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Real‐world data from a single Greek centre on the use of secukinumab in plaque psoriasis: effectiveness, safety, drug survival, and identification of patients that sustain optimal response

塞库金单抗 医学 银屑病面积及严重程度指数 银屑病 皮肤病科 内科学 临床终点 回顾性队列研究 斑块性银屑病 银屑病性关节炎 外科 临床试验
作者
N. Rompoti,P. Sidiropoulou,P. Panagakis,A Stratigos,M Papoutsaki,E Stefanaki,Vavouli C,M Politou,Befon A,P. Kostakis,D. Rigopoulos,E Nicolaidou,N. Rompoti,P. Sidiropoulou,P. Panagakis,A Stratigos,M Papoutsaki,E Stefanaki,Vavouli C,M Politou
出处
期刊:Journal of The European Academy of Dermatology and Venereology [Wiley]
卷期号:34 (6): 1240-1247 被引量:33
标识
DOI:10.1111/jdv.16202
摘要

Abstract Background Few studies have investigated the long‐term outcomes of secukinumab in real‐life psoriasis treatment where diverse patient profiles require a personalized approach. Objectives To determine long‐term performance of secukinumab in moderate‐to‐severe plaque psoriasis, and identify potential clinical factors predictive of sustained optimal response under real‐world conditions. Methods In this 78‐week, single‐centre, retrospective study, effectiveness, safety and drug survival of secukinumab were evaluated. Effectiveness data are reported as observed. Co‐primary endpoints were absolute Psoriasis Area and Severity Index ( PASI ) ≤3 at week 4, 16, 52, 78, and clinical predictors of PASI ≤3 and PASI 100 responses at week 52 and 78. Results A total of 85 patients (75.3% male; mean age 48.6 years) were included. Absolute PASI ≤3 was achieved in 73% and 83% of patients at week 52 and 78, respectively. PASI 75/90/100 responses at week 52 (71.6%, 50.8%, and 40.3%, respectively) were sustained at week 78 (73.6%, 64.2%, and 45.3%, respectively). Median absolute PASI remained low at week 52/78 (0.9/0.6, respectively), while mean absolute PGA also sustained low (0–1) values after 16–78 weeks. Investigator's Global Assessment 0/1 response rate was maintained by week 52/78 (72/83%, respectively). The drug survival rate of secukinumab at week 78 was 79.1%. Treatment was discontinued in 17.9% of patients after an average of 41.7 weeks, mainly due to loss of effectiveness (10.4%). A total of 27% experienced adverse events, without critical safety concerns. Based on multivariate analysis, advanced body mass index ( BMI ) and presence of ≥3 comorbidities decreased the chance of achieving PASI ≤3 at week 78 [ OR (95% CI ) 0.78 (0.64–0.97); P = 0.024, and OR (95% CI ) 0.045 (0.002–0.83); P = 0.037, respectively]. Conclusions Secukinumab showed consistently high effectiveness in this real‐life cohort, with an acceptable safety profile. Over time, persistence of PASI ≤3 response appears to be lower in patients with high BMI or multiple comorbidities.
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