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真实世界中托珠单抗注射液转换为皮下注射制剂后类风湿关节炎复发的预测因素。

Predictive Factors for Rheumatoid Arthritis Flare After Switching From Intravenous to Subcutaneous Formulation of Tocilizumab in Real-World Practice.

机构信息

Department of Rheumatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Department of Information Medicine, Big Data Research Center, Asan Medical Center, Seoul, Korea.

出版信息

J Korean Med Sci. 2022 May 2;37(17):e138. doi: 10.3346/jkms.2022.37.e138.

Abstract

BACKGROUND

To evaluate the incidence and related factors of rheumatoid arthritis (RA) flares after switching from intravenous tocilizumab (TCZ-IV) to subcutaneous tocilizumab (TCZ-SC) injection in stable RA patients.

METHODS

We retrospectively evaluated the medical records of stable RA patients who used TCZ-IV for more than 6 months and switched to TCZ-SC between January 2013 and April 2020. RA flare was defined as an increase of more than 1.2 in the RA disease activity as assessed by the disease activity score in 28 joints. The factors associated with RA flare were evaluated by logistic regression analysis.

RESULTS

Among 106 patients treated with TCZ-IV for > 6 months, 37 patients were switched to TCZ-SC after the acquisition of remission or low disease activity. RA flares occurred in 11 (29.7%) of patients who switched TCZ-SC. Results from the multivariable logistic analysis revealed that the dose of TCZ-IV per weight at switching (odds ratio [OR], 20.70; 95% confidence interval [CI], 2.22-192.84; = 0.008) and methotrexate (MTX) non-use (OR, 8.53; 95% CI, 1.21-60.40; = 0.032) were associated with the risk of RA flares after switching to TCZ-SC. Interestingly, most patients who switched back to TCZ-IV had their RA activity controlled again.

CONCLUSION

MTX non-use and high dose of TCZ-IV per weight were associated with a risk of RA flare after switching to TCZ-SC. RA patients with these factors need to be carefully observed for flare after switching from TCZ-IV to TCZ-SC.

摘要

背景

评估稳定类风湿关节炎(RA)患者从静脉注射托珠单抗(TCZ-IV)转换为皮下注射托珠单抗(TCZ-SC)后 RA 发作的发生率和相关因素。

方法

我们回顾性评估了 2013 年 1 月至 2020 年 4 月期间使用 TCZ-IV 超过 6 个月且转为 TCZ-SC 的稳定 RA 患者的病历。RA 发作定义为 28 关节疾病活动度评分(DAS28)评估的疾病活动度增加超过 1.2。通过逻辑回归分析评估与 RA 发作相关的因素。

结果

在接受 TCZ-IV 治疗超过 6 个月的 106 例患者中,有 37 例患者在获得缓解或低疾病活动后转为 TCZ-SC。转为 TCZ-SC 的患者中有 11 例(29.7%)出现 RA 发作。多变量逻辑分析结果显示,转换时 TCZ-IV 的体重剂量(比值比 [OR],20.70;95%置信区间 [CI],2.22-192.84;=0.008)和甲氨蝶呤(MTX)未使用(OR,8.53;95%CI,1.21-60.40;=0.032)与转为 TCZ-SC 后 RA 发作的风险相关。有趣的是,大多数转回 TCZ-IV 的患者再次控制了 RA 活动。

结论

MTX 未使用和 TCZ-IV 的高体重剂量与转为 TCZ-SC 后 RA 发作的风险相关。这些因素的 RA 患者在从 TCZ-IV 转换为 TCZ-SC 后需要仔细观察发作情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b123/9062274/58fcf83d017f/jkms-37-e138-g001.jpg

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