中华皮肤科杂志 ›› 2022, Vol. 55 ›› Issue (4): 304-307.doi: 10.35541/cjd.20210474

• 论著 • 上一篇    下一篇

【开放获取】巴瑞替尼治疗中重度特应性皮炎的疗效和安全性观察

刘擘    宋晓婷    廖双璐    于淼    栾婷婷    李若瑜    赵作涛   

  1. 北京大学第一医院皮肤性病科  皮肤病分子诊断北京市重点实验室  国家皮肤与免疫疾病临床医学研究中心，北京 100034
  • 收稿日期:2021-06-25 修回日期:2021-12-29 发布日期:2022-04-01
  • 通讯作者: 赵作涛 E-mail:zhaozuotaotao@163.com
  • 基金资助:
    国家自然科学基金中德合作项目（GZ901）

Efficacy and safety of baricitinib in the treatment of moderate-to-severe atopic dermatitis: a clinical observation

Liu Bo, Song Xiaoting, Liao Shuanglu, Yu Miao, Luan Tingting, Li Ruoyu, Zhao Zuotao   

  1. Department of Dermatology and Venereology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Diseases, Beijing 100034, China
  • Received:2021-06-25 Revised:2021-12-29 Published:2022-04-01
  • Contact: Zhao Zuotao E-mail:zhaozuotaotao@163.com
  • Supported by:
    Joint Sino-German Research Project of National Natural Science Foundation of China and DFG（GZ901）

PDF

547

摘要： 【摘要】 目的 评价巴瑞替尼治疗中重度特应性皮炎（AD）患者的疗效和安全性。方法 2020年6月至2021年6月，在北京大学第一医院皮肤科门诊纳入对外用药物治疗不敏感或不耐受的中重度AD患者。治疗前由皮肤科医生和患者完成4项量表评估，包括研究者整体评估（IGA）、湿疹面积及严重程度指数（EASI）、瘙痒数字评价量表（NRS）以及皮肤病生活质量指数（DLQI），同时留取患者皮疹照片并行血常规、生化指标及总IgE检查，除外禁忌后予口服巴瑞替尼2 mg/d治疗16周。治疗开始后在第1、2、4、8、12、16和20周定期随访，评估以上4种评分，并记录出现的不良反应事件。结果 纳入24例AD患者，均完成16周的药物治疗和20周的随访观察。4种评分开始治疗后20周内均呈持续下降趋势。第20周时，IGA评分由基线（4.13 ± 0.61）分降至（1.12 ± 0.49）分（t = 22.70，P < 0.001），EASI评分由（37.59 ± 14.86）分降至（4.53 ± 3.78）分（t = 10.55，P < 0.001），NRS评分由（6.83 ± 2.26）分降至（0.72 ± 0.58）分（t = 10.69，P < 0.001），DLQI评分由（18.67 ± 8.64）分降至（1.39 ± 0.85）分（t = 8.40，P < 0.001）。随访期间患者无严重不良反应，3例在开始口服药物时出现胃部不适，继续治疗后症状消失；3例出现急性过敏表现（1例过敏性结膜炎、2例急性荨麻疹），使用抗组胺药物后很快缓解且无复发。结论 巴瑞替尼可为AD尤其是外用药物控制不佳、需考虑加用系统药物的中重度AD患者提供更为安全有效的治疗选择。

关键词: 皮炎, 特应性, Janus激酶类, 蛋白激酶抑制剂, 治疗结果, 巴瑞替尼

Abstract: 【Abstract】 Objective To evaluate the efficacy and safety of baricitinib in the treatment of moderate-to-severe atopic dermatitis （AD）. Methods From June 2020 to June 2021, patients with moderate-to-severe AD who were insensitive or intolerant to topical agents were enrolled from Department of Dermatology, Peking University First Hospital. Before treatment, the patients were evaluated by 4 scales, including the Investigator′s Global Assessment （IGA）, Eczema Area and Severity Index （EASI）, Itch Numeric Rating Scale （NRS）, and Dermatology Life Quality Index （DLQI）; meanwhile, photos of skin lesions were taken, routine blood test was performed, blood biochemical indices and total IgE levels were measured. After exclusion of contraindications, the patients were treated with oral baricitinib at a dose of 2 mg/d for 16 weeks. Regular follow-up was conducted at weeks 1, 2, 4, 8, 12, 16 and 20 after the start of treatment, clinical evaluation was carried out with the above 4 scales, and adverse events were recorded during the treatment. Results A total of 24 patients were enrolled in the study, and all completed 16-week oral treatment and 20-week follow-up. All the 4 scale scores showed a continuous downward trend within 20 weeks after the start of treatment. At week 20, the patients′ IGA, EASI, NRS, and DLQI scores significantly decreased from 4.13 ± 0.61, 37.59 ± 14.86, 6.83 ± 2.26 and 18.67 ± 8.64 points respectively at baseline to 1.12 ± 0.49, 4.53 ± 3.78, 0.72 ± 0.58 and 1.39 ± 0.85 points respectively （t = 22.70, 10.55, 10.69, 8.40, respectively, all P < 0.001）. During the follow-up period, no serious adverse reactions were observed; 3 patients experienced gastric discomfort at the start of oral treatment, but the symptoms disappeared after the treatment continued; 3 developed acute allergic manifestations （1 case of allergic conjunctivitis, 2 cases of acute urticaria）, which resolved rapidly after the use of antihistamines without recurrence. Conclusion Baricitinib can provide a safer and more effective treatment option for patients with moderate-to-severe AD, especially those who are insensitive or intolerant to topical agents and need systemic treatments.

Key words: Dermatitis, atopic, Janus kinases, Protein kinase inhibitors, Treatment outcome, Baricitinib