Incidence of Disease Flare After BNT162b2 Coronavirus Disease 2019 Vaccination in Patients With Rheumatoid Arthritis in Remission.
Incidence of Disease Flare After BNT162b2 Coronavirus Disease 2019 Vaccination in Patients With Rheumatoid Arthritis in Remission.
复制标题
DOI：
10.1002/acr2.11336
复制
发表时间：
2021-12
影响因子：
3.4
通讯作者：
Rossini M
中科院分区：
文献类型：
--
作者：
Bixio R;Bertelle D;Masia M;Pistillo F;Carletto A;Rossini M
随着2019冠状病毒病（COVID-19）疫苗接种计划在全球范围内取得进展，有关COVID-19疫苗在风湿病和肌肉骨骼疾病（RMD）患者中的安全性和免疫原性的首批数据估计，COVID-19疫苗接种后RMD发作的发生率在5%至17%之间（1,2）。然而，我们认为需要更多的细节来帮助RMD患者做出疫苗决策。我们前瞻性评估了接种前3个月77例连续临床缓解的类风湿性关节炎（RA）患者（28例关节疾病活动评分基于C反应蛋白[DAS28-CRP]< 2.6）的发作率（表1）。根据意大利政府规定，所有患者在2021年3月至4月期间接种了BNT162b2 （BioNTech-Pfizer）疫苗。根据美国风湿病学会（ACR） COVID-19建议，所有患者均停止抗风湿病治疗(3)。我们使用DAS28-CRP评估3个月后的疾病活动性，并将患者和风湿病学家评估的一致性和DAS28-CRP升高超过1.2定义为耀斑。6例患者（7.8%；95%可信区间：6.9-8.7%）均有一次疾病发作。大多数耀斑（5/6）发生在第二次给药后（平均：2.6天），所有耀斑在2周内消退（平均：6.4天）。一个耀斑被归类为“严重”，涉及关节的平均数量为2.7个。所有患者均给予糖皮质激素（6/6）和抗炎药物（3/6）治疗。有耀斑的患者接受了Janus激酶抑制剂（3/6）、甲氨蝶呤（2/6）、静脉注射阿巴接受普（1/6）、皮下肿瘤坏死因子α抑制剂（1/6）和利妥昔单抗（1/6）的治疗。在随访期间或发作后，我们没有记录到抗风湿病治疗的任何变化。我们的数据显示，缓解期RA患者接种BNT162b2 COVID-19疫苗后的爆发率非常低，这与之前关于水痘带状疱疹病毒（6.7%）(4)和乙型肝炎病毒（2.2%）(5)接种的研究结果一致。由于缓解在现实世界中并不常见，我们意识到我们的研究结果可能不适用于所有接受COVID-19疫苗接种的RA患者。根据ACR指南，6例有耀斑的患者中有5例在接近接种疫苗时退出或延迟抗风湿病治疗。即使没有直接证据表明持有疗法可能在更高比例的疾病发作中发生，我们建议临床医生在咨询患者关于COVID-19疫苗接种的可能性时考虑这种可能性。
As vaccination programs against coronavirus disease 2019 (COVID-19) progress worldwide, the first data about COVID-19 vaccines’ safety and immunogenicity in patients with rheumatic and musculoskeletal diseases (RMDs) have estimated an incidence of between 5% and 17% for RMD flares after COVID-19 vaccination (1, 2). However, we feel that more details are needed to help inform vaccine decision-making for patients with an RMD. We prospectively assessed flare rates in 77 consecutive patients with rheumatoid arthritis (RA) in clinical remission (28 joints disease activity score based on C reactive protein [DAS28-CRP]< 2.6) in the 3 months before vaccination (Table 1.). All patients underwent vaccination with BNT162b2 (BioNTech-Pfizer) between March and April 2021 following the Italian government regulations. All patients discontinued antirheumatic therapies according to American College of Rheumatology (ACR) COVID-19 recommendations (3). We evaluated disease activity after 3 months using DAS28-CRP and defined flares as concordance between patient and rheumatologist assessment and DAS28-CRP elevation of more than 1.2. Six patients (7.8%; 95% confidence interval: 6.9-8.7%) had one disease flare each. Most flares (5/6) occurred after the second dose (mean: 2.6 days) and all flares resolved within 2 weeks (mean: 6.4 days). One flare was classified as “severe,” and the mean number of involved joints was 2.7. All patients were treated with glucocorticoids (6/6) and anti-inflammatory drugs (3/6). The patients with flares were undergoing treatment with Janus kinase inhibitors (3/6), methotrexate (2/6), intravenous abatacept (1/6), subcutaneous tumor necrosis factor α inhibitor (1/6), and rituximab (1/6). We did not record any change in antirheumatic therapy during follow-up or after flares. Our data show a very low flare rate after the BNT162b2 COVID-19 vaccine in patients with RA in remission and are consistent with previous findings about Varicella-zoster virus (6.7%)(4) and Hepatitis B virus (2.2%)(5) vaccinations. Because remission is not commonly obtained in the real world, we are aware that our findings may not be generalizable to all patients with RA receiving COVID-19 vaccination.Five out of six patients with flares withdrew or delayed antirheumatic therapies in the proximity of vaccination according to ACR guidelines. Even if there is no direct evidence that holding therapies could occur in a higher proportion of disease flares, we suggest that clinicians consider this possibility when counseling patients about COVID-19 vaccination.
影响因子：
13.3
作者：
Curtis, Jeffrey R.;Johnson, Sindhu R.;Mikuls, Ted R.
通讯作者：
Mikuls, Ted R.
影响因子：
3.4
作者：
Intongkam, Samanan;Samakarnthai, Parinya;Chaiamnuay, Sumapa
通讯作者：
Chaiamnuay, Sumapa
影响因子：
3.4
作者：
Stevens, Emma;Weinblatt, Michael E.;Desai, Sonali
通讯作者：
Desai, Sonali