ABSTRACT
Background: Initial studies have shown that patients with inflammatory bowel disease (IBD) have a humoral immune response rate of 95–99% to a two-dose SARS-CoV-2 mRNA vaccine series. A third mRNA vaccine dose has been recommended for the IBD population. The aim of our study was to evaluate the humoral immunogenicity a third SARS-CoV-2 mRNA vaccine dose in patients with IBD. Methods: This was a multicenter, prospective, nonrandomized study comprised of patients with IBD and healthy controls (HC) in the HERCULES cohort. IBD subject eligibility criteria included a diagnosis of IBD, stable doses of maintenance therapy (≥ 2 months), and completion of a two-dose mRNA vaccines series. IBD subjects may have received a third mRNA vaccine dose. HC eligibility criteria included absence of immunosuppressive therapy and completion of a two-dose mRNA vaccine series. HC did not receive a third dose. Those with prior COVID-19 infection were excluded. The primary outcome was total serum SARS-CoV-2 anti-spike IgG antibody concentrations following a third dose compared to antibody concentrations following the two-dose series in IBD subjects. In IBD subjects, we measured antibody concentrations at 28–35 days following completion of the two-dose series and 28–65 days following the third dose. In HC, we measured antibody concentrations at 180 days following completion of the twodose series. Antibody concentrations between groups were compared using Mann-Whitney U tests. Results: One hundred thirty-nine IBD subjects and 46 HC were enrolled. Eightyfive IBD subjects received a third dose (Table 1). One hundred thirty-five IBD subjects (97.1%) had detectable antibody concentrations post-two-dose series, while 85 IBD subjects (100%) had detectable antibody concentrations post-third dose. For IBD subjects that received a third dose, antibody concentrations were significantly higher post-third dose compared to post-two-dose series (median 68 (IQR 32–147) vs 31 (IQR 16–61), p<0.001) (Figure 1). Post-third dose, IBD subjects on systemic corticosteroids or anti-TNF combination therapy had significantly lower antibody concentrations than IBD subjects that were not (median 29 (IQR 10–39) vs 72 (IQR 37–164), p<0.001). For HC, antibody concentrations were significantly lower 180 days compared to 30 days post-two-dose series (median 17 (IQR 11–22) vs 120 (IQR 88–190), p<0.001). HC had lower antibody concentrations 180 days post-two-dose series compared to IBD subjects post-third dose (median 17 (IQR 11– 22) vs 68 (IQR 32–147), p<0.001). Conclusion: All patients with IBD receiving a third SARS-CoV-2 mRNA vaccine dose were seropositive, and median antibody concentrations were higher than those measured after the two-dose series. Patients on corticosteroids and anti-TNF combination therapy had lower antibody concentrations than patients not on such therapy following a third dose. (Table Presented) (Figure Presented)
ABSTRACT
Background: SARS-CoV-2 mRNA vaccines have been demonstrated to have robust and durable humoral immune response in healthy individuals. However, their effectiveness in immunocompromised patients, particularly cancer patients, remains less known. Newer data suggests that cancer patients may not mount adequate protective immune response after vaccination. Methods: A retrospective study of patients ≥ 18 years old who had SARS-CoV-2 spike antibody (anti-S Ab) testing after 2 doses of SARS-CoV-2 mRNA vaccines between 12-90 days at Mayo Clinic between January 1, 2021 and May 10, 2021 was performed. The Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay (Roche Diagnostics, Switzerland) was used to measure the antibody response. Patients with prior COVID-19 infection and patients on immunosuppressive therapy for an indication other than cancer were excluded. Categorical variables were summarized as frequencies (percentages) and continuous variables were reported as median with range. Wilcoxon signed rank test was used to compare continuous variables between groups and Chi-squared or Fisher's exact test was used to compare categorical variables. All tests were two-sided with p value < 0.05 considered statistically significant. The analysis was done using R program version 3.6.2. Results: Among 201 patients, 79 had breast cancer, 91 had a hematologic malignancy, 6 had other solid malignancies, and 25 had no history of cancer. All breast S cancer patients on endocrine therapy or trastuzumab ± pertuzumab without chemotherapy (n=35) had anti-S Ab titer ≥ 500 U/mL. Patients on cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) appeared to have low level of anti-S Ab with 28.6% (n=4/14) had anti-S Ab titer ≤ 500 U/mL.Patients on chemotherapy also had low levels of anti-S Ab with 47% (n=14/30) having anti-S Ab titers ≤ 500 U/mL. When combining breast cancer patients on endocrine therapy alone or anti-HER2 therapy with patients without history of cancer as an immunocompetent group, there was significantly greater proportion of immunocompetent patients (97%) who had anti-S Ab titer ≥ 500 U/mL compared with only 8% of patients with hematologic malignancy and 55% of patients with solid malignancy on chemotherapy or CDK4/6i (p < 0.001). Using multivariate logistic regression analysis adjusted for age, gender, and vaccine type, patients with solid malignancies and treatment-related cytopenia, including chemotherapy and CDK4/6i, (OR 35.51 [95%CI 8.38-255.25, p < 0.001]) were more likely than immunocompetent patients to have a suboptimal anti-S Ab results ≤ 500 U/mL. Conclusion: A significant number of breast cancer patients on chemotherapies and CDK4/6i had poor humoral responses after SARS-CoV-2 mRNA vaccination. While CDK4/6i is not commonly considered as immunosuppressive therapy, breast cancer patients on CDK4/6i appeared to have suboptimal response to SARS-CoV-2 mRNA vaccine. Our study also highlights the significance of assessing antibody response after COVID-19 vaccines in these vulnerable patients.
ABSTRACT
Introduction: Early in the COVID-19 pandemic, Brazil adopted measures to minimize the spread of the virus, including quarantine orders where people only left home for essential business. This practice could negatively impact sleep by reducing exposure to daylight and physical activity. We examined subjective sleep quality in Baependi, a small rural town in Brazil during the COVID-19 quarantine order. Methods: This sample is from the Baependi Heart Study, a familybased cohort of adults. Participants (n=800, 71% women, mean age 51.6±15.6 years) completed the Pittsburgh Sleep Quality Index (PSQI) early in the COVID pandemic (April-May, 2020). They were also asked about their compliance to the quarantine order (yes/no). We compared sleep between quarantined (QT) and not-quarantined individuals (NQT). Longitudinal data was obtained from a subsample of 417 individuals who also completed a pre-COVID PSQI between January, 2010 and September, 2014. Results: Individuals compliant with the quarantine had worse sleep quality than non-quarantined individuals [QT PSQI= 6.1 (±3.9), NQT PSQI= 5.0 (±3.5), p<0.01]. Stratified analysis showed that differences in PSQI scores between QT and NQT was greater for women [QT = 6.4 (±4), NQT = 5.2 (±3.7), p<0.01] and older people [QT = 6.6 (±0.1), NQT = 5.5 (±3.3), p=0.02]. Associations were attenuated after adjusting for age and gender. PSQI components demonstrated a higher sleep latency for the QT group in the full sample (p=0.02), women (p<0.01) and young (<50 years, p=0.03). Sleep duration was shorter in the QT young subsample (p=0.03). QT women also reported lower sleep efficiency (p=0.01) and greater use of sleep medication than NQT women (p<0.01). In the longitudinal subsample, PSQI scores were significantly higher during COVID than pre-pandemic [COVID= 5.7 (±3.8), pre-COVID= 5 (±3.3), p<0.01]. The significant change in PSQI was only observed in the QT participants [COVID= 5.9 (±3.7), pre-COVID= 5.2 (±3.4), p<0.01] and not NQT [COVID= 5 (±3.7), pre- COVID= 4.5 (±3), p=0.12. Conclusion: Individuals who quarantined during COVID-19 had worse sleep quality than individuals who did not quarantine. Longitudinal comparison demonstrated that participants who quarantined had worse sleep quality during COVID compared to before to the pandemic.