Long-term outcomes of COVID-19 vaccination in patients with rare and complex connective tissue diseases: The ERN-ReCONNET VACCINATE study

IF 4.7 Q2 IMMUNOLOGY Journal of Translational Autoimmunity Pub Date : 2023-12-01 DOI:10.1016/j.jtauto.2023.100221
Chiara Tani , Chiara Cardelli , Roberto Depascale , Anna Gamba , Luca Iaccarino , Andrea Doria , Matilde Bandeira , Sara Paiva Dinis , Vasco C. Romão , Emanuele Gotelli , Sabrina Paolino , Maurizio Cutolo , Niccolò Di Giosaffatte , Alessandro Ferraris , Paola Grammatico , Lorenzo Cavagna , Veronica Codullo , Carlomaurizio Montecucco , Valentina Longo , Lorenzo Beretta , Marta Mosca
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Abstract

Background

Vaccination is one of the most important measures to contain the COVID-19 pandemic, especially for frail patients. VACCINATE is a multicentre prospective observational study promoted by the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET) aimed at assessing the long-term outcomes of COVID-19 vaccination in patients with rare and complex connective tissue diseases (rcCTDs) in terms of efficacy and safety.

Methods

Adult rcCTDs patients were eligible for recruitment. Demographic, clinical and vaccination data were collected at enrolment. Follow-up visits were scheduled 4, 12, 24, 36 and 48 weeks after completion of the first vaccination cycle; data on adverse events, disease exacerbations and the occurrence of new SARS-CoV-2 infections were collected at these time-points.

Findings

365 rcCTDs patients (87 % female, mean age 51.8 ± 14.6 years) were recruited. Overall, 200 patients (54.8 %) experienced at least one adverse event, generally mild and in most cases occurring early after the vaccination. During follow-up, 55 disease exacerbations were recorded in 39 patients (10.7 %), distributed over the entire observation period, although most frequently within 4 weeks after completion of the vaccination cycle. The incidence of new SARS-CoV-2 infections was 8.9 per 1000 person-months, with no cases within 12 weeks from vaccine administration and an increasing trend of infections moving away from the primary vaccination cycle. Only one case of severe COVID-19 was reported during the study period.

Interpretation

COVID-19 vaccination seems effective and safe in rcCTDs patients. The rate of new infections was rather low and serious infections were uncommon in our cohort. No increased risk of disease flares was observed compared to previous disease history; however, such exacerbations may be potentially severe, emphasising the need for close monitoring of our patients.

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罕见和复杂结缔组织疾病患者接种COVID-19疫苗的长期结局:ERN-ReCONNET疫苗接种研究
疫苗接种是控制COVID-19大流行的最重要措施之一,特别是对体弱患者。VACCINATE是由欧洲罕见和复杂结缔组织和肌肉骨骼疾病参考网络(ERN ReCONNET)推动的一项多中心前瞻性观察性研究,旨在评估罕见和复杂结缔组织疾病(rcCTDs)患者接种COVID-19疫苗的长期疗效和安全性。方法入选成人rcctd患者。在入组时收集人口统计、临床和疫苗接种数据。在第一个疫苗接种周期完成后的第4、12、24、36和48周安排随访;在这些时间点收集了有关不良事件、疾病恶化和新发SARS-CoV-2感染的数据。结果:共纳入365例rcCTDs患者(87%为女性,平均年龄51.8±14.6岁)。总体而言,200名患者(54.8%)经历了至少一次不良事件,通常是轻微的,在大多数情况下发生在接种疫苗后的早期。在随访期间,39名患者(10.7%)记录了55次疾病恶化,分布在整个观察期,尽管最常见的是在疫苗接种周期完成后的4周内。新发SARS-CoV-2感染的发生率为每1000人月8.9例,接种疫苗后12周内无病例发生,感染脱离初次接种周期呈上升趋势。在研究期间,仅报告了一例严重的COVID-19病例。covid -19疫苗接种在rcctd患者中似乎是有效和安全的。新发感染率相当低,严重感染在我们的队列中并不常见。与既往病史相比,未观察到疾病发作风险增加;然而,这种恶化可能是潜在的严重,强调需要密切监测我们的患者。
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来源期刊
Journal of Translational Autoimmunity
Journal of Translational Autoimmunity Medicine-Immunology and Allergy
CiteScore
7.80
自引率
2.60%
发文量
33
审稿时长
55 days
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