在系统性治疗初治的中重度斑块型银屑病患者中，与富马酸酯相比， risankizumab 的患者报告结局：一项 3 期临床试验。
Patient-reported outcomes with risankizumab versus fumaric acid esters in systemic therapy-naïve patients with moderate to severe plaque psoriasis: a phase 3 clinical trial.
机构信息
Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
AbbVie Inc., North Chicago, IL, USA.
出版信息
J Eur Acad Dermatol Venereol. 2021 Aug;35(8):1686-1691. doi: 10.1111/jdv.17109. Epub 2021 Jul 12.
BACKGROUND
In a phase 3 clinical study, patients from Germany with moderate to severe psoriasis who were naïve to systemic treatment and received risankizumab had greater and more rapid disease improvements compared with those who received fumaric acid esters (FAEs).
OBJECTIVE
To evaluate patient-reported outcomes (PROs) in patients treated with risankizumab compared with FAEs.
METHODS
Adult patients were randomized 1:1 to receive either risankizumab 150 mg subcutaneous injections at weeks 0, 4 and 16 or FAEs (Fumaderm ) provided according to the prescribing label. PRO secondary endpoints assessed were Psoriasis Symptom Scale (PSS), Dermatology Life Quality Index (DLQI), 36-Item Short Form Health Survey, version 2 (SF-36v2), Patient Benefit Index (PBI), Hospital Anxiety and Depression Scale (HADS), Patient Global Assessment (PtGA) and European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L). PROs were assessed at weeks 0, 16 and 24.
RESULTS
Sixty patients each were randomized to receive risankizumab or FAEs. A significant PSS improvement was observed with risankizumab vs. FAEs at weeks 16 and 24 for total and psoriasis-associated redness, itching and burning scores (P < 0.001). DLQI scores were significantly lower (reflecting better health-related quality of life) with risankizumab vs. FAEs, with least squares (LS) mean differences of -7.4 and -7.6 at weeks 16 and 24, respectively (both P < 0.001). Patients randomized to risankizumab also had larger improvements in SF-36 Physical and Mental Component Summary scores, HADS anxiety and depression scores, PtGA, and EQ-5D-5L index and visual analogue scale scores (all P ≤ 0.002) at weeks 16 and 24 compared with FAEs. PBI was significantly higher, indicating greater benefit, with risankizumab vs. FAEs, with an LS mean difference of 1.1 and 1.3 at weeks 16 and 24, respectively (both P < 0.001).
CONCLUSIONS
Risankizumab provides significant benefits over FAEs in improving PROs across several dimensions in patients with moderate to severe psoriasis.
背景
在一项 3 期临床研究中，来自德国的初治中重度银屑病患者接受 risankizumab 治疗相较于接受菝葜酸酯（FAEs）治疗，疾病改善程度更大且更快。
目的
评估与 FAEs 相比，接受 risankizumab 治疗的患者的患者报告结局（PROs）。
方法
成年患者按 1:1 随机接受 risankizumab 150mg 皮下注射，分别在第 0、4 和 16 周，或根据处方标签接受 FAEs（Fumaderm）。评估的次要 PRO 终点为银屑病症状量表（PSS）、皮肤病生活质量指数（DLQI）、36 项简明健康调查量表，第 2 版（SF-36v2）、患者获益指数（PBI）、医院焦虑和抑郁量表（HADS）、患者总体评估（PtGA）和欧洲五维健康量表 5 级（EQ-5D-5L）。PROs 在第 0、16 和 24 周进行评估。
结果
各有 60 名患者被随机分配接受 risankizumab 或 FAEs。risankizumab 治疗组在第 16 和 24 周时的 PSS 总评分和与银屑病相关的红斑、瘙痒和烧灼感评分均显著优于 FAEs（均 P<0.001）。risankizumab 治疗组的 DLQI 评分显著低于 FAEs，反映出更好的健康相关生活质量，第 16 和 24 周时 LS 平均差值分别为-7.4 和-7.6（均 P<0.001）。与 FAEs 相比，随机分配至 risankizumab 治疗组的患者在第 16 和 24 周时的 SF-36 身体和心理成分综合评分、HADS 焦虑和抑郁评分、PtGA 和 EQ-5D-5L 指数和视觉模拟评分也有更大的改善（均 P≤0.002）。在第 16 和 24 周时，PBI 显著更高，表明获益更大，risankizumab 与 FAEs 相比，LS 平均差值分别为 1.1 和 1.3（均 P<0.001）。
结论
与 FAEs 相比，risankizumab 能显著改善中重度银屑病患者的 PROs，在多个维度均具有获益。
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