Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients
Background The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging. Aim To evaluate Pfizer/BioNTech (BNT1...
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| Veröffentlicht in: | Clinical rheumatology 2022-12, Vol.41 (12), p.3879-3885 |
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| creator | Pri-Paz Basson, Yael Tayer-Shifman, Oshrat E. Naser, Rawand Tartakover Matalon, Shelly Kimhi, Oded Gepstein, Raz Halperin, Tamar Ziv-Baran, Tomer Ziv, Amit Parikh, Roma Kivity, Shaye Levy, Yair |
| description | Background
The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging.
Aim
To evaluate Pfizer/BioNTech (BNT162b2) mRNA-based vaccine second-dose immunogenicity and safety, and the relation between them, in patients with SARDs.
Methods
A total of one hundred forty tow adults who received two doses of the BNT162b2 vaccine were included in the study. The SARDs group included Ninety-nine patients and the control group (forty-three participants) comprised a mixture of healthy participants and patients who were seen at the rheumatology clinic for non-SARDs. Anti-SARS-CoV-2 IgG antibodies against the Spike protein were evaluated using a SARS-CoV-2 IgG immunoassay. A level of > 150 AU/mL was considered positive. An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination.
Results
Of the 142 participants, 116 were seropositive (81.7%) and 26 (18.3%) were seronegative. Of the seronegative participants, 96.2% were SARDs patients. The proportion of seropositivity in the SARDs patients treated with any immunosuppressant was significantly lower (69.9%) compared to the control group and SARDs patients not receiving immunosuppressants (96.8%). A significant negative correlation between seronegativity and treatment with rituximab, mycophenolate mofetil (MMF), and prednisone was found in the SARDs group (
p
= 0.004, 0.044, 0.007 respectively). No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (
p
= 0.045,
p
= 0.02 respectively).
Conclusion
A decline in the immunogenicity to the second dose of BNT162b2 mRNA is seen in patients with SARDs, especially in patients treated with rituximab, MMF, and prednisone. Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients.
Key Points
•
BNT162b2 mRNA vaccine is less immunogenic in SARDs patients compared to the control group.
•
Rituximab, prednisone, and mycophenolate mofetil significantly reduced immunogenicity to the vaccine.
•
There |
| doi_str_mv | 10.1007/s10067-022-06348-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9436715</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2735409287</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-30cb43f78a72f424824ae1becdf19a267cd416d902123ceab3c2f2e85a30f3233</originalsourceid><addsrcrecordid>eNp9UUtLHTEUDkWpt7Z_wEUJuE6b10wmm4KKtoIoFLsOmczJvREnuSYzwvXXG71W242bk3NyvseBD6EDRr8xStX3UmurCOWc0FbIjjx8QAsmhSRaS72DFlQpSgTT3R76VMoNpZR3mn1Ee6KlDW2YXKB0Po5zTEuIwYVpg20ccLEeaps8nlaAx9-XR6S3BQZ8fHnNWt5zfG-dCxFwiLhsygRjcNjOUwpPYoDzCubRTvVzCAUqteB1HSFO5TPa9fa2wJeXdx_9OTu9PvlFLq5-np8cXRAnlZyIoK6XwqvOKu4llx2XFlgPbvBMW94qN0jWDppyxoUD2wvHPYeusYJ6wYXYRz-2uuu5H2Fw1TvbW7POYbR5Y5IN5v9NDCuzTPdGS9Eq1lSBwxeBnO5mKJO5SXOO9WbDlWgk1bxTFcW3KJdTKRn8qwOj5ikksw3J1JDMc0jmoZK-_nvbK-VvKhUgtoBSV3EJ-c37HdlH0-GfeQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2735409287</pqid></control><display><type>article</type><title>Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Pri-Paz Basson, Yael ; Tayer-Shifman, Oshrat E. ; Naser, Rawand ; Tartakover Matalon, Shelly ; Kimhi, Oded ; Gepstein, Raz ; Halperin, Tamar ; Ziv-Baran, Tomer ; Ziv, Amit ; Parikh, Roma ; Kivity, Shaye ; Levy, Yair</creator><creatorcontrib>Pri-Paz Basson, Yael ; Tayer-Shifman, Oshrat E. ; Naser, Rawand ; Tartakover Matalon, Shelly ; Kimhi, Oded ; Gepstein, Raz ; Halperin, Tamar ; Ziv-Baran, Tomer ; Ziv, Amit ; Parikh, Roma ; Kivity, Shaye ; Levy, Yair</creatorcontrib><description>Background
The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging.
Aim
To evaluate Pfizer/BioNTech (BNT162b2) mRNA-based vaccine second-dose immunogenicity and safety, and the relation between them, in patients with SARDs.
Methods
A total of one hundred forty tow adults who received two doses of the BNT162b2 vaccine were included in the study. The SARDs group included Ninety-nine patients and the control group (forty-three participants) comprised a mixture of healthy participants and patients who were seen at the rheumatology clinic for non-SARDs. Anti-SARS-CoV-2 IgG antibodies against the Spike protein were evaluated using a SARS-CoV-2 IgG immunoassay. A level of > 150 AU/mL was considered positive. An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination.
Results
Of the 142 participants, 116 were seropositive (81.7%) and 26 (18.3%) were seronegative. Of the seronegative participants, 96.2% were SARDs patients. The proportion of seropositivity in the SARDs patients treated with any immunosuppressant was significantly lower (69.9%) compared to the control group and SARDs patients not receiving immunosuppressants (96.8%). A significant negative correlation between seronegativity and treatment with rituximab, mycophenolate mofetil (MMF), and prednisone was found in the SARDs group (
p
= 0.004, 0.044, 0.007 respectively). No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (
p
= 0.045,
p
= 0.02 respectively).
Conclusion
A decline in the immunogenicity to the second dose of BNT162b2 mRNA is seen in patients with SARDs, especially in patients treated with rituximab, MMF, and prednisone. Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients.
Key Points
•
BNT162b2 mRNA vaccine is less immunogenic in SARDs patients compared to the control group.
•
Rituximab, prednisone, and mycophenolate mofetil significantly reduced immunogenicity to the vaccine.
•
There is a correlation between immunogenicity and adverse effects of the vaccine.</description><identifier>ISSN: 0770-3198</identifier><identifier>EISSN: 1434-9949</identifier><identifier>DOI: 10.1007/s10067-022-06348-z</identifier><identifier>PMID: 36050514</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Antibodies, Viral ; BNT162 Vaccine ; Coronaviruses ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Fever ; Humans ; Immunogenicity ; Immunoglobulin G ; Immunoglobulin G - therapeutic use ; Immunosuppressive agents ; Medicine ; Medicine & Public Health ; mRNA ; mRNA Vaccines ; Mycophenolate mofetil ; Mycophenolic acid ; Mycophenolic Acid - therapeutic use ; Original ; Original Article ; Patients ; Prednisone ; Prednisone - therapeutic use ; Rheumatic diseases ; Rheumatic Diseases - drug therapy ; Rheumatic Diseases - epidemiology ; Rheumatology ; Rituximab ; Rituximab - therapeutic use ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; Side effects ; Spike protein ; Vaccines</subject><ispartof>Clinical rheumatology, 2022-12, Vol.41 (12), p.3879-3885</ispartof><rights>The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR) 2022. corrected publication 2022. Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2022. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).</rights><rights>The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR) 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-30cb43f78a72f424824ae1becdf19a267cd416d902123ceab3c2f2e85a30f3233</citedby><cites>FETCH-LOGICAL-c474t-30cb43f78a72f424824ae1becdf19a267cd416d902123ceab3c2f2e85a30f3233</cites><orcidid>0000-0002-8391-5446</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10067-022-06348-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10067-022-06348-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36050514$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pri-Paz Basson, Yael</creatorcontrib><creatorcontrib>Tayer-Shifman, Oshrat E.</creatorcontrib><creatorcontrib>Naser, Rawand</creatorcontrib><creatorcontrib>Tartakover Matalon, Shelly</creatorcontrib><creatorcontrib>Kimhi, Oded</creatorcontrib><creatorcontrib>Gepstein, Raz</creatorcontrib><creatorcontrib>Halperin, Tamar</creatorcontrib><creatorcontrib>Ziv-Baran, Tomer</creatorcontrib><creatorcontrib>Ziv, Amit</creatorcontrib><creatorcontrib>Parikh, Roma</creatorcontrib><creatorcontrib>Kivity, Shaye</creatorcontrib><creatorcontrib>Levy, Yair</creatorcontrib><title>Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients</title><title>Clinical rheumatology</title><addtitle>Clin Rheumatol</addtitle><addtitle>Clin Rheumatol</addtitle><description>Background
The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging.
Aim
To evaluate Pfizer/BioNTech (BNT162b2) mRNA-based vaccine second-dose immunogenicity and safety, and the relation between them, in patients with SARDs.
Methods
A total of one hundred forty tow adults who received two doses of the BNT162b2 vaccine were included in the study. The SARDs group included Ninety-nine patients and the control group (forty-three participants) comprised a mixture of healthy participants and patients who were seen at the rheumatology clinic for non-SARDs. Anti-SARS-CoV-2 IgG antibodies against the Spike protein were evaluated using a SARS-CoV-2 IgG immunoassay. A level of > 150 AU/mL was considered positive. An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination.
Results
Of the 142 participants, 116 were seropositive (81.7%) and 26 (18.3%) were seronegative. Of the seronegative participants, 96.2% were SARDs patients. The proportion of seropositivity in the SARDs patients treated with any immunosuppressant was significantly lower (69.9%) compared to the control group and SARDs patients not receiving immunosuppressants (96.8%). A significant negative correlation between seronegativity and treatment with rituximab, mycophenolate mofetil (MMF), and prednisone was found in the SARDs group (
p
= 0.004, 0.044, 0.007 respectively). No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (
p
= 0.045,
p
= 0.02 respectively).
Conclusion
A decline in the immunogenicity to the second dose of BNT162b2 mRNA is seen in patients with SARDs, especially in patients treated with rituximab, MMF, and prednisone. Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients.
Key Points
•
BNT162b2 mRNA vaccine is less immunogenic in SARDs patients compared to the control group.
•
Rituximab, prednisone, and mycophenolate mofetil significantly reduced immunogenicity to the vaccine.
•
There is a correlation between immunogenicity and adverse effects of the vaccine.</description><subject>Adult</subject><subject>Antibodies, Viral</subject><subject>BNT162 Vaccine</subject><subject>Coronaviruses</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Fever</subject><subject>Humans</subject><subject>Immunogenicity</subject><subject>Immunoglobulin G</subject><subject>Immunoglobulin G - therapeutic use</subject><subject>Immunosuppressive agents</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>mRNA</subject><subject>mRNA Vaccines</subject><subject>Mycophenolate mofetil</subject><subject>Mycophenolic acid</subject><subject>Mycophenolic Acid - therapeutic use</subject><subject>Original</subject><subject>Original Article</subject><subject>Patients</subject><subject>Prednisone</subject><subject>Prednisone - therapeutic use</subject><subject>Rheumatic diseases</subject><subject>Rheumatic Diseases - drug therapy</subject><subject>Rheumatic Diseases - epidemiology</subject><subject>Rheumatology</subject><subject>Rituximab</subject><subject>Rituximab - therapeutic use</subject><subject>SARS-CoV-2</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Side effects</subject><subject>Spike protein</subject><subject>Vaccines</subject><issn>0770-3198</issn><issn>1434-9949</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9UUtLHTEUDkWpt7Z_wEUJuE6b10wmm4KKtoIoFLsOmczJvREnuSYzwvXXG71W242bk3NyvseBD6EDRr8xStX3UmurCOWc0FbIjjx8QAsmhSRaS72DFlQpSgTT3R76VMoNpZR3mn1Ee6KlDW2YXKB0Po5zTEuIwYVpg20ccLEeaps8nlaAx9-XR6S3BQZ8fHnNWt5zfG-dCxFwiLhsygRjcNjOUwpPYoDzCubRTvVzCAUqteB1HSFO5TPa9fa2wJeXdx_9OTu9PvlFLq5-np8cXRAnlZyIoK6XwqvOKu4llx2XFlgPbvBMW94qN0jWDppyxoUD2wvHPYeusYJ6wYXYRz-2uuu5H2Fw1TvbW7POYbR5Y5IN5v9NDCuzTPdGS9Eq1lSBwxeBnO5mKJO5SXOO9WbDlWgk1bxTFcW3KJdTKRn8qwOj5ikksw3J1JDMc0jmoZK-_nvbK-VvKhUgtoBSV3EJ-c37HdlH0-GfeQ</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Pri-Paz Basson, Yael</creator><creator>Tayer-Shifman, Oshrat E.</creator><creator>Naser, Rawand</creator><creator>Tartakover Matalon, Shelly</creator><creator>Kimhi, Oded</creator><creator>Gepstein, Raz</creator><creator>Halperin, Tamar</creator><creator>Ziv-Baran, Tomer</creator><creator>Ziv, Amit</creator><creator>Parikh, Roma</creator><creator>Kivity, Shaye</creator><creator>Levy, Yair</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-8391-5446</orcidid></search><sort><creationdate>20221201</creationdate><title>Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients</title><author>Pri-Paz Basson, Yael ; Tayer-Shifman, Oshrat E. ; Naser, Rawand ; Tartakover Matalon, Shelly ; Kimhi, Oded ; Gepstein, Raz ; Halperin, Tamar ; Ziv-Baran, Tomer ; Ziv, Amit ; Parikh, Roma ; Kivity, Shaye ; Levy, Yair</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-30cb43f78a72f424824ae1becdf19a267cd416d902123ceab3c2f2e85a30f3233</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adult</topic><topic>Antibodies, Viral</topic><topic>BNT162 Vaccine</topic><topic>Coronaviruses</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Fever</topic><topic>Humans</topic><topic>Immunogenicity</topic><topic>Immunoglobulin G</topic><topic>Immunoglobulin G - therapeutic use</topic><topic>Immunosuppressive agents</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>mRNA</topic><topic>mRNA Vaccines</topic><topic>Mycophenolate mofetil</topic><topic>Mycophenolic acid</topic><topic>Mycophenolic Acid - therapeutic use</topic><topic>Original</topic><topic>Original Article</topic><topic>Patients</topic><topic>Prednisone</topic><topic>Prednisone - therapeutic use</topic><topic>Rheumatic diseases</topic><topic>Rheumatic Diseases - drug therapy</topic><topic>Rheumatic Diseases - epidemiology</topic><topic>Rheumatology</topic><topic>Rituximab</topic><topic>Rituximab - therapeutic use</topic><topic>SARS-CoV-2</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Side effects</topic><topic>Spike protein</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pri-Paz Basson, Yael</creatorcontrib><creatorcontrib>Tayer-Shifman, Oshrat E.</creatorcontrib><creatorcontrib>Naser, Rawand</creatorcontrib><creatorcontrib>Tartakover Matalon, Shelly</creatorcontrib><creatorcontrib>Kimhi, Oded</creatorcontrib><creatorcontrib>Gepstein, Raz</creatorcontrib><creatorcontrib>Halperin, Tamar</creatorcontrib><creatorcontrib>Ziv-Baran, Tomer</creatorcontrib><creatorcontrib>Ziv, Amit</creatorcontrib><creatorcontrib>Parikh, Roma</creatorcontrib><creatorcontrib>Kivity, Shaye</creatorcontrib><creatorcontrib>Levy, Yair</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pri-Paz Basson, Yael</au><au>Tayer-Shifman, Oshrat E.</au><au>Naser, Rawand</au><au>Tartakover Matalon, Shelly</au><au>Kimhi, Oded</au><au>Gepstein, Raz</au><au>Halperin, Tamar</au><au>Ziv-Baran, Tomer</au><au>Ziv, Amit</au><au>Parikh, Roma</au><au>Kivity, Shaye</au><au>Levy, Yair</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients</atitle><jtitle>Clinical rheumatology</jtitle><stitle>Clin Rheumatol</stitle><addtitle>Clin Rheumatol</addtitle><date>2022-12-01</date><risdate>2022</risdate><volume>41</volume><issue>12</issue><spage>3879</spage><epage>3885</epage><pages>3879-3885</pages><issn>0770-3198</issn><eissn>1434-9949</eissn><abstract>Background
The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging.
Aim
To evaluate Pfizer/BioNTech (BNT162b2) mRNA-based vaccine second-dose immunogenicity and safety, and the relation between them, in patients with SARDs.
Methods
A total of one hundred forty tow adults who received two doses of the BNT162b2 vaccine were included in the study. The SARDs group included Ninety-nine patients and the control group (forty-three participants) comprised a mixture of healthy participants and patients who were seen at the rheumatology clinic for non-SARDs. Anti-SARS-CoV-2 IgG antibodies against the Spike protein were evaluated using a SARS-CoV-2 IgG immunoassay. A level of > 150 AU/mL was considered positive. An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination.
Results
Of the 142 participants, 116 were seropositive (81.7%) and 26 (18.3%) were seronegative. Of the seronegative participants, 96.2% were SARDs patients. The proportion of seropositivity in the SARDs patients treated with any immunosuppressant was significantly lower (69.9%) compared to the control group and SARDs patients not receiving immunosuppressants (96.8%). A significant negative correlation between seronegativity and treatment with rituximab, mycophenolate mofetil (MMF), and prednisone was found in the SARDs group (
p
= 0.004, 0.044, 0.007 respectively). No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (
p
= 0.045,
p
= 0.02 respectively).
Conclusion
A decline in the immunogenicity to the second dose of BNT162b2 mRNA is seen in patients with SARDs, especially in patients treated with rituximab, MMF, and prednisone. Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients.
Key Points
•
BNT162b2 mRNA vaccine is less immunogenic in SARDs patients compared to the control group.
•
Rituximab, prednisone, and mycophenolate mofetil significantly reduced immunogenicity to the vaccine.
•
There is a correlation between immunogenicity and adverse effects of the vaccine.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>36050514</pmid><doi>10.1007/s10067-022-06348-z</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-8391-5446</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0770-3198 |
| ispartof | Clinical rheumatology, 2022-12, Vol.41 (12), p.3879-3885 |
| issn | 0770-3198 1434-9949 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9436715 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Antibodies, Viral BNT162 Vaccine Coronaviruses COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Fever Humans Immunogenicity Immunoglobulin G Immunoglobulin G - therapeutic use Immunosuppressive agents Medicine Medicine & Public Health mRNA mRNA Vaccines Mycophenolate mofetil Mycophenolic acid Mycophenolic Acid - therapeutic use Original Original Article Patients Prednisone Prednisone - therapeutic use Rheumatic diseases Rheumatic Diseases - drug therapy Rheumatic Diseases - epidemiology Rheumatology Rituximab Rituximab - therapeutic use SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Side effects Spike protein Vaccines |
| title | Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients |
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