TY - JOUR T1 - Immunogenicity and safety of a three-dose SARS-CoV-2 vaccination strategy in patients with immune-mediated inflammatory diseases on immunosuppressive therapy JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2022-002417 VL - 8 IS - 2 SP - e002417 AU - Silje Watterdal Syversen AU - Ingrid Jyssum AU - Anne Therese Tveter AU - Joe Sexton AU - Ingrid Egeland Christensen AU - Trung T Tran AU - Kristin Hammersbøen Bjørlykke AU - Siri Mjaaland AU - David J Warren AU - Tore K Kvien AU - Adity Chopra AU - Grete Birkeland Kro AU - Jorgen Jahnsen AU - Ludvig A Munthe AU - Espen A Haavardsholm AU - Gunnveig Grødeland AU - John Torgils Vaage AU - Sella Aarrestad Provan AU - Kristin Kaasen Jørgensen AU - Guro Løvik Goll Y1 - 2022/11/01 UR - http://rmdopen.bmj.com/content/8/2/e002417.abstract N2 - Objectives Humoral vaccine responses to SARS-CoV-2 vaccines are impaired and short lasting in patients with immune-mediated inflammatory diseases (IMID) following two vaccine doses. To protect these vulnerable patients against severe COVID-19 disease, a three-dose primary vaccination strategy has been implemented in many countries. The aim of this study was to evaluate humoral response and safety of primary vaccination with three doses in patients with IMID.Methods Patients with IMID on immunosuppressive therapy and healthy controls receiving three-dose and two-dose primary SARS-CoV-2 vaccination, respectively, were included in this prospective observational cohort study. Anti-Spike antibodies were assessed 2–4 weeks, and 12 weeks following each dose. The main outcome was anti-Spike antibody levels 2–4 weeks following three doses in patients with IMID and two doses in controls. Additional outcomes were the antibody decline rate and adverse events.Results 1100 patients and 303 controls were included. Following three-dose vaccination, patients achieved median (IQR) antibody levels of 5720 BAU/mL (2138–8732) compared with 4495 (1591–6639) in controls receiving two doses, p=0.27. Anti-Spike antibody levels increased with median 1932 BAU/mL (IQR 150–4978) after the third dose. The interval between the vaccine doses and vaccination with mRNA-1273 or a combination of vaccines were associated with antibody levels following the third dose. Antibody levels had a slower decline-rate following the third than the second vaccine dose, p<0.001. Adverse events were reported by 464 (47%) patients and by 196 (78%) controls. Disease flares were reported by 70 (7%) patients.Conclusions This study shows that additional vaccine doses to patients with IMID contribute to strong and sustained immune-responses comparable to healthy persons vaccinated twice, and supports repeated vaccination of patients with IMID.Trial registration number NCT04798625.Data are available on reasonable request. A deidentified patient data set can be made available to researchers on reasonable request. The data will only be made available after submission of a project plan outlining the reason for the request and any proposed analyses, and will have to be approved by the Nor-vaC steering group. Project proposals can be submitted to the corresponding author. Data sharing will have to follow appropriate regulations. ER -