{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T23:58:36Z","timestamp":1791244716131,"version":"4.1.0"},"reference-count":33,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,8,11]],"date-time":"2025-08-11T00:00:00Z","timestamp":1754870400000},"content-version":"unspecified","delay-in-days":41,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2025,6,20]]},"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the immunogenicity of adjuvanted recombinant zoster vaccine (RZV) in patients with rheumatoid arthritis receiving upadacitinib 15\u2009mg once daily (QD) with background methotrexate.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Eligible patients in SELECT-COMPARE (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02629159\">NCT02629159<\/jats:ext-link>) receiving upadacitinib 15\u2009mg QD and background methotrexate received RZV at weeks 0 and 12. Antibody titres were collected at weeks 0, 4, 16 and 60 (prevaccination, 4 weeks after first dose, and 4 and 48 weeks after second dose). The primary endpoint was the proportion of patients achieving a satisfactory humoral response to RZV at week 16 (\u2265\u20094-fold increase in prevaccination anti-glycoprotein E (gE) antibody titres). Cell-mediated immune (CMI) response to RZV (\u2265\u20092-fold increase in prevaccination gE-specific CD4+ [2+] T-cell frequency) was assessed at each time point in a subcohort of 38 patients. Safety was assessed for 30 days after each vaccination.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 93 patients received both RZV doses (78.5% female; mean age, 62.4 years). At baseline, 49.5% used concomitant corticosteroids (median daily dose, 5.0 mg). Satisfactory humoral responses to RZV were observed in 87.8% (95% CI 81.0 to 94.5) of patients at week 16. Age and concomitant corticosteroid use did not affect RZV antibody response. Over 60% of patients achieved a CMI response to RZV at all time points. No serious adverse events were reported. One patient developed herpes zoster 4 months after the second RZV dose.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Most patients receiving upadacitinib 15 mg QD with background methotrexate achieved satisfactory humoral and CMI responses 4 weeks after the second RZV vaccination (week 16).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2025-005521","type":"journal-article","created":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T07:30:26Z","timestamp":1755070226000},"page":"e005521","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct02629159","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02629159","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3892-6947","authenticated-orcid":false,"given":"Kevin L","family":"Winthrop","sequence":"first","affiliation":[{"name":"Schools of Medicine and Public Health, Oregon Health & Science University School of Medicine, Portland, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Klaff","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara K","family":"Penn","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanxi","family":"Liu","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrado","family":"Garc\u00eda","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Hospital General de M\u00e9xico Dr Eduardo Liceaga, Mexico City, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Mysler","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Organizaci\u00f3n M\u00e9dica de Investigaci\u00f3n SA, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alvin F","family":"Wells","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, American Medical Group, Destin, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianwei","family":"Bu","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Fish","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Chen","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony L","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Centre for Virus Research, The Westmead Institute for Medical Research, Sydney ID, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,8,12]]},"reference":[{"key":"2025081300302019000_11.3.e005521.1","doi-asserted-by":"publisher","DOI":"10.1002\/art.10524"},{"key":"2025081300302019000_11.3.e005521.2","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kes305"},{"key":"2025081300302019000_11.3.e005521.3","doi-asserted-by":"crossref","DOI":"10.3390\/ijerph20032123","article-title":"Herpes Zoster Risk in Patients with Rheumatoid Arthritis and Its Association with Medications Used","volume":"20","author":"Dlamini","year":"2023","journal-title":"Int J Environ Res Public Health"},{"key":"2025081300302019000_11.3.e005521.4","doi-asserted-by":"publisher","DOI":"10.1002\/art.23112"},{"key":"2025081300302019000_11.3.e005521.5","doi-asserted-by":"crossref","first-page":"854","DOI":"10.1002\/acr.21928","article-title":"Incidence and time trends of herpes zoster in rheumatoid arthritis: a population-based cohort study","volume":"65","author":"Veetil","year":"2013","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"2025081300302019000_11.3.e005521.6","doi-asserted-by":"crossref","first-page":"2328","DOI":"10.1002\/art.39670","article-title":"Risk of Herpes Zoster in Autoimmune and Inflammatory Diseases: Implications for Vaccination","volume":"68","author":"Yun","year":"2016","journal-title":"Arthritis Rheumatol"},{"key":"2025081300302019000_11.3.e005521.7","doi-asserted-by":"crossref","first-page":"2133","DOI":"10.1007\/s10067-024-06980-x","article-title":"Higher infection risk for JAK inhibitors tofacitinib and baricitinib compared to subcutaneous biological DMARDs","volume":"43","author":"Opdam","year":"2024","journal-title":"Clin 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SHINGRIX\u00ae (Zoster vaccine recombinant, adjuvanted). 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ZOSTAVAX\u00ae (Zoster vaccine live). Prescribing information, Available: https:\/\/www.fda.gov\/media\/82524\/download [Accessed Oct 2024]."},{"key":"2025081300302019000_11.3.e005521.22","doi-asserted-by":"crossref","first-page":"6205","DOI":"10.1016\/j.vaccine.2020.07.049","article-title":"A systematic literature review of the recombinant subunit herpes zoster vaccine use in immunocompromised 18\u201349 year old patients","volume":"38","author":"Racine","year":"2020","journal-title":"Vaccine (Auckl)"},{"key":"2025081300302019000_11.3.e005521.23","doi-asserted-by":"crossref","first-page":"1459","DOI":"10.1093\/cid\/ciab629","article-title":"The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70","volume":"74","author":"Boutry","year":"2022","journal-title":"Clin Infect Dis"},{"key":"2025081300302019000_11.3.e005521.24","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.9053"},{"key":"2025081300302019000_11.3.e005521.25","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2023-003902","article-title":"Immunogenicity and influence on disease activity of recombinant zoster vaccine in patients with rheumatoid arthritis treated with DMARDs","volume":"10","author":"Kojima","year":"2024","journal-title":"RMD Open"},{"key":"2025081300302019000_11.3.e005521.26","doi-asserted-by":"crossref","DOI":"10.3390\/ijms24086967","article-title":"Immunogenicity and Safety of Adjuvanted Recombinant Zoster Vaccine in Rheumatoid Arthritis Patients on Anti-Cellular Biologic Agents or JAK Inhibitors: A Prospective Observational Study","volume":"24","author":"Venerito","year":"2023","journal-title":"Int J Mol Sci"},{"key":"2025081300302019000_11.3.e005521.27","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2021-002110","article-title":"Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study","volume":"8","author":"Winthrop","year":"2022","journal-title":"RMD Open"},{"key":"2025081300302019000_11.3.e005521.28","doi-asserted-by":"crossref","DOI":"10.1172\/JCI172634","article-title":"Recruitment of naive CD4+ T cells by the recombinant zoster vaccine correlates with persistent immunity","volume":"133","author":"Laing","year":"2023","journal-title":"J Clin Invest"},{"key":"2025081300302019000_11.3.e005521.29","doi-asserted-by":"publisher","DOI":"10.1007\/82_2010_31"},{"key":"2025081300302019000_11.3.e005521.30","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2021.1930846"},{"key":"2025081300302019000_11.3.e005521.31","doi-asserted-by":"crossref","first-page":"1226","DOI":"10.1093\/rheumatology\/keaa424","article-title":"Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials","volume":"60","author":"Dagnew","year":"2021","journal-title":"Rheumatology (Oxford)"},{"key":"2025081300302019000_11.3.e005521.32","doi-asserted-by":"crossref","DOI":"10.1080\/21645515.2023.2278362","article-title":"Recombinant zoster vaccine in immunocompetent and immunocompromised adults: A review of clinical studies","volume":"19","author":"Mwakingwe-Omari","year":"2023","journal-title":"Hum Vaccin Immunother"},{"key":"2025081300302019000_11.3.e005521.33","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1186\/s13075-025-03528-5","article-title":"Achievement of treatment targets and maintenance of response with upadacitinib in patients with moderate-to-severe rheumatoid arthritis in real-world practice: 1-year outcomes from the UPHOLD observational study","volume":"27","author":"\u00d6st\u00f6r","year":"2025","journal-title":"Arthritis Res Ther"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2025-005521","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T07:30:29Z","timestamp":1755070229000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2025-005521"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7]]},"references-count":33,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2025,8,12]]},"published-print":{"date-parts":[[2025,7]]}},"alternative-id":["10.1136\/rmdopen-2025-005521"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2025-005521","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7]]}}}