中华皮肤科杂志 ›› 2023, Vol. 56 ›› Issue (3): 210-215.doi: 10.35541/cjd.20220378

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[开放获取]   依奇珠单抗治疗银屑病短期疗效的单中心病例回顾性研究

胡琨1    杨晶1    王巧林1    陈军臣1    张谧1    朱武1    张斌2    窦冠珅2    Wendong Chen3，4    匡叶红1
  

  1. 1中南大学湘雅医院皮肤科，长沙  410008；2礼来苏州制药有限公司，上海  200041；3长沙诺民医疗科技有限公司，长沙  410013；4Normin Health Consulting Ltd. Toronto, Ontario L5R 0E9, Canada
  • 收稿日期:2022-05-26 修回日期:2023-01-04 发布日期:2023-03-06
  • 通讯作者: 匡叶红 E-mail:yh_927@126.com

Real-world short-term treatment effects of Ixekizumab in Chinese patients with psoriasis: a single-center retrospective study

Hu Kun1, Yang Jing1, Wang Qiaolin1, Chen Junchen1, Zhang Mi1, Zhu Wu1, Zhang Bin2, Dou Guanshen2, Wendong Chen3,4, Kuang Yehong1#br#   

  1. 1Department of Dermatology, Xiangya Hospital, Central South University, Changsha 410008, China; 2Eli Lilly Suzhou Pharmaceutical Co., Ltd., Shanghai 200041, China；3Changsha Normin Health Technology Co., Ltd., Changsha 410013, China; 4Normin Health Consulting Ltd. Toronto, Ontario L5R 0E9, Canada
  • Received:2022-05-26 Revised:2023-01-04 Published:2023-03-06
  • Contact: Kuang Yehong E-mail:yh_927@126.com

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摘要： 【摘要】 目的 评估依奇珠单抗在真实世界中治疗银屑病患者的短期疗效，探讨影响依奇珠单抗短期疗效的因素。方法 回顾性收集2019年11月至2021年9月湘雅医院皮肤科收治接受依奇珠单抗治疗银屑病患者的基线特征和短期疗效评估结果。患者基线特征采用描述性分析方法，连续变量以M（Q1，Q3）描述，分类变量以百分比描述。依奇珠单抗治疗前后疾病严重程度的比较采用Wilcoxon符号秩和检验或配对McNemar检验。采用多因素logistic回归分析探索依奇珠单抗治疗4周的疗效影响因素。结果 共纳入118例银屑病患者，男94例、女24例，年龄M（Q1，Q3）为43.4（32.5，53.0）岁，以斑块状寻常型银屑病（99/118，83.9%）和重度银屑病（72/105，68.6%）为主，皮损主要位于头皮（59/116，50.9%）。49例接受依奇珠单抗治疗2周后，27例（55.1%）银屑病皮损面积和严重程度指数（PASI）评分改善50%（PASI50）；治疗4周后，分别有44例（89.8%）、30例（61.2%）、13例（26.5%）、10例（20.4%）达PASI50/75/90/100，且PASI评分［2.1（1.1，7.1）］、体表皮损面积［3.9%（0.5%，14.5%）］、皮肤病生活质量指数评分［1.0（0.0，2.0）］和医生整体评估（PGA）评分［1.0（1.0，3.0）］均显著低于基线各项评分［12.4（8.8，23.2）、22.0%（11.3%，43.4%）、6.0（3.0，11.0）、4.0（3.0，5.0），均P < 0.001］。多因素logistic回归分析显示，患者身体质量指数显著影响依奇珠单抗治疗4周后PASI75应答率（OR = 0.814，95% CI：0.659 ~ 0.958，P = 0.029）及PGA0/1的患者比例（OR = 0.743，95% CI: 0.562 ~ 0.917，P = 0.017），且基线BSA评分与依奇珠单抗治疗4周后PGA0/1的患者比例显著相关（OR = 0.924，95% CI：0.870 ~ 0.968，P = 0.003）。结论 依奇珠单抗治疗4周可显著改善银屑病严重程度，且在基线疾病严重程度较轻和体质指数较低的患者中依奇珠单抗疗效更佳。

关键词: 银屑病, 生物制剂, 治疗结果, 依奇珠单抗, 身体质量指数

Abstract: 【Abstract】 Objective To evaluate the real-world short-term effectiveness of ixekizumab in the treatment of psoriasis, and to investigate factors influencing the effectiveness. Methods Baseline data and short-term effectiveness evaluation results were retrospectively collected from patients with psoriasis, who received ixekizumab treatment in Department of Dermatology, Xiangya Hospital from November 2019 to September 2021. A descriptive analysis was performed on the baseline characteristics of patients, continuous data were described as median （lower quartile, upper quartile）, and categorical data were described as percentages. Comparisons of disease severity scores before and after the treatment with ixekizumab were performed using Wilcoxon signed-rank test or paired McNemar test. Multivariable logistic regression analysis was conducted to explore factors influencing the effectiveness of 4-week ixekizumab treatment. Results A total of 118 patients with psoriasis were included, including 94 males and 24 females, and their age ［M （Q1, Q3）］ was 43.4 （32.5, 53.0） years; plaque psoriasis （99 cases, 83.9%） and severe psoriasis （72 cases, 68.6%） predominated among the 118 patients, and skin lesions were mainly located on the scalp （59/116, 50.9%）. Among the 49 patients who had received 2-week ixekizumab treatment, 27 （55.1%） achieved a 50% improvement in the psoriasis area and severity index （PASI） score （PASI50）; after 4-week treatment, 44 （89.8%）, 30 （61.2%）, 13 （26.5%） and 10 （20.4%） patients achieved PASI50/75/90/100 respectively, and their PASI scores （2.1 ［1.1, 7.1］）, involved body surface area （3.9% ［0.5%, 14.5%］）, dermatology life quality index scores （1.0 ［0.0, 2.0］） and physician global assessment （PGA） scores （1.0 ［1.0, 3.0］） were significantly lower than the corresponding scores at baseline （12.4 ［8.8, 23.2］, 22.0% ［11.3%, 43.4%］, 6.0 ［3.0, 11.0］, 4.0 ［3.0, 5.0］, respectively; all P < 0.001］. Multivariable logistic regression analysis showed that the baseline body mass index was significantly associated with the PASI75 response rate （OR = 0.814, 95% CI: 0.659 - 0.958, P = 0.029）and the proportion of patients with PGA0/1 （OR = 0.743, 95% CI: 0.562 - 0.917, P = 0.017） after 4-week ixekizumab treatment, and the baseline BSA score was significantly associated with the proportion of patients with PGA0/1 after 4-week ixekizumab treatment（OR = 0.924, 95% CI: 0.870 - 0.968, P = 0.003）. Conclusion The 4-week ixekizumab treatment significantly decreased the severity of psoriasis, and may be more effective in patients with lower disease severity and lower body mass index at baseline.

Key words: Psoriasis, Biological agents, Treatment outcome, Ixekizumab, Body mass index

引用本文

胡琨 杨晶 王巧林 陈军臣 张谧 朱武 张斌 窦冠珅 Wendong Chen, 匡叶红. [开放获取]   依奇珠单抗治疗银屑病短期疗效的单中心病例回顾性研究[J]. 中华皮肤科杂志, 2023,56(3):210-215. doi:10.35541/cjd.20220378

Hu Kun, Yang Jing, Wang Qiaolin, Chen Junchen, Zhang Mi, Zhu Wu, Zhang Bin, Dou Guanshen, Wendong Chen, Kuang Yehong. Real-world short-term treatment effects of Ixekizumab in Chinese patients with psoriasis: a single-center retrospective study[J]. Chinese Journal of Dermatology, 2023, 56(3): 210-215.doi:10.35541/cjd.20220378