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司库奇尤单抗治疗131例中重度斑块状银屑病患者的真实疗效及安全性:一项52周回顾性研究

Real-Life Effectiveness and Safety of Risankizumab in 131 Patients Affected by Moderate-to-Severe Plaque Psoriasis: A 52-Week Retrospective Study.

作者信息

Gargiulo Luigi, Ibba Luciano, Pavia Giulia, Vignoli Carlo Alberto, Piscazzi Francesco, Valenti Mario, Sanna Federica, Perugini Chiara, Avagliano Jessica, Costanzo Antonio, Narcisi Alessandra

机构信息

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.

Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy.

出版信息

Dermatol Ther (Heidelb). 2022 Oct;12(10):2309-2324. doi: 10.1007/s13555-022-00795-x. Epub 2022 Sep 5.

Abstract

INTRODUCTION

Risankizumab is a humanized monoclonal antibody that selectively targets interleukin-23. It is approved for treatment of moderate-to-severe plaque psoriasis. We conducted a 52-week monocentric retrospective study to evaluate the effectiveness and safety of risankizumab in a real-life setting.

METHODS

Our study included 131 adults with moderate-to-severe plaque psoriasis all treated with risankizumab for at least 52 weeks. Patient characteristics and PASI (Psoriasis Area and Severity Index) at each visit were recorded. The percentages of patients achieving 75%/90%/100% (PASI 75/90/100) improvement in PASI with respect to baseline were registered.

RESULTS

At week 52, 93.9%, 78.6%, and 61.1% of patients achieved PASI 75/90/100, respectively. An absolute PASI ≤ 2 was reached by 90.8% at week 52. The higher body mass index and the presence of cardio-metabolic comorbidities did not interfere with the odds of reaching PASI 75/90/100 at each time-point. At week 52, comparable percentages of patients achieved PASI 100, regardless of the involvement of difficult-to-treat-areas. No significant safety findings were recorded and none of the patients had to interrupt the treatment because of adverse events.

CONCLUSIONS

Our findings confirmed that risankizumab is a safe and effective therapeutic option for the treatment of a wide "real-life" cohort of patients with psoriasis.

摘要

引言

瑞莎珠单抗是一种选择性靶向白细胞介素-23的人源化单克隆抗体。它被批准用于治疗中度至重度斑块状银屑病。我们进行了一项为期52周的单中心回顾性研究,以评估瑞莎珠单抗在实际临床环境中的有效性和安全性。

方法

我们的研究纳入了131例中度至重度斑块状银屑病成人患者,所有患者均接受瑞莎珠单抗治疗至少52周。记录每次就诊时的患者特征和银屑病面积和严重程度指数(PASI)。登记达到PASI相对于基线改善75%/90%/100%(PASI 75/90/100)的患者百分比。

结果

在第52周时,分别有93.9%、78.6%和61.1%的患者达到PASI 75/90/100。在第52周时,90.8%的患者达到绝对PASI≤2。较高的体重指数和存在心血管代谢合并症并未干扰在每个时间点达到PASI 75/90/100的几率。在第52周时,无论难治性区域是否受累,达到PASI 100的患者百分比相当。未记录到显著的安全性发现,且没有患者因不良事件而不得不中断治疗。

结论

我们的研究结果证实,瑞莎珠单抗是治疗广泛的“真实世界”银屑病患者群体的一种安全有效的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7f9/9515255/b6bd276c7627/13555_2022_795_Fig1_HTML.jpg

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