Ferri Clodoveo, Raimondo Vincenzo, Giuggioli Dilia, Gragnani Laura, Lorini Serena, Dagna Lorenzo, Bosello Silvia Laura, Foti Rosario, Riccieri Valeria, Guiducci Serena, Cuomo Giovanna, Tavoni Antonio, De Angelis Rossella, Cacciapaglia Fabio, Zanatta Elisabetta, Cozzi Franco, Murdaca Giuseppe, Cavazzana Ilaria, Romeo Nicoletta, Codullo Veronica, Pellegrini Roberta, Varcasia Giuseppe, De Santis Maria, Selmi Carlo, Abignano Giuseppina, Caminiti Maurizio, L'Andolina Massimo, Olivo Domenico, Lubrano Ennio, Spinella Amelia, Lumetti Federica, De Luca Giacomo, Ruscitti Piero, Urraro Teresa, Visentini Marcella, Bellando-Randone Silvia, Visalli Elisa, Testa Davide, Sciascia Gabriella, Masini Francesco, Pellegrino Greta, Saccon Francesca, Balestri Eugenia, Elia Giusy, Ferrari Silvia Martina, Tonutti Antonio, Dall'Ara Francesca, Pagano Mariano Giuseppa, Pettiti Giorgio, Zanframundo Giovanni, Brittelli Raffaele, Aiello Vincenzo, Dal Bosco Ylenia, Foti Roberta, Di Cola Ilenia, Scorpiniti Daniela, Fusaro Enrico, Ferrari Tommaso, Gigliotti Pietro, Campochiaro Corrado, Francioso Francesca, Iandoli Carlo, Caira Virginia, Zignego Anna Linda, D'Angelo Salvatore, Franceschini Franco, Matucci-Cerinic Marco, Giacomelli Roberto, Doria Andrea, Santini Stefano Angelo, Fallahi Poupak, Iannone Florenzo, Antonelli Alessandro
Rheumatology Unit, University of Modena & RE., School of Medicine, Modena, Italy.
Rheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
J Transl Autoimmun. 2023 Oct 9;7:100212. doi: 10.1016/j.jtauto.2023.100212. eCollection 2023 Dec.
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.
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.
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).
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.
新冠疫情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“脆弱”患者群体构成了严峻挑战。我们调查了新冠病毒感染疾病（COVID-19）在一系列SSc患者中的患病率和严重程度，以及在疫情整个期间（最初38个月）开展的COVID-19疫苗接种运动的效果。
这项前瞻性调查研究纳入了1755例未经筛选的SSc患者（男性186例，女性1569例；平均年龄58.7±13.4标准差岁，平均病程8.8±7.3标准差年），部分患者通过电话调查招募自2020年2月至2023年4月期间的37个转诊中心。仔细评估了以下参数：i. 人口统计学、临床、血清学和治疗特征；ii. COVID-19的患病率和严重程度；iii. COVID-19疫苗的安全性、免疫原性和有效性。
在整个疫情期间记录的COVID-19患病率显著高于意大利普通人群（47.3%对43.3%，p<0.000），COVID-19相关死亡率也更高（1.91%对0.72%，p<0.001）。关于预后较差的假定危险因素，与无SSc相关间质性肺受累的COVID-19阳性患者相比，有该受累情况的患者COVID-19相关住院率显著更高（5.85%对1.73%；p<0.0001），死亡率也更高（2.01%对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针；35.6%的患者接种了第四剂，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%的个体在接种前两剂疫苗后血清转化受损，8.4%的患者在接种加强针后也出现这种情况。此外，在通过QuantiFERON® SARS-CoV-2 Starter Set（Qiagen）检测的7例患者中有3例观察到T细胞免疫反应性缺失。通过比较疫苗接种前和接种后疫情期间记录的COVID-19相关死亡率来评估疫苗的有效性，结果显示SSc患者的死亡率相当稳定（从2.54%降至1.76%；p=无统计学意义），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<0.0001）。
SSc患者中记录到COVID-19患病率和死亡率增加；此外，与意大利普通人群相比，疫苗在改善预后方面的效果在SSc患者中不太明显。这种差异可能由伴随的不良预后因素解释：SSc患者系列中疫苗无反应者比例增加、接种四剂或更多剂疫苗的个体比例低、正在进行免疫调节治疗、疾病相关间质性肺病和/或疫情后半期预防措施减少。在疫情近期对这一脆弱患者群体，强烈建议密切监测对COVID-19疫苗的反应并采取适当的预防/治疗策略。
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