Stephanie Dauth, Ann Christina Foldenauer, Konstantin Hallmann, Christina Kunz, Anke König, Isabel Haferland, Christine Möser, Michaela Koehm, Andreas Pinter
{"title":"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。","authors":"Stephanie Dauth, Ann Christina Foldenauer, Konstantin Hallmann, Christina Kunz, Anke König, Isabel Haferland, Christine Möser, Michaela Koehm, Andreas Pinter","doi":"10.1159/000542348","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0000,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Brodalumab is Effective for Psoriasis Patients with Difficult-to-treat Body Regions: Results from an Observational Clinical Study.\",\"authors\":\"Stephanie Dauth, Ann Christina Foldenauer, Konstantin Hallmann, Christina Kunz, Anke König, Isabel Haferland, Christine Möser, Michaela Koehm, Andreas Pinter\",\"doi\":\"10.1159/000542348\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":11185,\"journal\":{\"name\":\"Dermatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2024-11-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000542348\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000542348","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Brodalumab is Effective for Psoriasis Patients with Difficult-to-treat Body Regions: Results from an Observational Clinical Study.
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.
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.
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