Tampouratzi Eleftheria, Papakonstantis Markos, Katsantonis John, Sidiropoulos Theodoros, Delli Florentina, Efthymiadis Konstantinos, Sfaelos Konstantinos, Christodoulou Athina, Chasapi Vasiliki, Panagakis Pantelis
Dermatological Department, Tzaneio General Hospital, Piraeus, Greece.
Clinic of Dermatology, 401 General Military Hospital of Athens, Athens, Greece.
Dermatol Ther. 2022 Jul;35(7):e15532. doi: 10.1111/dth.15532. Epub 2022 May 30.
Despite brodalumad demonstrated efficacy in clinical trials, real-world data reflecting clinical benefits in unselected patient populations treated in routine clinical practice are limited. Thus, we performed a longitudinal, retrospective, real-world analysis assessing the long-term clinical benefits of patients with moderate-to-severe psoriasis treated with brodalumab in Greece in the long term (up to 24 months). Main efficacy assessments included changes from baseline in the psoriasis area and severity index (PASI) and proportions of patients achieving at least 50%, 75%, 90% and 100% reduction from baseline in PASI scores (PASI50, PASI75, PASI90 and PASI100) at different timepoints up to 24 months. Other endpoints included changes in the dermatology life quality index (DLQI) and body surface area (BSA) involvement. Data from medical records of 180 patients with moderate-to-severe psoriasis treated with brodalumab for up to 24 months were assessed. Following treatment, mean [standard deviation (SD)] PASI scores were decreased across all visits compared to baseline (p < 0.001). The proportion of patients achieving PASI50, PASI75, PASI90 or PASI100 were high as early as at month 1 and consistently tended to increase over time, mainly during the first 6 months. Improvements on disease severity were further reflected by reductions from baseline on BSA scores across all visits (p < 0.001). Concurrent improvements on DLQI scores were observed across all visits (p < 0.001). This retrospective analysis provides real-world evidence supporting the long-term efficacy profile of brodalumab in Greek patients with moderate-to-severe psoriasis treated in standard clinical practice, which is characterized by a rapid onset of action generally sustained over time.
尽管在临床试验中布罗达单抗已证明其疗效，但反映在常规临床实践中未经过挑选的患者群体临床获益的真实世界数据有限。因此，我们进行了一项纵向、回顾性的真实世界分析，评估希腊中重度银屑病患者长期（长达24个月）使用布罗达单抗的长期临床获益。主要疗效评估包括银屑病面积和严重程度指数（PASI）相对于基线的变化，以及在长达24个月的不同时间点达到PASI评分相对于基线至少降低50%、75%、90%和100%的患者比例（PASI50、PASI75、PASI90和PASI100）。其他终点包括皮肤病生活质量指数（DLQI）和体表面积（BSA）受累情况的变化。评估了180例接受布罗达单抗治疗长达24个月的中重度银屑病患者的病历数据。治疗后，与基线相比，所有访视时的平均[标准差（SD）]PASI评分均降低（p<0.001）。早在第1个月时，达到PASI50、PASI75、PASI90或PASI100的患者比例就很高，并且随着时间推移持续上升，主要是在最初的6个月内。所有访视时BSA评分相对于基线的降低进一步反映了疾病严重程度的改善（p<0.001）。在所有访视中均观察到DLQI评分同时得到改善（p<0.001）。这项回顾性分析提供了真实世界证据，支持布罗达单抗在希腊接受标准临床实践治疗的中重度银屑病患者中的长期疗效概况，其特点是起效迅速且通常能持续一段时间。
