Di Brizzi Eugenia Veronica, Buononato Dario, Benvenuto Pierfrancesco, Argenziano Giuseppe, De Pasquale Rocco, Fiorella Carmen Silvia, Giofrè Claudia, Musumeci Maria Letizia, Palazzo Giovanni, Zichichi Leonardo, Balato Anna
Dermatology Unit, University of Campania "Luigi Vanvitelli", Naples, Italy.
U.O.C. Dermatology Unit, "G. Rodolico-S. Marco" Hospital, Catania, Italy.
Dermatol Pract Concept. 2023 Oct 1;13(4):e2023215. doi: 10.5826/dpc.1304a215.
Tildrakizumab is a humanized IgG1κ monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, approved in 2018 for the treatment of patients with moderate-to-severe chronic plaque psoriasis.
This study aimed to evaluate the effectiveness, safety and survival of tildrakizumab in the medium term (48 weeks) in psoriatic patients failure to previous biologic treatment in a real world setting.
This was a retrospective, multicenter observational study that included adult patients with moderate-to-severe plaque psoriasis, failure to previous biologic therapy, consecutively treated with tildrakizumab. Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) values were recorded at baseline, at 12 and 48 weeks of treatment. Safety and tolerability of tildrakizumab were investigated by examining the presence of any adverse events.
Overall 51 patients were enrolled. Baseline disease severity was moderate to severe with a mean PASI score of 19.2 ± 8.5, mean BSA of 16 ± 10.4, and mean Dermatology Life Quality Index (DLQI) of 18.2 ± 6.8. A significant reduction in the mean PASI score was detected at 12 weeks of tildrakizumab therapy (3.5 ± 2.7, P < 0.001), with a further improvement at week 48 (0.6 ± 1.5, P < 0.001). At week 12, there was a great improvement in BSA score for all groups (P <0.001) with further increase at week 48. The effectiveness was confirmed also by DLQI assessment, with a significant decrease at week 12 and even more at week 48 (P <0.001).
This study confirms the effectiveness of tildrakizumab in daily clinical practice in patients with moderate-to-severe plaque psoriasis.
替拉珠单抗是一种靶向白细胞介素（IL）-23 p19亚基的人源化IgG1κ单克隆抗体，于2018年获批用于治疗中度至重度慢性斑块状银屑病患者。
本研究旨在评估在现实世界中，替拉珠单抗对先前生物治疗无效的银屑病患者的中期（48周）有效性、安全性和生存率。
这是一项回顾性、多中心观察性研究，纳入了中度至重度斑块状银屑病成年患者，这些患者先前生物治疗无效，接受替拉珠单抗连续治疗。在基线、治疗12周和48周时记录银屑病面积和严重程度指数（PASI）以及体表面积（BSA）值。通过检查是否存在任何不良事件来研究替拉珠单抗的安全性和耐受性。
共纳入51例患者。基线疾病严重程度为中度至重度，平均PASI评分为19.2±8.5，平均BSA为16±10.4，平均皮肤病生活质量指数（DLQI）为18.2±6.8。替拉珠单抗治疗12周时，平均PASI评分显著降低（3.5±2.7，P<（此处原文有误，应为P<0.001）），48周时进一步改善（0.6±1.5，P<0.001）。在第12周时，所有组的BSA评分均有显著改善（P<0.001），并在第48周进一步提高。DLQI评估也证实了其有效性，在第12周时显著下降，在第48周时下降更明显（P<0.001）。
本研究证实了替拉珠单抗在中度至重度斑块状银屑病患者的日常临床实践中的有效性。
