Panchawagh Suhrud, Bohdana Doskaliuk, Kuwana Masataka, Yoshida Akira, Yomono Keina, Pauling John D, Makol Ashima, Kadam Esha, Day Jessica, Chatterjee Tulika, Katchamart Wanruchada, Goo Phonpen Akarawatcharangura, Nikiphorou Elena, Sen Parikshit, Dey Dzifa, Cavagna Lorenzo, Gutiérrez Carlos Enrique Toro, Agarwal Vishwesh, Milchert Marcin, Ziade Nelly, Distler Oliver, Group Covad Study, Chinoy Hector, Aggarwal Rohit, Gupta Latika, Agarwal Vikas
Smt Kashibai Navale Medical College, Pune, India.
Department of Pathophysiology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.
Rheumatol Int. 2023 Dec;43(12):2211-2220. doi: 10.1007/s00296-023-05441-z. Epub 2023 Sep 15.
Data on short-term safety of COVID-19 vaccination in patients with systemic sclerosis (SSc) were explored previously in the first COVID-19 vaccination in autoimmune diseases (COVAD) survey conducted in 2021. However, delayed adverse events (ADEs) (occurring > 7 days post-vaccination) are poorly characterized in these patients with SSc. In this study, we analysed delayed COVID-19 vaccine-related ADEs among patients with SSc, other systemic autoimmune and inflammatory disorders (SAIDs) and healthy controls (HCs) using data from the second COVAD study conducted in 2022. The COVAD-2 study was a cross-sectional, patient self-reported global e-survey conducted from February to June 2022. Data on demographics, SSc/SAID disease characteristics, COVID-19 infection history, and vaccination details including delayed ADEs as defined by the Centre for Disease Control were captured and analysed. Among 17,612 respondents, 10,041 participants fully vaccinated against COVID-19 were included for analysis. Of these, 2.6% (n = 258) had SSc, 63.7% other SAIDs, and 33.7% were HCs. BNT162b2 Pfizer (69.4%) was the most administered vaccine, followed by MRNA-1273 Moderna (32.25%) and ChadOx1 nCOV-19 Oxford/AstraZeneca (12.4%) vaccines. Among patients with SSc, 18.9% reported minor, while 8.5% experienced major delayed ADEs, and 4.6% reported hospitalization. These frequencies were comparable to those of the ADEs reported by other patients with SAIDs and HCs. However, patients with SSc reported a higher frequency of difficulty in breathing than HCs [OR 2.3 (1.0-5.1), p = 0.042]. Patients with diffuse cutaneous SSc experienced minor ADEs [OR 2.1 (1.1-4.4), p = 0.036] and specifically fatigue more frequently [OR 3.9 (1.3-11.7), p = 0.015] than those with limited cutaneous SSc. Systemic sclerosis patients with concomitant myositis reported myalgia more frequently [OR 3.4 (1.1-10.7), p = 0.035], while those with thyroid disorders were more prone to report a higher frequency of joint pain [OR 5.5 (1.5-20.2), p = 0.009] and dizziness [OR 5.9 (1.3-27.6), p = 0.024] than patients with SSc alone. A diagnosis of SSc did not confer a higher risk of delayed post-COVID-19 vaccine-related ADEs overall compared with other SAIDs and HCs. However, the diffuse cutaneous phenotype and coexisting autoimmune conditions including myositis and thyroid disease may increase the risk of minor ADEs. These patients may benefit from pre-vaccination counselling, close monitoring, and early initiation of appropriate care in the post-COVID-19 vaccination period.
2021年开展的自身免疫性疾病首次新冠疫苗接种（COVAD）调查中，曾对系统性硬化症（SSc）患者接种新冠疫苗的短期安全性数据进行过探索。然而，这些SSc患者中延迟性不良事件（ADEs）（接种疫苗7天后出现）的特征尚不明确。在本研究中，我们利用2022年开展的第二项COVAD研究的数据，分析了SSc患者、其他系统性自身免疫和炎症性疾病（SAIDs）患者及健康对照（HCs）中与新冠疫苗相关的延迟性ADEs。COVAD-2研究是一项于2022年2月至6月开展的横断面、患者自我报告的全球电子调查。收集并分析了人口统计学数据、SSc/SAID疾病特征、新冠病毒感染史以及包括美国疾病控制中心定义的延迟性ADEs在内的疫苗接种细节。在17612名受访者中，纳入10041名完全接种新冠疫苗的参与者进行分析。其中，2.6%（n = 258）患有SSc，63.7%患有其他SAIDs，33.7%为HCs。辉瑞的BNT162b2（69.4%）是使用最多的疫苗，其次是莫德纳的mRNA-1273（32.25%）和牛津/阿斯利康的ChAdOx1 nCoV-19（12.4%）疫苗。在SSc患者中，18.9%报告有轻微不良事件，8.5%经历了严重延迟性ADEs，4.6%报告住院治疗。这些发生率与其他SAIDs患者和HCs报告的ADEs发生率相当。然而，SSc患者报告呼吸困难的频率高于HCs [比值比（OR）2.3（1.0 - 5.1），p = 0.042]。弥漫性皮肤型SSc患者比局限性皮肤型SSc患者更频繁地出现轻微ADEs [OR 2.1（1.1 - 4.4），p = 0.036]，尤其更频繁地出现疲劳 [OR 3.9（1.3 - 11.7），p = 0.015]。合并肌炎的系统性硬化症患者更频繁地报告肌痛 [OR 3.4（1.1 - 10.7），p = 0.035]，而患有甲状腺疾病的患者比单纯患有SSc的患者更倾向于报告更高频率的关节疼痛 [OR 5.5（1.5 - 20.2），p = 0.009] 和头晕 [OR 5.9（1.3 - 27.6），p = 0.024]。总体而言，与其他SAIDs患者和HCs相比，SSc诊断并未使新冠疫苗接种后延迟性ADEs的风险更高。然而，弥漫性皮肤表型以及包括肌炎和甲状腺疾病在内的共存自身免疫性疾病可能会增加轻微ADEs的风险。这些患者可能会从接种前咨询、密切监测以及在新冠疫苗接种后早期开始适当护理中获益。
