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托珠单抗治疗六周延长给药间隔在类风湿关节炎患者缓解维持前瞻性队列中的疗效和耐受性

Efficacy and tolerability of six-week extended dosing interval with tocilizumab therapy in a prospective cohort as remission maintenance in patients with rheumatoid arthritis.

作者信息

Kikuchi Jun, Kondo Tsuneo, Shibata Akiko, Sakai Ryota, Okada Yusuke, Chino Kentaro, Okuyama Ayumi, Kurasawa Takahiko, Takei Hirofumi, Amano Koichi

机构信息

a Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Saitama , Japan.

b Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.

出版信息

Mod Rheumatol. 2018 May;28(3):444-451. doi: 10.1080/14397595.2017.1366092. Epub 2017 Aug 29.

Abstract

OBJECTIVES

To prospectively evaluate the efficacy and tolerability of a six-week extended dosing interval with tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in sustained remission.

METHODS

Patients who received over six doses of intravenous TCZ in clinical remission (disease activity score [DAS] 28 - erythrocyte sedimentation rate [ESR] ≤ 2.6) maintained over 3 months between December 2013 and December 2015 were included. Flare was defined as DAS28-ESR >3.2 at two consecutive visits.

RESULTS

Twenty-five patients were enrolled; 87.5% achieved clinical remission at week 54 after six-week extension and 95.5% achieved a van der Heijde modified total Sharp score (ΔmTSS) ≤0.5. The Health Assessment Questionnaire Disability Index (HAQ-DI) did not increase during 54 weeks. HAQ-DI at baseline and ΔDAS28-ESR at week six positively correlated with increase in DAS28-ESR at week 54. ΔSwollen joint count at week six positively correlated with ΔmTSS at week 54. A total of 12 adverse events occurring in 10 patients did not lead to cessation of TCZ except for one case of recurrent lymphoproliferative disorder at week five.

CONCLUSION

A six-week extended dosing interval of TCZ for patients with RA in sustained remission is proposed as an acceptable treatment option for maintaining efficacy and tolerability.

摘要

目的

前瞻性评估托珠单抗(TCZ)延长给药间隔至六周对类风湿关节炎(RA)持续缓解患者的疗效和耐受性。

方法

纳入2013年12月至2015年12月期间临床缓解(疾病活动评分[DAS]28-红细胞沉降率[ESR]≤2.6)超过3个月且接受过六剂以上静脉注射TCZ的患者。病情复发定义为连续两次就诊时DAS28-ESR>3.2。

结果

共纳入25例患者;延长给药间隔至六周后,87.5%的患者在第54周达到临床缓解,95.5%的患者范德海伊德改良总夏普评分(ΔmTSS)≤0.5。健康评估问卷残疾指数(HAQ-DI)在54周内未增加。基线时的HAQ-DI和第6周时的ΔDAS28-ESR与第54周时DAS28-ESR的增加呈正相关。第6周时的肿胀关节计数变化与第54周时的ΔmTSS呈正相关。10例患者共发生12起不良事件,除1例在第5周出现复发性淋巴增生性疾病外,均未导致停用TCZ。

结论

对于RA持续缓解患者,建议将TCZ给药间隔延长至六周,作为维持疗效和耐受性的可接受治疗选择。

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