Real-life Effectiveness and Safety of Guselkumab in Moderate-to-Severe Plaque Psoriasis: A 104-Week Retrospective Single-Center Study.

IF 1.8 4区 医学 Q3 DERMATOLOGY Journal of Drugs in Dermatology Pub Date : 2024-08-01 DOI:10.36849/JDD.7486
Luigi Gargiulo, Luciano Ibba, Andrea Cortese, Francesco Toso, Carlo A Vignoli, Giovanni Fiorillo, Francesco Piscazzi, Mario Valenti, Antonio Costanzo, Alessandra Narcisi
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Abstract

Background: Guselkumab is a monoclonal antibody approved for treating moderate-to-severe plaque psoriasis. Long-term data on the effectiveness and safety of guselkumab in a real-world setting are still limited.

Materials and methods: We conducted a 104-week monocentric retrospective study on 102 psoriasis patients, all treated with guselkumab for at least 16 weeks. At each visit, we used the Psoriasis Area and Severity Index (PASI): effectiveness endpoints were the percentages of patients achieving 75%/90%/100% (PASI 75/90/100) improvement in PASI compared with baseline. The Kaplan-Meier curve was used to assess the drug survival.

Results: At week 16, PASI 90 and PASI 100 were achieved by 49.02% and 32.35% of patients. At week 52, PASI 90 and PASI 100 were achieved by 71.58% and 55.79% of patients. After 2 years, PASI 90 and PASI 100 were achieved by 79.63% and 61.11% of patients. Obese and overweight patients had comparable PASI 90 and PASI 100 responses throughout the study. At week 104, no significant differences were observed between bio-naïve and bio-experienced patients regarding all effectiveness endpoints. No significant safety signals were reported in our study. After 24 months, 91.57% of our cohort was still on treatment with guselkumab.

Conclusion: Our findings, although limited by the study's retrospective nature, confirm that guselkumab is a safe and effective therapeutic option for a "real-life" cohort of patients with psoriasis. J Drugs Dermatol. 2024;23(8):632-639.  doi:10.36849/JDD.7486R1.

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古舍库单抗对中重度斑块状银屑病的实际疗效和安全性:一项为期 104 周的回顾性单中心研究。
背景介绍古舍库单抗是一种单克隆抗体,已被批准用于治疗中重度斑块状银屑病。有关古舍库单抗在现实世界中的有效性和安全性的长期数据仍然有限:我们对 102 名银屑病患者进行了为期 104 周的单中心回顾性研究,所有患者均接受了至少 16 周的古舍库单抗治疗。在每次就诊时,我们都使用了银屑病面积和严重程度指数(PASI):疗效终点是与基线相比,PASI 改善达到 75%/90%/100% (PASI 75/90/100)的患者百分比。采用 Kaplan-Meier 曲线评估药物存活率:第 16 周时,分别有 49.02% 和 32.35% 的患者达到了 PASI 90 和 PASI 100。第 52 周时,分别有 71.58% 和 55.79% 的患者达到了 PASI 90 和 PASI 100。两年后,分别有 79.63% 和 61.11% 的患者达到了 PASI 90 和 PASI 100。在整个研究过程中,肥胖和超重患者的 PASI 90 和 PASI 100 反应相当。在第104周时,在所有疗效终点方面,未观察到有生物治疗经验的患者与有生物治疗经验的患者之间存在明显差异。在我们的研究中,没有发现明显的安全性信号。24个月后,91.57%的患者仍在接受古舍库单抗治疗:结论:我们的研究结果虽然受限于研究的回顾性,但证实了古舍库单抗对于 "现实生活中 "的银屑病患者群体来说是一种安全有效的治疗选择。J Drugs Dermatol.2024;23(8):632-639.  doi:10.36849/JDD.7486R1.
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来源期刊
CiteScore
2.20
自引率
13.30%
发文量
289
审稿时长
3-6 weeks
期刊介绍: The Journal of Drugs in Dermatology (JDD) is a peer-reviewed publication indexed with MEDLINE®/PubMed® that was founded by the renowned Dr. Perry Robins MD. Founded in 2002, it offers one of the fastest routes to disseminate dermatologic information and is considered the fastest growing publication in dermatology. We present original articles, award-winning case reports, and timely features pertaining to new methods, techniques, drug therapy, and devices in dermatology that provide readers with peer reviewed content of the utmost quality. Our high standards of content are maintained through a balanced, peer-review process. Articles are reviewed by an International Editorial Board of over 160 renowned experts.
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