羟氯喹啉暴露前治疗对狼疮或舍格伦综合征患者感染新型冠状病毒肺炎风险及新型冠状病毒肺炎疫苗疗效的影响评估：Prepcov多中心试验
Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren's disease: Prepcov multicentre trial.
作者信息
Alric Laurent, Brusq Clara, Migueres Marion, Faure Stephanie, Lebray Pascal, Viallard Jean François, Chauveau Dominique, Sailler Laurent, Bérard Emilie, Pugnet Grégory, Cacoub Patrice
机构信息
Toulouse III University-Paul Sabatier, Toulouse, France
Unité de Soutien Méthodologique à la Recherche (USMR), Service d'Epidémiologie Clinique et de Santé Publique, CHU de Toulouse, Toulouse III University-Paul Sabatier, Toulouse, France.
出版信息
Lupus Sci Med. 2025 Mar 5;12(1):e001435. doi: 10.1136/lupus-2024-001435.
OBJECTIVES
Some patients with SLE or Gougerot-Sjögren's disease (GSD) receive long-term treatment with hydroxychloroquine (HCQ), sometimes combined with immunosuppressive therapy (IS). This study sought to assess whether long-term HCQ therapy that had been initiated long before the COVID-19 pandemic had a protective or adverse effect on COVID-19 risk, severity of infection or immunity protection.
METHODS
This prospective multicentre study included 547 patients with SLE, GSD, autoimmune hepatitis, primary biliary cholangitis or cured viral hepatitis C divided into four groups according to HCQ (+/-) and IS (+/-) intake prior to the pandemic: HCQ+IS+ (n=112), HCQ+IS- (n=121), HCQ-IS+ (n=115) and HCQ-IS- (n=199). When COVID-19 vaccination was possible, patients were vaccinated as recommended. Vaccination efficacy was prospectively assessed on the basis of the postvaccination antibody titre.
RESULTS
Compared with HCQ+IS+ patients, HCQ-IS+ patients had a decreased risk of COVID-19 infection (p<0.001). Compared with HCQ+IS+ patients, HCQ-IS- patients had a decreased risk of contracting COVID-19 (p<0.001). Patients in the HCQ-IS+ or HCQ-IS- group had a lower risk of symptomatic or severe infection than HCQ+IS+ patients did (p=0.001 and p<0.001, respectively). Only patients who had two or more exposures (to vaccine and/or infection) had an increased likelihood of COVID-19 immunity after the last dose (p<0.001).
CONCLUSIONS
HCQ treatment that was initiated before the pandemic did not protect against COVID-19 infection. Moreover, non-exposure to HCQ treatment (combined or not with IS) was associated with decreased risk of COVID-19 infection and of developing a symptomatic or severe infection. HCQ and IS do not influence the vaccine response. Only two or more doses of vaccine result in a good vaccine response.
TRIAL REGISTRATION NUMBER
NCT04481633.
目的
一些系统性红斑狼疮（SLE）或舍格伦综合征（GSD）患者长期接受羟氯喹（HCQ）治疗，有时联合免疫抑制治疗（IS）。本研究旨在评估在2019冠状病毒病（COVID-19）大流行之前很久就开始的长期HCQ治疗对COVID-19风险、感染严重程度或免疫保护是否有保护作用或不良影响。
方法
这项前瞻性多中心研究纳入了547例SLE、GSD、自身免疫性肝炎、原发性胆汁性胆管炎或已治愈的丙型病毒性肝炎患者，根据大流行前HCQ（+/-）和IS（+/-）的摄入情况分为四组：HCQ+IS+（n = 112）、HCQ+IS-（n = 121）、HCQ-IS+（n = 115）和HCQ-IS-（n = 199）。当可以进行COVID-19疫苗接种时，按照建议为患者接种疫苗。根据接种疫苗后的抗体滴度前瞻性评估疫苗效力。
结果
与HCQ+IS+患者相比，HCQ-IS+患者感染COVID-19的风险降低（p<0.001）。与HCQ+IS+患者相比，HCQ-IS-患者感染COVID-19的风险降低（p<0.001）。HCQ-IS+或HCQ-IS-组患者出现症状性或严重感染的风险低于HCQ+IS+患者（分别为p = 0.001和p<0.001）。只有经历过两次或更多次（疫苗接种和/或感染）暴露的患者在最后一剂疫苗接种后获得COVID-19免疫力的可能性增加（p<0.001）。
结论
大流行前开始的HCQ治疗不能预防COVID-19感染。此外，未接受HCQ治疗（联合或不联合IS）与COVID-19感染风险以及出现症状性或严重感染的风险降低相关。HCQ和IS不影响疫苗反应。只有接种两剂或更多剂疫苗才会产生良好的疫苗反应。
试验注册号
NCT04481633。
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