scholarly journals 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 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 35
Author(s):  
Karen Schreiber ◽  
Christine Graversgaard ◽  
Randi Petersen ◽  
Henning Jakobsen ◽  
Anders Bo Bojesen ◽  
...  
Keyword(s):  
Immune Response ◽  
Cohort Study ◽  
Antibody Response ◽  
Prospective Cohort Study ◽  
Rheumatic Diseases ◽  
Prospective Cohort ◽  
Healthcare Providers ◽  
Booster Vaccine ◽  
Dmard Treatment ◽  
Igg Level

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/bcs/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/bcs/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/bcs/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.

scholarly journals Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome among Tuberculosis Patients from Pakistan; Study Protocol for a Prospective Cohort Study (Micro-STOP)

2021 ◽  
Author(s):  
Muhammad Shahzad ◽  
Zia UlHaq ◽  
Simon C Andrews
Keyword(s):  
Immune Response ◽  
Cohort Study ◽  
Treatment Response ◽  
Prospective Cohort Study ◽  
Gut Microbiome ◽  
Prospective Cohort ◽  
Treatment Success ◽  
Anthropometric Measurement ◽  
Microbiome Diversity ◽  
Study Results

Introduction: Tuberculosis (TB) caused by Mycobacterium tuberculosis is a common infectious disease associated with significant morbidity and mortality, especially in low and middle-income countries. Successful treatment of the disease requires prolonged intake (6 to 8 months) of multiple antibiotics with potentially detrimental consequences on the composition and functional potential of the human microbiome. The protocol described in the current study aims to identify microbiome (oral and gut) signatures associated with TB pathogenesis, treatment response and, outcome in humans. Methods and analysis: Four hundred and fifty, newly diagnosed TB patients from three district levels (Peshawar, Mardan, Swat) TB diagnosis and treatment centers will be recruited in this non-interventional, prospective cohort study and will be followed and monitored until treatment completion. Demographic and dietary intake data, anthropometric measurement and blood, stool and salivary rinse samples will be collected at baseline, day 15, month-2 and end of the treatment. Additionally, we will recruit age and sex-matched healthy controls (n=30). Blood sampling will allow monitoring of the immune response during the treatment, while salivary rinse and fecal samples will allow monitoring of dynamic changes in oral and gut microbiome diversity. Within this prospective cohort study, a nested case-control study design will be conducted to assess perturbations in oral and gut microbiome diversity (microbial dysbiosis) and immune response and compare between the patients groups (treatment success vs failure). Ethics and dissemination The study has received ethics approval from the Ethic Board of Khyber Medical University Peshawar, and administrative approval from the Provincial TB Control Program of Khyber Pakhtunkhwa, Pakistan. The study results will be presented at national and international conferences and published in peer-reviewed journals. Trial registration number: NCT04985994; pre-results

scholarly journals Predictors and temporal trend of flu vaccination in auto-immune rheumatic diseases in the UK: a nationwide prospective cohort study

Rheumatology ◽  
2018 ◽  
Vol 57 (10) ◽  
pp. 1726-1734 ◽  
Author(s):  
Georgina Nakafero ◽  
Matthew J Grainge ◽  
Puja R Myles ◽  
Christian D Mallen ◽  
Weiya Zhang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Rheumatic Diseases ◽  
Prospective Cohort ◽  
Temporal Trend ◽  
Flu Vaccination ◽  
The Uk

scholarly journals Effects of Cardiovascular Comorbidities on Work Participation in Rheumatic Diseases: A Prospective Cohort Study Among Working Individuals

2013 ◽  
Vol 66 (1) ◽  
pp. 157-163 ◽  
Author(s):  
Lennart R. A. van der Burg ◽  
Annelies Boonen ◽  
Ludovic G. P. M. van Amelsvoort ◽  
Nicole W. H. Jansen ◽  
Robert B. M. Landewé ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Rheumatic Diseases ◽  
Prospective Cohort ◽  
Work Participation ◽  
Cardiovascular Comorbidities

scholarly journals The severity of symptoms and outcomes of patients admitted with rheumatic diseases and COVID-19; a prospective cohort study in Iran

2021 ◽  
Vol 7 (2) ◽  
pp. e34-e34
Author(s):  
Mansour Salesi ◽  
Ramin Sami ◽  
Somayeh Haji Ahmadi ◽  
Nilufar Khademi ◽  
Mehrnegar Dehghan ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Rheumatic Diseases ◽  
Prospective Cohort ◽  
Immunomodulatory Drugs ◽  
Composite Outcome ◽  
Increased Risk ◽  
High Prevalence ◽  
Before And After ◽  
Comorbidity Index

Introduction: In severe COVID-19 patients, a pre-inflamatory condition leads to a cytokine storm syndrome. This may signify the need for using immunomodulatory drugs. Patients with rheumatic diseases (RDs) are prone to severe infectious diseases. Objectives: Whether the presence of the RD itself or the use of its drugs in patients with COVID-19 increases the severity of symptoms and outcomes remains largely unknown. Patients and Methods: In a prospective cohort study conducted in Khorshid hospital of Isfahan, Iran, 219 patients with COVID-19 were enrolled and divided into two groups of patients with a positive history for RD (n=19) and those without this history (NRD, n=200). The severity of symptoms and outcomes was compared between the groups. Results: Shortness of breath (P=0.001), cough (P=0.019), and weakness (P=0.001) were significantly higher in the RD than the NRD group after, but not before, recovery. All the patients in the RD group had comorbid diseases (hypertension, diabetes mellitus, ischemic heart disease, and cerebrovascular disease), the number of which was significantly higher than that of the NRD group (P<0.001). The Charlson Comorbidity Index (CCI) was used to predict 10-year survival in patients with multiple comorbidities. It was significantly lower in the RD group as opposed to the NRD group (P<0.001). Logistic regression also showed a non-significantly higher chance of the composite outcome (ICU admission, death status, and intubation status) in the RD group as opposed to the NRD group, both before and after adjustment for confounding factors. However, no difference was found between the RD patient who received corticosteroid as a treatment (RD-CS) and those who did not (RD-NCS). Conclusion: The results showed an increased risk for severe forms of COVID-19 in RD patients. This risk is possibly attributable to a high prevalence of comorbidities in these patients.

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