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, Fabbrocini Gabriella, Franchi Chiara, Gaiani Francesca Maria, Girolomoni Giampiero, Guarneri Claudio, Lasagni Claudia, Loconsole Francesco, Marzano Angelo Valerio, Megna Matteo, Sampogna Francesca, Travaglini Massimo, Costanzo Antonio, Narcisi Alessandra
Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Front Med (Lausanne). 2023 Jul 3;10:1196966. doi: 10.3389/fmed.2023.1196966. eCollection 2023.
Brodalumab is a monoclonal antibody that targets the subunit A of the interleukin-17A receptor (IL17RA), inhibiting the signaling of various isoforms of the IL-17 family. It has been approved for the treatment of moderate-to-severe plaque psoriasis after being evaluated in three Phase-3 trials. However, long-term data on brodalumab in a real-life setting are still limited.
The aim of this study was to evaluate the long-term effectiveness and safety of brodalumab in psoriasis. We also assessed the drug survival of brodalumab in a 3 years timespan. We conducted a retrospective multicenter study on 606 patients followed up at 14 Italian dermatology units, all treated with brodalumab according to Italian guidelines. Patients' demographics and disease characteristics were retrieved from electronic databases. At baseline and weeks 12, 24, 52, 104 and 156, we evaluated the psoriasis area and severity index (PASI) score and investigated for adverse events. The proportions of patients reaching 75, 90 and 100% (PASI 75, PASI 90 and PASI 100, respectively) improvement in PASI, compared with baseline, were also recorded.
At week 12, 63.53% of the patients reached PASI 90 and 49.17% PASI 100. After 3 years of treatment, 65.22% of patients maintained a complete skin clearance, and 91.30% had an absolute PASI of 2 or less. Patients naïve to biological therapies had better clinical responses at weeks 12, 24 and 52. However, after 2 years of treatment, no significant differences were observed. Body mass index did not interfere with the effectiveness of brodalumab throughout the study. No new safety findings were recorded. After 36 months, 85.64% of our patients were still on treatment with brodalumab.
Our data confirm the effectiveness and the safety of brodalumab in the largest real-life cohort to date, up to 156 weeks.
布罗达单抗是一种单克隆抗体，靶向白细胞介素-17A受体（IL17RA）的A亚基，可抑制IL-17家族各种亚型的信号传导。在三项3期试验评估后，它已被批准用于治疗中度至重度斑块状银屑病。然而，在现实环境中关于布罗达单抗的长期数据仍然有限。
本研究的目的是评估布罗达单抗治疗银屑病的长期有效性和安全性。我们还评估了布罗达单抗在3年时间跨度内的药物留存率。我们对在14个意大利皮肤科单位接受随访的606例患者进行了一项回顾性多中心研究，所有患者均按照意大利指南接受布罗达单抗治疗。患者的人口统计学和疾病特征从电子数据库中获取。在基线以及第12、24、52、104和156周，我们评估了银屑病面积和严重程度指数（PASI）评分，并调查不良事件。还记录了与基线相比，PASI改善达到75%、90%和100%（分别为PASI 75、PASI 90和PASI 100）的患者比例。
在第12周时，63.53%的患者达到PASI 90，49.17%达到PASI 100。经过3年治疗后，65.22%的患者保持皮肤完全清除，91.30%的患者绝对PASI为2或更低。初次接受生物治疗的患者在第12、24和52周时有更好的临床反应。然而，在治疗2年后，未观察到显著差异。在整个研究过程中，体重指数并未干扰布罗达单抗的有效性。未记录到新的安全性发现。36个月后，我们85.64%的患者仍在接受布罗达单抗治疗。
我们的数据证实了布罗达单抗在迄今为止最大的现实队列中长达156周的有效性和安全性。
