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

IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Drugs in Research & Development Pub Date : 2022-09-01 Epub Date: 2022-08-03 DOI:10.1007/s40268-022-00396-1
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
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引用次数: 15

摘要

背景:upadacitinib治疗特应性皮炎(AD)的有效性和安全性已在临床试验中得到确定,但目前尚无实际数据。我们的目的是评估upadacitinib在现实世界AD患者队列中的安全性和有效性,该队列主要包括未能接受现有全身治疗(包括dupilumab)的患者。方法:前瞻性队列研究,收集upadacitinib治疗的AD成年患者完成至少16周治疗的数据。结果:43例患者对upadacitinib表现出快速而显著的反应,自第一次随访以来所有疾病严重程度评分均显著降低。第16周时,97.5%、82.1%和69.2%的患者湿疹面积和严重程度指数(EASI)为75、90和100。EASI 90反应反映了79.5%的患者自我评估达到了明确或几乎明确的状态(POEM 0-2)。患者的生活质量得到改善,在第4周达到DLQI 0/1的患者为38.5%,在第16周为76.9%。结论:upadacitinib在对dupilumab无反应的患者中证实了更高的有效性和良好的安全性,这些患者未被纳入upadacitinib试验。
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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.

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来源期刊
Drugs in Research & Development
Drugs in Research & Development Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
5.10
自引率
0.00%
发文量
31
审稿时长
8 weeks
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.
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