{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T18:58:02Z","timestamp":1769108282919,"version":"3.49.0"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,1,11]],"date-time":"2022-01-11T00:00:00Z","timestamp":1641859200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,11]],"date-time":"2022-01-11T00:00:00Z","timestamp":1641859200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100009882","name":"regione lombardia","doi-asserted-by":"publisher","award":["Lombardy Region 2014-2020 regional operational programme"],"award-info":[{"award-number":["Lombardy Region 2014-2020 regional operational programme"]}],"id":[{"id":"10.13039\/501100009882","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arthritis Res Ther"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Little is known about the safety of SARS-CoV-2 vaccination in patients with rheumatic musculoskeletal disease (RMD). We evaluated the occurrence of adverse events following immunization (AEFI) in RMD patients and heathy subjects who received anti-SARS-CoV-2 mRNA vaccine.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We performed a telephone interview collecting any adverse event (AE) following immunization (AEFI) that occurred in RMD patients and healthy controls after the two doses of mRNA vaccine including common local reactogenicity and systemic events (for example, fever, fatigue\/malaise, joint and muscle pain). We also investigated the onset of new signs or symptoms of the RMD after the vaccination.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>We evaluated 126 patients with RMDs [105 females and 19 males, median age 51(IQR 17)] and 85 controls [62 females and 23 males, (median age 49 (20)]. Seventy patients (55.6%) were taking immunosuppressants, conventional synthetic (<jats:italic>n<\/jats:italic>=31, 43.3%) and\/or biological [TNF inhibitors (<jats:italic>n<\/jats:italic>=49, 68.6%)], and 30 (23.8%) were taking hydroxychloroquine; treatment remained unchanged in 77% of patients. Eleven out of 126 patients and none of the 85 controls previously\u00a0contracted COVID-19. The median follow-up from the completion of vaccination was 15 (3) weeks both in patients and controls. We reviewed 5 suspected cases confirming mild articular flares in 3 women (2.8) with inflammatory arthritis (2 psoriatic arthritis and 1 rheumatoid arthritis) while no disease reactivation was recorded in patients with connective tissue diseases; the incidence rate of RMD reactivation was 0.007 person\/month. Multivariable logistic regression analysis showed similar frequencies of local and systemic AEFI in patients and controls with no effect of therapies or previous COVID-19. Local reaction\u2014pain in the injection site\u2014was the most frequently reported AEFI both in RMD and controls (71% and 75% of all the AEFI, respectively) after the first dose. Overall, up to 66% of patients experienced at least one AEFI at the second dose and up to 62% in the control group. Most of AEFI occurred within 2 days of vaccine administration. Two RMD patients developed pauci-symptomatic COVID-19 after the first dose of vaccine.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The low incidence rate of disease reactivation and the similar AEFI occurrence compared to controls should reassure on mRNA vaccine safety in RMD patients.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13075-021-02674-w","type":"journal-article","created":{"date-parts":[[2022,1,11]],"date-time":"2022-01-11T06:02:26Z","timestamp":1641880946000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":43,"title":["Low frequency of disease flare in patients with rheumatic musculoskeletal diseases who received SARS-CoV-2 mRNA vaccine"],"prefix":"10.1186","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1969-2097","authenticated-orcid":false,"given":"Francesca Romana","family":"Spinelli","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ennio Giulio","family":"Favalli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Garufi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martina","family":"Cornalba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serena","family":"Colafrancesco","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabrizio","family":"Conti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Caporali","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,1,11]]},"reference":[{"key":"2674_CR1","doi-asserted-by":"publisher","unstructured":"Connolly CM, Ruddy JA, Boyarsky BJ, Avery RK, Werbel WA, Segev DL, et al. Safety of\u00a0the\u00a0first\u00a0dose of\u00a0mRNA SARS-CoV-2\u00a0vaccines in\u00a0patients with rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2021:annrheumdis-2021-220231. https:\/\/doi.org\/10.1136\/annrheumdis-2021-220231.","DOI":"10.1136\/annrheumdis-2021-220231"},{"issue":"27","key":"2674_CR2","doi-asserted-by":"publisher","first-page":"2603","DOI":"10.1056\/NEJMoa2034577","volume":"383","author":"FP Polack","year":"2020","unstructured":"Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med. 2020;383(27):2603\u201315. https:\/\/doi.org\/10.1056\/NEJMoa2034577.","journal-title":"N Engl J Med."},{"issue":"5","key":"2674_CR3","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1056\/NEJMoa2035389","volume":"384","author":"LR Baden","year":"2021","unstructured":"Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403\u201316. https:\/\/doi.org\/10.1056\/NEJMoa2035389.","journal-title":"N Engl J Med."},{"key":"2674_CR4","doi-asserted-by":"publisher","first-page":"170","DOI":"10.12688\/f1000research.22600.2","volume":"9","author":"P Bellavite","year":"2020","unstructured":"Bellavite P. Causality assessment of adverse events following immunization: the problem of multifactorial pathology. F1000Res. 2020;9:170. https:\/\/doi.org\/10.12688\/f1000research.22600.2.","journal-title":"F1000Res."},{"key":"2674_CR5","doi-asserted-by":"publisher","unstructured":"Priori R, Pellegrino G, Colafrancesco S, Alessandri C, Ceccarelli F, Di Franco M, et al. SARS-CoV-2 vaccine hesitancy among patients with rheumatic and musculoskeletal diseases: a message for rheumatologists. Ann Rheum Dis. 2021:annrheumdis-2021-220059. https:\/\/doi.org\/10.1136\/annrheumdis-2021-220059.","DOI":"10.1136\/annrheumdis-2021-220059"},{"key":"2674_CR6","doi-asserted-by":"publisher","unstructured":"Campochiaro C, Trignani G, Tomelleri A, Cascinu S, Dagna L. Potential acceptance of COVID-19 vaccine in rheumatological patients: a monocentric comparative survey. Ann Rheum Dis. 2021:annrheumdis-2020-219811. https:\/\/doi.org\/10.1136\/annrheumdis-2020-219811.","DOI":"10.1136\/annrheumdis-2020-219811"},{"key":"2674_CR7","doi-asserted-by":"crossref","unstructured":"Felten R, Dubois M, Ugarte-Gil MF, Chaudier A, Kawka L, Bergier Het al. Vaccination against COVID-19: expectations and concerns of patients with autoimmune and rheumatic diseases. 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The Local Ethical Committee has approved the research (Sapienza Universit\u00e0 di Roma Ethical Committee - protocol 0501\/2021). All the subjects gave their informed consent to use their anonymized data for the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"21"}}