De Abhishek, Pal Shrayan, Singh Sushil, Chakroborty Disha, Godse Kiran
From the Department of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, India.
Department of Dermatology, DY Patil University, Navi Mumbai, Maharashtra, India.
Indian J Dermatol. 2024 Jul-Aug;69(4):312-316. doi: 10.4103/ijd.ijd_1085_23. Epub 2024 Aug 19.
Chronic spontaneous urticaria (CSU) is a distressing skin condition characterized by the recurrent appearance of itchy hives. A subset of CSU patients remains resistant to conventional treatment with high-dose antihistamines. Tofacitinib, a Janus kinase inhibitor, has shown promise in various inflammatory skin diseases. We aimed to evaluate the efficacy of oral tofacitinib in patients with CSU resistant to antihistamines.
This study examined data retrospectively from seven patients who were diagnosed with CSU and were treated with tofacitinib for at least six months. These patients initially exhibited resistance to treatment with four-fold up-dosed antihistamines. One of the patients was already on omalizumab, and another was tried on cyclosporine. The patients were administered oral tofacitinib at a dosage of 5 mg twice daily for six months. Patients were followed up monthly for disease control and side effects. The response to treatment was evaluated using the urticaria activity score over 7 days (UAS7) and urticaria control test (UCT). Paired t-tests were conducted to determine the statistical significance of the results using SPSS version 25 software.
Six out of the seven patients demonstrated a significant improvement in both UAS7 and UCT scores after six months of treatment with oral tofacitinib. The mean UAS7 score decreased from 24.86 at baseline to 3.83 at the study endpoint ( < 0.0001). Similarly, the mean UCT score increased from 0.57 at baseline to 14 at the study endpoint ( < 0.0001). The standard deviations for both measures were 4.85 and 0.98 at baseline and 3.1 and 3.1 at the study endpoint for UAS7 and UCT, respectively.
In this six-month follow-up study, oral tofacitinib demonstrated significant efficacy in treating CSU patients' resistant to high-dose antihistamines. Most patients experienced a remarkable reduction in urticaria activity and an improvement in disease control. These findings suggest that tofacitinib holds promise as a potential therapeutic option for this challenging subset of CSU patients. However, larger, randomized controlled trials are warranted to further investigate the long-term safety and effectiveness of tofacitinib in this population.
慢性自发性荨麻疹（CSU）是一种令人苦恼的皮肤病，其特征为反复出现瘙痒性风团。一部分CSU患者对高剂量抗组胺药的常规治疗仍有抵抗。托法替布是一种Janus激酶抑制剂，已在多种炎症性皮肤病中显示出前景。我们旨在评估口服托法替布对抵抗抗组胺药的CSU患者的疗效。
本研究回顾性分析了7例被诊断为CSU并接受托法替布治疗至少6个月的患者的数据。这些患者最初对四倍剂量增加的抗组胺药治疗表现出抵抗。其中1例患者已在使用奥马珠单抗，另1例曾试用环孢素。患者接受口服托法替布治疗，剂量为5 mg，每日2次，持续6个月。每月对患者进行随访，观察疾病控制情况和副作用。使用7天荨麻疹活动评分（UAS7）和荨麻疹控制试验（UCT）评估治疗反应。使用SPSS 25版软件进行配对t检验以确定结果的统计学意义。
7例患者中有6例在口服托法替布治疗6个月后UAS7和UCT评分均有显著改善。UAS7评分的平均值从基线时的24.86降至研究终点时的3.83（<0.0001）。同样，UCT评分的平均值从基线时的0.57升至研究终点时的14（<0.0001）。对于UAS7和UCT，这两项指标在基线时的标准差分别为4.85和0.98，在研究终点时分别为3.1和3.1。
在这项为期6个月的随访研究中，口服托法替布在治疗抵抗高剂量抗组胺药的CSU患者方面显示出显著疗效。大多数患者的荨麻疹活动显著减少，疾病控制得到改善。这些发现表明托法替布有望成为这一具有挑战性的CSU患者亚组的潜在治疗选择。然而，需要进行更大规模的随机对照试验，以进一步研究托法替布在该人群中的长期安全性和有效性。
