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托法替布在难治性类风湿关节炎患者中的真实生活经验:5年随访:单中心经验

Real-life experience of tofacitinib in patients with treatment-resistant rheumatoid arthritis: A 5-year follow-up: Monocentric experience.

作者信息

Pehlivan Ozlem

机构信息

Department of Rheumatology, University of Health Sciences, Umraniye Training and Research Hospital, Istanbul, Turkiye.

出版信息

North Clin Istanb. 2022 Aug 24;9(4):376-384. doi: 10.14744/nci.2022.05863. eCollection 2022.

Abstract

OBJECTIVE

The present study aims to assess the short- and long-term effects of tofacitinib (TOFA) therapy on efficacy, safety, and drug retention rate patients with rheumatoid arthritis (RA) refractory to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or biological disease-modifying anti-rheumatic drugs (bDMARDs).

METHODS

Thirty-five patients with RA who received TOFA therapy for at least 3 months in rheumatology outpatient clinic between December 2015 and December 2020 were included in the study. The prospectively follow-up results of the patients obtained on the 6 month and 5 year are presented. Demographic characteristics of the patients, the disease activity score-28 for RA with erythrocyte sedimentation rate (DAS 28-4 [ESR]), change in DAS-28, health assessment questionnaire score, patient visual analog scale score, and laboratory parameters were recorded. The data at 6 months and 5 years of treatment were compared with baseline data. All side effects were recorded at each follow-up visit. Wilcoxon signed-rank tests were used for analysis.

RESULTS

Of the 35 patients, 23 received TOFA treatment after receiving ≥1 bDMARDs, while the remaining 12 patients received TOFA therapy were biologic naive. On the 6-month follow-up, DAS 28-4 (ESR) score and DAS28 improvement significantly decreased at the 6 months from baseline (p<0.001 and p<0.001, respectively), and moderate disease activity was achieved in 13 patients. High disease activity persisted in four patients. DAS28 improvement according to the EULAR response criteria was good response in 86% of the patients. DAS 28-4 (ESR) score and DAS28 improvement significantly decreased at 5 years from baseline (p<0.01 and p<0.001, respectively), and the moderate disease activity was achieved in 10 patients. High disease activity persisted in two patients. Drug retention rate at 5-year follow-up was 54% and the daily glucocorticoid therapy could be discontinued in 9 patients (47%). Three patients (15%) were tested positive for COVID-19. None of them required hospitalization and no deaths were occurred due to COVID-19.

CONCLUSION

TOFA is effective and well-tolerated treatment options that reduce the need for steroids in patients with RA.

摘要

目的

本研究旨在评估托法替布(TOFA)治疗对传统合成改善病情抗风湿药(csDMARDs)和/或生物改善病情抗风湿药(bDMARDs)难治的类风湿关节炎(RA)患者的疗效、安全性及药物保留率的短期和长期影响。

方法

纳入2015年12月至2020年12月在风湿病门诊接受TOFA治疗至少3个月的35例RA患者。呈现患者6个月和5年的前瞻性随访结果。记录患者的人口统计学特征、红细胞沉降率的类风湿关节炎疾病活动评分28(DAS 28-4[ESR])、DAS-28变化、健康评估问卷评分、患者视觉模拟量表评分及实验室参数。将治疗6个月和5年时的数据与基线数据进行比较。每次随访均记录所有副作用。采用Wilcoxon符号秩检验进行分析。

结果

35例患者中,23例在接受≥1种bDMARDs后接受TOFA治疗,其余12例患者初治时接受TOFA治疗。在6个月随访时,DAS 28-4(ESR)评分和DAS28改善情况较基线在6个月时显著降低(分别为p<0.001和p<0.001),13例患者达到中度疾病活动度。4例患者持续存在高疾病活动度。根据欧洲抗风湿病联盟(EULAR)反应标准,86%的患者DAS28改善情况为良好反应。DAS 28-4(ESR)评分和DAS28改善情况较基线在5年时显著降低(分别为p<0.01和p<0.001),10例患者达到中度疾病活动度。2例患者持续存在高疾病活动度。5年随访时药物保留率为54%,9例患者(47%)可停用每日糖皮质激素治疗。3例患者(15%)新冠病毒检测呈阳性。他们均无需住院治疗,且无因新冠病毒感染导致死亡的情况发生。

结论

TOFA是一种有效且耐受性良好的治疗选择,可减少RA患者对类固醇的需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff84/9514069/ef2c4ab597fa/NCI-9-376-g001.jpg

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