Brodalumab is Effective for Psoriasis Patients with Difficult-to-treat Body Regions: Results from an Observational Clinical Study.

IF 3 3区医学 Q2 DERMATOLOGY Dermatology Pub Date : 2024-11-06 DOI:10.1159/000542348

Stephanie Dauth, Ann Christina Foldenauer, Konstantin Hallmann, Christina Kunz, Anke König, Isabel Haferland, Christine Möser, Michaela Koehm, Andreas Pinter

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Abstract

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 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 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.

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布达鲁单抗对难以治疗身体部位的银屑病患者有效：一项观察性临床研究的结果。

简介Brodalumab是一种选择性抑制白细胞介素（IL）-17受体亚基A的人类单克隆抗体，已被批准用于治疗中重度斑块状银屑病。多项临床研究已明确证实了布达鲁单抗的治疗效果。然而，对于难以治疗的身体部位，尤其是日常临床实践中的疗效数据仍然有限：在这项探索性观察临床研究中，德国的 7 个中心招募了在常规临床治疗中接受过布达鲁单抗治疗的指甲和头皮受累银屑病患者。对患者进行了 60 周的观察。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%，第24周时指甲银屑病严重程度指数（NAPSI75）改善75%。次要终点包括一般皮肤和疾病结果评估、生活质量以及患者对治疗的满意度：结果：共纳入 87 名患者。平均年龄为 46.8 岁，70.1% 的患者为男性，平均体重指数为 28.9 kg/m²。90%以上符合疗效分析标准的患者（62 人）达到了共同主要终点：93.6%的患者在第12周达到了PSSI75，90.3%的患者在第24周达到了NAPSI75。受累体表面积中位数从基线时的14%分别降至第12周和第24周时的1.5%和1%。皮肤病生活质量指数中位数从基线时的16分分别降至第12周和第24周时的2分和1分。在为期60周的研究中，大多数患者的病情都得到了改善。布达鲁单抗的耐受性良好，患者对治疗非常满意：结论：本研究评估的结果，包括头皮和指甲症状的评估，在开始使用布达鲁单抗治疗后都有所改善。这项针对真实世界中银屑病患者的研究证明，布洛达单抗对难以治疗的身体部位具有长期临床疗效。

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来源期刊

Dermatology 医学-皮肤病学

CiteScore

6.40

自引率

2.90%

发文量

审稿时长

1 months

期刊介绍： Published since 1893, ''Dermatology'' provides a worldwide survey of clinical and investigative dermatology. Original papers report clinical and laboratory findings. In order to inform readers of the implications of recent research, editorials and reviews prepared by invited, internationally recognized scientists are regularly featured. In addition to original papers, the journal publishes rapid communications, short communications, and letters to ''Dermatology''. ''Dermatology'' answers the complete information needs of practitioners concerned with progress in research related to skin, clinical dermatology and therapy. The journal enjoys a high scientific reputation with a continually increasing impact factor and an equally high circulation.