度普利尤单抗治疗哮喘合并特应性共病有效性和安全性回顾性分析

Retrospective analysis on efficacy and safety of Dupilumab for treatment of asthma with atopic comorbidities

目的评估度普利尤单抗治疗哮喘合并特应性共病的临床有效性及安全性。方法采用回顾性分析,纳入2020年3月至2023年10月在上海交通大学医学院附属仁济医院变态反应科接受度普利尤单抗治疗16周以上的过敏性哮喘伴特应性共病的患者。分析比较患者治疗前、后临床症状改善及安全性状况,吸入性糖皮质激素用量、肺功能、呼出气一氧化氮、相关实验室指标等变化。结果共纳入过敏性哮喘伴特应性皮炎患者21例,其中19例为传统治疗药物控制不佳者,2例奥马珠单抗治疗应答不佳而转为度普利尤单抗治疗的患者。21例患者均完成至少16周以上的治疗和随访。哮喘改善方面:与基线对比,治疗16周后患者的FeNO中位数由(40.33±26.97)ppb下降至(24.52±10.75)ppb(P<0.01);第1秒用力呼气容积占预计值%(FEV_(1)pred%)均值由(85.34%±5.82%)上升至(91.1%±11.65%)(P<0.05);吸入ICS用量由400(200,600)(μg/d)下降至0(0,100)μg/d(P<0.05);哮喘生活质量评分(AQLQ)下降(P<0.01)。治疗前嗜酸性粒细胞(eosinophils,EOS)水平与治疗后的肺功能改善呈正相关(Pearson相关系数r=0.642658,P<0.05)。共病改善方面:治疗后患者总IgE、VAS评分、特应性皮炎评分(SCORAD)、瘙痒峰值评分(NRS)、鼻结膜炎生活质量评分(RQLQ)均下降(P<0.01)。治疗期间,仅5例(5/21)出现轻度不良反应,未见药物相关严重不良反应。结论度普利尤单抗可显著改善哮喘的临床症状,降低气道炎症,提升肺功能,且不良反应轻微。

Objective To evaluate clinical efficacy and safety of Dupilumab for treatment of asthmatic patients with atopic dermatitis(AD).Methods A retrospective analysis was conducted,while allergic asthmatic patients with atopic dermatitis who were prescribed Dupilumab for more than 16 weeks were included from Department of Allergy,Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine since March 2020 to October 2023.Data related to alleviation of clinical symptoms and safety,inhaled corticosteroid(ICS)dosage,lung function,exhaled nitric oxide(FeNO)and laboratory data were collected,analyzed and compared pre and after treatment.Results Of 21 allergic asthmatic patients with atopic dermatitis,19 were poorly controlled by standard regimen and another 2 were administrated with Dupilumab due to poor response to Omalizumab.All 21 patients completed at least 16 weeks treatment and follow-up.Results of data related to alleviation of asthma:FeNO decreased from 40.33±26.97 to 24.52±10.75 ppb after 16 weeks treatment(P<0.01),compared with baseline;the proportion of forced expiratory volume in predicted value%in the first second(FEV_(1)pred%)increased from 85.34±5.82 to 91.1±11.65%(P<0.05);ICS dosage decreased from 400(200,600)to 0(0,100)(μg/d)(P<0.05);asthma quality of life score(AQLQ)was decreased(P<0.01).Eosinophils(EOS)levels of pretreatment were positively correlated with the increase of lung function after treatment(Pearson correlation coefficient r=0.642658,P<0.05).Results of data related to improvement of comorbidities of asthma:total IgE,VAS score,Scoring Atopic Dermatitis(SCORAD),pruritus numeric rating scale(NRS)and allergic rhinitis quality of life questionnaire(RQLQ)were all decreased after treatment(P<0.01).During the therapeutic period,mild adverse reactions were observed among 5 cases(5/21)only,without drug-related serious adverse reactions.Conclusions Dupilumab can significantly alleviate clinical symptoms of allergic asthma,reduce severity of airway inflammation and improve pulmonary function,while adverse reactions were mild.