experience in the use of ixekizumab in outpatient setting.

Methods: Fifteen Caucasian individuals (10 male, 5 females; mean age: 58.1; range: 30-75 years) affected by moderate to severe plaque psoriasis (PASI≥10 and/or DLQI≥10 and/or BSA≥10) were treated with ixekizumab, following dosing regimen of technical data sheet and clinically evaluated after 4 weeks (T4) and 12 weeks (T12) after. At baseline median PASI was 16.3 (range: 10-30, SD=6.0). The median BSA was 21.3 (10-35, SD=7.0), the median PGA was 3.4 (2-6, SD=1.2), the median DLQI was 18.6 (14-25, SD=3.6), the median m-NAPSI was 42.0 (30-56, SD=13.11). The median absolute value of PASI, BSA, PGA, DLQI and m-NAPSI showed a statistically significant decrease (P<0.05) already after 4 weeks of treatment, in order to testify treatment effectiveness.

Results: At T4, 93.3% of the patients reached PASI50, 6.9% reached PASI75; at T12, 100% of the patients reached PASI50, 80% reached PASI75, 13% reached PASI90 and 6.9% reached PASI100. One-third of observed patients reached MDA after 12 weeks of treatment. Injection site reactions were the only side effects occurring during the first 12 weeks of treatment.

Conclusions: Our preliminary results seem to confirm the efficacy and safety profile provided through the UNCOVER pivotal trials (UNCOVER 1-3) although further larger observational studies are needed.

Ixekizumab用于治疗中度至重度斑块性银屑病:真实世界的临床经验。
背景:关于ixekizumab治疗银屑病的临床经验数据仍然很少。因此,本报告的目的是提供我们在门诊环境中使用ixekizumab的经验。方法:15例高加索人(男性10例,女性5例;平均年龄:58.1岁;范围:30-75岁),受中度至重度斑块型银屑病(PASI≥10和/或DLQI≥10和/或BSA≥10)影响的患者接受ixekizumab治疗,按照技术数据表的给药方案,并在4周(T4)和12周(T12)后进行临床评估。基线时PASI中位数为16.3(范围:10-30,SD=6.0)。BSA中位数为21.3 (10-35,SD=7.0), PGA中位数为3.4 (2-6,SD=1.2), DLQI中位数为18.6 (14-25,SD=3.6), m-NAPSI中位数为42.0 (30-56,SD=13.11)。PASI、BSA、PGA、DLQI、m-NAPSI的中位绝对值下降有统计学意义(结果:T4时,93.3%的患者达到PASI50, 6.9%的患者达到PASI75;T12时,100%的患者达到PASI50, 80%达到PASI75, 13%达到PASI90, 6.9%达到PASI100。三分之一的观察患者在治疗12周后达到MDA。注射部位反应是治疗前12周发生的唯一副作用。结论:我们的初步结果似乎证实了通过reveal关键试验(reveal 1-3)提供的有效性和安全性,尽管需要进一步的更大规模的观察性研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
1.90
自引率
0.00%
发文量
0
审稿时长
6-12 weeks
期刊介绍: The journal Giornale Italiano di Dermatologia e Venereologia publishes scientific papers on dermatology and sexually transmitted diseases. Manuscripts may be submitted in the form of editorials, original articles, review articles, case reports, therapeutical notes, special articles and letters to the Editor. Manuscripts are expected to comply with the instructions to authors which conform to the Uniform Requirements for Manuscripts Submitted to Biomedical Editors by the International Committee of Medical Journal Editors (www.icmje.org). Articles not conforming to international standards will not be considered for acceptance.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信