Andrea Chiricozzi, Niccolò Gori, Alessandra Narcisi, Anna Balato, Alessio Gambardella, Michela Ortoncelli, Angelo Valerio Marzano, Riccardo Balestri, Giovanni Palazzo, Michele Pellegrino, Marco Romanelli, Giovanni Tripepi, Ketty Peris, Antonio Costanzo
{"title":"Upadacitinib治疗中重度特应性皮炎的有效性和安全性:一项多中心、前瞻性、真实世界队列研究","authors":"Andrea Chiricozzi, Niccolò Gori, Alessandra Narcisi, Anna Balato, Alessio Gambardella, Michela Ortoncelli, Angelo Valerio Marzano, Riccardo Balestri, Giovanni Palazzo, Michele Pellegrino, Marco Romanelli, Giovanni Tripepi, Ketty Peris, Antonio Costanzo","doi":"10.1007/s40268-022-00396-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab.</p><p><strong>Methods: </strong>Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy.</p><p><strong>Results: </strong>Forty-three patients showed rapid and marked response to upadacitinib with significant reduction of all disease severity scores since the first follow-up visit. At week 16, Eczema Area and Severity Index (EASI) 75, EASI 90, and EASI 100 response was observed in 97.5%, 82.1%, and 69.2% of patients, respectively. EASI 90 response reflected the achievement of a clear or almost clear condition (POEM 0-2), self-evaluated by 79.5% of patients. Patients' quality of life improved as suggested by the achievement of DLQI 0/1 by 38.5% of patients at week 4, and by 76.9% at week 16.</p><p><strong>Conclusion: </strong>Elevated effectiveness and favorable safety of upadacitinib were confirmed in patients unresponsive to dupilumab, who were not included in upadacitinib trials.</p>","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 3","pages":"245-252"},"PeriodicalIF":2.2000,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a5/e9/40268_2022_Article_396.PMC9362214.pdf","citationCount":"15","resultStr":"{\"title\":\"Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study.\",\"authors\":\"Andrea Chiricozzi, Niccolò Gori, Alessandra Narcisi, Anna Balato, Alessio Gambardella, Michela Ortoncelli, Angelo Valerio Marzano, Riccardo Balestri, Giovanni Palazzo, Michele Pellegrino, Marco Romanelli, Giovanni Tripepi, Ketty Peris, Antonio Costanzo\",\"doi\":\"10.1007/s40268-022-00396-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab.</p><p><strong>Methods: </strong>Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy.</p><p><strong>Results: </strong>Forty-three patients showed rapid and marked response to upadacitinib with significant reduction of all disease severity scores since the first follow-up visit. At week 16, Eczema Area and Severity Index (EASI) 75, EASI 90, and EASI 100 response was observed in 97.5%, 82.1%, and 69.2% of patients, respectively. EASI 90 response reflected the achievement of a clear or almost clear condition (POEM 0-2), self-evaluated by 79.5% of patients. Patients' quality of life improved as suggested by the achievement of DLQI 0/1 by 38.5% of patients at week 4, and by 76.9% at week 16.</p><p><strong>Conclusion: </strong>Elevated effectiveness and favorable safety of upadacitinib were confirmed in patients unresponsive to dupilumab, who were not included in upadacitinib trials.</p>\",\"PeriodicalId\":49258,\"journal\":{\"name\":\"Drugs in Research & Development\",\"volume\":\"22 3\",\"pages\":\"245-252\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2022-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a5/e9/40268_2022_Article_396.PMC9362214.pdf\",\"citationCount\":\"15\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drugs in Research & Development\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40268-022-00396-1\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/8/3 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs in Research & Development","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40268-022-00396-1","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/8/3 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study.
Background: The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab.
Methods: Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy.
Results: Forty-three patients showed rapid and marked response to upadacitinib with significant reduction of all disease severity scores since the first follow-up visit. At week 16, Eczema Area and Severity Index (EASI) 75, EASI 90, and EASI 100 response was observed in 97.5%, 82.1%, and 69.2% of patients, respectively. EASI 90 response reflected the achievement of a clear or almost clear condition (POEM 0-2), self-evaluated by 79.5% of patients. Patients' quality of life improved as suggested by the achievement of DLQI 0/1 by 38.5% of patients at week 4, and by 76.9% at week 16.
Conclusion: Elevated effectiveness and favorable safety of upadacitinib were confirmed in patients unresponsive to dupilumab, who were not included in upadacitinib trials.
期刊介绍:
Drugs in R&D is an international, peer reviewed, open access, online only journal, and provides timely information from all phases of drug research and development that will inform clinical practice. Healthcare decision makers are thus provided with knowledge about the developing place of a drug in therapy.
The Journal includes:
Clinical research on new and established drugs;
Preclinical research of direct relevance to clinical drug development;
Short communications and case study reports that meet the above criteria will also be considered;
Reviews may also be considered.