PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■本研究观察了ustekinumab治疗中国大陆银屑病患者并发潜伏性结核感染（LTBI）和非活动性乙型肝炎病毒（HBV）感染的有效性和再激活风险。
■这次回顾展，多中心，在中国的三个中心进行了观察性研究。患有中度至重度斑块状银屑病的成年患者接受ustekinumab治疗28周。有效性终点包括银屑病面积严重程度指数（PASI75/90）反应率的75％和90％改善，PASI改进的百分比，绝对PASI评分和体表面积受累（BSA）评分的变化，在第4、16和28周，绝对PASI≤1/3，医师全球评估（PGA）=0/1，以及皮肤科生活质量指数（DLQI）=0/1缓解率。在基线和第28周进行结核病和肝炎的筛查。
■在2021年3月至2023年5月之间共招募了82名患者，合并LTBI和非活动性HBV感染的患者人数分别为20和21。第28周的PASI75和PASI90应答率分别为95.1%和81.7%。平均PASI评分从基线时的14.93±12.07下降至第28周的0.78±1.86，平均BSA评分从基线时的21%±18%下降至第28周的1%±2%（与基线相比均P<0.001）。28周时DLQI0/1应答率为73.2%。在基线时，没有LTBI和非活动性HBV感染的患者没有LTBI和非活动性HBV感染的再激活，也没有新发结核病和乙型肝炎发生。
■Ustekinumab在中国斑块状银屑病患者中表现出巨大的有效性，并且在真实世界环境下，在合并LTBI和非活动性HBV感染的银屑病中具有良好的安全性。
■这次回顾展，多中心，在中国的三个中心进行了观察性研究。患有中度至重度斑块状银屑病的成年患者接受ustekinumab治疗28周。有效性终点包括银屑病面积严重程度指数（PASI75/90）反应率的75％和90％改善，PASI改进的百分比，绝对PASI评分和体表面积受累（BSA）评分的变化，在第4、16和28周，绝对PASI≤1/3，医师全球评估（PGA）=0/1，以及皮肤科生活质量指数（DLQI）=0/1缓解率。在基线和第28周进行结核病和肝炎的筛查。
■在2021年3月至2023年5月之间共招募了82名患者，合并LTBI和非活动性HBV感染的患者人数分别为20和21。第28周的PASI75和PASI90应答率分别为95.1%和81.7%。平均PASI评分从基线时的14.93±12.07下降至第28周的0.78±1.86，平均BSA评分从基线时的21%±18%下降至第28周的1%±2%（与基线相比均P<0.001）。28周时DLQI0/1应答率为73.2%。在基线时，没有LTBI和非活动性HBV感染的患者没有LTBI和非活动性HBV感染的再激活，也没有新发结核病和乙型肝炎发生。
■Ustekinumab在中国斑块状银屑病患者中表现出巨大的有效性，并且在真实世界环境下，在合并LTBI和非活动性HBV感染的银屑病中具有良好的安全性。
