Real‐world data on the effectiveness of brodalumab in patients with moderate‐to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study)

医学 皮肤科生活质量指数 银屑病 观察研究 皮肤病科 临床试验 内科学 银屑病面积及严重程度指数 生活质量(医疗保健) 队列 护理部
作者
Dimitrios Rigopoulos,Eleftheria Tampouratzi,Charalampos Angelakopoulos,Zoé Apalla,Ioannis Barkis,Sophia Georgiou,Florentina Delli,Alexandros A. Drosos,Efterpi Zafiriou,John Katsantonis,Elizabeth Lazaridou,Pantelis Panagakis,Evangelia Papadavid,Markos Papakonstantis,Angeliki‐Viktoria Roussaki‐Schulze,Elena Sotiriou,Georgios Anastasiadis,Vasiliki Chasapi,Konstantinos Sfaelos,D. Ioannides
出处
期刊:Journal of The European Academy of Dermatology and Venereology [Wiley]
卷期号:38 (6): 1121-1130 被引量:3
标识
DOI:10.1111/jdv.19816
摘要

Abstract Background Despite that brodalumab's efficacy and safety have been assessed in randomized clinical trials, real‐life data remain scarce. BrIDGE was an observational, prospective, single‐cohort, multicentre study that recruited patients with moderate‐to severe plaque psoriasis in Greece. Objectives The primary objective was to assess the proportion of patients who achieved Psoriasis Area and Severity Index (PASI)100 after 24 weeks. Other endpoints included: the maintenance of PASI90/100 through to 104 weeks, the short‐term response [PASI75/90/100 and static Physician's Global Assessment (sPGA) 0/1] to brodalumab at 12–16 weeks and time to complete clearance. Moreover, we explored the change in quality of life [Dermatology Life Quality Index (DLQI) 0/1] and adherence to brodalumab. Methods Two hundred patients who were initiating treatment with or switching to brodalumab, were recruited. Analyses were conducted using the as observed data and three imputation approaches were also applied for the missing data (last observation carried forward, ‘worst case’ and ‘best case’ scenario). Continuous variables were reported using summary statistics, whereas categorical variables were reported in frequency tables. Results Based on the ‘as observed data’, 42.0% of patients achieved PASI100 at Week 24 after 25.9 ± 3.5 weeks and 65% of patients attained PASI100 at Week 104. In total, 70.2%, 47.5% and 32.0% achieved PASI75/90/100, respectively, whereas 72.6% of patients achieved sPGA 0/1, at Weeks 12–16. With respect to sPGA status 82.8%, 89.2% and 92.5% of patients achieved sPGA 0/1 at Weeks 24, 52 and 104, respectively. The time to achieve PASI100 at Weeks 12–16 was 13.7 ± 1.3, 52.1 ± 3.4 weeks at Week 52 and 105.5 ± 4.8 weeks at Week 104. Mean DLQI and Psoriasis Symptom Inventory (PSI) scores decreased by 11.4 ± 7.0 and 15.4 ± 6.5 points from baseline to Week 104, respectively. Adherence to treatment was equal to 98.9%. Conclusions Brodalumab confers rapid and durable responses, as well as improvements in the quality of life of moderate‐to‐severe psoriasis patients.
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