Impact of COVID-19 and vaccination campaign on 1,755 systemic sclerosis patients during first three years of pandemic. Possible risks for individuals with impaired immunoreactivity to vaccine, ongoing immunomodulating treatments, and disease-related lung involvement during the next pandemic phase

IF 4.7 Q2 IMMUNOLOGY Journal of Translational Autoimmunity Pub Date : 2023-10-09 DOI:10.1016/j.jtauto.2023.100212
Clodoveo Ferri , Vincenzo Raimondo , Dilia Giuggioli , Laura Gragnani , Serena Lorini , Lorenzo Dagna , Silvia Laura Bosello , Rosario Foti , Valeria Riccieri , Serena Guiducci , Giovanna Cuomo , Antonio Tavoni , Rossella De Angelis , Fabio Cacciapaglia , Elisabetta Zanatta , Franco Cozzi , Giuseppe Murdaca , Ilaria Cavazzana , Nicoletta Romeo , Veronica Codullo , Alessandro Antonelli
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Abstract

Introduction

The impact of COVID-19 pandemic represents a serious challenge for ‘frail’ patients' populations with inflammatory autoimmune systemic diseases such as systemic sclerosis (SSc). We investigated the prevalence and severity of COVID-19, as well the effects of COVID-19 vaccination campaign in a large series of SSc patients followed for the entire period (first 38 months) of pandemic.

Patients and method

This prospective survey study included 1755 unselected SSc patients (186 M, 1,569F; mean age 58.7 ± 13.4SD years, mean disease duration 8.8 ± 7.3SD years) recruited in part by telephone survey at 37 referral centers from February 2020 to April 2023. The following parameters were carefully evaluated: i. demographic, clinical, serological, and therapeutical features; ii. prevalence and severity of COVID-19; and iii. safety, immunogenicity, and efficacy of COVID-19 vaccines.

Results

The prevalence of COVID-19 recorded during the whole pandemic was significantly higher compared to Italian general population (47.3 % vs 43.3 %, p < 0.000), as well the COVID-19-related mortality (1.91 % vs 0.72 %, p < 0.001). As regards the putative prognostic factors of worse outcome, COVID-19 positive patients with SSc-related interstitial lung involvement showed significantly higher percentage of COVID-19-related hospitalization compared to those without (5.85 % vs 1.73 %; p < 0.0001), as well as of mortality rate (2.01 % vs 0.4 %; p = 0.002). Over half of patients (56.3 %) received the first two plus one booster dose of vaccine; while a fourth dose was administered to 35.6 %, and only few of them (1.99 %) had five or more doses of vaccine. Of note, an impaired seroconversion was recorded in 25.6 % of individuals after the first 2 doses of vaccine, and in 8.4 % of patients also after the booster dose. Furthermore, the absence of T-cell immunoreactivity was observed in 3/7 patients tested by QuantiFERON® SARSCoV-2 Starter Set (Qiagen). The efficacy of vaccines, evaluated by comparing the COVID-19-related death rate recorded during pre- and post-vaccination pandemic periods, revealed a quite stable outcome in SSc patients (death rate from 2.54 % to 1.76 %; p = ns), despite the significant drop of mortality observed in the Italian general population (from 2.95 % to 0.29 %; p < 0.0001).

Conclusions

An increased COVID-19 prevalence and mortality rate was recorded in SSc patients; moreover, the efficacy of vaccines in term of improved outcomes was less evident in SSc compared to Italian general population. This discrepancy might be explained by concomitant adverse prognostic factors: increased rate of non-responders to vaccine in SSc series, low percentage of individuals with four or more doses of vaccine, ongoing immunomodulating treatments, disease-related interstitial lung disease, and/or reduced preventive measures in the second half of pandemic. A careful monitoring of response to COVID-19 vaccines together with adequate preventive/therapeutical strategies are highly recommendable in the near course of pandemic in this frail patients’ population.

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COVID-19和疫苗接种运动对大流行前三年1755名系统性硬化症患者的影响在下一个大流行阶段,对疫苗免疫反应性受损、正在进行的免疫调节治疗和疾病相关肺部受累的个体可能面临的风险
COVID-19大流行的影响对患有炎症性自身免疫性全身性疾病(如系统性硬化症(SSc))的“虚弱”患者群体构成了严峻挑战。我们调查了COVID-19的流行程度和严重程度,以及在大流行期间(前38个月)随访的大量SSc患者中开展COVID-19疫苗接种活动的效果。患者和方法本前瞻性调查研究纳入了1755例未选择的SSc患者(186例M, 1569例f;平均年龄58.7±13.4SD年,平均病程8.8±7.3SD年),部分通过电话调查于2020年2月至2023年4月在37个转诊中心招募。仔细评估以下参数:1 .人口学、临床、血清学和治疗特征;2COVID-19的流行和严重程度;ⅲ。COVID-19疫苗的安全性、免疫原性和有效性。结果在整个大流行期间记录的COVID-19患病率明显高于意大利普通人群(47.3% vs 43.3%, p <0.000),以及与covid -19相关的死亡率(1.91%对0.72%,p <0.001)。至于预后较差的推定预后因素,伴有ssc相关间质性肺受损伤的COVID-19阳性患者的COVID-19相关住院率明显高于未伴有ssc相关肺间质性肺受损伤的患者(5.85% vs 1.73%;p & lt;0.0001),以及死亡率(2.01% vs 0.4%;p = 0.002)。超过一半的患者(56.3%)接种了前两剂加一剂加强剂疫苗;而35.6%的人接种了第四剂疫苗,其中只有少数人(1.99%)接种了五剂或更多剂疫苗。值得注意的是,25.6%的人在接种前两剂疫苗后血清转化受损,8.4%的患者在接种加强剂后也出现血清转化受损。此外,在QuantiFERON®SARSCoV-2 Starter Set (Qiagen)检测的患者中,有3/7观察到t细胞免疫反应性缺失。通过比较疫苗接种前和接种后大流行期间记录的covid -19相关死亡率来评估疫苗的有效性,结果显示SSc患者的结果相当稳定(死亡率从2.54%降至1.76%;p = ns),尽管意大利普通人群的死亡率显著下降(从2.95%降至0.29%;p & lt;0.0001)。结论SSc患者的COVID-19患病率和死亡率均有升高;此外,与意大利普通人群相比,疫苗在SSc中改善结果的功效不太明显。这种差异可能是由伴随的不良预后因素解释的:SSc系列疫苗无应答率增加,接种四剂或四剂以上疫苗的个体百分比低,正在进行的免疫调节治疗,疾病相关的间质性肺疾病,和/或大流行后半期预防措施减少。强烈建议在这一虚弱患者群体大流行的近期过程中,仔细监测对COVID-19疫苗的反应,并制定适当的预防/治疗战略。
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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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