司库奇尤单抗在真实世界环境中的有效性、耐受性和药物留存率：一项为期三年的回顾性多中心研究-IL PSO（意大利银屑病概况）

Effectiveness, Tolerability, and Drug Survival of Risankizumab in a Real-World Setting: A Three-Year Retrospective Multicenter Study-IL PSO (ITALIAN LANDSCAPE PSORIASIS).

作者信息

Gargiulo Luigi, Ibba Luciano, Malagoli Piergiorgio, Amoruso Fabrizio, Argenziano Giuseppe, Balato Anna, Bardazzi Federico, Burlando Martina, Carrera Carlo Giovanni, Damiani Giovanni, Dapavo Paolo, Dini Valentina, Franchi Chiara, Gaiani Francesca Maria, Girolomoni Giampiero, Guarneri Claudio, Lasagni Claudia, Loconsole Francesco, Marzano Angelo Valerio, Maurelli Martina, Megna Matteo, Orsini Diego, Sampogna Francesca, Travaglini Massimo, Valenti Mario, Costanzo Antonio, Narcisi Alessandra

机构信息

Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20089 Milan, Italy.

出版信息

J Clin Med. 2024 Jan 16;13(2):495. doi: 10.3390/jcm13020495.

BACKGROUND

Risankizumab is a humanized monoclonal antibody that selectively inhibits interleukin-23. It has been approved for moderate-to-severe plaque psoriasis and has shown efficacy and safety in clinical trials and real-world experiences. This study aimed to evaluate the long-term effectiveness, safety, and drug survival of risankizumab in a real-life setting.

MATERIALS AND METHODS

We included patients treated with risankizumab from January 2019 to February 2023. A Psoriasis Area and Severity Index score (PASI) was collected at weeks 0, 16, 28, 52, 104, and 156, when available. The occurrence of any adverse events was recorded at each visit.

RESULTS

We enrolled 1047 patients. At week 52, a ≥90% improvement in PASI was observed in 81.44% of patients, with a continuous improvement throughout the study (88.99% and 99.07% at weeks 104 and 156, respectively). After three years of treatment, all patients involving the scalp, palms/soles, and genitalia and 95% of patients with nail psoriasis achieved a complete or almost complete skin clearance. No significant safety findings were observed, and 90.73% of the patients were still on treatment after 36 months.

CONCLUSIONS

This study supports the long-term effectiveness and safety of risankizumab in a real-world setting, even in patients involving difficult-to-treat areas.

背景

瑞莎珠单抗是一种选择性抑制白细胞介素-23的人源化单克隆抗体。它已被批准用于治疗中度至重度斑块状银屑病，并且在临床试验和实际应用中均显示出疗效和安全性。本研究旨在评估瑞莎珠单抗在实际应用中的长期有效性、安全性和药物留存率。

材料与方法

我们纳入了2019年1月至2023年2月期间接受瑞莎珠单抗治疗的患者。在第0、16、28、52、104和156周（如有数据）收集银屑病面积和严重程度指数（PASI）评分。每次就诊时记录任何不良事件的发生情况。

结果

我们共纳入1047例患者。在第52周时，81.44%的患者PASI改善≥90%，且在整个研究过程中持续改善（在第104周和156周时分别为88.99%和99.07%）。经过三年治疗，所有累及头皮、手掌/足底和生殖器的患者以及95%的甲银屑病患者实现了皮肤完全或几乎完全清除。未观察到显著的安全性问题，36个月后90.73%的患者仍在接受治疗。