新冠肺炎疫苗接种后稳定型类风湿关节炎患者疾病活动度的 flares 和变化：一项前瞻性中国队列研究。

Flare and change in disease activity among patients with stable rheumatoid arthritis following coronavirus disease 2019 vaccination: A prospective Chinese cohort study.

机构信息

Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing 100034, China.

出版信息

Chin Med J (Engl). 2023 Oct 5;136(19):2324-2329. doi: 10.1097/CM9.0000000000002562.

DOI:10.1097/CM9.0000000000002562

PMID:36921105

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10538871/

Abstract

BACKGROUND

Vaccination has been shown effective in controlling the global coronavirus disease 2019 (COVID-19) pandemic and reducing severe cases. This study was to assess the flare and change in disease activity after COVID-19 vaccination in patients with stable rheumatoid arthritis (RA).

METHODS

A prospective cohort of RA patients in remission or with low disease activity was divided into a vaccination group and a non-vaccination group based on their COVID-19 vaccination status. Each of them was examined every 3 to 6 months. In the vaccination group, disease activity was compared before and after vaccination. The rates of flare defined as disease activity scores based on 28-joint count (DAS28) >3.2 with ΔDAS28 ≥0.6 were compared between vaccination and non-vaccination groups.

RESULTS

A total of 202 eligible RA patients were enrolled. Of these, 98 patients received no vaccine shot (non-vaccination group), and 104 patients received two doses of vaccine (vaccination group). The median time interval from pre-vaccination visit to the first immunization and from the second dose of vaccine to post-vaccination visit was 67 days and 83 days, respectively. The disease activity scores at pre-vaccination and post-vaccination visits in the vaccination group patients were similar. At enrollment, gender, RA disease course, seropositivity, and disease activity were comparable across the two groups. Flare was observed in five (4.8%) of the vaccination group patients and nine (9.2%) of the non-vaccination group patients at post-vaccination assessment ( P = 0.221). In terms of safety, 29 (27.9%) patients experienced adverse events (AEs) after vaccination. No serious AEs occurred.

CONCLUSIONS

COVID-19 vaccinations had no significant effect on disease activity or risk of flare in RA patients in remission or with low disease activity. Patients with stable RA should be encouraged to receive the COVID-19 vaccination.

摘要

背景

疫苗接种已被证明能有效控制全球 2019 年冠状病毒病（COVID-19）大流行并减少重症病例。本研究旨在评估 COVID-19 疫苗接种对稳定期类风湿关节炎（RA）患者疾病活动度的波动和变化。

方法

根据 COVID-19 疫苗接种情况，将缓解或疾病活动度低的 RA 患者前瞻性队列分为疫苗接种组和非疫苗接种组。每组每 3 至 6 个月检查一次。在疫苗接种组中，比较接种前后的疾病活动度。比较接种组和非接种组基于 28 关节计数（DAS28）>3.2 且ΔDAS28≥0.6 的疾病活动度定义为发作的发生率。

结果

共纳入 202 例符合条件的 RA 患者。其中，98 例患者未接种疫苗（非接种组），104 例患者接种了两剂疫苗（接种组）。从接种前就诊到第一剂疫苗接种和从第二剂疫苗接种到接种后就诊的中位时间间隔分别为 67 天和 83 天。接种组患者接种前和接种后的疾病活动评分相似。在入组时，两组患者的性别、RA 病程、血清阳性和疾病活动度无差异。接种后评估时，接种组中有 5 例（4.8%）患者和非接种组中有 9 例（9.2%）患者出现发作（P=0.221）。就安全性而言，接种后 29 例（27.9%）患者出现不良事件（AE）。未发生严重 AE。