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Current pandemic implies changes in patient care in rheumatology to reduce the risk of coronavirus transmission to patients visiting health-care facilities, by organizing less frequent blood tests, using teleconsultations, and switching from intravenous to subcutaneous drug administration. Patients under immunosuppressive treatment are considered at high risk of severe outcome and are protected accordingly by the Swiss authorities. However, current, scarce scientific evidence suggests that patients under immunosuppressive therapy do not necessarily develop severe COVID-19 presentations. Therefore, the current guidelines recommend pursuing the treatment throughout the pandemic. In case of SARS-CoV-2 infection, immunosuppressive drugs should be temporarily stopped, except for glucocorticoids, hydroxychloroquine and sulfasalazine.Copyright © 2020 Editions Medecine et Hygiene. All rights reserved.
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Objectives: BIOBADAGUAY is the Paraguayan/Uruguayan registry of adverse events in patients with inflammatory rheumatic conditions under biologic therapy (BT). Three years have elapsed from the first case of coronavirus and data about South American patients with COVID are still scarce. In this study we analyzed the frequency and clinical outcomes of COVID-19 in a cohort of patients with rheumatic diseases from Paraguay. Method(s): A cross sectional study of Paraguayan patients with rheumatic diseases from BIOBADAGUAY and controls without BT. Clinical, epidemiological, and COVID-19 data were analyzed. Only cases confirmed by SARSCoV-2 positive PCR test were included. Descriptive analysis were performed for this study. Result(s): 832 patients were included (696 under BT and 136 controls). 116 (13.9%) had COVID-19. 22 had a second infection and 9 a third reinfection. Table 1 shows characteristic of COVID-19 patients. The most frequent diagnosis was rheumatoid arthritis (n = 93, 80.2%) followed by ankylosing spondylitis (n = 6, 5.2%), undifferentiated spondylarthritis (n = 5, 4.3%), psoriatic arthritis (n = 4, 3.4%), juvenile onset arthritis (n = 2, 1.7%), vasculitis (n = 2, 1.7%). Only 1 case (0.8%) were registered for Still's disease, enteropathic spondylarthritis, systemic sclerosis and seronegative polyarthritis, respectively. When comorbidities were analyzed, 46 (39.6%) patients had at least one (Table 1). Of the total treatments received: 65 (56.0%) had methotrexate, 53 (45.7%) leflunomide, 3 (2.5%) sulfasalazine, 15 (12.9%) hydroxychloroquine, 25 (21.5%) glucocorticoid, 52 (44.8%) anti-TNF and 20 (17.2%) non-anti-TNF. COVID-19 severity outcomes were: 101(87%) non severe, 31 (26.7%) severe and 1 fatal(0.8%). 189 (90.9%) patients received vaccination and the mean number of doses were 2.5 doses. 55 (26.4%) had COVID prior to vaccination Conclusion(s): In this study we examined the frequency of COVID-19 in Paraguayan patients with rheumatic diseases. In this cohort of rheumatologic patients, COVID 19 severity was similar to the one in the general population.
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Intro: The ongoing pandemic caused by the SARS-CoV-2 virus has brought many new insights into medicine. During the first months of the pandemic, when there were no comprehensive guidelines for precise antimicrobial therapy, empirical overuse of broad-spectrum antibiotics was observed. Which resulted in the development of clostidium infection in certain cases. In our report, we address 83 cases of clostridial colitis in post-covid patients from 3/2020 to 3/2021 and their specific therapy. Method(s): Retrospective analysis of risk factors for clostridial infection and therapy of clostridial colitis. Finding(s): In the period 3/2020-3/2021, 9617 patients were diagnosed with SARS-CoV-2 virus infection in our hospital, of which 1247 were hospitalized. In 83 cases, clostridial colitis occurred during or after the covid infection had resolved. Mortality in this group was 17%, which corresponds to 14 patients. Previous empirical administered antiobiotics in COVID-19 infection contributed to the development of clostridial colitis in case of 22 patients (27%) by clarithromycin, in 14 pacients (17%) by penicillins and by 3rd generation cephalosporins in 9 patients (11%). The average duration of therapy with broad-spectrum antibiotics was 15.63 days (+-8.99). Other risk factors we observed are: PPI use (25%), active malignant disease (10%), previous glucocorticoid therapy (22%). Vancomycin was used in clostridial infection therapy in 47% (39), metronidazole in 31% (25) and fidaxonicin in 7% (6). In the group, we observed recurrence of clostridium difficile infection in 14% of patients and FMT was performed in 6 patients. Conclusion(s): This study shows a higher percentage of clostridial infection in cases of long-term therapy with broad-spectrum antibiotics. It also points to the effect of specific antimicrobial therapy for infection caused by the bacterium Clostridium difficile and the possibility of using fecal bacteriotherapy.Copyright © 2023
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Objectives: To assess the severity of SARS-CoV-2 infection in patients with axSpA from the SAR-COVID registry, comparing them with patients with rheumatoid arthritis (RA), and to determine the factors associated with poor outcomes and death. Method(s): Patients >=18 years of age from the SAR-COVID national registry with diagnosis of axSpA (2009 ASAS criteria) and RA (2010 ACR/EULAR criteria) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology), recruited from August 2020 to June 2022 were included. Sociodemographic and clinical data, comorbidities, treatment and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS): ambulatory (1), mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death (8). Result(s): A total of 1226 patients were included, 59 (4.8%) with axSpA and 1167 (95.2%) with RA. RA patients were significantly older, more frequently female, and had a longer disease duration. 43.9 % presented comorbidities. t the time of SARS-Cov-2 diagnosis, patients with RA used glucocorticoids and conventional DMARDs more frequently than those with axSpA, while 74.6% of the latter were under treatment with biological DMARDs being anti-TNF the most used (61%). 94.9 % of the patients in both groups reported symptoms related to SARS-CoV-2 infection. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All the patients with axSpA were admitted to the general ward, while 26.6%of those with RA were admitted to the intensive care units. No patient with axSpA had complications or severe COVID-19 (WHO-OS> = 5) or died as a result of the infection while mortality in the RA group was 3.3% (Figure 1). In the multivariate analysis adjusted for poor prognosis factors, no association was found between the diagnosis of axSpA and severity of SARS-CoV-2 infection assessed with the WHO-OS (OR-0.18, IC 95%(-0.38, 0.01, p = 0.074). Conclusion(s): Patients with axSpA did not present complications from SARSCoV-2 infections and none of them died due COVID-19.
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AIM: to estimate the features of pseudomembranous colitis in patients with COVID-19, diagnostics, conservative treatment and surgery for complications. PATIENTS AND METHODS: a retrospective analysis of 396 patients with pseudomembranous colitis (PMC) in patients with new coronavirus infection was carried out for the period from March 2020 to November 2021. Among them there were 156 (39.3%) males, females - 240 (60.6%), moderate and severe forms of COVID-19 occurred in 97.48%. The diagnosis of PMC was established due to clinical picture, laboratory, instrumental methods (feces on Cl. difficile, colonoscopy, CT, US, laparoscopy). RESULT(S): the PMC rate in COVID-19 was 1.17%. All patients received antibiotics, 2 or 3 antibiotics - 44.6%, glu-cocorticoids were received by all patients. At 82.8%, PMC developed during the peak of COVID-19. To clarify the PMC, CT was performed in 33.8% of patients, colonoscopy - 33.08%, laparoscopy - in 37.1% (to exclude bowel perforation, peritonitis). Conservative treatment was effective in 88.8%, 76 (19.1%) patients had indications for surgery (perforation, peritonitis, toxic megacolon). Most often, with peritonitis without clear intraoperative confir-mation of perforation, laparoscopic lavage of the abdominal cavity was performed (60 patients - 78.9%, mortality - 15.0%), colon resection (n = 6 (7.9%), mortality - 66.6%), ileo-or colostomy (n = 8 (10.5%), mortality - 37.5%), colectomy (n = 2 (2.6%), mortality - 50.0%). The overall postoperative mortality rate was 22.4%, the incidence of surgical complications was 43.4%. In addition, in the postoperative period, pneumonia was in 76.3%, thrombosis and pulmonary embolism in 22.3% of patients. In general, the overall mortality in our patients with PMC was 11.4%, with conservative treatment - 8.8%. CONCLUSION(S): pseudomembranous colitis is a severe, life-threatening complication of COVID-19. In the overwhelm-ing majority of patients, conservative therapy was effective, but almost 1/5 of patients developed indications for surgery, the latter being accompanied by high mortality and a high morbidity rate. Progress in the treatment of PMC, apparently, is associated with early diagnosis, intensive conservative therapy, and in the case of indications for surgery, their implementation before decompensation of the patient's condition and the development of severe intra-abdominal complications and sepsis.Copyright © 2022, Association of Coloproctologists of Russia. All rights reserved.
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Objectives: Systemic lupus erythematosus (SLE) is an autoimmune disease which presents infections as one of the most frequent complications, including more severe outcomes of Coronavirus disease 2019 (COVID-19). Immunization of these patients has been strongly recommended, however, data on safety are still scarce. In this study we evaluate the safety after vaccination against SARS-CoV2 in patients with SLE. Method(s): Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease - the 'SAFER' study, is a longitudinal Brazilian multicenter phase IV study. In this study patients with SLE (according to the 2019 ACR/EULAR criteria), older than 18 years who received vaccination against SARS-CoV-2 CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) were included. The evaluation of adverse events (AEs) was done by telephone contact, symptom diaries and a face-to-face visit on the 28th day after each dose. Patients were followed up also by disease activity, assessed using SLEDAI-2 K score. Result(s): A total of 367 individuals with SLE were included, 207 received CoronaVac, 128 received ChadOx-1 and 32 received BNT162b2. Ninety percent of the subjects were female with a mean age of 37 years. About 50% (182) of patients were using oral glucocorticoids and azathioprine was the most frequent immunosuppressive therapy. Regarding disease activity parameters, 38%(140) of patients had zero SLEDAI-2Kat baseline and 41%(147) had zero SLEDAI-2 K 28 days after the 2nd dose. After the first and second dose the most frequent AEs were pain at injection site (58%/44%), headache (48%/33%) and pruritus (42%/37%). Comparing the three vaccines, after the first dose, local symptoms, myalgia, and fever were less frequent in patients who received CoronaVac (p alpha 0.001) as well as headache, tiredness (p = 0.001) and arthralgia (p = 0.003). After the second dose, only local symptoms such as pain at the application site and thickening of the skin around the application site were less frequent in the CoronaVac group (p alpha 0.05). Headache, tiredness, musculoskeletal symptoms and fever were more common in patients receiving AstraZeneca. No serious adverse events were reported regardless of the vaccination schedule used. Conclusion(s): This study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Neither severe AEs were reported nor worsening of disease activity were reported. Comparing the different vaccines, CoronaVac had fewer adverse events.
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Background/Aims Patients with immune-mediated rheumatic diseases (IMRD) are commonly treated with immunosuppressors and are prone to infections. Recently introduced mRNA SARS-Cov2 vaccines have demonstrated extraordinary efficacy across all ages. Immunosuppressed patients were excluded from phase III trials with SARS-We aim to fully characterize B and T cell immune responses elicited by mRNA SARS-Cov2 vaccines in patients with rheumatic diseases under immunotherapies, and to identify which drugs reduce vaccine's immunogenicity. Methods Humoral, CD4 and CD8 immune responses were investigated in 147 SARS-Cov2-naive patients with selected rheumatic diseases under immunosuppression after a two-dose regimen of SARS-Cov2 mRNA vaccine. Responses were compared with age, gender, and diseasematched IMRD patients not receiving immunosuppressors and with healthy controls Results IMRD patients showed decreased seroconversion rates (63% vs 100%, p=0.04) and cellular immune responses (59% vs 100%, p=0.007). Patients on methotrexate achieved seroconversion in 62% of cases and cellular responses in 80% of cases. Abatacept deeply affected humoral and cellular responses. Rituximab (31% responders) and belimumab (50% responders) showed severely impaired humoral responses but cellular responses were often preserved. Antibody titers were reduced with mycophenolate and azathioprine but preserved with leflunomide. Conclusion IMRD patients exhibit impaired SARS-CoV-2 vaccine-immunogenicity, variably reduced with immunosuppressors. Among commonly used therapies, abatacept and B-cell depleting therapies show the most deleterious effects, while anticytokines preserved immunogenicity. The effects of cumulative methotrexate and glucocorticoid doses on immunogenicity should be considered. Humoral and cellular responses are weakly correlated, but CD4 and CD8 tightly correlate. Seroconversion alone might not reflect the vaccine's immunogenicity.
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Objective: assessment of the efficacy and safety of the use of anticoagulant, glucocorticosteroid, metabolic therapy in patients with COVID-19 at the inpatient stage of treatment. Material and methods. In February 2021, a prospective, randomized, single-center, continuous comparative study was organized on the basis of the Gomel City Clinical Hospital No. 3, which included 827 patients with moderate and severe clinical course of COVID-19. Results. Stratification of the risks of an unfavorable outcome in patients with moderate and severe clinical course of COVID-19 made it possible to optimize treatment, with the selection of optimal doses of anticoagulant and glucocorticosteroid therapy, which led to an increase in patient survival. A high level of blood lactate reflects the degree of damage to the lung tissue, the severity of the course of the disease and requires an increase in the dose of anticoagulant therapy. The use of thiotriazoline effectively reduces the level of lactate, which makes it possible to restore the energy balance of the cell. Conclusion. The use of therapeutic (intermediate) doses of anticoagulant and optimal glucorticosteroid therapy in patients at high risk of poor outcomes with moderate and severe clinical course of COVID-19, can increase the survival rate from 82.1 to 96.8%, p<0.0001. The appointment of anticoagulant therapy was complicated by "minor" bleeding in 2.13% in the main group, in 2.11% in the control group, p>0.05, and the use of glucocorticosteroids was complicated by newly diagnosed diabetes mellitus (2.13% in the main group, 1.81% in the control group, p>0.05), which allows us to consider the therapy used is safe. The use of the metabolic, antioxidant agent thiotriazoline in patients with an LDH level of more than 800 U/L and with a high risk of an unfavorable outcome led to a decrease in LDH within five days of treatment by 447.9 U/L in the main group compared with the control group by 124.0 U/L (p=0.0001), which was accompanied by an improvement in the general condition, increased physical activity, and an earlier start of rehabilitation.Copyright © 2022 by the authors.
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Objectives: The use of glucocorticoids (GC) has been associated with increased risk of hospitalization for coronavirus infection and reduced immunogenicity of SARS-CoV-2 vaccines in immune-mediated diseases (IMD) patients. However, there is still controversy of which dose of GC is correlated with impaired vaccine response on each of the diverse COVID-19 vaccines available, as well as the possible influence of other concurrent immunosuppressants. This study aimed at evaluating the effect of GC on serological response after two doses of BNT162b2 (Pfizer/BioNTech), CoronaVac (inactivated SARS-CoV-2 Vaccine) and ChadOx1 (AstraZeneca) and after the booster dose in patients with IMD. Method(s): The data were extracted from a multicenter longitudinal observational Brazilian cohort (SAFER: Safety and Efficacy on COVID19 Vaccine in Rheumatic Disease). Patients >18 years of age with IMD were evaluated after 2 doses of the same vaccine against COVID-19 and after a booster vaccine, applied according to Brazilian National Immunization Program. All patients underwent clinical examination and collected blood samples for immunogenicity tests. Serological response was evaluated by Anti-RBD titers (IgG) at baseline and 4 weeks after each vaccine dose. Result(s): Among the 1009 patients evaluated, 301 were using GC (196/401 SLE, 52/199 RA and 27/74 vasculitis). Patients using GC were younger (38.2 vs 40,8 years, p = 0,002), had higherBMI (27,6 vs 26,4 p = 0,008), higher prevalence of kidney disease (3,3% vs 0,5%, p = 0,001) and of thrombosis (11,6% vs 5,9%, p = 0,002) than non-users. Regarding the type of vaccine, most of the GC users received CoronaVac (61.7%), while only 31.9%of non-users received this vaccine (p alpha 0.001). Although there were similar rates of pre-vaccination infections among them, patients with GC tended to have a higher incidence of confirmed COVID-19 infection after the 2nd dose of the vaccine compared to non-users (4.5% vs 2.0% p = 0.054). The antibody titers after the 1st dose of COVID-19 vaccines were similar between groups, but there was a worse response in the GC group after the 2nd dose (p = 0.039). However, this difference was not statistically significant after the 3rd dose (Figure). Conclusion(s): GC use may compromise vaccine-induced immunogenicity after a 2-dose regimen;however, this effect does not remain significant after the booster dose. Multivariate analysis is still pending to assess the potential difference in the impact of GC on the immune response depending on GC dose, type of vaccine and associated drugs.
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Multisystem inflammatory syndrome in children is a novel entity first described in April 2020. It is a complication of COVID-19 that appears with a latency of 2-6 weeks and is characterized by fever, multiorgan involvement, and elevated inflammatory markers. Diagnosis is based on certain diagnostic criteria, and in these recommendations we chose the World Health Organization case definition. Patients should be treated with intravenous immuno-globulin and glucocorticoids together with other symptomatic and supportive measures. Follow-up should be at least a year-long, and even longer in case of cardiac complications. The aim of these recommendations is to help clinicians in diagnosing and treating this disease.Copyright © 2022, University Hospital of Infectious Diseases. All rights reserved.
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Objectives: Patients with systemic lupus erythematosus (SLE) present greater severity of SARS-CoV-2 infection compared to the general population, particularly those with glomerulonephritis and who are treated with glucocorticoids. Likewise, high disease activity and some immunosuppressants have been associated with worse outcomes. The aim of this study was to describe the characteristics of SARS-CoV-2 infection in patients with SLE in Argentina from the SAR-COVID registry and to establish factors associated with a worse outcome. Method(s): Observational study. Patients diagnosed with SLE with confirmed SARS-CoV-2 infection (RT-PCR and/or positive serology) from the SAR-COVID registry were included. Data were collected from August 2020 to March 2022. The outcome of the infection was measured using the World Health Organization-ordinal scale (WHO-OS). Severe COVID-19 was defined as an WHO-OS value >=5. Descriptive analysis, Student's t , Mann Whitney U, ANOVA, Chi2 and Fisher's tests. Multivariable logistic regression. Result(s): A total of 399 patients were included, 93%female, with a mean age of 40.9 years (SD 12.2), 39.6% had at least one comorbidity. At the time of infection, 54.9% were receiving glucocorticoids, 30.8% immunosuppressants, and 3.3% biological agents. SARS-CoV-2 infection was mild in most cases, while 4.6% had a severe course and/or died. The latter had comorbidities, used glucocorticoids, and had antiphospholipid syndrome (APS) more frequently and higher disease activity at the time of infection. In the multivariate analysis, high blood pressure (OR 5.1, 95% CI 1.8-15.0), the diagnosis of APS (4.7, 95% CI 1.2-15.8), and the use of glucocorticoids (10 mg/day or more: OR 5.5, 95% CI 1.6-20.5) were associated with severe hospitalization and/or death from COVID-19 (WHO-EO >= 5). Conclusion(s): In this cohort of SLE patients with confirmed SARS-CoV-2 infection, most had a symptomatic course, 22.1% were hospitalized, and 5% required mechanical ventilation. Mortality was close to 3%. The diagnosis of APS, having high blood pressure, and the use of glucocorticoids were significantly associated with severe COVID-19.
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Background: Previous research has demonstrated that epigenetic changes in specific hypothalamic-pituitary-adrenal (HPA) genes may predict successful psychotherapy in post-traumatic stress disorder (PTSD). A recent Phase 3 clinical trial reported high efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for treating patients with severe PTSD compared to a therapy with placebo group (NCT03537014). This raises important questions regarding potential mechanisms of MDMA-assisted therapy. In the present study, we examined epigenetic changes in three key HPA axis genes before and after MDMA and placebo with therapy. As a pilot sub-study to the parent clinical trial, we assessed potential HPA epigenetic predictors for treatment response with genomic DNA derived from saliva (MDMA, n = 16; placebo, n = 7). Methylation levels at all 259 CpG sites annotated to three HPA genes (CRHR1, FKBP5, and NR3C1) were assessed in relation to treatment response as measured by the Clinician-Administered PTSD Scale (CAPS-5; Total Severity Score). Second, group (MDMA vs. placebo) differences in methylation change were assessed for sites that predicted treatment response. Results: Methylation change across groups significantly predicted symptom reduction on 37 of 259 CpG sites tested, with two sites surviving false discovery rate (FDR) correction. Further, the MDMA-treatment group showed more methylation change compared to placebo on one site of the NR3C1 gene. Conclusion: The findings of this study suggest that therapy-related PTSD symptom improvements may be related to DNA methylation changes in HPA genes and such changes may be greater in those receiving MDMA-assisted therapy. These findings can be used to generate hypothesis driven analyses for future studies with larger cohorts.