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.

IF 3.5 2区 医学 Q1 RHEUMATOLOGY Lupus Science & Medicine Pub Date : 2025-03-05 DOI:10.1136/lupus-2024-001435
Laurent Alric, Clara Brusq, Marion Migueres, Stephanie Faure, Pascal Lebray, Jean François Viallard, Dominique Chauveau, Laurent Sailler, Emilie Bérard, Grégory Pugnet, Patrice Cacoub
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Abstract

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.

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评估暴露前羟氯喹治疗对狼疮或 Gougerot-Sjögren 病期间 COVID-19 感染风险和抗 COVID-19 疫苗接种疗效的影响:Prepcov 多中心试验。
目的:一些SLE或Gougerot-Sjögren病(GSD)患者接受羟氯喹(HCQ)的长期治疗,有时联合免疫抑制治疗(IS)。本研究旨在评估早在COVID-19大流行之前就开始的长期HCQ治疗对COVID-19风险、感染严重程度或免疫保护是否具有保护作用或不利作用。方法:本前瞻性多中心研究纳入547例SLE、GSD、自身免疫性肝炎、原发性胆管炎或治愈的病毒性丙型肝炎患者,根据大流行前HCQ(+/-)和IS(+/-)摄入情况分为4组:HCQ+IS+ (n=112)、HCQ+IS- (n=121)、HCQ-IS+ (n=115)和HCQ-IS- (n=199)。当有可能接种COVID-19疫苗时,患者按建议接种疫苗。根据疫苗接种后抗体滴度前瞻性评估疫苗接种效果。结果:与HCQ+IS+患者相比,HCQ-IS+患者的COVID-19感染风险降低(p)结论:大流行前开始的HCQ治疗对COVID-19感染没有保护作用。此外,未接触HCQ治疗(与IS联合或不联合)与COVID-19感染风险降低以及出现症状或严重感染的风险降低相关。HCQ和IS不影响疫苗反应。只有两剂或两剂以上的疫苗才能产生良好的疫苗反应。试验注册号:NCT04481633。
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来源期刊
Lupus Science & Medicine
Lupus Science & Medicine RHEUMATOLOGY-
CiteScore
5.30
自引率
7.70%
发文量
88
审稿时长
15 weeks
期刊介绍: Lupus Science & Medicine is a global, peer reviewed, open access online journal that provides a central point for publication of basic, clinical, translational, and epidemiological studies of all aspects of lupus and related diseases. It is the first lupus-specific open access journal in the world and was developed in response to the need for a barrier-free forum for publication of groundbreaking studies in lupus. The journal publishes research on lupus from fields including, but not limited to: rheumatology, dermatology, nephrology, immunology, pediatrics, cardiology, hepatology, pulmonology, obstetrics and gynecology, and psychiatry.
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