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乌帕替尼联合外用糖皮质激素治疗中度至重度特应性皮炎青少年患者的有效性和安全性。

Effectiveness and Safety of Upadacitinib in Combination with Topical Corticosteroids in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis.

作者信息

Hagino Teppei, Hamada Risa, Yoshida Mai, Fujimoto Eita, Saeki Hidehisa, Kanda Naoko

机构信息

Department of Dermatology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.

Department of Dermatology, Nippon Medical School, Tokyo, Japan.

出版信息

Clin Cosmet Investig Dermatol. 2023 Nov 7;16:3201-3212. doi: 10.2147/CCID.S439053. eCollection 2023.

Abstract

PURPOSE

To investigate the therapeutic effectiveness and safety of Janus kinase 1 inhibitor upadacitinib in adolescent patients with atopic dermatitis (AD).

PATIENTS AND METHODS

This study examined therapeutic effectiveness and safety of upadacitinib for 39 Japanese adolescent patients (aged 12-17 years) diagnosed with moderate-to-severe AD from August 2021 to January 2023. The patients were treated with upadacitinib 15 mg/day plus twice daily topical corticosteroids. Total eczema area and severity index (EASI) or EASI on head and neck, upper limbs, lower limbs, and trunk or for erythema, edema/papulation, excoriation, or lichenification, atopic dermatitis control tool (ADCT), peak pruritus-numerical rating scale (PP-NRS), and laboratory indexes were assessed at weeks 0, 4, and 12 of treatment. Treatment-emergent adverse events were recorded.

RESULTS

Total EASI or EASI on 4 anatomical sites or for 4 rash types, ADCT, and PP-NRS were significantly reduced at week 4 and 12 compared to week 0. The achievement rates at weeks 4 or 12 were 64.1% or 62.5% for EASI 75, 93.5% or 73.1% for ADCT <7-point, and 80.6% or 60% for PP-NRS ≥4-point improvement, respectively, indicating their peak at week 4 and slight decrease at week 12. The percent reduction of EASI for excoriation was higher than that for lichenification or edema/papulation at week 4 or week 12, respectively. The percent reductions of EASI for erythema and edema/papulation on head and neck were lower than those on lower limbs at week 12. Total eosinophil counts (TEC) and IgE reduced at week 4 compared to week 0 while TARC, IgE, TEC, and LDH increased at week 12 compared to week 4.

CONCLUSION

These results suggest therapeutic effectiveness and tolerability of upadacitinib and support its therapeutic usefulness for adolescent AD patients.

摘要

目的

研究Janus激酶1抑制剂乌帕替尼治疗青少年特应性皮炎(AD)的疗效和安全性。

患者与方法

本研究考察了2021年8月至2023年1月期间39例诊断为中度至重度AD的日本青少年患者(年龄12 - 17岁)使用乌帕替尼的疗效和安全性。患者接受15 mg/天的乌帕替尼治疗,外加每日两次外用糖皮质激素。在治疗的第0、4和12周评估总湿疹面积和严重程度指数(EASI)或头颈部、上肢、下肢和躯干的EASI,或针对红斑、水肿/丘疹、抓痕或苔藓化的EASI、特应性皮炎控制工具(ADCT)、峰值瘙痒数值评定量表(PP - NRS)以及实验室指标。记录治疗中出现的不良事件。

结果

与第0周相比,第4周和第12周时总EASI或4个解剖部位或4种皮疹类型的EASI、ADCT和PP - NRS均显著降低。第4周或第12周时,EASI改善75%的达标率分别为64.1%或62.5%,ADCT<7分的达标率分别为93.5%或73.1%,PP - NRS改善≥4分的达标率分别为80.6%或60%,表明在第4周达到峰值,在第12周略有下降。在第4周或第12周时,抓痕部位EASI的降低百分比分别高于苔藓化或水肿/丘疹部位。在第12周时,头颈部红斑和水肿/丘疹的EASI降低百分比低于下肢。与第0周相比,第4周时总嗜酸性粒细胞计数(TEC)和IgE降低,而与第4周相比,第12周时TARC、IgE、TEC和LDH升高。

结论

这些结果表明乌帕替尼具有治疗效果和耐受性,并支持其对青少年AD患者的治疗作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2cf/10638939/a87f1f93cae9/CCID-16-3201-g0001.jpg

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