Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study

<b>Background/Purpose</b><b>:</b> 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 avai...

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Main Authors: Karen Schreiber, Christine Graversgaard, Randi Petersen, Henning Jakobsen, Anders Bo Bojesen, Niels Steen Krogh, Bente Glintborg, Merete Lund Hetland, Oliver Hendricks
Format: Article
Language:English
Published: MDPI AG 2021-12-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/10/1/35
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author Karen Schreiber
Christine Graversgaard
Randi Petersen
Henning Jakobsen
Anders Bo Bojesen
Niels Steen Krogh
Bente Glintborg
Merete Lund Hetland
Oliver Hendricks
author_facet Karen Schreiber
Christine Graversgaard
Randi Petersen
Henning Jakobsen
Anders Bo Bojesen
Niels Steen Krogh
Bente Glintborg
Merete Lund Hetland
Oliver Hendricks
author_sort Karen Schreiber
collection DOAJ
description <b>Background/Purpose</b><b>:</b> 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 ‘<i>Detection of SARS-CoV-2 antibodies in Danish Inflammatory Rheumatic Outpatients</i>’ 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. <b>Methods:</b> 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. <b>Results:</b> 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 (<i>p</i> < 0.01)). <b>Conclusion:</b> 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.
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spelling doaj.art-2110d1f4684949aebd09065c9d4405fe2023-11-23T15:38:17ZengMDPI AGVaccines2076-393X2021-12-011013510.3390/vaccines10010035Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort StudyKaren Schreiber0Christine Graversgaard1Randi Petersen2Henning Jakobsen3Anders Bo Bojesen4Niels Steen Krogh5Bente Glintborg6Merete Lund Hetland7Oliver Hendricks8Danish Hospital for Rheumatic Diseases, 6400 Sønderborg, DenmarkDanish Hospital for Rheumatic Diseases, 6400 Sønderborg, DenmarkDanish Hospital for Rheumatic Diseases, 6400 Sønderborg, DenmarkDanish Hospital for Rheumatic Diseases, 6400 Sønderborg, DenmarkDanish Hospital for Rheumatic Diseases, 6400 Sønderborg, DenmarkDanish Hospital for Rheumatic Diseases, 6400 Sønderborg, DenmarkDANBIO, The Danish Rheumatologic Biobank and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, 2100 Glostrup, DenmarkDANBIO, The Danish Rheumatologic Biobank and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, 2100 Glostrup, DenmarkDanish Hospital for Rheumatic Diseases, 6400 Sønderborg, Denmark<b>Background/Purpose</b><b>:</b> 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 ‘<i>Detection of SARS-CoV-2 antibodies in Danish Inflammatory Rheumatic Outpatients</i>’ 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. <b>Methods:</b> 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. <b>Results:</b> 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 (<i>p</i> < 0.01)). <b>Conclusion:</b> 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.https://www.mdpi.com/2076-393X/10/1/35COVID-19 vaccineRMDhumoral response
spellingShingle Karen Schreiber
Christine Graversgaard
Randi Petersen
Henning Jakobsen
Anders Bo Bojesen
Niels Steen Krogh
Bente Glintborg
Merete Lund Hetland
Oliver Hendricks
Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study
Vaccines
COVID-19 vaccine
RMD
humoral response
title Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study
title_full Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study
title_fullStr Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study
title_full_unstemmed Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study
title_short Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases—An Interim Report from a Danish Prospective Cohort Study
title_sort reduced humoral response of sars cov 2 antibodies following vaccination in patients with inflammatory rheumatic diseases an interim report from a danish prospective cohort study
topic COVID-19 vaccine
RMD
humoral response
url https://www.mdpi.com/2076-393X/10/1/35
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