Zhou Jiaxin, Chen Zhe, Li Jing, Yang Yunjiao, Zhao Jiuliang, Chen Hu, Liu Min, Sun Fei, Li Mengtao, Tian Xinping, Zeng Xiaofeng
Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.
Department of Rheumatology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, Jiangxi, China.
Clin Exp Rheumatol. 2017 Mar-Apr;35 Suppl 103(1):171-175. Epub 2017 Apr 10.
The aim of this study was to evaluate the efficacy and safety of tocilizumab (TCZ) in Chinese Takayasu's arteritis (TAK) patients.
This was a single-centre prospective study. Sixteen consecutive TAK patients were included. Patients were treated with tocilizumab infusions with a dosage of 8 mg/kg. Serum inflammation markers including erythrocyte sedimentation rate (ESR) and hypersensitivity C-reactive protein (hsCRP) were recorded at baseline and before each TCZ infusion. Doppler ultrasonography was used to track vascular changes every 6 months during the study. The efficacy and safety profile of patients during the study were collected and analysed.
Sixteen patients with a median age of 26.5 (18-47) were recruited and analysed. One patient was treatment naïve; the others had taken a median of 3 (1-5) conventional immune suppressants before TCZ therapy. Three patients withdrew TCZ after 1 infusion due to unbearable neck pain. The other 13 patients were treated with TCZ for a median of 13 (7-20) months. After TCZ treatment, the median ESR, hsCRP level, mural thickness of common carotid artery and subclavical artery decreased from 39 (7-92) mm/h, 28.88 (7.6-155.93) mg/L, 0.24 (0.06-0.59) cm, 0.18 (0.07-0.47) cm to 6 (1-30) mm/h (p<0.001), 0.59 (0.08-19.12) mg/L (p=0.006), 0.17 (0.04-0.53) cm (p<0.001), and 0.12 (0.07-0.18) cm (p=0.035) respectively. The glucocorticosteroid dosage was tapered or maintained in all patients. One episode of urinary infection was recorded and relieved after antibiotic therapy. Neither neutropenia nor abnormal liver enzyme was observed.
Our study suggests that TCZ is a safe and effective agent for long-term treatment in Chinese TAK patients.
本研究旨在评估托珠单抗（TCZ）在中国大动脉炎（TAK）患者中的疗效和安全性。
这是一项单中心前瞻性研究。纳入了16例连续的TAK患者。患者接受剂量为8mg/kg的托珠单抗静脉输注治疗。在基线时以及每次TCZ输注前记录血清炎症标志物，包括红细胞沉降率（ESR）和超敏C反应蛋白（hsCRP）。在研究期间每6个月使用多普勒超声跟踪血管变化。收集并分析患者在研究期间的疗效和安全性数据。
招募并分析了16例患者，中位年龄为26.5岁（18 - 47岁）。1例患者未曾接受过治疗；其他患者在接受TCZ治疗前，使用传统免疫抑制剂的中位时间为3次（1 - 5次）。3例患者在1次输注后因颈部疼痛难以忍受而停用TCZ。其他13例患者接受TCZ治疗的中位时间为13个月（7 - 20个月）。TCZ治疗后，ESR的中位数从39（7 - 92）mm/h降至6（1 - 30）mm/h（p<0.001），hsCRP水平从28.88（7.6 - 155.93）mg/L降至0.59（0.08 - 19.12）mg/L（p = 0.006），颈总动脉和锁骨下动脉的壁厚度分别从0.24（0.06 - 0.59）cm和0.18（0.07 - 0.47）cm降至0.17（0.04 - 0.53）cm（p<0.001）和0.12（0.07 - 0.18）cm（p = 0.035）。所有患者的糖皮质激素剂量均逐渐减少或维持不变。记录到1例泌尿系统感染，经抗生素治疗后缓解。未观察到中性粒细胞减少或肝酶异常。
我们的研究表明，TCZ是中国TAK患者长期治疗的一种安全有效的药物。
