Short-term effectiveness and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from a 16-week real-world multicenter retrospective study - il AD (Italian landscape atopic dermatitis).

Luigi Gargiulo, Luciano Ibba, Angela Alfano, Piergiorgio Malagoli, Fabrizio Amoruso, Anna Balato, Francesca Barei, Anna G Burroni, Stefano Caccavale, Piergiacomo Calzavara-Pinton, Maria Esposito, Maria C Fargnoli, Silvia M Ferrucci, Caterina Foti, Giampiero Girolomoni, Massimo Gola, Mario B Guanti, Carlotta Gurioli, Manfredi Magliulo, Martina Maurelli, Pietro Morrone, Maria L Musumeci, Maddalena Napolitano, Michela Ortoncelli, Cataldo Patruno, Bianca M Piraccini, Elena Pezzolo, Simone Ribero, Mariateresa Rossi, Paola Savoia, Claudio Sciarrone, Benedetta Tirone, Marco Vaccino, Federica Veronese, Antonio Costanzo, Alessandra Narcisi
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Abstract

Aim: Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD.

Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg.

Methods: Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively).

Results: At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab.Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.

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阿昔替尼治疗成人中重度特应性皮炎的短期有效性和安全性:一项为期 16 周的真实多中心回顾性研究 - il AD(意大利景观特应性皮炎)的结果。
目的:阿昔替尼是一种JAK-1抑制剂,已被批准用于治疗中重度特应性皮炎(AD)。我们开展了一项为期16周的多中心回顾性研究,以评估阿罗西替尼在中重度特应性皮炎患者中的短期有效性和安全性。我们的回顾性研究纳入了来自意大利14个皮肤科单位的85名接受阿罗西替尼100/200毫克治疗的中重度特应性皮炎成年患者:方法:使用湿疹面积和严重程度指数(EASI)、研究者全球评估(IGA)、瘙痒峰值和睡眠数字评定量表(分别为PP-NRS和S-NRS)评估阿罗西替尼在第4周和第16周的疗效:第16周时,分别有49.4%和61.2%的患者EASI(EASI90)和IGA 0/1改善了至少90%。与基线相比,70.6%的患者的PP-NRS和S-NRS两项终点均降低了至少4分。研究期间未发现重大安全性报告。与之前失败过杜比鲁单抗的患者相比,新患者的EASI 90率更高:我们的数据证实了阿罗西替尼在真实世界中的有效性,与III期临床试验相比,阿罗西替尼在第4周和第16周的临床反应更好。要进一步确定阿罗西替尼的安全性,还需要进行更长时间的分析。
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