类风湿关节炎患者达到治疗目标后托珠单抗减量的后果：一项全国性队列研究
The Aftermath of Tapering Tocilizumab After Achieving Treatment Target in Patients With Rheumatoid Arthritis: A Nationwide Cohort Study.
作者信息
Park Jun Won, Kim Min Jung, Kim Hyoun-Ah, Kim Jin Hyun, Lee Eun Bong, Shin Kichul
机构信息
Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Division of Rheumatology, Department of Internal Medicine, Seoul Metropolitan Government-Seoul Boramae Medical Center, Seoul, South Korea.
出版信息
Front Med (Lausanne). 2022 Feb 8;9:839206. doi: 10.3389/fmed.2022.839206. eCollection 2022.
BACKGROUND
Although recent guidelines recommend that tapering of biologic disease-modifying anti-rheumatic drugs (bDMARDs) can be considered in patients with rheumatoid arthritis (RA), there has been little evidence supporting the strategy during the non-tumor necrosis factor inhibitor treatment. This study aims to investigate the effectiveness and safety of tapering tocilizumab (TCZ) dose in patients with RA who attain low disease activity (LDA) after TCZ therapy in a nationwide cohort.
METHODS
Data were collected from a nationwide cohort of patients with RA receiving biologic disease-modifying anti-rheumatic drugs in South Korea (KOBIO-RA). This study included 350 patients who were treated with TCZ and achieved Clinical Disease Activity Index-low disease activity (CDAI)-LDA (CDAI ≤ 10) after 1 year of treatment. We performed longitudinal analysis considering clinical data measured at all 1-year intervals for the included patients using the generalized estimating equation. A total of 575 intervals were classified into two groups according to their dose quotient (DQ) of TCZ (tapering group vs. standard-dose group). The main outcome was maintaining CDAI-LDA in the following 1-year interval.
RESULTS
Tapering TCZ dose strategy was used in 282 (49.0%) intervals with a mean (SD) DQ of 66.0 (15.5) %. Loss of CDAI-LDA occurred in 91 (15.1%) intervals. Multivariable GEE showed that the tapering group was associated with more frequent failure to sustain CDAI-LDA (adjusted OR [95% CI]: 0.57 [0.33-0.99]), which subsequently led to impaired functional status. The likelihood of achieving DAS28-deep remission (DAS28-ESR <1.98) was also significantly lower in the tapering group (adjusted OR 0.68 [0.46-0.99]). CDAI remission was achieved in only 69 (12.0%) of the total intervals, with no significant difference in the proportion of intervals achieving the target between the two groups. Incidence of adverse events was comparable in both groups except for hypercholesterolemia, which was lower in the tapering group.
CONCLUSIONS
Tapering TCZ dose after achieving LDA increases the risk of losing LDA without a significant merit in safety.
背景
尽管最近的指南建议，对于类风湿关节炎（RA）患者，可以考虑逐渐减少生物性病情缓解抗风湿药物（bDMARDs）的用量，但在非肿瘤坏死因子抑制剂治疗期间，几乎没有证据支持这一策略。本研究旨在调查在全国范围内的队列中，接受托珠单抗（TCZ）治疗后达到低疾病活动度（LDA）的RA患者逐渐减少TCZ剂量的有效性和安全性。
方法
数据来自韩国接受生物性病情缓解抗风湿药物治疗的全国性RA患者队列（KOBIO-RA）。本研究纳入了350例接受TCZ治疗且在治疗1年后达到临床疾病活动指数-低疾病活动度（CDAI-LDA，CDAI≤10）的患者。我们使用广义估计方程对纳入患者在所有1年间隔期测量的临床数据进行纵向分析。根据TCZ的剂量商（DQ），将总共575个间隔期分为两组（减量组与标准剂量组）。主要结局是在接下来的1年间隔期维持CDAI-LDA。
结果
282个（49.0%）间隔期采用了逐渐减少TCZ剂量的策略，平均（标准差）DQ为66.0（15.5）%。91个（15.1%）间隔期出现了CDAI-LDA的丧失。多变量广义估计方程显示，减量组维持CDAI-LDA失败的频率更高（调整后的比值比[95%置信区间]：0.57[0.33-0.99]），这随后导致功能状态受损。减量组达到DAS28深度缓解（DAS28-ESR<1.98）的可能性也显著较低（调整后的比值比0.68[0.46-0.99]）。在所有间隔期中，仅69个（12.0%）实现了CDAI缓解，两组达到目标的间隔期比例无显著差异。除高胆固醇血症外，两组不良事件的发生率相当，减量组的高胆固醇血症发生率较低。
结论
达到LDA后逐渐减少TCZ剂量会增加失去LDA的风险，且在安全性方面没有显著优势。
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