类风湿关节炎患者达到疾病活动评分 28-红细胞沉降率缓解后停用阿达木单抗（HONOR 研究）：一项观察性研究。
Discontinuation of adalimumab after attaining disease activity score 28-erythrocyte sedimentation rate remission in patients with rheumatoid arthritis (HONOR study): an observational study.
出版信息
Arthritis Res Ther. 2013 Sep 25;15(5):R135. doi: 10.1186/ar4315.
INTRODUCTION
Evidences of biologics-free disease control after discontinuing adalimumab (ADA) in rheumatoid arthritis (RA) patients in clinical practice have not been sufficiently investigated. Purpose of this study is to investigate whether disease activity score 28 (DAS28)- erythrocyte sedimentation rate (ESR) remission was preserved after discontinuation of ADA in patients with RA.
METHODS
This is an observational but not a randomized controlled study. Among 197 RA patients who initiated with combination of ADA with concomitant MTX, 69 (35%) acquired DAS28 (ESR) < 2.6 for at least 24 weeks. Of those 69 patients, 51 went on ADA discontinuation with their consent, and finally 50 of those with follow-up of > 24 weeks were evaluated. The effect of discontinuing ADA on clinical disease activity, functional disability and radiographic progression were evaluated by DAS28 (ESR), the clinical disease activity index (CDAI) and the simplified disease activity index (SDAI), by a health assessment questionnaire-disability index (HAQ-DI) and by the modified total Sharp score (mTSS), respectively.
RESULTS
The mean age of the participants was 59.5 years with the mean disease duration of 7.1 years. Out of the 50 patients, 29 (58%) were maintained in DAS28 (ESR) < 2.6 at 24 weeks after discontinuing ADA. A logistic regression analysis showed that DAS28 (ESR) at baseline significantly predicted a DAS28 (ESR) < 2.6 maintained after discontinuation of ADA, and a receiver-operating characteristic (ROC) analysis showed that the cut-off value of DAS28 (ESR) at discontinuation was 2.16. The mean HAQ-DI at six months after discontinuing ADA was 0.1 in patients who kept in DAS28 (ESR) < 2.6, and 94.9% (37/39) showed no evidence of radiographic progression (> 0.5 per year of a change in mTSS) at 1 year.
CONCLUSIONS
It was possible to maintain DAS28 (ESR) < 2.6 after discontinuation of ADA without functional and radiographic progression and very low DAS28 (ESR) at the discontinuation was associated with successful ADA-free DAS28 (ESR) < 2.6 in patients with RA.
TRIAL REGISTRATION
University Hospital Medical Information Network Identifier: UMIN000006669.
简介
在类风湿关节炎（RA）患者的临床实践中，停止使用阿达木单抗（ADA）后生物制剂免费疾病控制的证据尚未得到充分研究。本研究的目的是调查在 RA 患者中停止 ADA 治疗后，疾病活动评分 28（DAS28）-红细胞沉降率（ESR）缓解是否得到维持。
方法
这是一项观察性而非随机对照研究。在 197 名开始使用 ADA 联合甲氨蝶呤（MTX）治疗的 RA 患者中，有 69 名（35%）至少 24 周达到 DAS28（ESR）<2.6。在这 69 名患者中，有 51 名患者同意停止 ADA 治疗，最终有 50 名患者随访时间>24 周进行了评估。通过 DAS28（ESR）、临床疾病活动指数（CDAI）和简化疾病活动指数（SDAI）评估停止 ADA 对临床疾病活动、功能障碍和放射学进展的影响，通过健康评估问卷残疾指数（HAQ-DI）和改良总Sharp 评分（mTSS）分别评估。
结果
参与者的平均年龄为 59.5 岁，平均病程为 7.1 年。在 50 名患者中，有 29 名（58%）在停止 ADA 治疗 24 周后仍维持 DAS28（ESR）<2.6。逻辑回归分析显示，DAS28（ESR）基线值显著预测 ADA 停药后 DAS28（ESR）<2.6 的维持，ROC 分析显示，DAS28（ESR）停药时的截断值为 2.16。在停止 ADA 治疗后 6 个月，DAS28（ESR）<2.6 的患者 HAQ-DI 平均为 0.1，94.9%（37/39）在 1 年内无放射学进展证据（mTSS 每年变化>0.5）。
结论
在不出现功能和放射学进展的情况下，ADA 停药后仍可维持 DAS28（ESR）<2.6，并且较低的 DAS28（ESR）在停药时与 RA 患者 ADA 免费 DAS28（ESR）<2.6 的成功维持相关。
试验注册
大学医院医疗信息网络标识符：UMIN000006669。
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