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1.
NeuroQuantology ; 20(8):7678-7684, 2022.
Article in English | EMBASE | ID: covidwho-2010533

ABSTRACT

Background: The World Health Organization (WHO) and health authorities have devoted significant attention to understanding risk factors for coronavirus disease 19 (COVID-19) and their role in disease outcomes including tumer necrosis factor. In addition, diabetes may lead to lung dysfunction, such as decreased forced expiratory volume and forced vital capacity. Therefore, diabetes could possibly be a risk factor for covid-19. Our study aims to investigate the clinical characteristics of patients with severe covid-19 with diabetes mellitus, and the association of diabetes with the outcome in patients with severe covid-19. Materials and Methods: This study was carried out in a period between November 2021 and March 2022, blood was taken from patients (80) with covid-19. Samples were taken from patients who were present in Al-Zahraa teaching hospital in Iraq. A total of samples were subjected to laboratory examinations including Tumor necrosis factor α using specific ELISA Kit. Result: The result of this observational study was depending on the analysis of data from 80 COVID-19 patients. All selected sociodemographic features, disease indicators, and history of chronic disease were listed as frequencies and percentages. The mean age was 52 years old. The SPO2 for those patients was ranged from 79 to 95% with a mean equal to 90.10 ±3.48. All patients showed elevated CRP value with a mean = 83.52. More than half of the sample (52.5%) were females and near half of the (48.8%) were overweighted when calculate their BMI. The majority (92.5%) mentioned having no family history of diabetes mellitus and 95% of them have no any other diagnosed chronic disease. Near two thirds (67.5%) were prescribed steroid in the treatment regime for their COVID-19 infection. Mean difference of TNF was tested among positive Covid-19 having diabetic status, results showed that.

2.
Medical Journal of Indonesia ; 31(2):96-101, 2022.
Article in English | EMBASE | ID: covidwho-2010504

ABSTRACT

BACKGROUND Coagulopathy is a serious COVID-19 complication that requires rapid diagnosis and anticoagulation. This study aimed to determine the role of coagulation examination using thromboelastography (TEG) on the decision-making time of anticoagulant therapy in COVID-19 patients and its clinical outcomes. METHODS A prospective observational study was conducted in Cipto Mangunkusumo Hospital, Indonesia, from October 2020 to March 2021. We consecutively recruited moderate and severe COVID-19 patients in the high and intensive care units. Turnaround time, time to anticoagulant therapy decision, and clinical outcomes (length of stay and 30-day mortality) were compared between those who had a TEG examination in addition to the standard coagulation profile examination (thrombocyte count, PT, APTT, D-dimer, and fibrinogen) and those who had only a standard coagulation profile laboratory examination. RESULTS Among 100 moderate to severe COVID-19 patients recruited, 50 patients had a TEG examination. The turnaround time of TEG was 45 (15–102) min versus 82 (19– 164) min in the standard examination (p<0.001). The time to decision was significantly faster in the TEG group than the standard group (75 [42–133] min versus 184 [92–353] min, p<0.001). The turnaround time was positively correlated with time to decision (r = 0.760, p<0.001). However, TEG did not improve clinical outcomes such as length of stay (10.5 [3–20] versus 9 [2–39] days) and 30-day mortality (66% versus 64%). CONCLUSIONS The TEG method significantly enables quicker decision-making time for moderate to severe coagulation disorder in COVID-19 patients.

3.
Journal of SAFOG ; 14(4):374-380, 2022.
Article in English | EMBASE | ID: covidwho-2010446

ABSTRACT

Aim: Coronavirus disease 2019 (COVID-19) pandemic is an ongoing emergency with limited data on perinatal outcomes. The aim of the study was to describe key maternal, perinatal, and neonatal outcomes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from low–middle income settings. Materials and methods: We conducted a retrospective observational study in a tertiary level public hospital in India. All pregnant women admitted from May 2020 to July 2020 were included in the study. Maternal demography, medical and obstetric complications, clinical characteristics, and investigations were described. Symptomatic infected women were compared with the asymptomatic group for important outcomes. Key perinatal outcomes such as early pregnancy losses, fetal distress, stillbirths, and placental changes were evaluated. Neonatal characteristics of SARS-CoV-2 positive and negative pregnancies were described and compared. Results: Among the 702 pregnant women enrolled, the incidence of SARS-CoV-2 infection was 16.2%, with the majority being asymptomatic. Infected women had an increased mortality, while symptomatic women had a significant risk of stillbirth. Mean placental weight of infected women was significantly higher. Neonatal infection rate was 9.1%, with 50% manifesting mild respiratory symptoms without any mortality. Conclusion: This study provides a comprehensive description of important antenatal, intrapartum and neonatal complications and outcomes in a low–middle income setting characterized by high disease burden and an overwhelmed health care system. Clinical significance: Incidence of SARS-CoV-2 infection in pregnancy was 16.2%. The symptomatic infected women had increased stillbirth and mortality. Neonatal transmission was seen in 9.1% with good survival.

4.
Journal of SAFOG ; 14(4):365-369, 2022.
Article in English | EMBASE | ID: covidwho-2010445

ABSTRACT

Background: The present study aims to understand the perceptions, apprehensions, and fears of peripartum COVID-positive women in low-resource settings. Study design: Cross-sectional observational study. Methodology: All COVID-positive postpartum women who delivered in the institution (vaginal delivery and cesarean section) were included in the study. Exclusion criteria included ICU admission and known mental illness. Results: A total of 61 COVID-positive women delivered in the facility during the study period. About 33 out of 61 women were nulliparous, while 28 were multigravida. Two babies tested positive for COVID-19 within 24 hours of birth. Majority of the patients were anxious prior to coming to hospital (51/61, i.e., 83.6%). The most common perceived fear reported by patients was fear of not receiving support from partner and provider (80%). Due to restrictions imposed on birth companion, 80% (49/61) women feared loneliness during labor. Apprehension of not receiving respectful maternity care was experienced by 75.4% (46/61) of women. Only 16 (26.2%) patients feared progression of disease, and 32 women (52%) were afraid of infection being transmitted to baby. However, 85% of the women reported a positive birthing experience. Good support from the family was observed in 76% of women. Despite regular visits by the doctors, eight patients (13%) felt a lack of connect due to the prevailing situation. Inability to celebrate joyful moments with family, neonatal separation, and delay in discharge were the major causes of discontent among the postpartum women. Conclusion: The study shows that the excitement and joy of pregnancy and delivery in pre-COVID times has been replaced by fear, anxiety, and uncertainty in this COVID era. Strategies, like good communication and provision of adequate support, may be particularly useful to help these women have a positive birthing experience.

5.
Frontiers in Medicine ; 9, 2022.
Article in English | EMBASE | ID: covidwho-2009877

ABSTRACT

Context: The COVID-19 pandemic has placed a tremendous stress on healthcare systems and caused reorganization. As the pandemic intensifies, identifying the profile of patients with COVID-19 was primordial in order to predict negative outcomes and organize healthcare resources. Age is associated with COVID-19’s mortality, but for obvious ethical reasons, chronological age cannot be the sole criterion for predicting negative outcomes. Objective: The objective of this study was to determine the relationship between frailty index (FI) and length of hospital stay, and death in a non-COVID population of patients aged 75 years old and above. Methods and design: A retrospective, analytical, single-centered observational study was performed in the geriatric short-stay accommodation unit at Guadeloupe University Hospital. For this study, 158 patients who were at least 75 years old were recruited from November 2020 to May 2021. FI was calculated as the number of deficits in a participant divided by the total number of deficits considered (the cut-off of FI is.25 in outpatient). Multivariate logistics regression analyses were conducted to assess the association between frailty and death, and length of stay. Results: The average age of the participants was 85.7 ± 6.74 with a range of 75–104. Twenty-four of the patients died during hospitalization. FI was only significantly associated with mortality even after adjustment for age and gender (HR 26.3, 95% CI 1.7–413.4, P = 0.021). The association was stronger in the highest tertile of the FI (age- and gender-adjusted HR 4.6, 95% CI 1.39–15.11, P = 0.01). There was no significant interaction between FI and length of stay. Conclusion: Our study shows an association between FI (in terms of age-related deficit accumulation) and mortality in a non-COVID geriatric short-stay unit in Guadeloupe. The FI seems to have a lower capacity to catch events such as length of stay in this very complex population. Further research studies have to be conducted for better understanding and investigation of our findings.

6.
Neuropsychiatric Disease and Treatment ; 18:1907-1916, 2022.
Article in English | EMBASE | ID: covidwho-2009784

ABSTRACT

Background: There have been reports suggesting an increased incidence of acute ischemic stroke among anti-SARS-CoV-2 vaccinees. We aimed to systematically review the literature to summarize the available evidence on the association between SARS-CoV-2 vaccination and acute ischemic stroke. Methods: A systematic literature search on MEDLINE, LitCovid and LIVIVO databases was performed for eligible randomized controlled trials, observational studies, registries and case reports that reported on imaging-confirmed acute ischemic stroke in the context of any SARS-CoV-2 vaccination with BNT162b2, mRNA-1273, Ad26.COV2.S, ChAdOx1 or Gam-COVID-Vac. Literature search was limited to English and German languages and publication date before October 19, 2021. Results: We identified a total of 395,105,670 individuals who underwent vaccination. We found 21 sources, including 2 cohort studies, 4 registry studies, 3 randomized clinical trials, and 12 case reports. Individuals included in these studies were at least 16 years old. Cari et al observed a higher likelihood of acute ischemic stroke in vaccinees aged 18–64 years, compared to Whiteley et al observing vaccinees older than 70 years when vaccinated. In addition, differences in the likelihood of acute ischemic stroke were found among the vaccines studied, although no overall increased stroke incidence was demonstrated with vaccination. Conclusion: In this systematic review of the available literature, we found that the risk of acute ischemic stroke does not appear to be increased in vaccinated individuals who have received any of the currently licensed SARS-CoV-2 vaccines compared with the baseline incidence of stroke.

7.
Journal of Asthma and Allergy ; 15:1195-1203, 2022.
Article in English | EMBASE | ID: covidwho-2009779

ABSTRACT

Purpose: Patients with severe asthma (SA) are at an increased risk of asthma-related hospitalizations and exacerbations. Despite concerns that COVID-19 circulation would increase exacerbations of SA, anecdotal reports suggest that social distancing and exposure avoidance may have led to reduced exacerbations. Patients and methods: CHRONICLE is an ongoing noninterventional observational study of 3100 subspecialist-treated patients with SA. Eligible adults (≥ 18 years of age) have (1) current use of monoclonal antibody (ie, biologic) therapy for SA, (2) use of maintenance systemic corticosteroids (mSCS) or other systemic immunosuppressants for ≥ 50% of the prior 12 months for SA, or (3) persistently uncontrolled asthma while treated with high-dosage inhaled corticosteroids with additional controllers. For enrolled patients, electronic medical records were reviewed to record all exacerbations and asthma-related hospitalizations. Descriptive analyses were conducted of the monthly incidence of exacerbations, exacerbation-related visits to the emergency department (ED), and asthma hospitalizations from July 2018 through July 2021. Results: Exacerbations, exacerbation-related ED visits, and hospitalizations decreased since April 2020. Exacerbations in 2020 were 20% to 52% lower in April through August relative to the same months in 2019. Exacerbations remained lower than the prior year through May 2021. Similar results were observed by United States (US) census region, with an earlier decrease in exacerbation rates in the western US versus other regions. Across all months, exacerbation rates were lower among biologic recipients. Conclusion: In a clinical cohort of subspecialist-treated patients with SA, there was a meaningful reduction in exacerbations, exacerbation-related ED visits, and asthma hospitalizations following COVID-19–related stay-at-home orders and social distancing recommendations. Reasons for these reductions are likely multifactorial, including reduced viral infections due to less social contact and altered patient behavior.

8.
Journal of Behavioral Addictions ; 11:182, 2022.
Article in English | EMBASE | ID: covidwho-2009738

ABSTRACT

Objectives: The current study aimed to assess the pattern of digital media use and screen time among students during lockdown. It also aimed to explore possible correlates of problematic digital media use and screen-time among students. Methodology: It was a prospective observational study. Students pursuing undergraduate courses in Public and Private State Universities constituted the study universe. The study used a survey approach for data collection. Besides the screen time, the mental well being of the study participants was assessed by the WHO Well-being Index and the personality was assessed using the Big Five Inventory (BFI)-10. Results: A total of 731 responses were included in the analysis. Around 93% self-reported an increase in daily screen time during COVID-19. A small but significant negative correlation between increased screen time and QoL (rs = -0.154, p < .001) was found. Increased screen time due to the use of social media for non-communication purposes was associated with poorer QoL (U = 32947.50;p = .02) and greater COVID stress (U = 32381.50;p = .01). Out of total of 202 students who shared the screenshot of the phone ST function, 145 (71.8%) underestimated their daily smartphone ST, whereas 56 (27.7%) overestimated ST. In the regression analysis the predicted odds of poor mental well-being were 1.430 times greater for subjects with higher neuroticism scores for the overall sample.

9.
PLoS ONE ; 17(8 August), 2022.
Article in English | EMBASE | ID: covidwho-2009687

ABSTRACT

During the COVID-19 pandemic, a number of infection clusters associated with choral singing have been reported. Singing generates droplets and carries the risk of spreading infection. However, no reports have explored droplet flight and aerosol production rates by singing and speaking in Japanese. First, we conducted an observation experiment evaluating the maximum flight distance and number of droplets generated by singing in Japanese, using a high-speed camera and particle counter. Twenty amateur choir members, 10 male and 10 female (five members for each of the four voices), participated in the experiment. Subsequently, although the maximum distance that droplets traveled by singing in Japanese was 61 cm for men (median of 46.5, interquartile range, 36-57) and 56 cm for women (median of 27.5, interquartile range, 20-50), droplets were observed anteriorly and laterally to be up to 66.8 cm. At the singer's mouth, ≥ 5 μm droplets were observed, whereas not observed at 1 meter toward the front of the singers in women and men, respectively. In German singing, droplets were observed up to 111 cm toward the front of the singer, possibly reflecting differences in pronunciation. In Japanese reading aloud, droplets were also observed up to 47 cm toward the front, whereas no droplet dispersion was observed by speaking the Japanese /a/ vowel or singing with wearing surgical mask toward the front. The aerosols produced when reading singing the /u/ vowels were significantly higher than those in other vowels. When singing in a choral group, keeping a sufficient distance at the front and side is recommended in minimizing infectious spread. If distance is not possible, practicing with /a/ vowels and avoiding consonants may be an alternative method. Our observations lasted only 50 seconds per song, and further observational studies are needed to determine the dynamics of aerosols that stay for long periods.

10.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009642

ABSTRACT

Background: The rapid spread of SARS-CoV-2 has elicited an equally rapid development of effective vaccines, leading to a reduction of COVID-19 severity and deaths. There is limited data on COVID-19- related immunity in chronic myeloid leukemia (CML) patients. Methods: SPARTA (SARS2 SeroPrevalence And Respiratory Tract Assessment) is an ongoing observational study for participants age ≥18 years to investigate immunity to SARS-CoV-2 after infection and/or vaccination. We included patients with CML and compared them with a non-cancer group. We collected saliva and peripheral blood to measure antigen levels by RT-PCR and antibodies (secretory IgG antibodies and neutralizing antibodies). Results: From October 1, 2021, to February 4, 2022, we prospectively enrolled 49 participants (23 CML, 26 non-cancer). Most were male (56.5%) in the CML group and female in the control group (61.5%), mean age 56.39 y vs. 51.96 y, respectively, and self-identified as white (87% vs. 76.9%). In the CML group, 11 (47.8%) had ≥1 comorbidities, vs 13 (50%) in the control group. Twenty-one (91.3%) CML patients were receiving tyrosine-kinase inhibitors;4 (18.2%) non-cancer subjects reported taking any medication. Most participants in both groups had received at least one dose of COVID- 19 vaccine (73.9% vs. 73.1%);100% of CML patients received two doses vs. 84.2% of controls;the CML group had a higher percentage of subjects fully vaccinated (66.7% vs. 25%). The CML group had a lower percentage of patients previously diagnosed with COVID-19 (8.8% vs. 57.7%). However, there was no difference in the detection of SARS-CoV-2 antigen at the time of enrollment (0% vs. 4%). SARS-CoV-2 IgG antibodies were detected in most of the participants regardless of cancer status (78.3% in the CML cohort and 88% in the non-cancer cohort), and neutralizing antibodies were detected in 82.6% and 95.6%, respectively. The two groups had comparable IgG (mean 146.3 Ru/ml vs. 148.9 Ru/ml) and neutralizing (mean 1329.1 ng/ml vs. 1112 ng/ml) antibody levels. Conclusions: Our preliminary data comparing concomitant cohorts with similar socio-demographic characteristics and medical history indicate that a diagnosis of CML did not impact the development of antibodies against SARS-CoV-2. We are conducting continuous analysis of antibodies levels over time to assess the evolution of antibody immunity and functional studies including cellular immunity assessments.

11.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009636

ABSTRACT

Background: Since cancer patients (pts) are at increased risk of severe morbidity and mortality due to COVID-19, SARS-CoV-2 vaccination is crucial to prevent severe disease course. The efficacy and longevity of vaccine protection, however, is still in question. Methods: In this prospective observational study we assessed immunogenicity of cancers patients on active treatment for solid cancers in two Slovenian Oncology Centres receiving SARS-CoV-2 vaccine by detection of anti-SARS-CoV-2 S1 IgG antibodies in serum;before, after first and second dose, 3 and 6 months (mo) after complete primary course of vaccination and 1 mo after the 3rd booster dose. Samples with ≥ 175 ng/ml were considered positive. Results: There were 125 pts included in the study, 112 completed the primary course of vaccination with 2 vaccine doses and 34 received the booster 3rd dose. Out of 34 pts receiving booster 3rd dose, the majority received mRNA based vaccines (88%) for the primary course of vaccination and all patients received mRNA based vaccines for the booster 3rd dose. Median time from 2nd to booster 3rd dose of vaccine was 6.75 mo, median age of pts was 66 yrs and 59% were male. Patients were receiving chemotherapy (ChT), immune checkpoint inhibitors (IO) or targeted therapy (TT) in 9%, 56% and 35%, respectively. They achieved seroconversion in 94% after the 2nd and in 97% after the 3rd booster dose. Overall, the median anti-SARS-CoV-2 S1 IgG titer was 11,191 ng/ml (mean 25,394;range 0 - 100,000) after complete primary course of vaccination and 1892 ng/ml (mean 6413;range 0 - 72,000) 6 mo after, P < 0.0001. However anti-SARS-CoV-2 S1 IgG antibodies increased significantly after the 3rd booster dose with median antibody value 51,310 ng/ml (mean 51,787;range 0 - 100,000), P < 0.001. Only one pt in this group got infected with SARS-CoV-2 and had a mild disease course. Conclusions: Cancer pts treated for solid malignancies achieve a high rate of seroconversion through the primary course of vaccination. However, significant waning of immunity against SARSCoV-2 is observed 6 months thereafter, which can be potentiated with additional 3rd booster dose of vaccine.

12.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009590

ABSTRACT

Background: In the 1990s, it was demonstrated that Black patients were less likely to receive timely treatment for Stage 3 lung cancer than White patients. While contemporary work has found racial disparities in accessing insurance, diagnostics, and treatments, we wished to explore whether patients faced disparities once in treatment. To do this, we examined whether racial disparities were observable in a 2019 cohort of Medicare Advantage beneficiaries receiving treatment for lung cancer. Methods: This retrospective, observational study used health plan claims data to identify Black and White patients aged 18 to 89 years with a Medicare Advantage health plan in calendar year 2019 who received diagnostic imaging (computed tomography or positron emission tomography) followed by lung cancer treatment (radiation therapy [RT] or surgery claims mentioning a diagnosis of lung cancer) within 90 days. Only patients treated in 2019 were considered so that the findings would reflect the state of care immediately preceding the COVID-19 pandemic. Patients were excluded if they had a history of RT or lung surgery in the year prior to the diagnostic imaging date. Other databases were used to determine cancer stage, patient demographics, comorbidities, the urbanicity and median income of patients' home ZIP code, and whether treatment was ordered by a hospital-based physician. A multivariate logistic model was used to examine the association between race and surgery, and a multivariate negative binomial model was used to examine the association between race and days to treatment (surgery or RT). Results: We identified 823 patients, 83.8% White (690), and 16.2% (133) Black. Surgery was received by 3.1% [4/133] of Black patients and 9.7% [61/690]) of White patients. Black patients received treatment on average 36.9 days after diagnosis, versus 35.1 days for White patients. Adjusted analysis did not find a significant association between race and receipt of surgery (P = 0.07) or race and days to treatment (P = 0.77). No covariate was significantly associated with receipt of surgery. Residence in a state with a higher obesity rate was associated with fewer days to treatment (P = 0.02). Conclusions: In a uniformly insured population that successfully received treatment, adjusted analysis found no evidence of a Black / White racial disparity in use of lung surgery for Stage 3 lung cancer or in timeliness of treatment. Given the directionality of the findings, they could potentially have been significant if the sample size had been increased by extending the enrollment period. The implication of these findings is that it may be most fruitful to address racial disparities at the frontend of the care process;working to ensure that patients have access to insurance, diagnostics, and treatments, as disparities were not observed in a population that had accessed treatment. Further research is needed to assess whether racial disparities in lung cancer treatment have dissipated over time.

13.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009576

ABSTRACT

Background: We provide care for the rural, low-income, and underserved population of Oroville. The community has a vaccination rate of 50% and booster rate of over 20% in the 3rd year of the ongoing global SARS-CoV-2 pandemic in 2022. During this period, a subset of our cancer patients benefited from the use of immune checkpoint inhibitors. Methods: This is a cross-sectional observational study of the effectiveness of a mRNA-based vaccine in medical care workers compared to patients with systemic malignancies treated with immunomodulation of PD-1 and CTLA-4 inhibitors. The study was approved by the hospital IRB. We evaluated the total anti-Spike protein antibody titer using a commercial semi-quantitative assay, Labcorp Test #164090. All subjects received 3 doses of the mRNA vaccine. We excluded anyone who was administered therapeutic monoclonal antibodies (mAb) or had a recent infection within 120 days. Results: Subjects with systemic malignancies were significantly older, p = 0.0001 by t-test: median age: 76, range: 64-82, compared to health care workers: median age: 52, range: 21-75. Accrual had to be prematurely stopped upon the arrival of Omicron wave in the community. Out of the seven subjects treated with immunomodulation, six received nivolumab, including two in combination with ipilimumab. One subject received pembrolizumab. Six of the subjects had metastatic disease: one was treated adjuvantly for locally advanced esophageal adenocarcinoma. The rest had NSCLC and one case of urothelioma. We divided the groups to those who had the highest titer of antibody versus everybody else and found a similar distribution in both groups using the Chi2 test. The vast majority of the healthcare workers, 24/27 or 89%, had above the upper limit antibody titer. Patients with systemic malignancy, 5/7 or 71%, had above the upper limit antibody titer p = N.S. Conclusions: Three doses of the mRNA vaccine provided high titers irrespective of frailty or age. We hypothesize that immunomodulation could favorably affect vaccination response.

14.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009515

ABSTRACT

Background: Vaccination is an essential strategy to prevent infection in the SARS-CoV-2 pandemic. However, there are concerns about vaccine efficacy and the impact of vaccination on cancer treatment. Additionally, the emergence of novel variants may affect vaccination efficacy. This multi-center, prospective, observational study investigated the efficacy and impact of vaccination against SARS-CoV-2 variants on treatment among breast cancer patients in Japan. Methods: Breast cancer patients scheduled to be vaccinated with the SARS-CoV-2 vaccine from May to November 2021 were included. They were stratified into five groups according to their cancer treatment: no treatment, endocrine therapy, CDK4/6 inhibitor, chemotherapy, anti-HER2 therapy. Serum samples were collected before the first vaccination and after the second vaccination. Immunoglobulin (Ig)G levels against the SARS-CoV-2 S protein and neutralizing antibody titers against wild-type (WT), alpha (α), delta (δ), kappa (κ), and omicron (o) variants were measured by ELISA assay. The effect of vaccination on cancer treatment was also investigated. Results: There were 85 eligible patients (no treatment, n = 5;endocrine therapy, n = 30;CDK4/6 inhibitor, n = 14;chemotherapy, n = 21;and anti-HER2 therapy, n = 15) with a median age of 65 years. The overall seroconversion rate of anti-SARS-CoV-2 IgG was 95.3%. The seroconversion rate of the chemotherapy group was 81.8%. The anti-SARS-CoV-2 IgG antibody concentration was positively correlated with the lymphocyte count before vaccination (r = 0.232, p = 0.039). Overall neutralizing antibody titers against each variant were significantly lower than for WT. Overall positive rates of neutralizing antibodies against WT, α, δ, γ, and o variants were 90.2%, 81.7%, 96.3%, 84.1%, and 8.5%, respectively. A downward trend of neutralizing antibody titers against each variant was seen in chemotherapy and CDK4/6 inhibitor groups compared with other groups. Significant decreases were detected in neutralizing antibody titers against WT, α, and κ variants in the chemotherapy group, and WT and α variants in the CDK4/6 inhibitor group compared with the no treatment group. Withdrawal or postponement of systemic therapy because of vaccination was only observed in one patient. Conclusions: Our data support SARS-CoV-2 vaccination for cancer patients being treated with systemic therapy. However, neutralizing antibody titers against the o variant were very low even after two vaccinations among patients with or without cancer treatment. Further, a decrease in neutralizing antibody titer was suggested during chemotherapy and CDK4/6 inhibitor, raising concerns about the impact on long-term infection prevention. For these patients, infection-preventive behaviors should be recommended even after vaccination. They will also be good candidates for booster vaccinations.

15.
Annals of the Rheumatic Diseases ; 81:1244, 2022.
Article in English | EMBASE | ID: covidwho-2009205

ABSTRACT

Background: The risk of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) is higher than individuals from the general population due to chronic infammation. Current CV risk screening and management strategies underestimate the actual CV risk in RA. Thus, an adequate CV risk stratifcation has special relevance in RA to identify patients at risk of CV disease. Objectives: To assess the incidence of cardiovascular events in a RA cohort after a 2 years follow-up. Methods: A cohort study was performed in which inclusion criteria were adult RA patients and matched adults in terms of age, sex and CV risk factors (controls). Population over 75 years old, patients with established CV disease and/or stage III chronic kidney disease were excluded. Controls with other infam-matory diseases, pregnant women or any malignancy were also excluded. This study was performed from July-2019 to January-2022. CV risk assessment included risk factors collection and US evaluation consisted in detection of plaques and measurement of the intima-media thickness in both right and left carotid. Results: Overall, a total of 200 cases and 111 healthy controls were enrolled in the study. Demographical and clinical variables were comparable between cases and controls and are shown in Table 1. US study revealed a higher IMT in both right and left carotid arteries with greater presence of plaques in patients than in controls (CI 95% [1.542;3.436], p<0.001). Plaques were found in both carotid arteries in the 32% of cases and 9.91% of controls. The longer duration of RA was related to a higher presence of carotid plaques (95% [1.015;1.056], p<0.001). Eight patients (4%) presented a cardiovascular event, and one of them died (0.5%). The events consisted in 2 angina pectoris, 3 transient ischemic attack, 1 acute myocardial infarction, 1 lacunar stroke and 1 cardiac arrest. Six out those 8 patients demonstrated bilateral plaque presence at baseline. Two patient caused loss of follow up due to death related to Covid-19. Not a single cardiovascular event was reported in the control group. Conclusion: Our results shows that cardiovascular events are increased in RA patients and US study may be useful in predicting an event.

16.
Annals of the Rheumatic Diseases ; 81:979, 2022.
Article in English | EMBASE | ID: covidwho-2009196

ABSTRACT

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease 2019 (COVID-19) raised many questions and concerns about the safety of different immunosuppressive agents in patients (pts) with rheumatic diseases during the pandemic. There is some data that anti-B-cell depletion strategies could lead to more severe disease course. Rituximab (RTM) is one of the most effective, safe and well tolerated agents in IgG4-related disease (IgG4-RD) treatment. Information about the course of COVID-19 in pts with IgG4-RD is lacking. Objectives: To examine clinical course of COVID-19 in pts with IgG4-RD treated with anti-CD20 monoclonal antibody (RTM). Methods: Single center observational study. We searched in our clinical base from 2019 to 2021 years for pts with IgG4-RD, treated with RTM within this period. Diagnosis of IgG4-RD was based on comprehensive diagnostic criteria (H. Umehara, 2011). COVID-19 infection was registered when PCR test results were positive. RTM was administered in two 1000 mg infusions 14 days apart for the 1st course, then 500 mg every 6 months. We used mean ± standard deviation and median values with interquartile range of 25-75 percentile to characterize quantitative data. Results: Fifteen pts, 6 women and 9 men, mean age 53.2 ± 12 years, receiving RTM monotherapy were included. The majority of patients (80%) had multiple organ involvement, mean number 2,3 (from 1 to 5): dacryadenitis-11 pts, sialadenitis-10 pts, AIP 1-4 pts, lung disease-3 pts, sclerosing cholangiris-2 pts, kidney disease-2 pts, retroperitoneal fbrosis-1 pt, aortitis-1 pt, prostatitis-1 pt. Median duration of IgG4-RD before COVID-19 onset was 48 [27;72] months, median duration of RTM treatment was 22 [11,5;30,5] months and median time from the last dose of RTM was 2 [1;4,5] months. Three pts had arterial hypertension or coronary heart disease anamnesis, 4 pts had asthma, 2 pts were overweight and 1 had class 3 obesity. No pts were vaccinated against SARS-CoV-2. Six patients (40%) required hospitalization and 4 of them received IL-6 inhibitors, only 1 required mechanical lung ventilation, 6 patients (40%) had only minor symptoms and didn't require any specifc treatment, glucocorticoids were administered to 8 patients. All patients, except one, were older than 50, but they didn't have severe comorbidities. One patient, a 46 year-old man with a long anamnesis of IgG4-related dacryo-and sialad-enitis, bronchial asthma, arterial hypertension class 3 and class 3 obesity, died. Due to small number of studied pts no statistical correlations could be established. Conclusion: The proportion of hospitalized pts with IgG4-RD and RTM treatment was surprisingly high. The worst course was in patient with severe comorbidity. It appears that RTM can have negative impact on susceptibility to COVID-19 and its disease course.

17.
Annals of the Rheumatic Diseases ; 81:1707-1708, 2022.
Article in English | EMBASE | ID: covidwho-2009195

ABSTRACT

Background: The most common etiology of acute pericarditis is usually infectious, especially viral. When its cause is infammatory (up to 7% of cases), it can be presented as an isolated process or be a clinical manifestation in the context of multiple systemic autoimmune diseases (SAD), therefore it is necessary to make a broad differential diagnosis. Nowadays, an increased incidence has been described in relation to SARS-CoV-2 infection, and especially in global vaccination against this one. This represents a clinical challenge when we have to identify the cause of this pathology with a not insignifcant comorbidity. Objectives: To describe the characteristics of a series of patients with acute pericarditis and its association with SAD. Methods: Retrospective and descriptive observational study. Digitalised records of patients with acute pericarditis evaluated in the Rheumatology unit of a tertiary hospital in Seville during 2021 were reviewed. Demographic, epidemiological, clinical and therapeutic variables were analysed. Results: Eight cases of acute pericarditis were detected. The average age of the patients was 51.50 ± 18.601 years. 62.5% were women. 50% had previous rheumatological pathology: two rheumatoid arthritis (RA), one systemic lupus erythematosus (SLE) and one limited systemic sclerosis (LSS);with an average disease duration of 8.63 ± 2.387 months. Of these, 3 were on treatment with steroids and DMARDs (lefunomide or hydroxychloroquine) and 1 had previously received rituximab. Pericardial effusion was moderate in 50% of cases, severe in 33.3% and mild in 16.7%. One patient had cardiac tamponade. Five patients had pleural effusion, which was moderate in 80%, and in one case associated with pneumonia. As complications, one patient developed heart failure and the patient with ESL was diagnosed with pulmonary arterial hypertension. Two patients had previous COVID19 and 7 were vaccinated against Sars-CoV2. Treatment was colchicine in 57.15% of cases, steroids in 85.7%, DMARDsc in 85.8% (3 hydroxychloroquine and 3 azathioprine) and DMARDsb in 42.9% (1 anakinra, 1 tocilizumab and 1 rituximab). Pericarditis resolved in all patients. Table 1. Conclusion: In the previous year, an increase in consultations from other departments for acute pericarditis with suspected infammatory origin was observed. The possibility of a correlation with COVID19 or vaccination against COVID was initially considered, but it could not be demonstrated, since vaccination was later in vaccinated patients, and in those who had been infected, the time interval until the development of pericarditis was too long for it in order to be attributed to COVID19. Finally, in 5 of the 8 patients, pericarditis was related to SAD, in particular with the rheumatic pathologies most associated with this clinical manifestation (RA and SLE). Therefore, in the middle of the COVID pandemic, in addition to considering COVID19 or its vaccine in the differential diagnosis of acute pericarditis, we must not forget to include SAD in this diagnosis.

18.
Annals of the Rheumatic Diseases ; 81:1707, 2022.
Article in English | EMBASE | ID: covidwho-2009190

ABSTRACT

Background: The lockdown and mobility restrictions in early COVID19 pandemic had a great impact in chronic patient care due to limited access and scheduled visits. In our hospital, coordinated non-pharmacological interventions (NPI) were designed in Rheumatology and Pharmacy services to maintain the accessibility and continuity of care for patients with IMID. Objectives: To evaluate the patient reported experience (PRE), health status and quality of life in Rheumatology outpatient IMID subjects since March 14, 2020 when lockdown was imposed and during subsequent restrictions, related to the healthcare team and medications accessibility, and continuity of care. Methods: Observational study, using a patient survey. Adult patients attending the rheumatology outpatient clinic between Nov 2, 2020 to Feb 13, 2021, with rheumatoid arthritis (RA), psoriatic arthritis (PsA), spondylarthritis (SpA) or systemic autoimmune diseases (SAD), with at least 1 year from diagnosis and 1 month of treatment with conventional synthetic (cs) targeted synthetic (ts) or biological (b) disease modifying antirheumatic drugs (DMARD). Face to face or phone interviews were conducted using an ad hoc designed questionnaire that included COVID19 related questions, the 11 IEXPAC scale items (5 point Likert scale ranging from never to always) (www.iexpac.org), and 4 items (5 points, very good to very bad) of the global scale PROMIS 10 (Patient-Reported Outcomes, PRO). All questions refer to the patient's experience during the 6 months prior to data collection. Results: From 174 screening patients, 158 completed the survey, mainly woman (66.5%) with a median age of 60 (IQR 47-69,3) years. The most frequent diagnosis was RA (43%) followed by ESAP (35%), EAS (22%) and PsA (13%). 46.8% of the patients have been prescribed b or ts DMARD and 53.2% sc DMARD, 32.9% in combination. From 158, 39 persons requested healthcare for COVID-19 related symptoms and diagnosis was confrmed in 17 (10,8%). Just 2 patients required hospital admission. Clinical control and continuity of care for COVID19+ patients were carried out from their primary care center and by phone consultation. Some key results of the survey are displayed in Table 1. Conclusion: Lessons have learned during the COVID19 lockdown and restrictions by assessing patients' health status and patients-reported experience. Coordinated NPI such as medication monitoring and home delivery, appointment reorganization and protocolized phone visits can result in a good patient perception and medication adherence whilst receiving care in a challenging situation.

19.
Annals of the Rheumatic Diseases ; 81:1721, 2022.
Article in English | EMBASE | ID: covidwho-2009187

ABSTRACT

Background: Multimodal rheumatologic complex treatment (MRCT) is a treatment concept for patients with rheumatologic diseases requiring acute inpatient care suffering from exacerbated pain and/or functional impairment. A rheumatol-ogist directs the treatment program including multimodal assessments and treatment from three of the following: ergotherapy, physiotherapy, pain medicine and cognitive behavioural treatment. Most studies evaluated data from a two-week inpatient MRCT program.1 Available data on the effectiveness of a one-week inpatient multimodal treatment program are scarce. However, whether a shorter program might also be effective has not been studied so far. Objectives: To evaluate the effectiveness of a one-week inpatient multimodal and interprofessional treatment program on musculoskeletal pain and function of patients with rheumatologic disorders. Methods: 59 consecutive patients were entered into a program of multimodal treatment courses (MRCT) from January 2021 until December 2021. All patients completed a total of 11 hours of therapy in one week. Two patients were excluded for evaluation (one patient acquired COVID 19 during hospitalization and one patient was excluded due to missing data). Pain was assessed via visual analogue scale (VAS) and functional impairment via the 'Funktionsfragebogen Hanover (FFbH)' and the 'Health Assessment Questionnaire (HAQ)' at admission, at discharge and at 12 weeks of follow up. Paired t-test analyses for all treatment episodes were performed. Results: The mean treatment duration (days, ±SD) was 8.1 ± 0.8. Mean age (years, ±SD) of the 57 patients treated in the MRCT program was 57.2 ± 12.5, with 72% female and 28% male patients. Of all patients, 40% had an underlying infammatory disorder, 60% a non-infammatory rheumatic disease. 23% of all patients had 'back pain', 14% 'spondyloarthritis' and 11 % 'rheumatoid arthritis'. Overall, VAS (pain) mean at admission was 6.9 ± 1.0 (SD), HAQ mean 0.57 ± 0.23 (SD) and FFbH mean 81.44 ± 7.95 (SD), respectively. Signifcant improvements in VAS, HAQ and FFbH were demonstrated at discharge (day 8), with a mean improvement of VAS of-2.86 (95% CI:-3.07 to-2.64, P value: <0.0001), a mean improvement of HAQ of-0.24 (95% CI:-0.28 to-0.20, P value: <0.0001) and a mean improvement of FFbH of 5.38 (95% CI: 3.78 to 6.98, P value: <0.0001). Follow up assessment at week 12 was recorded in 22 patients (39%) with a signifcant mean improvement in VAS of-2.23 (95% CI:-2.98 to-1.48), P value < 0.0001) (Table 1 and Figure 1). Conclusion: Signifcant improvement of pain and function was demonstrated at discharge and at week 12 in patients with rheumatologic diseases and mus-culoskeletal pain completing a one-week inpatient multimodal interprofessional treatment program. A multimodal therapeutic approach may provide an effective treatment strategy superior to unimodal standard management.

20.
Annals of the Rheumatic Diseases ; 81:208-209, 2022.
Article in English | EMBASE | ID: covidwho-2009182

ABSTRACT

Background: Pausing methotrexate (MTX) for two to four weeks, improved immunogenicity of infuenza vaccination in patients with rheumatoid arthritis (RA), albeit a risk of disease fare (1). This guided the framing of guidelines on MTX withdrawal for COVID-19 vaccination (2). However, evidence for MTX withdrawal for COVID-19 vaccination is limited to observational studies only. Objectives: To compare the efficacy and safety of holding MTX after each (MIVAC 1) and only after the second dose (MIVAC II) of the ChAdOx1 vaccine versus continuation of MTX in two randomized controlled trials (RCTs). Methods: Two single centre, investigator-blinded, RCTs were conducted in patients with RA or Psoriatic arthritis (PsA) on stable doses of MTX without prior COVID-19 (CTRI reg. no. MIVAC I: CTRI/2021/07/03463 & MIVAC II: CTRI/2021/07/035307). In MIVAC I, unvaccinated patients were randomised (1:1) to hold or continue MTX for two weeks after each dose of the vaccine. MIVAC II included patients who had continued MTX during the frst dose of ChA-dOx1 and were randomised (1:1) to hold or continue MTX for 2 weeks after the second vaccine dose. The primary outcome for both the trials was the anti-Receptor Binding Domain (RBD) antibody titres measured four weeks after the second vaccine dose (per protocol analysis). Secondary outcome was the fare rate, defned as an increase in disease activity scores (DAS28/cDAPSA) or physician intent to hike DMARDs. Results: 250 patients were randomized for MIVAC 1 and 178 for MIVAC II and after due exclusions, 158 and 157 were eligible for analysis respectively (Figure 1). In MIVAC I, median anti-RBD titres were signifcantly high in the MTX hold group [2484 (1050-4388) versus 1147(433-2360), p=0.001] but the fare rate was higher in the hold group [20 (25%) versus 6(8%) p=0.005] compared to continue group. In MIVAC II median anti-RBD titres were signifcantly high for the MTX hold group [2553 (1792-4823) versus 990 (356-2252), p=0.001] when compared to continue group but there was no difference in the fare rate between the groups [9(11.8%) and 4(7.9%), p=0.15] (Table 1). Since both were parallel studies in similar population, MTX hold arms across both the trials were compared for anti-RBD titres and fare. There was no difference in the anti-RBD titres [p=0.2] between the groups. In MIVAC I, 29(36.25%) patients had reported fare (19 in either frst or second dose, 10 for both doses) when compared to MIVAC II where only 9(11.84%) patients had reported fare after the second dose (P <0.001). Conclusion: Holding MTX after both the doses or only after the second dose of ChAdOx1 yields higher anti-RBD antibody titres as compared to continuing MTX. Comparing across the trials, holding MTX only after the second dose appears to be non-inferior to holding MTX after both doses of the vaccine with a lesser risk of fare.

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