布罗达单抗对身体部位难治性银屑病患者有效：一项观察性临床研究结果
Brodalumab Is Effective for Psoriasis Patients with Difficult-To-Treat Body Regions: Results from an Observational Clinical Study.
作者信息
Dauth Stephanie, Foldenauer Ann Christina, Hallmann Konstantin, Kunz Christina, König Anke, Haferland Isabel, Möser Christine, Koehm Michaela, Pinter Andreas
机构信息
Department for Clinical Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany.
Fraunhofer Cluster of Excellence Immune-Mediated Diseases CIMD, Frankfurt, Germany.
出版信息
Dermatology. 2025;241(1):80-91. doi: 10.1159/000542348. Epub 2024 Nov 6.
INTRODUCTION
Brodalumab, a human monoclonal antibody that selectively inhibits the interleukin (IL)-17 receptor subunit A, has been approved for the treatment of moderate-to-severe plaque psoriasis. The treatment benefit of brodalumab has been clearly demonstrated in multiple clinical studies. However, data on effectiveness for difficult-to-treat body regions, especially in everyday clinical practice, are still limited.
METHODS
In this exploratory observational clinical study, psoriasis patients suffering from nail and scalp involvement who received brodalumab during routine clinical care were enrolled at 7 centers in Germany. Patients were observed for over 60 weeks. The co-primary endpoints were 75% improvement in Psoriasis Scalp Severity Index (PSSI75) at week 12 and 75% improvement in Nail Psoriasis Severity Index (NAPSI75) at week 24. Secondary endpoints included assessment of general skin and disease outcomes, quality-of-life, and patient satisfaction with treatment.
RESULTS
Eighty-seven patients were included. Mean age was 46.8 years, 70.1% patients were male, and mean body mass index was 28.9 kg/m2. The co-primary endpoints were achieved by more than 90% of patients who met criteria for effectiveness analyses (n = 62): 93.6% of patients achieved PSSI75 at week 12 and 90.3% of patients achieved NAPSI75 at week 24. Median body surface area involvement improved from 14% at baseline to 1.5% and 1% at weeks 12 and 24, respectively. Median Dermatology Life Quality Index scores improved from 16 at baseline to 2 and 1 at weeks 12 and 24, respectively. Improvements were maintained in the majority of patients throughout the 60-week study. Brodalumab was well tolerated and patients were highly satisfied with the treatment.
CONCLUSION
Outcomes assessed in this study, including assessments of scalp and nail symptoms, improved following initiation of brodalumab therapy. This study of psoriasis patients in a real-world setting supports the long-term clinical effectiveness of brodalumab on difficult-to-treat body regions.
INTRODUCTION
Brodalumab, a human monoclonal antibody that selectively inhibits the interleukin (IL)-17 receptor subunit A, has been approved for the treatment of moderate-to-severe plaque psoriasis. The treatment benefit of brodalumab has been clearly demonstrated in multiple clinical studies. However, data on effectiveness for difficult-to-treat body regions, especially in everyday clinical practice, are still limited.
METHODS
In this exploratory observational clinical study, psoriasis patients suffering from nail and scalp involvement who received brodalumab during routine clinical care were enrolled at 7 centers in Germany. Patients were observed for over 60 weeks. The co-primary endpoints were 75% improvement in Psoriasis Scalp Severity Index (PSSI75) at week 12 and 75% improvement in Nail Psoriasis Severity Index (NAPSI75) at week 24. Secondary endpoints included assessment of general skin and disease outcomes, quality-of-life, and patient satisfaction with treatment.
RESULTS
Eighty-seven patients were included. Mean age was 46.8 years, 70.1% patients were male, and mean body mass index was 28.9 kg/m2. The co-primary endpoints were achieved by more than 90% of patients who met criteria for effectiveness analyses (n = 62): 93.6% of patients achieved PSSI75 at week 12 and 90.3% of patients achieved NAPSI75 at week 24. Median body surface area involvement improved from 14% at baseline to 1.5% and 1% at weeks 12 and 24, respectively. Median Dermatology Life Quality Index scores improved from 16 at baseline to 2 and 1 at weeks 12 and 24, respectively. Improvements were maintained in the majority of patients throughout the 60-week study. Brodalumab was well tolerated and patients were highly satisfied with the treatment.
CONCLUSION
Outcomes assessed in this study, including assessments of scalp and nail symptoms, improved following initiation of brodalumab therapy. This study of psoriasis patients in a real-world setting supports the long-term clinical effectiveness of brodalumab on difficult-to-treat body regions.
引言
布罗达单抗是一种选择性抑制白细胞介素（IL）-17受体亚基A的人源单克隆抗体，已被批准用于治疗中度至重度斑块状银屑病。布罗达单抗的治疗益处已在多项临床研究中得到明确证实。然而，关于其对难治性身体部位有效性的数据，尤其是在日常临床实践中的数据，仍然有限。
方法
在这项探索性观察性临床研究中，在德国7个中心招募了在常规临床护理期间接受布罗达单抗治疗的伴有指甲和头皮受累的银屑病患者。对患者进行了60周以上的观察。共同主要终点是第12周时头皮银屑病严重程度指数（PSSI75）改善75%和第24周时指甲银屑病严重程度指数（NAPSI75）改善75%。次要终点包括对一般皮肤和疾病结局、生活质量以及患者对治疗的满意度的评估。
结果
纳入了87例患者。平均年龄为46.8岁，70.1%的患者为男性，平均体重指数为28.9kg/m²。超过90%符合有效性分析标准的患者（n = 62）达到了共同主要终点：93.6%的患者在第12周时达到PSSI75，90.3%的患者在第24周时达到NAPSI75。中位体表面积受累情况从基线时的14%分别改善至第12周时的1.5%和第24周时的1%。皮肤病生活质量指数中位数得分从基线时的16分别改善至第12周时的2和第24周时的1。在整个60周的研究中，大多数患者的改善情况得以维持。布罗达单抗耐受性良好，患者对治疗高度满意。
结论
本研究评估的结果，包括对头皮和指甲症状的评估，在开始布罗达单抗治疗后有所改善。这项针对现实环境中银屑病患者的研究支持了布罗达单抗对难治性身体部位的长期临床有效性。
引言
布罗达单抗是一种选择性抑制白细胞介素（IL）-17受体亚基A的人源单克隆抗体，已被批准用于治疗中度至重度斑块状银屑病。布罗达单抗的治疗益处已在多项临床研究中得到明确证实。然而，关于其对难治性身体部位有效性的数据，尤其是在日常临床实践中的数据，仍然有限。
方法
在这项探索性观察性临床研究中，在德国7个中心招募了在常规临床护理期间接受布罗达单抗治疗的伴有指甲和头皮受累的银屑病患者。对患者进行了60周以上的观察。共同主要终点是第12周时头皮银屑病严重程度指数（PSSI75）改善75%和第24周时指甲银屑病严重程度指数（NAPSI75）改善75%。次要终点包括对一般皮肤和疾病结局、生活质量以及患者对治疗的满意度的评估。
结果
纳入了87例患者。平均年龄为46.8岁，70.1%的患者为男性，平均体重指数为28.9kg/m²。超过90%符合有效性分析标准的患者（n = 62）达到了共同主要终点：93.6%的患者在第12周时达到PSSI75，90.3%的患者在第24周时达到NAPSI75。中位体表面积受累情况从基线时的14%分别改善至第12周时的1.5%和第24周时的1%。皮肤病生活质量指数中位数得分从基线时的16分别改善至第12周时的2和第24周时的1。在整个60周的研究中，大多数患者的改善情况得以维持。布罗达单抗耐受性良好，患者对治疗高度满意。
结论
本研究评估的结果，包括对头皮和指甲症状的评估，在开始布罗达单抗治疗后有所改善。这项针对现实环境中银屑病患者的研究支持了布罗达单抗对难治性身体部位的长期临床有效性。
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