Chen Baili, Gao Xiang, Zhong Jie, Ren Jianlin, Zhu Xuan, Liu Zhanju, Wu Kaichun, Kalabic Jasmina, Yu Zhuqing, Huang Bidan, Kwatra Nisha, Doan Thao, Robinson Anne M, Chen Min-Hu
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Therap Adv Gastroenterol. 2020 Jul 16;13:1756284820938960. doi: 10.1177/1756284820938960. eCollection 2020.
Efficacy of adalimumab in Crohn's disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD.
This 26-week, multicenter, phase III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (⩾3 mg/l) who were naïve to anti-tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160/80 mg at weeks 0/2 and 40 mg at weeks 4/6 or placebo at weeks 0/2 followed by blinded adalimumab 160/80 mg at weeks 4/6. At week 8, all patients received open-label 40 mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) <150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI ⩾70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study.
At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38/102 patients (37%) receiving adalimumab and 7/103 (7%) receiving placebo ( < 0.001) achieved clinical remission. Among week-8 responders, 93/144 (65%) achieved clinical remission at week 26 ( < 0.001). No unexpected AEs and no malignancies, active tuberculosis, or deaths were reported.
Adalimumab induced and maintained remission in Chinese patients with CD. Safety results were consistent with the known safety profile of adalimumab.
NCT02499783.
在中国，阿达木单抗治疗克罗恩病（CD）的疗效尚未得到证实。本研究旨在评估阿达木单抗在中国CD患者中的疗效和安全性。
这项为期26周的多中心III期研究评估了中度至重度活动性CD且高敏C反应蛋白升高（≥3mg/l）、未接受过抗肿瘤坏死因子治疗的患者。患者被随机分为两组，一组在第0/2周接受160/80mg阿达木单抗双盲治疗，第4/6周接受40mg治疗；另一组在第0/2周接受安慰剂治疗，第4/6周接受160/80mg阿达木单抗盲法治疗。在第8周时，所有患者从第8周开始至第26周每两周接受一次40mg阿达木单抗开放标签治疗。主要终点是第4周时的临床缓解[克罗恩病活动指数（CDAI）<150]。对第8周有反应的患者（第8周时CDAI较基线下降≥70分）评估第26周时的临床缓解情况，并与30%这一具有临床意义的阈值进行比较。在整个研究过程中记录不良事件（AE）。
在基线时，共纳入205例患者，平均[标准差（SD）]年龄为32.9（9.9）岁，CD病程为2.7（3.0）年。在第4周时，接受阿达木单抗治疗的102例患者中有38例（37%）达到临床缓解，接受安慰剂治疗的103例患者中有7例（7%）达到临床缓解（<0.001）。在第8周有反应的患者中，144例中有93例（65%）在第26周时达到临床缓解（<0.001）。未报告意外不良事件，也未报告恶性肿瘤、活动性结核或死亡病例。
阿达木单抗可诱导并维持中国CD患者的缓解。安全性结果与阿达木单抗已知的安全性特征一致。
NCT02499783。
