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Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study
Drugs in R&D ( IF 3 ) Pub Date : 2022-08-03 , DOI: 10.1007/s40268-022-00396-1
Andrea Chiricozzi 1, 2 , Niccolò Gori 1, 2 , Alessandra Narcisi 3, 4 , Anna Balato 5 , Alessio Gambardella 5 , Michela Ortoncelli 6 , Angelo Valerio Marzano 7, 8 , Riccardo Balestri 9 , Giovanni Palazzo 10 , Michele Pellegrino 11 , Marco Romanelli 12 , Giovanni Tripepi 13 , Ketty Peris 1, 2 , Antonio Costanzo 1, 2 ,
Affiliation  

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.



中文翻译:

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、真实世界的队列研究

背景

upadacitinib 在特应性皮炎 (AD) 中的疗效和安全性已在临床试验中确定,但目前尚无实际数据。我们的目的是评估 upadacitinib 在真实世界 AD 患者队列中的安全性和有效性,该队列主要包括那些无法使用包括 dupilumab 在内的可用全身疗法的患者。

方法

前瞻性队列研究收集了 upadacitinib 治疗的 AD 成年患者完成至少 16 周治疗的数据。

结果

自第一次随访以来,43 名患者对 upadacitinib 表现出快速和显着的反应,所有疾病严重程度评分均显着降低。在第 16 周,湿疹面积和严重程度指数 (EASI) 75、EASI 90 和 EASI 100 分别在 97.5%、82.1% 和 69.2% 的患者中观察到。EASI 90 反应反映了明确或几乎明确的情况(POEM 0-2),79.5% 的患者自我评估。38.5% 的患者在第 4 周达到 DLQI 0/1,在第 16 周达到 76.9%,这表明患者的生活质量有所改善。

结论

在对 dupilumab 无反应的患者中证实了 upadacitinib 的有效性和良好的安全性,这些患者未包括在 upadacitinib 试验中。

更新日期:2022-08-04
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