RT Journal Article
SR Electronic
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
FD EULAR
SP e002417
DO 10.1136/rmdopen-2022-002417
VO 8
IS 2
A1 Silje Watterdal Syversen
A1 Ingrid Jyssum
A1 Anne Therese Tveter
A1 Joe Sexton
A1 Ingrid Egeland Christensen
A1 Trung T Tran
A1 Kristin Hammersbøen Bjørlykke
A1 Siri Mjaaland
A1 David J Warren
A1 Tore K Kvien
A1 Adity Chopra
A1 Grete Birkeland Kro
A1 Jorgen Jahnsen
A1 Ludvig A Munthe
A1 Espen A Haavardsholm
A1 Gunnveig Grødeland
A1 John Torgils Vaage
A1 Sella Aarrestad Provan
A1 Kristin Kaasen Jørgensen
A1 Guro Løvik Goll
YR 2022
UL http://rmdopen.bmj.com/content/8/2/e002417.abstract
AB 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.