{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T12:06:11Z","timestamp":1791461171518,"version":"4.3.4"},"reference-count":58,"publisher":"American Society for Clinical Investigation","issue":"1","license":[{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"vor","delay-in-days":45,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006492","name":"Division of Intramural Research, National Institute of Allergy and Infectious Diseases","doi-asserted-by":"crossref","award":["U19AI144306,U19AI082714,U19AI110483,UM1AI110494,UM1AI144292,UM1AI144295,UM1AI144288,UM1AI144298,UM2AI117870,U19AI110483-08S4,75N93022C00003"],"award-info":[{"award-number":["U19AI144306,U19AI082714,U19AI110483,UM1AI110494,UM1AI144292,UM1AI144295,UM1AI144288,UM1AI144298,UM2AI117870,U19AI110483-08S4,75N93022C00003"]}],"id":[{"id":"10.13039\/100006492","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100006492","name":"Division of Intramural Research, National Institute of Allergy and Infectious Diseases","doi-asserted-by":"crossref","award":["UM1AI110557"],"award-info":[{"award-number":["UM1AI110557"]}],"id":[{"id":"10.13039\/100006492","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,9]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Individuals with autoimmune diseases (ADs) on immunosuppressants often have suboptimal responses to COVID-19 vaccines. We evaluated the efficacy and safety of additional COVID-19 vaccines in those treated with mycophenolate mofetil\/mycophenolic acid (MMF\/MPA), methotrexate (MTX), and B cell\u2013depleting therapy (BCDT), including the impact of withholding MMF\/MPA and MTX.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>In this open-label, multicenter, randomized trial, 22 participants taking MMF\/MPA, 26 taking MTX, and 93 treated with BCDT who had suboptimal antibody responses to initial COVID-19 vaccines (2 doses of BNT162b2 or mRNA-1273 or 1 dose of AD26.COV2.S) received an additional homologous vaccine. Participants taking MMF\/MPA and MTX were randomized (1:1) to continue or withhold treatment around vaccination. The primary outcome was the change in anti\u2013Wuhan-Hu-1 receptor-binding domain (RBD) concentrations at 4 weeks after additional vaccination. Secondary outcomes included adverse events, COVID-19, and AD activity through 48 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Additional vaccination increased anti-RBD concentrations in participants taking MMF\/MPA and MTX, irrespective of immunosuppressant withholding. BCDT-treated participants also demonstrated increased anti-RBD concentrations, albeit lower than MMF\/MPA- and MTX-treated cohorts. COVID-19 occurred in 33% of participants; infections were predominantly mild and included only 3 nonfatal hospitalizations. Additional vaccination was well tolerated, with low frequencies of severe disease flares and adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Additional COVID-19 vaccination is effective and safe in individuals with ADs treated with immunosuppressants, regardless of whether MMF\/MPA or MTX is withheld.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>TRIAL REGISTRATION<\/jats:title>\n                    <jats:p>ClinicalTrials.gov (NCT05000216; registered August 6, 2021: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05000216).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>FUNDING<\/jats:title>\n                    <jats:p>The NIH\/NIAID supported the study through the Autoimmunity Centers of Excellence and the Intramural Research Program<\/jats:p>\n    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