尼达尼布治疗系统性硬化症相关间质性肺病:SENSCIS研究中国亚组分析  

Nintedanib for patients with systemic sclerosis-associated interstitial lung disease:A subgroup analysis of Chinese patients in the SENSCIS trial

作　　者：周佳鑫 徐东 邹和建 姜振宇[3] 刘毅[4] 肖卫国[5] 郑毅[6] 程永静[7] 徐建华[8] 宋成园 田疆 曾小峰 ZHOU Jia-xin;XU Dong;ZOU He-jian;JIANG Zhen-yu;LIU Yi;XIAO Wei-guo;ZHENG Yi;CHENG Yong-jing;XU Jian-hua;SONG Cheng-yuan;TIAN Jiang;ZENG Xiao-feng(Department of Rheumatology and Clinical Immunology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Key Laboratory of Rheumatology and Clinical Immunology,Ministry of Education,State Key Laboratory of Complex Severe and Rare Diseases,National Clinical Research Center for Dermatologic and Immunologic Diseases(NCRC-DID),Beijing 100730,China;Department of Rheumatology and Immunology,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Rheumatology and Immunology,The First Hospital of Jilin University,Jilin 130021,China;Department of Rheumatology and Immunology,West China Hospital,Sichuan University,Chengdu 610041,China;Department of Rheumatology and Immunology,The First Hospital of China Medical University,Shenyang 110001,China;Department of Rheumatology and Immunology,Beijing Chaoyang Hospital of Capital Medical University,Beijing 100020,China;Department of Rheumatology and Immunology,Beijing Hospital,National Clinical Research Center for Geriatric Diseases,Beijing 100730,China;Department of Rheumatology and Immunology,The First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Boehringer Ingelheim(China)Investment Co.Ltd,Shanghai 200040,China)

机构地区：[1]中国医学科学院、北京协和医学院、北京协和医院风湿免疫科,风湿免疫病学教育部重点实验室,疑难重症及罕见病国家重点实验室,国家皮肤与免疫疾病临床医学研究中心,北京100730 [2]复旦大学附属华山医院风湿免疫科,上海200040 [3]吉林大学第一医院风湿免疫科,长春130021 [4]四川大学华西医院风湿免疫科,成都610041 [5]中国医科大学附属第一医院风湿免疫科,沈阳110001 [6]首都医科大学附属北京朝阳医院风湿免疫科,北京100020 [7]北京医院风湿免疫科,国家老年医学中心,北京100730 [8]安徽医科大学第一附属医院风湿免疫科,合肥230022 [9]勃林格殷格翰(中国)投资有限公司,上海200040

出　　处：《中华临床免疫和变态反应杂志》2023年第5期415-422,共8页Chinese Journal of Allergy & Clinical Immunology

摘　　要：目的 分析尼达尼布在中国系统性硬化症相关间质性肺病(SSc-ILD)患者中的有效性与安全性。方法 SENSCIS是一项多国家、多中心、前瞻性、随机双盲、安慰剂对照Ⅲ期临床研究,本研究对其中22例中国患者进行亚组分析。入选患者以1∶1的比例随机接受尼达尼布(口服150 mg,一日两次)或安慰剂治疗,治疗时长为52至100周。主要终点为52周时用力肺活量(FVC,mL)年下降率,关键次要终点为第52周时改良版Rodnan皮肤评分(mRSS)自基线的绝对值改变,及第52周时圣乔治呼吸问卷(SGRQ)总分自基线的绝对值改变。结果 22例中国患者(尼达尼布组9例、安慰剂组13例)中,20例为女性。尼达尼布和安慰剂组患者的平均年龄分别为(50.8±17.3)岁和(51.5±13.3)岁。尼达尼布组52周时经校正的FVC平均年下降率低于安慰剂组[分别为(70.6±79.2)mL/年和(-112.2±62.2)mL/年,校正差异(182.77±100.62)mL/年,95%置信区间(CI-14.90,380.45)]。最常见的不良反应是腹泻。结论 在SENSCIS研究中国亚组分析中,尼达尼布组患者52周时FVC下降率的减缓趋势与整体人群一致。中国患者最常见的不良事件为腹泻,未发现新的安全性问题。Objective To fevaluate the efficacy and safety of nintedanib in Chinese systemic sclerosis patients with interstitial lung disease(SSc-ILD).Methods SENSCIS is a multinational,multicenter,prospective,randomized,double-blind,placebo-controlled,phaseⅢtrial.We conducted a subgroup analysis of 22 Chinese patients in the SENSCIS study.Eligible patients were randomly assigned in 1∶1 ratio,to receive nintedanib(150 mg,twice daily)or placebo for 52-100 weeks.The primary endpoint was the annual rate of decline in forced vital capacity(FVC,mL)over 52 weeks.The key secondary endpoints were the absolute change from baseline in the modified Rodnan skin score(mRSS)and the absolute change from baseline in the St.George’s Respiratory Questionnaire(SGRQ)total score at week 52.Results A total of 22 Chinese patients were analyzed(nintedanib:9 patients;placebo:13 patients),and 20 patients were females.The mean age of patients in the nintedanib and placebo group were(50.8±17.3)years and(51.5±13.3)years,respectively.The adjusted mean annual rate of decline in FVC over 52 weeks was(70.6±79.2)mL/year in nintedanib group and(-112.2±62.2)mL/year in placebo group[adjusted difference(182.77±100.62)mL/year,95%confidence interval(-14.90,380.45)].Diarrhea was the most common adverse event over 52 weeks.Conclusions The trend of annual rate of decline in FVC over 52 weeks in Chinese population is consistent with that in the global population.The most common adverse event in Chinese population is diarrhea,and no new safety events are detected.

关 键 词：系统性硬化症相关间质性肺病 尼达尼布 SENSCIS研究 中国患者 

分 类 号：R593.2[医药卫生—内科学] R563[医药卫生—临床医学]