Abstract
Background/Purpose: In light of the current COVID-19 pandemic, whether patients with rheumatic musculoskeletal disease (RMD) treated with conventional (cs) or biologic (b) disease-modifying drugs (DMARDs) exhibit an adequate immune response to the currently available SARS-CoV-2 vaccinations remains a major concern. There is an urgent need for more SARS-CoV-2 vaccine efficacy data to inform healthcare providers on the potential need for a booster vaccine. We established the ‘Detection of SARS-CoV-2 antibodies in Danish Inflammatory Rheumatic Outpatients’ study (DECODIR) in March 2021 in order to assess and compare the immunoglobulin G (IgG response) of the SARS-CoV-2 BNT162b2 vaccine (Pfizer, Groton, CT, USA/BioNTech, Mainz, Germany) and mRNA-1273 vaccine (Moderna, Cambridge, MA, USA) administered as part of the national vaccine roll out in patients with RMDs, irrespective of treatment. Patients’ SARS-CoV-2 IgG level was used as proxy to determine vaccination response. Methods: The study is a longitudinal prospective cohort study in which the SARS-CoV-2 antibody response was measured and compared at baseline and at six weeks following vaccination. The study population consisted of patients with rheumatoid arthritis (RA), spondyloarthropathies (SpA), or psoriatic arthritis (PsA) receiving their outpatient treatment at the Danish Hospital for Rheumatic Diseases, Sonderborg. Bloods, patient reported outcome measurements (PROMS), clinical data, and treatment information (cs/bDMARD) were collected at baseline/6 weeks and documented in the Danish DANBIO registry. Commercially available antibody tests (ThermoFisher, Waltham, MA, USA) were used, and SARS-CoV-2 IgG levels were reported in EliA U/mL. Sufficient IgG response was defined as ≥10 EliA U/mL (manufacturers cut-off). Associations between antibody response, age, gender, disease (RA/PsA/SpA), no treatment or cs/bDMARD treatment, and disease activity were tested using proportional odds regression and bootstrapped tests of medians. Results were reported using mean, median (IqR), and bootstrapped 95% confidence interval (CI) of the median. Results: A total of 243 patients were included. We observed a significant increase in IgG levels (median of <0.7 EliA U/mL at baseline versus 34.5 EliA U/mL at 6 weeks). Seventy-two patients (32%) had an insufficient IgG response. The median IgG level in patients treated with cs/bDMARD combination therapy was significantly lower compared to patients without any DMARD treatment (12 EliA U/mL vs. 92 EilA U/mL (p < 0.01)). Conclusion: Patients treated with a combination of cs/bDMARD are at significantly higher risk of an inadequate response to SARS-CoV-2 vaccines as measured by IgG level compared to patients without DMARD treatment. IgG SARS-CoV-2 are only part of the immune response, and further data are urgently needed. At present, our results may inform healthcare providers and policy makers on the decision for the need of a booster vaccine in this particular patient group.
Highlights
The COVID-19 pandemic has resulted in almost 4 million deaths globally, and the availability and consistent application of effective SARS-CoV-2 vaccines is the cornerstone to controlling the pandemic.Rheumatic musculoskeletal diseases (RMD) are mainly chronic, systemic inflammatory conditions, and most patients require long-term treatment with immosuppressive medications by means of either conventional synthetic and/or biologic (b) disease-modifying antirheumatic drugs
Data from large cohort studies in Denmark and the United States suggest that the risk for hospitalization compared to the background population is 30% increased in rheumatoid arthritis (RA) [3] and threefold in the case of patients with systemic lupus erythematosus (SLE) [4]
We observed a significant increase in IgG levels comparing baseline versus 6 weeks
Summary
The COVID-19 pandemic has resulted in almost 4 million deaths globally, and the availability and consistent application of effective SARS-CoV-2 vaccines is the cornerstone to controlling the pandemic. Data from large cohort studies in Denmark and the United States suggest that the risk for hospitalization compared to the background population is 30% increased in RA [3] and threefold in the case of patients with systemic lupus erythematosus (SLE) [4]. Data from the U.K. biobank cohort showed that patients with RA are at higher risk of COVID-19-related death compared to the background population [5]. Data on the efficacy of the BNT162b2 vaccine and mRNA-1273 vaccine in patients with RMDs assessing the effect of cs/bDMARD treatment remain scarce, and the currently available evidence stems mainly from limited-sized cohort studies. While healthy individuals with SARS-CoV-2 infection develop antibodies, with IgG remaining detectable for at least four months [8], patients with RMDs apparently have a reduced humoral immune response after their first vaccine dose [9]. CoV-2 IgG in individual patients was used as proxy to determine vaccination response at baseline and after 6 weeks and documented in the Danish DANBIO registry
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