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

Abstract

BackgroundThe 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.MethodsA 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.ResultsAt 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 advanced therapies such as biologics or small molecules, had reduced S-antibody seroconversion. S-antibody response was also lower in patients without prior SARS-CoV-2 infection and in active smokers. A subset of patients (4.1%) had no S- nor N-antibody seroconversion following complete baseline vaccination.ConclusionThe BELCOMID study results confirm the benign course of COVID19 infection and vaccination in a large real-life IMID-population. However, our results underscore the need for repeated vaccination and smoking cessation in patients with IMIDs treated with immune-modulating therapies or systemic steroids during the pandemic.

The Effect of Exposure to SARS-CoV-2 Vaccination and Infection on Humoral and Cellular Immunity in a Cohort of Patients with Immune-Mediated Diseases: A Pilot Study

“…Although not completely, most patients exhibited the primary components of circulating (or tissue) adaptive immunity. Other authors found similar results; our study confirms them in a longer time frame [ 28 ]. The improving clinical outcomes of COVID-19 in IMIDs observed during the pandemic may also be related to the fact that our data come from the frequent cases of those who received a three-vaccine regimen and then had SARS-CoV-2 infection [ 29 ].…”

The risk of COVID-19 in IBD patients is increased by urban living and is not influenced by disease activity or intravenous biologics

“…Recent data suggest that pre-existing auto-immune disease is associated with increased severity of COVID-19, but IBD was not the most frequent auto-immune disease in the dataset and the same study showed a protective effect of anti-TNF therapy, which is the most frequently used in patients with IBD ( 38 ). Conversely, the BELCOMID study described a benign course of COVID-19 infection in a cohort of more than 2000 patients with immune mediated inflammatory diseases (IMID) of whom more than 60% had IBD ( 39 ). The MICI-SARS-CoV-2 study provides physicians with data on this specific population of patients with IBD theoretically immunocompromised by their biological therapy before the start of the vaccination campaign.…”