司库奇尤单抗治疗中重度斑块状银屑病疗效及安全性的真实世界研究

Real-World Efficacy and Safety of Secukinumab in the Treatment of Patients with Moderate to Severe Plaque Psoriasis

目的观察真实世界司库奇尤单抗治疗中重度斑块状银屑病的临床疗效及安全性。方法本研究共纳入45例中重度斑块状银屑病患者,接受司库奇尤单抗150 mg或300 mg治疗,持续至少24周。通过银屑病皮损面积及严重程度指数(PASI)、体表受累面积(BSA)、皮肤病生活质量指数(DLQI)的变化来评估疗效,并对其安全性进行分析。结果所有患者经过24周治疗,PASI、BSA及DLQI评分均显著下降(P<0.001)。其中16例接受150 mg治疗的患者第12周PASI75、PASI90、PASI100的应答率分别为93.75%、62.50%和12.50%,在第24周时达到100.00%、93.75%和43.75%。而29例接受300 mg治疗的患者第12周时PASI75、PASI90、PASI100应答率分别为100.00%、79.31%和34.48%,第24周时则为100%、93.10%和62.07%。而在改善患者生活质量上,150 mg组患者第12周和第24周DLQI 0/1的应答率分别为50.00%和75.00%;300 mg组患者第12、24周DLQI 0/1的应答率分别为51.72%和79.31%。所有患者均未因不良反应或疗效不佳而停药。结论司库奇尤单抗在真实世界中重度斑块状银屑病患者的治疗中,可获得较高的PASI75、PASI90、PASI100应答率,安全性较高,300 mg治疗可获得更高的PASI100应答率,但150 mg与300 mg治疗量在DLQI 0/1的应答率上无显著差异。

Objective To observe the clinical efficacy and safety of secukinumab in the treatment of patients with moderate to severe plaque psoriasis.Methods A total of 45 patients with moderate to severe plaque psoriasis were enrolled in this study,with secukinumab 150 mg or 300 mg treatment for at least 24 weeks.The efficacy was evaluated by the changes in Psoriasis Area and Severity Index(PASI),Body Surface Area(BSA),and Dermatology Life Quality Index(DLQI).The safety was also analyzed.Results After 24 weeks of treatment,all patients'PASI,BSA and DLQI scores decreased significantly(P<0.001).The PASI75,PASI90,PASI100 response rates of 16 patients receiving 150 mg treatment in the 12th week were 93.75%,62.50%and 12.50%,respectively,reaching 100.00%,93.75%and 43.75%in the 24th week.The PASI75,PASI90,PASI100 response rates of 29 patients receiving 300 mg treatment were 100.00%,79.31%and 34.48%in the 12th week and 100.00%,93.10%and 62.07%in the 24th week.Regarding improving patients'quality of life,the DLQI 0/1 response rate in the 150 mg group in weeks 12 and 24 was 50.00%and 75.00%;and the 300 mg group was 51.72%and 79.31%,respectively.No patient stopped treatment due to adverse reactions or poor efficacy.Conclusion In the real-world treatment of Chinese patients with moderate to severe plaque psoriasis,secukinumab can obtain high PASI75,PASI90,PASI100 response rates and high safety.The treatment with a 300 mg dose can attain a higher PASI100 response rate,but there is no significant difference between 150 mg and 300 mg treatment in DLQI 0/1 response rate.