Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study

被引：537

作者：

Furer, Victoria ^{[1
,2
]}

Eviatar, Tali ^{[1
,2
]}

Zisman, Devy ^{[3
,4
]}

Peleg, Hagit ^{[5
]}

Paran, Daphna ^{[1
,2
]}

Levartovsky, David ^{[1
]}

Zisapel, Michael ^{[1
]}

Elalouf, Ofir ^{[1
,2
]}

Kaufman, Ilana ^{[1
,2
]}

Meidan, Roni ^{[2
,6
]}

Broyde, Adi ^{[1
,2
]}

Polachek, Ari ^{[1
,2
]}

Wollman, Jonathan ^{[1
,2
]}

Litinsky, Ira ^{[1
,2
]}

Meridor, Katya ^{[1
,2
]}

Nochomovitz, Hila ^{[1
,2
]}

Silberman, Adi ^{[1
,2
]}

Rosenberg, Dana ^{[1
,2
]}

Feld, Joy ^{[3
]}

Haddad, Amir ^{[3
]}

Gazzit, Tal ^{[3
]}

Elias, Muna ^{[3
]}

Higazi, Nizar ^{[3
]}

Kharouf, Fadi ^{[5
,7
]}

Shefer, Gabi ^{[8
]}

Sharon, Orly ^{[8
]}

Pel, Sara ^{[1
]}

Nevo, Sharon ^{[1
]}

Elkayam, Ori ^{[1
,2
]}

机构：

[1] Tel Aviv Sourasky Med Ctr, Rheumatol Dept, Tel Aviv, Israel

[2] Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel

[3] Carmel Hosp, Rheumatol Unit, Haifa, Israel

[4] Technion Israel Inst Technol, Med, Haifa, Israel

[5] Hadassah Univ Hosp, Rheumatol Unit, Jerusalem, Israel

[6] Tel Aviv Sourasky Med Ctr, Internal Med, Tel Aviv, Israel

[7] Hebrew Univ Jerusalem, Fac Med, Jerusalem, Israel

[8] Tel Aviv Sourasky Med Ctr, Endocrinol Dept, Tel Aviv, Israel

来源：

ANNALS OF THE RHEUMATIC DISEASES | 2021年 / 80卷 / 10期

关键词：

PNEUMOCOCCAL POLYSACCHARIDE VACCINE; CLASSIFICATION CRITERIA; INFLUENZA VACCINATION; ANTIBODY-RESPONSE; AMERICAN-COLLEGE; TREATED PATIENTS; IMMUNE-RESPONSE; ARTHRITIS; METHOTREXATE; RITUXIMAB;

D O I：

10.1136/annrheumdis-2021-220647

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Vaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited. Methods A multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2-6 weeks after the second vaccine dose. Seropositivity was defined as IgG >= 15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose. Results Following vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9 +/- 91.7 vs 218.6 +/- 82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients. Conclusion mRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.

引用

页码：1330 / 1338

页数：9

共 47 条

[1] 2010 Rheumatoid Arthritis Classification Criteria An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative [J].

Aletaha, Daniel ;

Neogi, Tuhina ;

Silman, Alan J. ;

Funovits, Julia ;

Felson, David T. ;

Bingham, Clifton O., III ;

Birnbaum, Neal S. ;

Burmester, Gerd R. ;

Bykerk, Vivian P. ;

Cohen, Marc D. ;

Combe, Bernard ;

Costenbader, Karen H. ;

Dougados, Maxime ;

Emery, Paul ;

Ferraccioli, Gianfranco ;

Hazes, Johanna M. W. ;

Hobbs, Kathryn ;

Huizinga, Tom W. J. ;

Kavanaugh, Arthur ;

Kay, Jonathan ;

Kvien, Tore K. ;

Laing, Timothy ;

Mease, Philip ;

Menard, Henri A. ;

Moreland, Larry W. ;

Naden, Raymond L. ;

Pincus, Theodore ;

Smolen, Josef S. ;

Stanislawska-Biernat, Ewa ;

Symmons, Deborah ;

Tak, Paul P. ;

Upchurch, Katherine S. ;

Vencovsky, Jiri ;

Wolfe, Frederick ;

Hawker, Gillian .

ARTHRITIS AND RHEUMATISM, 2010, 62 (09) :2569-2581

[2] Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept [J].

Alten, Rieke ;

Bingham, Clifton O., III ;

Cohen, Stanley B. ;

Curtis, Jeffrey R. ;

Kelly, Sheila ;

Wong, Dennis ;

Genovese, Mark C. .

BMC MUSCULOSKELETAL DISORDERS, 2016, 17

[3] Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis The VELOCE study [J].

Bar-Or, Amit ;

Calkwood, Jonathan C. ;

Chognot, Cathy ;

Evershed, Joanna ;

Fox, Edward J. ;

Herman, Ann ;

Manfrini, Marianna ;

McNamara, John ;

Robertson, Derrick S. ;

Stokmaier, Daniela ;

Wendt, Jeanette K. ;

Winthrop, Kevin L. ;

Traboulsee, Anthony .

NEUROLOGY, 2020, 95 (14) :E1999-E2008

[4] Immunization Responses in Rheumatoid Arthritis Patients Treated With Rituximab Results From a Controlled Clinical Trial [J].

Bingham, Clifton O., III ;

Looney, R. John ;

Deodhar, Atul ;

Halsey, Neal ;

Greenwald, Maria ;

Codding, Christine ;

Trzaskoma, Benjamin ;

Martin, Flavius ;

Agarwal, Sunil ;

Kelman, Ariella .

ARTHRITIS AND RHEUMATISM, 2010, 62 (01) :64-74

[5] Herpes zoster following inactivated COVID-19 vaccine: A coexistence or coincidence? [J].

Bostan, Ecem ;

Yalici-Armagan, Basak .

JOURNAL OF COSMETIC DERMATOLOGY, 2021, 20 (06) :1566-1567

[6] Antibody response to a single dose of SARS-CoV-2 mRNA vaccine in patients with rheumatic and musculoskeletal diseases [J].

Boyarsky, Brian J. ;

Ruddy, Jake A. ;

Connolly, Caoilfhionn M. ;

Ou, Michael T. ;

Werbel, William A. ;

Garonzik-Wang, Jacqueline M. ;

Segev, Dorry L. ;

Paik, Julie J. .

ANNALS OF THE RHEUMATIC DISEASES, 2021, 80 (08) :1098-1099

[7] Safety of the first dose of mRNA SARS-CoV-2 vaccines in patients with rheumatic and musculoskeletal diseases [J].

Connolly, Caoilfhionn M. ;

Ruddy, Jake A. ;

Boyarsky, Brian J. ;

Avery, Robin K. ;

Werbel, William A. ;

Segev, Dorry L. ;

Garonzik-Wang, Jacqueline ;

Paik, Julie J. .

ANNALS OF THE RHEUMATIC DISEASES, 2021, 80 (08) :1100-1101

[8] Weak correlation between antibody titers and neutralizing activity in sera from SARS-CoV-2 infected subjects [J].

Criscuolo, Elena ;

Diotti, Roberta A. ;

Strollo, Marta ;

Rolla, Serena ;

Ambrosi, Alessandro ;

Locatelli, Massimo ;

Burioni, Roberto ;

Mancini, Nicasio ;

Clementi, Massimo ;

Clementi, Nicola .

JOURNAL OF MEDICAL VIROLOGY, 2021, 93 (04) :2160-2167

[9] BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting [J].

Dagan, Noa ;

Barda, Noam ;

Kepten, Eldad ;

Miron, Oren ;

Perchik, Shay ;

Katz, Mark A. ;

Hernan, Miguel A. ;

Lipsitch, Marc ;

Reis, Ben ;

Balicer, Ran D. .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (15) :1412-1423

[10] Herpes zoster emergence following mRNA COVID-19 vaccine [J].

Eid, Edward ;

Abdullah, Lina ;

Kurban, Mazen ;

Abbas, Ossama .

JOURNAL OF MEDICAL VIROLOGY, 2021, 93 (09) :5231-5232

← 1 2 3 4 5 →