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在常规护理中对类风湿关节炎患者进行生物治疗的剂量渐减和停药 - 2 年结果和预测因素。

Dose tapering and discontinuation of biological therapy in rheumatoid arthritis patients in routine care - 2-year outcomes and predictors.

机构信息

Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

出版信息

Rheumatology (Oxford). 2019 Jan 1;58(1):110-119. doi: 10.1093/rheumatology/key244.

Abstract

OBJECTIVES

A cohort of routine care RA patients in sustained remission had biological DMARD (bDMARDs) tapered according to a treatment guideline. We studied: the proportion of patients whose bDMARD could be successfully tapered or discontinued; unwanted consequences of tapering/discontinuation; and potential baseline predictors of successful tapering and discontinuation.

METHODS

One-hundred-and-forty-three patients (91% receiving TNF inhibitor and 9% a non-TNF inhibitor) with sustained disease activity score (DAS28-CRP)⩽2.6 and no radiographic progression the previous year were included. bDMARD was reduced to two-thirds of standard dose at baseline, half after 16 weeks, and discontinued after 32 weeks. Patients who flared (defined as either DAS28-CRP ⩾ 2.6 and ΔDAS28-CRP ⩾ 1.2 from baseline, or erosive progression on X-ray and/or MRI) stopped tapering and were escalated to the previous dose level.

RESULTS

One-hundred-and-forty-one patients completed 2-year follow-up. At 2 years, 87 patients (62%) had successfully tapered bDMARDs, with 26 (18%) receiving two-thirds of standard dose, 39 (28%) half dose and 22 (16%) having discontinued; and 54 patients (38%) were receiving full dose. ΔDAS28-CRP0-2yrs was 0.1((-0.2)-0.4) (median (interquartile range)) and mean ΔTotal-Sharp-Score0-2yrs was 0.01(1.15)(mean(s.d.)). Radiographic progression was observed in nine patients (7%). Successful tapering was independently predicted by: ⩽1 previous bDMARD, male gender, low baseline MRI combined inflammation score or combined damage score. Negative IgM-RF predicted successful discontinuation.

CONCLUSION

By implementing a clinical guideline, 62% of RA patients in sustained remission in routine care were successfully tapered, including 16% successfully discontinued at 2 years. Radiographic progression was rare. Maximum one bDMARDs, male gender, and low baseline MRI combined inflammation and combined damage scores were independent predictors for successful tapering.

摘要

目的

对处于持续缓解状态的常规治疗 RA 患者队列,根据治疗指南减少生物 DMARD(bDMARD)的剂量。我们研究了:能够成功减少或停止 bDMARD 的患者比例;减少或停止的不良后果;以及成功减少和停止的潜在基线预测因素。

方法

纳入 143 例(91%接受 TNF 抑制剂,9%接受非 TNF 抑制剂)疾病活动评分(DAS28-CRP)持续⩽2.6 且前一年无放射学进展的患者。bDMARD 在基线时减少至标准剂量的三分之二,16 周后减少至一半,32 周后停止。出现复发(定义为 DAS28-CRP ⩾2.6 且与基线相比 DAS28-CRP ⩾1.2,或 X 射线和/或 MRI 显示侵蚀性进展)的患者停止减少剂量并升级至先前的剂量水平。

结果

141 例患者完成了 2 年随访。在 2 年时,87 例(62%)患者成功减少了 bDMARD,其中 26 例(18%)接受三分之二的标准剂量,39 例(28%)接受半剂量,22 例(16%)停止使用;54 例(38%)患者接受全剂量。DAS28-CRP0-2yrs 为 0.1((-0.2)-0.4)(中位数(四分位距)),DAS28-CRP0-2yrs 平均变化值为 0.01(1.15)(均值(标准差))。9 例患者(7%)出现放射学进展。成功减少的独立预测因素为:≤1 种既往 bDMARD、男性、基线时低 MRI 联合炎症评分或联合损伤评分。阴性 IgM-RF 预测成功停药。

结论

通过实施临床指南,在常规治疗中处于持续缓解状态的 62%的 RA 患者成功减少了 bDMARD 的剂量,包括 16%的患者在 2 年内成功停药。放射学进展罕见。既往使用最大 1 种 bDMARD、男性和基线时低 MRI 联合炎症和联合损伤评分是成功减少的独立预测因素。

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