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

• Published in: Rheumatic & musculoskeletal diseases open Vol. 10; no. 2; p. e003545
• Main Authors: Ørbo, Hilde S, Bjørlykke, Kristin H, Sexton, Joseph, Jyssum, Ingrid, Tveter, Anne T, Christensen, Ingrid E, Mjaaland, Siri, Kvien, Tore K, Grødeland, Gunnveig, Kro, Grete B, Jahnsen, Jørgen, Haavardsholm, Espen A, Munthe, Ludvig A, Provan, Sella A, Vaage, John T, Goll, Guro Løvik, Jørgensen, Kristin Kaasen, Syversen, Silje Watterdal
• Format: Journal Article
• Language: English
• Published: England EULAR 09.04.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Adaptive Immunity; Age; Antibodies; Antigens; Arthritis; autoimmunity; biological therapy; Cohort analysis; Comorbidity; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - therapeutic use; Drug dosages; Health care; Hospitals; Humans; Immunization; Immunology; Immunomodulating Agents; Immunosuppression Therapy; Incidence; Infections; Inflammatory diseases; Patients; Prospective Studies; Questionnaires; Regression analysis; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Spike Glycoprotein, Coronavirus; Vaccination; Vaccines; Web portals; COVID-19; autoimmunity; biological therapy; vaccination
• ISSN: 2056-5933; 2056-5933
• DOI: 10.1136/rmdopen-2023-003545

ObjectivesTo 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.MethodsIMIDs 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.ResultsBetween 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)).ConclusionVaccinated 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.