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托法替布在印度难治性中重度特应性皮炎患者中的真实世界研究、经济考量及免疫学原理

A Real-World Study of Tofacitinib in Indian Patients with Refractory Moderate-to-Severe Atopic Dermatitis, its Economic Considerations and Immunological Rationale.

作者信息

Sardana Kabir, Sharath Savitha, Meena Sumitra Kumari, Khurana Ananta, Dhir Bhawuk

机构信息

Department of Dermatology, Venereology and Leprosy, Atal Bihari Vajpayee Institute of Medical Sciences and Research Institute and Dr. Ram Manohar Lohia Hospital, New Delhi, India.

出版信息

Indian Dermatol Online J. 2025 Apr 15;16(3):420-425. doi: 10.4103/idoj.idoj_665_24. eCollection 2025 May-Jun.

DOI:10.4103/idoj.idoj_665_24
PMID:40395576
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12088487/
Abstract

BACKGROUND

The response of atopic dermatitis (AD) to different biologics and JAK inhibitors (JAKibs) is variable due to the varied immunological endotypes of AD.

AIM AND OBJECTIVES

To assess the effectiveness and adverse effect profile of tofacitinib in recalcitrant, moderate-to-severe AD patients and to compare the cost of therapy of tofacitinib with dupilumab.

PATIENTS AND METHODS

We retrospectively analyzed records of moderate to severe AD treated with tofacitinib monotherapy. The response to tofacitinib was assessed using clinical scores including Numerical Rating Scale (NRS), Scoring Atopic Dermatitis (SCORAD), and Eczema Area and Severity Index (EASI) at 4 weeks and 8 weeks of treatment. We also analyzed the duration of remission and time after which recurrences were seen after stopping tofacitinib. The cost of tofacitinib was compared with dupilumab.

RESULTS

Twelve cases of recalcitrant moderate-severe AD who had failed systemic agents [oral corticosteroids (n = 7), cyclosporine (n = 4), and azathioprine (n = 2)] were treated with tofacitinib monotherapy. There was a statistically significant reduction in SCORAD, EASI, and NRS scores at 4 weeks and 8 weeks of tofacitinib therapy [mean at baseline: 4 weeks: 8 weeks = SCORAD- 43.54: 22.74: 11.87 ( = 0.002); EASI-19.5: 6.45: 1.6 ( = 0.002); NRS-5.75: 3.25: 1.08 ( = 0.002)]. EASI 90 was achieved by 66% of patients in 8 weeks with treatment failure in one patient. The mean time to achieve complete/near complete resolution (n = 8) of the disease was 6.1 weeks (3-8 weeks). Relapse of the disease was noted in 4/11 (36.3%) patients. Side effects were observed in 5/12 (41.6%) patients (herpes zoster, dyslipidemia, anemia, impetigo, and thrombocytosis). The cost of therapy with dupilumab is 122 times higher than that of tofacitinib therapy (8 weeks treatment).

LIMITATIONS

Small sample size and lack of tissue cytokines analysis pre- and post-treatment.

CONCLUSION

Tofacitinib (pan JAK inhibitor) inhibits T helper 2 (Th2), Th1, Th17, and Th22 cell lines, and thus has potential for refractory AD. There is a need to generate tissue-based cytokine expression data in Indian patients with AD.

摘要

背景

由于特应性皮炎(AD)的免疫内型各不相同,其对不同生物制剂和JAK抑制剂(JAKibs)的反应存在差异。

目的

评估托法替布在难治性中重度AD患者中的有效性和不良反应情况,并比较托法替布与度普利尤单抗的治疗成本。

患者和方法

我们回顾性分析了接受托法替布单药治疗的中重度AD患者的记录。在治疗4周和8周时,使用包括数字评定量表(NRS)、特应性皮炎评分(SCORAD)和湿疹面积及严重程度指数(EASI)在内的临床评分评估对托法替布的反应。我们还分析了缓解期的持续时间以及停用托法替布后复发的时间。比较了托法替布与度普利尤单抗的成本。

结果

12例难治性中重度AD患者,之前使用全身药物治疗失败[口服糖皮质激素(n = 7)、环孢素(n = 4)和硫唑嘌呤(n = 2)],接受了托法替布单药治疗。在托法替布治疗4周和8周时,SCORAD、EASI和NRS评分有统计学意义的降低[基线平均值:4周:8周 = SCORAD - 43.54:22.74:11.87(P = 0.002);EASI - 19.5:6.45:1.6(P = 0.002);NRS - 5.75:3.25:1.08(P = 0.002)]。8周时66%的患者达到EASI 90,1例患者治疗失败。疾病达到完全/接近完全缓解(n = 8)的平均时间为6.1周(3 - 8周)。11例患者中有4例(36.3%)出现疾病复发。5/12(41.6%)的患者观察到副作用(带状疱疹、血脂异常、贫血、脓疱病和血小板增多症)。度普利尤单抗的治疗成本比托法替布治疗(8周治疗)高122倍。

局限性

样本量小,且缺乏治疗前后的组织细胞因子分析。

结论

托法替布(泛JAK抑制剂)可抑制辅助性T细胞2(Th2)、Th1、Th17和Th22细胞系,因此对难治性AD有治疗潜力。有必要生成印度AD患者基于组织的细胞因子表达数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/6e514f13333b/IDOJ-16-420-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/0aab6739c6c0/IDOJ-16-420-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/7705f2ab8d14/IDOJ-16-420-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/6e514f13333b/IDOJ-16-420-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/0aab6739c6c0/IDOJ-16-420-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/7705f2ab8d14/IDOJ-16-420-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e4/12088487/6e514f13333b/IDOJ-16-420-g003.jpg

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