A prospective multicenter study assessing humoral immunogenicity and safety of the mRNA SARS-CoV-2 vaccines in Greek patients with systemic autoimmune and autoinflammatory rheumatic diseases.

A prospective multicenter study assessing humoral immunogenicity and safety of the mRNA SARS-CoV-2 vaccines in Greek patients with systemic autoimmune and autoinflammatory rheumatic diseases.
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DOI:
10.1016/j.jaut.2021.102743
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发表时间:
2021-12
影响因子:
12.8
通讯作者:
Moutsopoulos HM
Moutsopoulos HM
中科院分区:
医学1区
文献类型:
--
作者:
Tzioufas AG;Bakasis AD;Goules AV;Bitzogli K;Cinoku II;Chatzis LG;Argyropoulou OD;Venetsanopoulou AI;Mavrommati M;Stergiou IE;Pezoulas V;Voulgari PV;Katsimpari C;Katechis S;Gazi S;Katsifis G;Sfontouris CI;Georgountzos AI;Liossis SN;Papagoras C;Fotiadis DI;Skopouli FN;Vlachoyiannopoulos PG;Moutsopoulos HM

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研究全身性自身免疫性和自身炎性风湿病(SAARD)患者接种SARS-CoV-2疫苗后的体液应答和安全性,无论是否在接种过程中进行了治疗调整。一项包括605名SAARD患者和116名对照的全国性多中心研究前瞻性地评估了血清抗SARS-CoV-2 S1蛋白IgG抗体滴度、副作用和疾病活动性,在完全接种疫苗后一个月,根据不同的治疗修改策略(无、部分和扩展修改)。通过数据驱动的多变量逻辑回归分析确定了与体液反应障碍相关的独立危险因素。接受延长治疗调整的患者对疫苗的反应与对照组以及未接受免疫抑制治疗的SAARD患者相似(分别为97.56% vs 100%,p = 0.2468和97.56% vs 97.46%,p > 0.9999)。相比之下,部分或未进行治疗调整的患者的缓解率分别为87.50%和84.50%。此外,与未进行或进行部分修改的SAARD患者相比,进行扩展治疗修改的SAARD患者产生更高的抗SARS-CoV-2抗体水平(中位数:分别为7.90 vs 7.06 vs 7.1,p = 0.0003和p = 0.0195)。霉酚酸酯(MMF)、利妥昔单抗(RTX)和甲氨蝶呤(MTX)对抗SARS-CoV-2的体液应答有负面影响。在10.5%的接种患者中,观察到轻度临床恶化;然而,在不同的治疗调整SAARD亚组中未观察到恶化发生率差异。SAARD患者和对照组的副作用基本相当。在SAARD患者中,mRNA SARS-CoV-2疫苗在副作用和疾病爆发方面都是有效和安全的。用MMF、RTX和/或MTX治疗损害抗SARS-CoV-2抗体应答,其在延长治疗修改后恢复而不影响疾病活性。
To investigate humoral responses and safety of mRNA SARS-CoV-2 vaccines in systemic autoimmune and autoinflammatory rheumatic disease (SAARD) patients subjected or not to treatment modifications during vaccination. A nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis. Patients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls. In SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.
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DOI: 10.1136/annrheumdis-2021-220597
发表时间: 2021-10
影响因子: 27.4
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Haberman RH;Herati R;Simon D;Samanovic M;Blank RB;Tuen M;Koralov SB;Atreya R;Tascilar K;Allen JR;Castillo R;Cornelius AR;Rackoff P;Solomon G;Adhikari S;Azar N;Rosenthal P;Izmirly P;Samuels J;Golden B;Reddy SM;Neurath MF;Abramson SB;Schett G;Mulligan MJ;Scher JU
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DOI: 10.1056/nejmoa2034577
发表时间: 2020-12-31
期刊: The New England journal of medicine
影响因子: --
作者:
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
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发表时间: 2012-08
影响因子: --
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Petri, Michelle;Orbai, Ana-Maria;Alarcon, Graciela S.;Gordon, Caroline;Merrill, Joan T.;Fortin, Paul R.;Bruce, Ian N.;Isenberg, David;Wallace, Daniel J.;Nived, Ola;Sturfelt, Gunnar;Ramsey-Goldman, Rosalind;Bae, Sang-Cheol;Hanly, John G.;Sanchez-Guerrero, Jorge;Clarke, Ann;Aranow, Cynthia;Manzi, Susan;Urowitz, Murray;Gladman, Dafna;Kalunian, Kenneth;Costner, Melissa;Werth, Victoria P.;Zoma, Asad;Bernatsky, Sasha;Ruiz-Irastorza, Guillermo;Khamashta, Munther A.;Jacobsen, Soren;Buyon, Jill P.;Maddison, Peter;Dooley, Mary Anne;van vollenhoven, Ronald F.;Ginzler, Ellen;Stoll, Thomas;Peschken, Christine;Jorizzo, Joseph L.;Callen, Jeffrey P.;Lim, S. Sam;Fessler, Barri J.;Inanc, Murat;Kamen, Diane L.;Rahman, Anisur;Steinsson, Kristjan;Franks, Andrew G., Jr.;Sigler, Lisa;Hameed, Suhail;Fang, Hong;Ngoc Pham;Brey, Robin;Weisman, Michael H.;McGwin, Gerald, Jr.;Magder, Laurence S.
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