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下肢是银屑病患者最难治疗的身体部位:司库奇尤单抗与乌司奴单抗治疗不同身体部位的 CLEAR 和 CLARITY 研究的汇总分析。

Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region.

机构信息

Dermatology Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal.

Dermatology University Clinic, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.

出版信息

BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.

Abstract

BACKGROUND

The impact of psoriasis, response to treatment, and patients' perceptions of treatment satisfaction vary by body area.

OBJECTIVES

We aimed to evaluate the level of response in lower limbs versus other body regions in patient with moderate to severe psoriasis treated with secukinumab and ustekinumab.

METHODS

Data were pooled from CLEAR and CLARITY trials, which included patients with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index [PASI] score of ≥ 12) aged ≥ 18 years and a diagnosis of ≥ 6 months before randomisation. Patients received either secukinumab 300 mg or ustekinumab 45/90 mg. The PASI 100 responders and mean PASI scores at weeks 4, 12, 16, 28, 40 and 52 in the head and neck, trunk, upper limbs and lower limbs were measured.

RESULTS

At baseline, analysis of PASI scores for each body region revealed that the lower limbs were the most severely affected body region in both treatment arms (mean PASI scores: secukinumab 24.0; ustekinumab 24.4). For both drugs, the highest clearance rates at week 52 were achieved in the trunk (secukinumab 85.2% vs ustekinumab 68.7%) and head and neck (80.7% vs 68.9%), followed by the upper limbs (72.6% vs 61.9%) and lower limbs (68.1% vs 57.2%). At week 52, the mean PASI score was higher in the lower limbs in both treatment arms versus other body regions.

CONCLUSIONS

Lower limbs were the most severely affected and most difficult-to-treat regions in patients with psoriasis. Consistent with the individual results of both studies, secukinumab demonstrated numerically faster and higher skin clearance than ustekinumab in all body regions.

CLINICAL TRIAL REGISTRATION

CLEAR: NCT02074982; CLARITY: NCT02826603.

摘要

背景

银屑病的影响、治疗反应以及患者对治疗满意度的感知因身体部位而异。

目的

我们旨在评估中重度银屑病患者接受司库奇尤单抗和乌司奴单抗治疗时下肢与其他身体区域的反应水平。

方法

数据来自 CLEAR 和 CLARITY 两项试验,纳入了年龄≥18 岁、疾病诊断时间≥6 个月、中重度斑块型银屑病(银屑病面积和严重程度指数 [PASI]评分≥12)的患者。患者接受司库奇尤单抗 300mg 或乌司奴单抗 45/90mg 治疗。评估头颈部、躯干部、上肢和下肢的 PASI100 应答者和治疗第 4、12、16、28、40 和 52 周时的平均 PASI 评分。

结果

基线时,对各身体区域的 PASI 评分进行分析显示,治疗组下肢的疾病负担最重(司库奇尤单抗:平均 PASI 评分 24.0;乌司奴单抗:24.4)。在第 52 周时,两种药物的清除率最高部位均为躯干(司库奇尤单抗:85.2%;乌司奴单抗:68.7%)和头颈部(80.7%;68.9%),其次是上肢(72.6%;61.9%)和下肢(68.1%;57.2%)。第 52 周时,与其他身体区域相比,司库奇尤单抗和乌司奴单抗治疗组的下肢平均 PASI 评分均较高。

结论

下肢是银屑病患者疾病负担最重、最难治疗的部位。与两项研究的个体结果一致,司库奇尤单抗在所有身体区域均显示出更快、更高的皮肤清除率,且优于乌司奴单抗。

临床试验注册

CLEAR:NCT02074982;CLARITY:NCT02826603。

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