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目的:观察曾接受托珠单抗(tocilizumab,TCZ)治疗半年以上的类风湿关节炎(rheumatoid arthritis,RA)患者停用TCZ后的长期疗效和安全性。方法:随访我科曾参与的方案号为WA19926(入组4例)、WA18696(入组11例)和ML21753(入组20例)的TCZ临床研究受试患者,评估其压痛关节数、肿胀关节数、患者对疼痛的总体评价、患者和医生对疾病活动度的总体评价、健康评估问卷、疲劳量表、晨僵时间、血沉和C反应蛋白等指标,疾病活动度采用DAS28-ESR进行评价。结果:3项临床研究曾纳入患者35例,本次共回访患者29例(失访率17.14%),纳入分析28例(29例中有1例因试验尚未揭盲,无法确定是否使用TCZ而未纳入分析),包括WA19926中3例、WA18696中9例和ML21753中16例。TCZ停药时,17例(17/28,60.71%)患者达到临床缓解,其中,WA19926中1例(1/3,33.33%),WA18696中8例(8/9,88.89%),ML21753中8例(8/16,50.00%),另有3例(3/28,10.71%)患者(ML21753中3例(3/16,18.75%))达到低疾病活动度(low disease activity,LDA)。以上20例患者中,12例患者在TCZ停药后能规律服用改善病情抗风湿药(disease modifying antirheumatic drugs,DMARDs),其中WA19926中1例,WA18696中4例,ML21753中7例。回访时,此12例患者中有6例仍处于缓解状态(WA19926中1例,WA18696中2例,ML21753中3例),2例仍处于LDA(ML21753中2例)。有2例患者停用TCZ后未再服用DMARDs,回访时仍保持达标状态(WA18696中1例,ML21753中1例)。未发现肿瘤、结核、胃肠穿孔病例。结论:RA患者使用TCZ治疗达标率高,停用TCZ后仍应根据病情需要,遵医嘱服用DAMRDs,以达到良好的疾病控制状态。
Objective: To observe the long-term efficacy and safety of TCZ after having been treated with tocilizumab (TCZ) for more than six months in patients with rheumatoid arthritis (RA). METHODS: The TCZ clinical trial patients who were involved in our study were WA19926 (enrolled in 4 cases), WA18696 (enrolled in 11 cases) and ML21753 (enrolled in 20 cases). The number of tender joints, swollen joints The patients ’and physicians’ overall assessment of disease activity, health assessment questionnaire, fatigue scale, morning stiffness time, erythrocyte sedimentation rate and C-reactive protein were evaluated by DAS28-ESR. RESULTS: Thirty-five clinical studies were enrolled in this study. Totally 29 patients (17.14% of the respondents) were enrolled in this study. Twenty-eight patients were enrolled in the analysis (one of 29 patients was not unblinded because of the test, Not included in the analysis), including 3 cases of WA19926, 9 cases of WA18696 and 16 cases of ML21753. Seventeen patients (17/28 and 60.71%) achieved clinical remission when TCZ was discontinued, among which, 1 case (1 / 3,33.33%) in WA19926, 8 cases (8/9, 88.89%) in WA18696, 8 cases (8/50, 50.00%) and 3 cases (3/28, 10.71%) (3 cases (3/16, 18.75%) in ML21753) had low disease activity (LDA) . Of the above 20 patients, 12 were regularly treated with disease modifying antirheumatic drugs (DMARDs) after discontinuation of TCZ, including 1 in WA19926, 4 in WA18696, and 7 in ML21753. At the time of visit, 6 of these 12 patients were still in remission (1 in WA19926, 2 in WA18696, 3 in ML21753) and 2 in LDA (2 in ML21753). Two patients discontinued DMZ after discontinuation of TCZ and remained up-to-standard on return visits (1 in WA18696 and 1 in ML21753). No tumor, tuberculosis, gastrointestinal perforation cases were found. Conclusion: TC patients treated with RA have high compliance rate. After TCZ is discontinued, DAMRDs should be taken according to the needs of patients and achieved good disease control status.