dc.contributor.author | Abhishek, A | en_US |
dc.contributor.author | Peckham, N | en_US |
dc.contributor.author | Pade, C | en_US |
dc.contributor.author | Gibbons, JM | en_US |
dc.contributor.author | Cureton, L | en_US |
dc.contributor.author | Francis, A | en_US |
dc.contributor.author | Barber, V | en_US |
dc.contributor.author | Williams, JAE | en_US |
dc.contributor.author | Appelbe, D | en_US |
dc.contributor.author | Eldridge, L | en_US |
dc.contributor.author | Julier, P | en_US |
dc.contributor.author | Altmann, DM | en_US |
dc.contributor.author | Bluett, J | en_US |
dc.contributor.author | Brooks, T | en_US |
dc.contributor.author | Coates, LC | en_US |
dc.contributor.author | Rombach, I | en_US |
dc.contributor.author | Semper, A | en_US |
dc.contributor.author | Otter, A | en_US |
dc.contributor.author | Valdes, AM | en_US |
dc.contributor.author | Nguyen-Van-Tam, JS | en_US |
dc.contributor.author | Williams, HC | en_US |
dc.contributor.author | Boyton, RJ | en_US |
dc.contributor.author | McKnight, Á | en_US |
dc.contributor.author | Cook, JA | en_US |
dc.contributor.author | VROOM study investigators | en_US |
dc.date.accessioned | 2024-02-14T09:49:50Z | |
dc.date.available | 2023-10-30 | en_US |
dc.date.issued | 2024-02 | en_US |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/94625 | |
dc.description.abstract | BACKGROUND: Methotrexate is the first-line treatment for immune-mediated inflammatory diseases and reduces vaccine-induced immunity. We evaluated if a 2-week interruption of methotrexate treatment immediately after COVID-19 booster vaccination improved antibody response against the S1 receptor binding domain (S1-RBD) of the SARS-CoV-2 spike protein and live SARS-CoV-2 neutralisation compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases. METHOD: We did a multicentre, open-label, parallel-group, randomised, superiority trial in secondary-care rheumatology and dermatology clinics in 26 hospitals in the UK. Adults (aged ≥18 years) with immune-mediated inflammatory diseases taking methotrexate (≤25 mg per week) for at least 3 months, who had received two primary vaccine doses from the UK COVID-19 vaccination programme were eligible. Participants were randomly assigned (1:1) using a centralised validated computer program, to temporarily suspend methotrexate treatment for 2 weeks immediately after COVID-19 booster vaccination or continue treatment as usual. The primary outcome was S1-RBD antibody titres 4 weeks after COVID-19 booster vaccination and was assessed masked to group assignment. All randomly assigned patients were included in primary and safety analyses. This trial is registered with ISRCTN, ISRCTN11442263; following a pre-planned interim analysis, recruitment was stopped early. FINDING: Between Sept 30, 2021, and March 7, 2022, we screened 685 individuals, of whom 383 were randomly assigned: to either suspend methotrexate (n=191; mean age 58·8 years [SD 12·5], 118 [62%] women and 73 [38%] men) or to continue methotrexate (n=192; mean age 59·3 years [11·9], 117 [61%] women and 75 [39%] men). At 4 weeks, the geometric mean S1-RBD antibody titre was 25 413 U/mL (95% CI 22 227-29 056) in the suspend methotrexate group and 12 326 U/mL (10 538-14 418) in the continue methotrexate group with a geometric mean ratio (GMR) of 2·08 (95% CI 1·59-2·70; p<0·0001). No intervention-related serious adverse events occurred. INTERPRETATION: 2-week interruption of methotrexate treatment in people with immune-mediated inflammatory diseases enhanced antibody responses after COVID-19 booster vaccination that were sustained at 12 weeks and 26 weeks. There was a temporary increase in inflammatory disease flares, mostly self-managed. The choice to suspend methotrexate should be individualised based on disease status and vulnerability to severe outcomes from COVID-19. FUNDING: National Institute for Health and Care Research. | en_US |
dc.format.extent | e92 - e104 | en_US |
dc.language | eng | en_US |
dc.relation.ispartof | Lancet Rheumatol | en_US |
dc.rights | This is an Open Access article under the CC BY 4.0 license. | |
dc.subject | Adult | en_US |
dc.subject | Male | en_US |
dc.subject | Humans | en_US |
dc.subject | Female | en_US |
dc.subject | Adolescent | en_US |
dc.subject | Middle Aged | en_US |
dc.subject | COVID-19 Vaccines | en_US |
dc.subject | Methotrexate | en_US |
dc.subject | COVID-19 | en_US |
dc.subject | SARS-CoV-2 | en_US |
dc.subject | Spike Glycoprotein, Coronavirus | en_US |
dc.title | Effect of a 2-week interruption in methotrexate treatment on COVID-19 vaccine response in people with immune-mediated inflammatory diseases (VROOM study): a randomised, open label, superiority trial. | en_US |
dc.type | Article | |
dc.rights.holder | © 2022 The Author(s). Published by Elsevier Ltd. | |
dc.identifier.doi | 10.1016/S2665-9913(23)00298-9 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/38267107 | en_US |
pubs.issue | 2 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 6 | en_US |
dcterms.dateAccepted | 2023-10-30 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |