托珠单抗治疗难治性类风湿关节炎的疗效与安全性

Efficacy and safety of tocilizumab in the treatment of active rheumatoid arthritis

目的评价托珠单抗治疗中重度活动性类风湿关节炎(rheumatoid arthritis,RA)的疗效及安全性。方法回顾性分析2013年11月—2015年4月于四川大学华西医院风湿免疫科门诊就诊的77例有随访纪录的RA患者临床资料,其治疗方法为托珠单抗静脉输入,每4周1次,剂量为8 mg/kg,同时口服甲氨蝶呤和(或)其他改变病情抗风湿药物(disease-modifying anti-rheumatic drugs,DMARD)。每4周随访,评价疗效。疗效评价采用疾病活动性评分-28(Disease Activity Score-28,DAS28)、欧洲抗风湿联盟(European League Against Rheumatism,EULAR)反应标准。结果治疗后DAS28由基线水平的(6.88±1.09)分,降至第4周的(4.99±1.53)分,第8周为(4.31±1.37)分,第12周为(3.74±1.15)分,第24周时进一步下降至(2.66±0.68)分(P<0.05)。疾病活动水平(以DAS28为评价标准),在第8周时缓解为11.1%,低度活动为9.5%;第12、24周时分别为10.5%和32.2%、66.6%和16.7%(P<0.05)。EULAR反应标准在第8周时反应良好为17.5%,反应一般为76.2%;第12、24周时分别为39.0%和57.4%、66.7%和33.3%(P<0.05)。患者关节压痛计数、关节肿胀计数、患者的自身综合评估(采用疼痛视觉模拟评分)、红细胞沉降率、C反应蛋白及健康评估问卷治疗后均较基线水平明显下降(P<0.05)。治疗过程中出现不良反应21例,除1例过敏外,其余不良反应均较轻,对症治疗后均好转。结论托珠单抗治疗难治性RA起效快,疗效持久且安全性好。

Objective To evaluate the efficacy and safety oftocilizumab for treating active rheumatoid arthritis （RA）. Methods Seventy-seven patients with active RA who treated from November 2013 to April 2015 in the Outpatient Department of Rheumatology in West China Hospital of Sichuan Universiy with follow-up data were involved. Their clinical data were retrospectively analyzed. Tocilizumab was infused every 4 weeks at a dose of 8 mg/kg and concomitant use of other disease-modifying anti-rheumatic drugs （DMARDs） was allowed. Activity and efficacy were evaluated by Disease Activity Score-28 （DAS28） and European League Against Rheumatism （EULAR） response. Result After the treatment, the DAS28 devreased from the baseline 6.88±1.09 to 4.99±1.53 （4th week）, 4.31±1.37 （8th week）, 3.74±1.15 （12th week） and 2.66±0.68 （24th week） （P〈0.05）. The disease activity level assessed by DAS28 was 11.1%, and the low activity was 9.5%, and the values were 10.5%, 32.2% and 66.6%, 16.7% （P〈0.05） respectively at the 12th and 24tb week. EULAR good/moderate response rates were 17.5%/76.2%, 39.0%/57.4% and 66.7%/33.3% at 8, 12 and 24 weeks. The differences in the decline over time in tender joint count, swollen joint count visual analogue score, Health Assessment Questionnaire score, erythrocyte sedimentation rate and C-reactive protein before and after the treatment were statistically significant （P〈0.05）. Adverse event was found in 21 cases who were alleviated after the treatment （1 anaphylactic reaction, and the other were mild）, Conclusion Tocilizumab is safe and effective in treatment of active RA patients.