Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine

Most of the published data relate to classical forms of rheumatic diseases (RD) and information on rare inflammatory disorders such as Behçet’s syndrome (BS) and familial Mediterranean fever (FMF) is limited. We studied the frequency of side effects and disease flares after COVID-19 vaccination with...

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Veröffentlicht in:Rheumatology international 2022-06, Vol.42 (6), p.973-987
Hauptverfasser: Ozdede, Ayse, Guner, Sabriye, Ozcifci, Guzin, Yurttas, Berna, Toker Dincer, Zeynep, Atli, Zeynep, Uygunoğlu, Uğur, Durmaz, Eser, Uçar, Didar, Uğurlu, Serdal, Saip, Sabahattin, Tabak, Fehmi, Hamuryudan, Vedat, Seyahi, Emire
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container_issue 6
container_start_page 973
container_title Rheumatology international
container_volume 42
creator Ozdede, Ayse
Guner, Sabriye
Ozcifci, Guzin
Yurttas, Berna
Toker Dincer, Zeynep
Atli, Zeynep
Uygunoğlu, Uğur
Durmaz, Eser
Uçar, Didar
Uğurlu, Serdal
Saip, Sabahattin
Tabak, Fehmi
Hamuryudan, Vedat
Seyahi, Emire
description Most of the published data relate to classical forms of rheumatic diseases (RD) and information on rare inflammatory disorders such as Behçet’s syndrome (BS) and familial Mediterranean fever (FMF) is limited. We studied the frequency of side effects and disease flares after COVID-19 vaccination with either Pfizer/BioNTech or Sinovac/CoronaVac in 256 patients with BS, 247 with FMF, and 601 with RD. Telephone interviews were conducted using a questionnaire survey in a cross-sectional design in patients with BS, FMF, and RD followed by a single university hospital. Study participants were vaccinated either with CoronaVac (BS:109, FMF: 90, and RD: 343,) or BioNTech (BS: 147, FMF: 157 and RD: 258). The majority have received double dose (BS: 94.9%, FMF 92.3% and RD: 86.2%). BioNTech ensured a significantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS: 1.4% vs 10.1%; FMF: 3.2% vs 12.2%, RD:2.7% vs 6.4%). Those with at least one adverse event (AE) were significantly more frequent among those vaccinated with BioNTech than those with CoronaVac (BS: 86.4% vs 45%; FMF: 83.4% vs 53.3%; and RD: 83.3% vs 45.5%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS: 5.5%, FMF: 3.3%, and RD:2.9%) or BioNTech (BS: 5.4%, FMF: 1.9%, and RD: 4.7%). The main causes for medical assistance were disease flare and cardiovascular events. Patients with BS (16.0%) and FMF (17.4%) were found to flare significantly more frequently when compared to those with RD (6.0%) ( p  
doi_str_mv 10.1007/s00296-022-05119-y
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We studied the frequency of side effects and disease flares after COVID-19 vaccination with either Pfizer/BioNTech or Sinovac/CoronaVac in 256 patients with BS, 247 with FMF, and 601 with RD. Telephone interviews were conducted using a questionnaire survey in a cross-sectional design in patients with BS, FMF, and RD followed by a single university hospital. Study participants were vaccinated either with CoronaVac (BS:109, FMF: 90, and RD: 343,) or BioNTech (BS: 147, FMF: 157 and RD: 258). The majority have received double dose (BS: 94.9%, FMF 92.3% and RD: 86.2%). BioNTech ensured a significantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS: 1.4% vs 10.1%; FMF: 3.2% vs 12.2%, RD:2.7% vs 6.4%). Those with at least one adverse event (AE) were significantly more frequent among those vaccinated with BioNTech than those with CoronaVac (BS: 86.4% vs 45%; FMF: 83.4% vs 53.3%; and RD: 83.3% vs 45.5%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS: 5.5%, FMF: 3.3%, and RD:2.9%) or BioNTech (BS: 5.4%, FMF: 1.9%, and RD: 4.7%). The main causes for medical assistance were disease flare and cardiovascular events. Patients with BS (16.0%) and FMF (17.4%) were found to flare significantly more frequently when compared to those with RD (6.0%) ( p  &lt; 0.001). This was true for either vaccine. BS patients reported mainly skin-mucosa lesions; there were however, 11 (4.3%) who developed major organ attack such as uveitis, thrombosis or stroke. Flare in FMF patients were associated mainly with acute serositis with or without fever. Arthralgia/arthritis or inflammatory back pain were observed mainly in the RD group. Our study demonstrates that BS and FMF patients vaccinated with either CoronaVac or BioNTech demonstrated similar AE profile and frequency compared to RD patients. AEs that required physician consultation or hospitalization occurred in all study groups after either CoronaVac or BioNTech. Increased frequency of flares in BS and FMF compared to that seen in RD might reflect defects in innate immunity and deserves further investigation. Caution should be required when monitoring these patients after vaccination.</description><identifier>ISSN: 1437-160X</identifier><identifier>ISSN: 0172-8172</identifier><identifier>EISSN: 1437-160X</identifier><identifier>DOI: 10.1007/s00296-022-05119-y</identifier><identifier>PMID: 35376962</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Behcet Syndrome - complications ; Coronaviruses ; COVID-19 - prevention &amp; control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Cross-Sectional Studies ; Familial Mediterranean Fever - complications ; Fever ; Humans ; Medicine ; Medicine &amp; Public Health ; Observational Research ; Pain - complications ; Rheumatic Diseases - complications ; Rheumatology ; RNA ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; Vaccination - adverse effects ; Vaccines, Inactivated ; Vein &amp; artery diseases</subject><ispartof>Rheumatology international, 2022-06, Vol.42 (6), p.973-987</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022</rights><rights>2022. 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We studied the frequency of side effects and disease flares after COVID-19 vaccination with either Pfizer/BioNTech or Sinovac/CoronaVac in 256 patients with BS, 247 with FMF, and 601 with RD. Telephone interviews were conducted using a questionnaire survey in a cross-sectional design in patients with BS, FMF, and RD followed by a single university hospital. Study participants were vaccinated either with CoronaVac (BS:109, FMF: 90, and RD: 343,) or BioNTech (BS: 147, FMF: 157 and RD: 258). The majority have received double dose (BS: 94.9%, FMF 92.3% and RD: 86.2%). BioNTech ensured a significantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS: 1.4% vs 10.1%; FMF: 3.2% vs 12.2%, RD:2.7% vs 6.4%). Those with at least one adverse event (AE) were significantly more frequent among those vaccinated with BioNTech than those with CoronaVac (BS: 86.4% vs 45%; FMF: 83.4% vs 53.3%; and RD: 83.3% vs 45.5%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS: 5.5%, FMF: 3.3%, and RD:2.9%) or BioNTech (BS: 5.4%, FMF: 1.9%, and RD: 4.7%). The main causes for medical assistance were disease flare and cardiovascular events. Patients with BS (16.0%) and FMF (17.4%) were found to flare significantly more frequently when compared to those with RD (6.0%) ( p  &lt; 0.001). This was true for either vaccine. BS patients reported mainly skin-mucosa lesions; there were however, 11 (4.3%) who developed major organ attack such as uveitis, thrombosis or stroke. Flare in FMF patients were associated mainly with acute serositis with or without fever. Arthralgia/arthritis or inflammatory back pain were observed mainly in the RD group. Our study demonstrates that BS and FMF patients vaccinated with either CoronaVac or BioNTech demonstrated similar AE profile and frequency compared to RD patients. AEs that required physician consultation or hospitalization occurred in all study groups after either CoronaVac or BioNTech. Increased frequency of flares in BS and FMF compared to that seen in RD might reflect defects in innate immunity and deserves further investigation. Caution should be required when monitoring these patients after vaccination.</description><subject>Behcet Syndrome - complications</subject><subject>Coronaviruses</subject><subject>COVID-19 - prevention &amp; control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Cross-Sectional Studies</subject><subject>Familial Mediterranean Fever - complications</subject><subject>Fever</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Observational Research</subject><subject>Pain - complications</subject><subject>Rheumatic Diseases - complications</subject><subject>Rheumatology</subject><subject>RNA</subject><subject>SARS-CoV-2</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Vaccination - adverse effects</subject><subject>Vaccines, Inactivated</subject><subject>Vein &amp; artery diseases</subject><issn>1437-160X</issn><issn>0172-8172</issn><issn>1437-160X</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>eNp9ks1uEzEUhUcIREvhBVggS2zYGPwzsWdYIIWIP6kFqQHEznLs68bVjJ3aTlB2vAaPw6vwJDhNKYUF3tiWv3vu8dVpmoeUPKWEyGeZENYLTBjDZEJpj7e3mkPacompIF9u3zgfNPdyPieESiHI3eaAT7gUvWCHzY-5dlC2KDo0n57O8Sx-xgxttDE-6OJjQD6gVT1BKBl99WWJXsLSQPn57XtGeRtsiiMgHSxyevSD1wM6AesLpKQD6IAcbCA9RxqZFHPGGcxOtmImjiudqvQGUC5rW00EVJaAwLkK5Z2nE3z6fooWOoO97FFN1fKNLvW-Nwn3mztODxkeXO1HzafXrz7O3uLjD2_ezabH2LSkLbh33EpjyMJaYwXVktDeck3MonOaOqPtAuTE1sU70_WUdJwJ2kk74a1p-54fNS_2uqv1YgRr6kCSHtQq-VGnrYraq79fgl-qs7hRXS9ly3kVeHIlkOLFGnJRo88GhqHOKa6zYqIVfTthlFT08T_oeVynOrQdJaRgrOU7iu2py8kmcNdmKFG7hKh9QlRNiLpMiNrWokc3v3Fd8jsSFeB7INencAbpT-__yP4CsRzM6A</recordid><startdate>20220601</startdate><enddate>20220601</enddate><creator>Ozdede, Ayse</creator><creator>Guner, Sabriye</creator><creator>Ozcifci, Guzin</creator><creator>Yurttas, Berna</creator><creator>Toker Dincer, Zeynep</creator><creator>Atli, Zeynep</creator><creator>Uygunoğlu, Uğur</creator><creator>Durmaz, Eser</creator><creator>Uçar, Didar</creator><creator>Uğurlu, Serdal</creator><creator>Saip, Sabahattin</creator><creator>Tabak, Fehmi</creator><creator>Hamuryudan, Vedat</creator><creator>Seyahi, Emire</creator><general>Springer Berlin Heidelberg</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>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>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9561-2282</orcidid><orcidid>https://orcid.org/0000-0002-9582-8374</orcidid><orcidid>https://orcid.org/0000-0002-2802-7227</orcidid><orcidid>https://orcid.org/0000-0002-6531-8138</orcidid><orcidid>https://orcid.org/0000-0002-1468-0153</orcidid><orcidid>https://orcid.org/0000-0002-2959-0978</orcidid><orcidid>https://orcid.org/0000-0002-6096-0340</orcidid><orcidid>https://orcid.org/0000-0002-4774-9284</orcidid><orcidid>https://orcid.org/0000-0003-4965-2918</orcidid><orcidid>https://orcid.org/0000-0003-2866-4004</orcidid><orcidid>https://orcid.org/0000-0001-6625-1652</orcidid><orcidid>https://orcid.org/0000-0002-0762-7725</orcidid><orcidid>https://orcid.org/0000-0001-8632-2825</orcidid><orcidid>https://orcid.org/0000-0002-3469-7307</orcidid></search><sort><creationdate>20220601</creationdate><title>Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine</title><author>Ozdede, Ayse ; Guner, Sabriye ; Ozcifci, Guzin ; Yurttas, Berna ; Toker Dincer, Zeynep ; Atli, Zeynep ; Uygunoğlu, Uğur ; Durmaz, Eser ; Uçar, Didar ; Uğurlu, Serdal ; Saip, Sabahattin ; Tabak, Fehmi ; Hamuryudan, Vedat ; Seyahi, Emire</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c404t-9f3d7cc0bddcd61a7019d3a0cb8fa1fcadbe75dddd38c89108326187d534c4993</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Behcet Syndrome - complications</topic><topic>Coronaviruses</topic><topic>COVID-19 - prevention &amp; control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Cross-Sectional Studies</topic><topic>Familial Mediterranean Fever - complications</topic><topic>Fever</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Observational Research</topic><topic>Pain - complications</topic><topic>Rheumatic Diseases - complications</topic><topic>Rheumatology</topic><topic>RNA</topic><topic>SARS-CoV-2</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Vaccination - adverse effects</topic><topic>Vaccines, Inactivated</topic><topic>Vein &amp; 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We studied the frequency of side effects and disease flares after COVID-19 vaccination with either Pfizer/BioNTech or Sinovac/CoronaVac in 256 patients with BS, 247 with FMF, and 601 with RD. Telephone interviews were conducted using a questionnaire survey in a cross-sectional design in patients with BS, FMF, and RD followed by a single university hospital. Study participants were vaccinated either with CoronaVac (BS:109, FMF: 90, and RD: 343,) or BioNTech (BS: 147, FMF: 157 and RD: 258). The majority have received double dose (BS: 94.9%, FMF 92.3% and RD: 86.2%). BioNTech ensured a significantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS: 1.4% vs 10.1%; FMF: 3.2% vs 12.2%, RD:2.7% vs 6.4%). Those with at least one adverse event (AE) were significantly more frequent among those vaccinated with BioNTech than those with CoronaVac (BS: 86.4% vs 45%; FMF: 83.4% vs 53.3%; and RD: 83.3% vs 45.5%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS: 5.5%, FMF: 3.3%, and RD:2.9%) or BioNTech (BS: 5.4%, FMF: 1.9%, and RD: 4.7%). The main causes for medical assistance were disease flare and cardiovascular events. Patients with BS (16.0%) and FMF (17.4%) were found to flare significantly more frequently when compared to those with RD (6.0%) ( p  &lt; 0.001). This was true for either vaccine. BS patients reported mainly skin-mucosa lesions; there were however, 11 (4.3%) who developed major organ attack such as uveitis, thrombosis or stroke. Flare in FMF patients were associated mainly with acute serositis with or without fever. Arthralgia/arthritis or inflammatory back pain were observed mainly in the RD group. Our study demonstrates that BS and FMF patients vaccinated with either CoronaVac or BioNTech demonstrated similar AE profile and frequency compared to RD patients. AEs that required physician consultation or hospitalization occurred in all study groups after either CoronaVac or BioNTech. Increased frequency of flares in BS and FMF compared to that seen in RD might reflect defects in innate immunity and deserves further investigation. Caution should be required when monitoring these patients after vaccination.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>35376962</pmid><doi>10.1007/s00296-022-05119-y</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0002-9561-2282</orcidid><orcidid>https://orcid.org/0000-0002-9582-8374</orcidid><orcidid>https://orcid.org/0000-0002-2802-7227</orcidid><orcidid>https://orcid.org/0000-0002-6531-8138</orcidid><orcidid>https://orcid.org/0000-0002-1468-0153</orcidid><orcidid>https://orcid.org/0000-0002-2959-0978</orcidid><orcidid>https://orcid.org/0000-0002-6096-0340</orcidid><orcidid>https://orcid.org/0000-0002-4774-9284</orcidid><orcidid>https://orcid.org/0000-0003-4965-2918</orcidid><orcidid>https://orcid.org/0000-0003-2866-4004</orcidid><orcidid>https://orcid.org/0000-0001-6625-1652</orcidid><orcidid>https://orcid.org/0000-0002-0762-7725</orcidid><orcidid>https://orcid.org/0000-0001-8632-2825</orcidid><orcidid>https://orcid.org/0000-0002-3469-7307</orcidid><oa>free_for_read</oa></addata></record>
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identifier ISSN: 1437-160X
ispartof Rheumatology international, 2022-06, Vol.42 (6), p.973-987
issn 1437-160X
0172-8172
1437-160X
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8977433
source MEDLINE; SpringerLink Journals - AutoHoldings
subjects Behcet Syndrome - complications
Coronaviruses
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Cross-Sectional Studies
Familial Mediterranean Fever - complications
Fever
Humans
Medicine
Medicine & Public Health
Observational Research
Pain - complications
Rheumatic Diseases - complications
Rheumatology
RNA
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Vaccination - adverse effects
Vaccines, Inactivated
Vein & artery diseases
title Safety of SARS-CoV-2 vaccination in patients with Behcet’s syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine
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