Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort

Abstract

Introduction: In light of the SARS-CoV-2 pandemic, protecting vulnerable groups has become a high priority. Persons at risk of severe disease, for example, those receiving immunosuppressive therapies for chronic inflammatory cdiseases (CIDs), are prioritised for vaccination. However, data concerning generation of protective antibody titres in immunosuppressed patients are scarce. Additionally, mRNA vaccines represent a new vaccine technology leading to increased insecurity especially in patients with CID.

Objective: Here we present for the first time, data on the efficacy and safety of anti-SARS-CoV-2 mRNA vaccines in a cohort of immunosuppressed patients as compared with healthy controls.

Methods: 42 healthy controls and 26 patients with CID were included in this study (mean age 37.5 vs 50.5 years). Immunisations were performed according to national guidelines with mRNA vaccines. Antibody titres were assessed by ELISA before initial vaccination and 7 days after secondary vaccination. Disease activity and side effects were assessed prior to and 7 days after both vaccinations.

Results: Anti-SARS-CoV-2 antibodies as well as neutralising activity could be detected in all study participants. IgG titres were significantly lower in patients as compared with controls (2053 binding antibody units (BAU)/mL ±1218 vs 2685±1102). Side effects were comparable in both groups. No severe adverse effects were observed, and no patients experienced a disease flare.

Conclusion: We show that SARS-CoV-2 mRNA vaccines lead to development of antibodies in immunosuppressed patients without considerable side effects or induction of disease flares. Despite the small size of this cohort, we were able to demonstrate the efficiency and safety of mRNA vaccines in our cohort.

Keywords: COVID-19; arthritis; rheumatoid; tumor necrosis factor inhibitors; vaccination.

Figure 1

SARS-CoV-2 specific antibodies are detectable in patients and healthy controls. (A) Anti-SARS-CoV-2 IgG antibodies in patients with CID and controls 7 days after secondary immunisation. (B) IgG titres in patients with CID and controls at baseline on the day of the second immunisations and 7 days later. (C) Neutralising activity at 7 days post secondary immunisation. (D) Change in neutralising antibodies from baseline to day 7 after the second immunisation. (E) Anti-SARS-CoV-2 IgA levels 1 week after the second mRNA vaccination in patients and controls. (E) IgA titres at baseline and 7 days after second vaccination. Anti-SARS-CoV2-IgG titres (G) and neutralising capacity (H) in healthy controls and patients by age group 7 days after secondary vaccination. Each symbol represents a single study participant. Bars represent means. Cut-offs for commercial test are displayed as horizontal dashed lines. CID, chronic inflammatory disease; HCo, healthy control.

Figure 2

Disease activity does not increase over time after SARS-CoV-2 vaccination. (A) Delta DAS28 for patients with inflammatory arthritis during the 42-day study period. (B) Delta patients global assessment in patients with CID from baseline to day 42. Disease activity was assessed before the first and the second immunisation and 7 days after each vaccination. Each symbol represents one patient. CID, chronic inflammatory disease; DAS28, disease activity score 28.