皮下注射托珠单抗治疗类风湿关节炎1年的疗效和安全性：一项英国真实世界、开放标签研究

Efficacy and safety of subcutaneous tocilizumab in rheumatoid arthritis over 1 year: a UK real-world, open-label study.

作者信息

Isaacs John D, Salih Abdelrazig, Sheeran Thomas, Patel Yusuf I, Douglas Karen, McKay Neil D, Naisbett-Groet Barbara, Choy Ernest

机构信息

Arthritis Research UK Experimental Arthritis Treatment Centre, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne.

Musculoskeletal Unit, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne.

出版信息

Rheumatol Adv Pract. 2019 Apr 19;3(1):rkz010. doi: 10.1093/rap/rkz010. eCollection 2019.

OBJECTIVE

The ACT-MOVE study assessed the real-world efficacy and safety of s.c. tocilizumab (TCZ-SC), provided as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs) over 1 year, in patients with RA and an inadequate response to csDMARD therapy and/or first TNF inhibitor.

METHODS

In this UK multicentre, open-label phase IIIb study, patients received TCZ-SC 162 mg once weekly for 52 weeks as monotherapy or with csDMARDs. Efficacy and safety were evaluated at baseline, weeks 2 and 4 and every 4 weeks thereafter up to week 52.

RESULTS

Of 161 patients who received at least one dose of TCZ-SC, 21 (13.0%) received TCZ-SC alone and 140 (87.0%) TCZ-SC with a csDMARD(s). From baseline to week 52, there was a mean decrease in DAS28-ESR score among all patients (-3.68), and within monotherapy (-3.75) and combination therapy (-3.67) groups. The proportion of patients who achieved DAS28 clinical remission (DAS28-ESR <2.6) at week 52 was 75.4% (95% CI 66.8, 82.8). At the same time point, ≥80% of patients who remained on TCZ-SC achieved DAS28 clinical remission or had low disease activity (DAS28-ESR ≥2.6 and ≤3.2). Overall, 6.2% of patients had at least one serious adverse event (10.2/100 patient-years), and there was one death; 11.2% of patients discontinued owing to adverse events.

CONCLUSION

TCZ-SC was effective and tolerated in a real-world setting over 1 year. The efficacy of TCZ-SC was similar whether given as monotherapy or with csDMARDs; its safety profile was consistent with that previously established.

TRIAL REGISTRATION

ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT02046603.

目的

ACT-MOVE研究评估了皮下注射托珠单抗（TCZ-SC）作为单药治疗或与传统合成改善病情抗风湿药（csDMARDs）联合使用超过1年，在对csDMARD治疗和/或首个肿瘤坏死因子抑制剂反应不足的类风湿关节炎患者中的真实疗效和安全性。

方法

在这项英国多中心、开放标签的IIIb期研究中，患者接受TCZ-SC 162 mg，每周一次，共52周，作为单药治疗或与csDMARDs联合使用。在基线、第2周和第4周以及此后每4周直至第52周评估疗效和安全性。

结果

在161例接受至少一剂TCZ-SC的患者中，21例（13.0%）单独接受TCZ-SC，140例（87.0%）接受TCZ-SC与一种或多种csDMARDs联合治疗。从基线到第52周，所有患者的DAS28-ESR评分平均下降（-3.68），单药治疗组（-3.75）和联合治疗组（-3.67）也是如此。在第52周达到DAS28临床缓解（DAS28-ESR<2.6）的患者比例为75.4%（95%CI 66.8，82.8）。在同一时间点，继续使用TCZ-SC的患者中，≥80%达到DAS28临床缓解或疾病活动度低（DAS28-ESR≥2.6且≤3.2）。总体而言，6.2%的患者发生至少一次严重不良事件（10.2/100患者年），有1例死亡；11.2%的患者因不良事件停药。