托珠单抗治疗类风湿关节炎复发患者的疗效和安全性（RESTORE）研究。
Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study.
机构信息
Osaka Rheumatology Clinic , Tatsuno-Sinsaibashi-Building 5th Floor, 4-4-10 Minamisenba Chuo-ku, Osaka 542-0081 , Japan.
出版信息
Mod Rheumatol. 2014 Jan;24(1):26-32. doi: 10.3109/14397595.2013.854080.
OBJECTIVES
To evaluate the safety and efficacy of retreatment with tocilizumab (TCZ) in patients who had participated in the DREAM study (Drug free remission/low disease activity after cessation of tocilizumab [Actemar] monotherapy study) and had experienced loss of efficacy.
METHODS
Patients were retreated with TCZ or other disease modifying antirheumatic drugs (DMARDs). Disease activity was measured using the 28-joint disease activity score (DAS28) for 12 weeks.
RESULTS
A total of 164 eligible patients, including 161 who experienced loss of efficacy within 52 weeks of the DREAM study, resumed treatment: 157 with TCZ and 7 with DMARDs and/or infliximab. Of TCZ-treated patients, 88.5 % (139 patients) achieved DAS28 <2.6 within 12 weeks, whereas among patients treated with DMARDs and/or infliximab only 14.3 % (1 patient) achieved DAS28 <2.6. Adverse events were observed in 70 TCZ-treated patients (44.0 %), but no serious infusion reactions were observed.
CONCLUSIONS
Retreatment with TCZ was well-tolerated and effective in patients who had responded to the preceding TCZ monotherapy but had experienced loss of efficacy after cessation of TCZ.
目的
评估托珠单抗（TCZ）再治疗在经历疗效丧失的 DREAM 研究（停药后无托珠单抗[Actemar]单药治疗缓解/低疾病活动度研究）参与者中的安全性和疗效。
方法
患者接受 TCZ 或其他疾病修饰抗风湿药物（DMARDs）的再治疗。通过 28 关节疾病活动评分（DAS28）测量 12 周的疾病活动度。
结果
共有 164 名符合条件的患者，包括在 DREAM 研究的 52 周内经历疗效丧失的 161 名患者，恢复治疗：157 名接受 TCZ 治疗，7 名接受 DMARDs 和/或英夫利昔单抗治疗。在接受 TCZ 治疗的患者中，88.5%（139 名患者）在 12 周内达到 DAS28<2.6，而接受 DMARDs 和/或英夫利昔单抗治疗的患者中只有 14.3%（1 名患者）达到 DAS28<2.6。在 70 名接受 TCZ 治疗的患者（44.0%）中观察到不良反应，但未观察到严重的输注反应。
结论
在对先前 TCZ 单药治疗有反应但在 TCZ 停药后出现疗效丧失的患者中，TCZ 再治疗耐受性良好且有效。
Zotero 插件