Lu Wensheng, Wang JianFeng, Zhang YuanJing, Chang Ruixue, Zhao Jun
Department of Dermatology, The No. 1 Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, People's Republic of China.
Department of Dermatology, The No. 1 Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, Anhui, People's Republic of China.
Clin Cosmet Investig Dermatol. 2024 Jun 14;17:1413-1422. doi: 10.2147/CCID.S454971. eCollection 2024.
This study observed the effectiveness of ustekinumab and reactivation risk of concurrent latent tuberculosis infection (LTBI) and inactive hepatitis B virus (HBV) infection in Chinese mainland psoriasis patients on ustekinumab treatment.
This retrospective, multicenter, observational study was conducted in three centers in China. Adult patients with moderate to severe plaque psoriasis were treated with ustekinumab for 28 weeks. The effectiveness endpoint included 75% and 90% improvement in Psoriasis Area Severity Index (PASI75/90) response rate, percentage of PASI improvement, change of absolute PASI score and body surface area involvement (BSA) score, absolute PASI ≤1/3 and Physicians' Global Assessment (PGA)=0/1, as well as Dermatology life quality index (DLQI)=0/1 response rate at week 4, 16 and 28. Screening of tuberculosis and hepatitis were performed at baseline and week 28.
A total of 82 patients were enrolled between March 2021 and May 2023 and the number of patients combined with LTBI and inactive HBV infection was 20 and 21 respectively. The PASI75 and PASI90 response rate at week 28 was 95.1% and 81.7% respectively. The mean PASI score decreased from 14.93 ± 12.07 at baseline to 0.78 ± 1.86 at week 28, and the mean BSA score decreased from 21% ± 18% at baseline to 1% ± 2% at week 28 (both P<0.001 compared with baseline). DLQI 0/1 response rate at week 28 was 73.2%. No reactivation of LTBI and inactive HBV infection and also no new-onset tuberculosis and hepatitis B occurred in patients without LTBI and inactive HBV infection at baseline.
Ustekinumab demonstrated great effectiveness in Chinese plaque psoriasis patients and good safety in psoriasis concurrent with LTBI and inactive HBV infection under the real-world setting.
本研究观察了乌司奴单抗治疗中国大陆银屑病患者的疗效以及潜伏性结核感染（LTBI）和慢性乙型肝炎病毒（HBV）感染同时激活的风险。
本回顾性、多中心、观察性研究在中国的三个中心进行。成年中重度斑块状银屑病患者接受乌司奴单抗治疗28周。疗效终点包括银屑病面积和严重程度指数（PASI75/90）改善率达75%和90%、PASI改善百分比、绝对PASI评分变化和体表面积受累（BSA）评分、绝对PASI≤1/3以及医师整体评估（PGA）=0/1，以及在第4、16和28周时皮肤病生活质量指数（DLQI）=0/1的缓解率。在基线和第28周时进行结核和肝炎筛查。
2021年3月至2023年5月共纳入82例患者，合并LTBI和慢性HBV感染的患者分别为20例和21例。第28周时PASI75和PASI90缓解率分别为95.1%和81.7%。平均PASI评分从基线时的14.93±12.07降至第28周时的0.78±1.86，平均BSA评分从基线时的21%±18%降至第28周时的1%±2%（与基线相比均P<0.001）。第28周时DLQI 0/1缓解率为73.2%。基线时无LTBI和慢性HBV感染的患者未发生LTBI和慢性HBV感染再激活，也未出现新发结核和乙型肝炎。
在真实世界环境中，乌司奴单抗在中国大陆斑块状银屑病患者中显示出显著疗效，在合并LTBI和慢性HBV感染的银屑病患者中安全性良好。
