Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy: identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study
Tore K Kvien,
Joseph Sexton,
Espen A Haavardsholm,
Sella A Provan,
Jorgen Jahnsen,
Silje Watterdal Syversen,
Guro Løvik Goll,
Ingrid Jyssum,
Siri Mjaaland,
Ludvig A Munthe,
Gunnveig Grødeland,
Kristin Kaasen Jørgensen,
Hilde S Ørbo,
Kristin H Bjørlykke,
Anne T Tveter,
Ingrid E Christensen,
Grete B Kro,
John T Vaage
Affiliations
Tore K Kvien
Faculty of Medicine, University of Oslo, Oslo, Norway
Joseph Sexton
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Espen A Haavardsholm
2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Sella A Provan
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Jorgen Jahnsen
2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Silje Watterdal Syversen
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Guro Løvik Goll
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Ingrid Jyssum
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Siri Mjaaland
4 Division of Infection Control, Section for Immunology, Norwegian Institute of Public Health, Oslo, Norway
Ludvig A Munthe
2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Gunnveig Grødeland
2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Kristin Kaasen Jørgensen
3 Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway
Hilde S Ørbo
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Kristin H Bjørlykke
2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Anne T Tveter
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Ingrid E Christensen
1 Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Grete B Kro
6 Department of Microbiology, Oslo University Hospital, Oslo, Norway
John T Vaage
2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
Objectives To assess incidence, severity and predictors of COVID-19, including protective post-vaccination levels of antibodies to the receptor-binding domain of SARS-CoV-2 spike protein (anti-RBD), informing further vaccine strategies for patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive medication.Methods IMIDs on immunosuppressives and healthy controls (HC) receiving SARS-CoV-2 vaccines were included in this prospective observational study. COVID-19 and outcome were registered and anti-RBD antibodies measured 2–5 weeks post-immunisation.Results Between 15 February 2021 and 15 February 2023, 1729 IMIDs and 350 HC provided blood samples and self-reported COVID-19. The incidence of COVID-19 was 66% in patients and 67% in HC, with re-infection occurring in 12% of patients. Severe COVID-19 was recorded in 22 (2%) patients and no HC. No COVID-19-related deaths occurred. Vaccine-induced immunity gave higher risk of COVID-19 (HR 5.89 (95% CI 4.45 to 7.80)) than hybrid immunity. Post-immunisation anti-RBD levels <6000 binding antibody units/mL were associated with an increased risk of COVID-19 following three (HR 1.37 (95% CI 1.08 to 1.74)) and four doses (HR 1.28 (95% CI 1.02 to 1.62)), and of COVID-19 re-infection (HR 4.47 (95% CI 1.87 to 10.67)).Conclusion Vaccinated patients with IMID have a low risk of severe COVID-19. Hybrid immunity lowers the risk of infection. High post-immunisation anti-RBD levels protect against COVID-19. These results suggest that knowledge on COVID-19 history, and assessment of antibody levels post-immunisation can help individualise vaccination programme series in high-risk individuals.Trial registration number NCT04798625.
