Antibody response to BNT162b2 SARS-CoV-2 mRNA vaccine in adult patients with systemic sclerosis

Abstract

Objectives Systemic sclerosis (SSc) patients are at risk for a severe disease course during SARS-CoV-2 infection either due to comorbidities or immunosuppression. The availability of SARS-CoV-2 vaccines is crucial for the prevention of this hard-to-treat illness. The aim of this study is to assess the humoral response after mRNA vaccination against SARS-CoV-2 in SSc patients. Method Seropositivity rate and serum IgG levels were evaluated 1 month (t1) and 3 months (t3) after the second dose of vaccine in a cohort of SSc patients and healthy controls (HC). Differences were made with Student’s or Mann–Whitney’s t-test and with the chi-square or Fisher exact test. Logistic regression model including immunosuppressive treatments (corticosteroids, CCS; mycophenolate mofetil, MMF; methotrexate, MTX; rituximab, RTX) was built to assess the predictivity for seropositivity. Results The seropositivity rate was similar in 78 SSc patients compared to 35 HC at t1 but lower at t3. SSc patients had lower serum IgG levels than HC at t1 but not at t3. SSc patients treated with immunosuppressive therapy showed both a lower seropositive rate (t1, 90.3% vs 100%; t3, 87.1% vs 97.9%; p < 0.05) and serum IgG levels than untreated patients both at t1 [851 BAU/ml (IQR 294–1950) vs 1930 BAU/ml (IQR 1420–3020); p < 0.001] and t3 [266 BAU/ml (IQR 91.7–597) vs 706 BAU/ml (IQR 455–1330); p < 0.001]. In logistic regression analysis, only MTX was significant [OR 39.912 (95% CI 1.772–898.728); p < 0.05]. Conclusions SSc patients treated with MTX had a lower serological response to mRNA vaccine, and even low doses of CCS can adversely affect antibody titer and vaccination response. Key Points• SSc patients are able to produce vaccine-induced antibodies after mRNA vaccination.• In SSc patients, clinical characteristics of disease did not influence seropositivity rate.• In SSc patients, even low doses of CCS can adversely affect antibody titer and vaccination response.• In SSc patients, MTX treatment is mainly associated with reduced seropositivity and lower serum IgG levels.

Impact of COVID-19 and vaccination campaign on 1,755 systemic sclerosis patients during first three years of pandemic. Possible risks for individuals with impaired immunoreactivity to vaccine, ongoing immunomodulating treatments, and disease-related lung involvement during the next pandemic phase

“…4 ). As suggested by the clinical history of individual patients here described and by other observations [ 31 , 37 , 38 ], not infrequently we will have to manage patients with only the first 2–3 doses of COVID-19 vaccine but needing long-term treatment with immunomodulatory drugs; in these instances, it would be highly recommendable to verify their actual anti-COVID-19 immunogenic condition starting with the serum NAb level detection ( Fig. 4 ).…”

“…The effects of anti-COVID-19 vaccination are reported in small patients' series [ [31] , [32] , [33] , [34] , [35] , [36] ], showing a generally good tolerability to different anti-COVID-19 vaccines, mostly mRNA types [ [19] , [20] , [21] , 35 , 37 ]. The percentage of impaired seroconversion largely varied among different patients’ series [ 19 , 31 , 34 , 37 , 38 ].…”

“…The effects of anti-COVID-19 vaccination are reported in small patients' series [ [31] , [32] , [33] , [34] , [35] , [36] ], showing a generally good tolerability to different anti-COVID-19 vaccines, mostly mRNA types [ [19] , [20] , [21] , 35 , 37 ]. The percentage of impaired seroconversion largely varied among different patients’ series [ 19 , 31 , 34 , 37 , 38 ]. It was frequently evaluated after the first two doses of vaccine [ 31 , 32 , 34 , 39 ] and in only two reports after the booster dose [ 19 , 21 ]; one of them included the detection of the T-cell immunoreactivity [ 21 ].…”

COVID-19 and the Immune Response: A Multi-Phasic Approach to the Treatment of COVID-19

“…However, it is important to note that this antibody response to the vaccine is not uniform in all patient populations. For example, immunosuppressed patients such as those with chronic immunological diseases, dialysis, transplant patients, and patients with hematological malignances have a lower seroconversion rate [ 45 , 46 ].…”

Systemic sclerosis in the time of COVID-19

“…International scientific initiatives are ongoing and will provide robust evidence on the effect of COVID-19 on the disease course of systemic sclerosis and the development and management of complications related to the disease. Similarly, data on the use of the COVID-19 vaccines in patients with systemic sclerosis continue to accrue [9][10][11] and will provide evidence for the most appropriate timing of vaccination as a preventive measure. As it is clear that we have to learn to live with the SARS-CoV-2 virus, the data being collected during the pandemic will support rheumatologists in continuing to improve approaches to the future care of patients with systemic sclerosis.…”