DataSheet_1_SARS-CoV-2 infection and COVID19 vaccination across eight immune-mediated inflammatory disorders: A prospective, real-life Belgian cohort study – the BELCOMID study.pdf

Background The risks and impact of COVID19 disease and vaccination in patients with Immune Mediated Inflammatory Diseases (IMID) remain incompletely understood. IMID patients and particularly patients receiving immunosuppressive treatment were excluded from the original, registrational phase-3 COVID19 vaccination efficacy and safety trials. Real-world observational data can help to fill this gap in knowledge. The BELCOMID study aims to explore the interaction between IMIDs, immune-modulating treatment modalities and SARS-CoV-2 infection and vaccination in a real-life patient cohort. Methods A... Mehr ...

Verfasser: Jeroen Geldof
Marie Truyens
João Sabino
Marc Ferrante
Jo Lambert
Hilde Lapeere
Tom Hillary
An Van Laethem
Kurt de Vlam
Patrick Verschueren
Elizaveta Padalko
Triana Lobaton
Séverine Vermeire
Dokumenttyp: Dataset
Erscheinungsdatum: 2023
Schlagwörter: Immunology / Applied Immunology (incl. Antibody Engineering / Xenotransplantation and T-cell Therapies) / Autoimmunity / Cellular Immunology / Humoural Immunology and Immunochemistry / Immunogenetics (incl. Genetic Immunology) / Innate Immunity / Transplantation Immunology / Tumour Immunology / Immunology not elsewhere classified / Genetic Immunology / Animal Immunology / Veterinary Immunology / SARS-CoV-2 / COVID19 / IMID / biologic / immunomodulator / real-world data
Sprache: unknown
Permalink: https://search.fid-benelux.de/Record/base-26924792
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.3389/fimmu.2023.1126351.s001

Background The risks and impact of COVID19 disease and vaccination in patients with Immune Mediated Inflammatory Diseases (IMID) remain incompletely understood. IMID patients and particularly patients receiving immunosuppressive treatment were excluded from the original, registrational phase-3 COVID19 vaccination efficacy and safety trials. Real-world observational data can help to fill this gap in knowledge. The BELCOMID study aims to explore the interaction between IMIDs, immune-modulating treatment modalities and SARS-CoV-2 infection and vaccination in a real-life patient cohort. Methods A multidisciplinary, prospective, observational cohort study was set up. Consecutive patients with IMIDs of the gut, joints and skin followed at two high-volume referral centers were invited. Both patients under conventional treatment or targeted immune modulating therapies were included. Patient data and serological samples were collected at 3 predefined periods (before COVID19 vaccination, before booster vaccination, after booster vaccination). Primary endpoints were positive PCR-test and SARS-CoV-2 serology reflecting previous SARS-CoV-2 infection or vaccination. Associations with IMID treatment modality and IMID disease activity were assessed. Results of the first two inclusion periods (before booster vaccination) are reported. Results At the first inclusion period data was assessed of 2165 IMID-patients before COVID19 vaccination. At the second inclusion period, data of 2065 patients was collected of whom 1547 had received complete baseline COVID19 vaccination and 222 were partially vaccinated. SARS-CoV-2 infection rate remained low in both groups. No significant increase in IMID flare-up rate was noted in patients with prior SARS-CoV-2 infection. Multiple logistic regression analyses did not show a significant influence of IMID-treatment modality or IMID activity on SARS-CoV-2 infection risk (based on PCR positivity or N-serology). Patients treated with conventional immunomodulators, systemic steroids, and patients on ...