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古塞库单抗和优特克单抗治疗银屑病患者的有效性、安全性及生活质量影响:来自非干预性、前瞻性、德国多中心PERSIST研究的第104周结果

Effectiveness, safety and quality-of-life effects of guselkumab and ustekinumab in patients with psoriasis: Week 104 results from the non-interventional, prospective, German multicentre PERSIST study.

作者信息

Gerdes S, Hoffmann M, Asadullah K, Korge B, Mortazawi D, Krüger N, Personke Y, Tabori S, Gomez M, Wegner S, Kreimendahl F, Taut F, Sticherling M

机构信息

Psoriasis-Center Kiel, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.

Dermatology Practice Dr. Matthias Hoffmann, Witten, Germany.

出版信息

J Eur Acad Dermatol Venereol. 2025 Mar;39 Suppl 1(Suppl 1):38-49. doi: 10.1111/jdv.19296. Epub 2023 Jul 18.

Abstract

BACKGROUND

PERSIST was a prospective, non-interventional, real-world study of guselkumab and ustekinumab in adult patients with moderate-to-severe plaque psoriasis in Germany.

OBJECTIVES

To examine effectiveness, safety and quality-of-life (QoL) outcomes to Week (W) 104 of treatment with guselkumab and ustekinumab in patients with moderate-to-severe plaque psoriasis.

METHODS

Patients (≥18 years of age) received guselkumab or ustekinumab as per routine clinical practice. Outcomes to W104 were examined separately in guselkumab and ustekinumab recipients. An ad hoc exploratory analysis of outcomes with guselkumab versus ustekinumab was also performed following propensity score matching.

RESULTS

Overall, 302 and 313 patients received guselkumab and ustekinumab, respectively. Patients in both cohorts experienced improvements in disease activity and QoL that were maintained to W104, with 64.7% and 63.6% of guselkumab- and 54.6% and 64.4% of ustekinumab-treated patients achieving a Psoriasis Area and Severity Index (PASI) 90 response and a Dermatology Life Quality Index (DLQI) 0/1 score, respectively. Propensity score matching yielded well-balanced baseline characteristics except for prior biologic use, which was higher in guselkumab versus ustekinumab recipients (51.7% vs. 32.0%). Achievement of PASI ≤1 at W104 was more common in guselkumab versus ustekinumab recipients (58.7% vs. 49.7%). The W104 PASI90 response rate was 65.6% with guselkumab and 56.0% with ustekinumab; corresponding rates for PASI100 were 44.3% and 28.5%. In guselkumab recipients, response rates were higher in biologic-naïve versus biologic-experienced patients (PASI90, 77.1% vs. 53.4%; PASI100, 55.0% vs. 33.0%). A high level of response for QoL outcomes was observed for both treatments.

CONCLUSIONS

Ustekinumab and guselkumab led to improvements in physician-assessed and patient-reported outcomes that were sustained for up to 2 years, with no new safety signals identified. Following propensity score matching, greater improvements in PASI outcomes were observed with guselkumab versus ustekinumab. Improvements with guselkumab were highest in biologic-naïve patients, highlighting the value of early treatment.

摘要

背景

PERSIST是一项在德国对中度至重度斑块状银屑病成年患者使用古塞库单抗和优特克单抗进行的前瞻性、非干预性、真实世界研究。

目的

研究中度至重度斑块状银屑病患者使用古塞库单抗和优特克单抗治疗至第104周时的有效性、安全性和生活质量(QoL)结果。

方法

患者(≥18岁)按照常规临床实践接受古塞库单抗或优特克单抗治疗。分别对接受古塞库单抗和优特克单抗治疗的患者至第104周的结果进行研究。在倾向得分匹配后,还对古塞库单抗与优特克单抗的结果进行了特设探索性分析。

结果

总体而言,分别有302例和313例患者接受了古塞库单抗和优特克单抗治疗。两个队列中的患者疾病活动度和生活质量均有改善,并维持至第104周,接受古塞库单抗治疗的患者中分别有64.7%和63.6%、接受优特克单抗治疗的患者中分别有54.6%和64.4%达到银屑病面积和严重程度指数(PASI)90反应以及皮肤病生活质量指数(DLQI)0/1分。倾向得分匹配产生了平衡良好的基线特征,但既往生物制剂使用情况除外,接受古塞库单抗治疗的患者中既往生物制剂使用率高于接受优特克单抗治疗的患者(51.7%对32.0%)。在第104周时,接受古塞库单抗治疗的患者中达到PASI≤1更为常见(58.7%对49.7%)。第104周时,古塞库单抗的PASI90反应率为65.6%,优特克单抗为56.0%;PASI100的相应反应率分别为44.3%和28.5%。在接受古塞库单抗治疗的患者中,初治患者的反应率高于曾使用过生物制剂的患者(PASI90,77.1%对53.4%;PASI100,55.0%对33.0%)。两种治疗方法的生活质量结果均观察到较高的反应水平。

结论

优特克单抗和古塞库单抗使医生评估和患者报告的结果得到改善,并持续长达2年,未发现新的安全信号。在倾向得分匹配后,观察到与优特克单抗相比,古塞库单抗在PASI结果方面有更大改善。古塞库单抗在初治患者中的改善最为显著,突出了早期治疗的价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d32/11862868/d23f5ac37acb/JDV-39-38-g002.jpg

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