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BackgroundSystemic lupus erythematosus (SLE) is an autoimmune disease, which presents an immune disorder that leads to the production of autoantibodies with potential involvement of multiple organs. Infections are one of the most frequent causes of hospitalization and death in lupus patients, and SARS-CoV-2 infection has been a global threat since March 2020. Immunization of these patients has been strongly recommended, although vaccine evaluation studies have not included this profile of patients.ObjectivesTo evaluate the immunogenicity and safety after 2 doses of the vaccine against SARS-CoV2 in patients with SLE.MethodsSubgroup of SLE patients from the prospective multicenter cohort of patients with immune-mediated diseases "SAFER” – Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease, a phase IV study. Vaccination against SARS-CoV-2 took place with vaccines approved by Brazilian regulatory bodies CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) and this project followed in line with the guidelines of the National Immunization Plan in Brazil. Patients aged 18 years or older with a previous diagnosis of SLE (according to the 2019 ACR/EULAR criteria) were included. Patients were evaluated by telephone contact and in a face-to-face visit on the 28th day after each dose. Patients were followed up by means of blood collection for measurement of IgG antibody against SARS-COV-2 by chemiluminescence and disease activity assessed using SLEDAI-2K score.ResultsA total of 367 individuals with SLE were included, of whom 207 received 2 doses of CoronaVac, 128 received 2 doses of ChadOx-1 and 32 received 2 doses of BNT162b2. 90% of the subjects were female with a mean age of 37 years. About 42% (154) of the individuals included did not have any other associated comorbidity. 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-2K at baseline and 41% (147) had zero SLEDAI-2K 28 days after the 2nd dose. Anti-DNA positivity was 30.7% (16/52) at inclusion and 32.6% (17/52) 28 days after the 2nd dose. Complement consumption was present in 18% (10/55) at inclusion and in 14.5% (8/55) 28 days after the 2nd vaccine dose. The geometric mean titers of IgG antibodies against SARS-COV-2 increased in the different vaccine groups, log 2.27 BAU/mL at inclusion and log 5.58 BAU/mL 28 days after the 2nd dose. Antibody titers after second dose varied between different vaccines, 4.96 BAU/mL CoronaVac, 6.00 BAU/mL ChadOx-1 and 7.31 BAU/mL BNT162b2 vaccine, p < 0.001. Only 3.54% (13/367) patients had covid-19 infection after the 15th day of the second dose of immunization, 9 of them having received 2 doses of CoronaVac, 4 of them of ChadOx-1 and none of them receiving BNT162b2, with p-value of 0.63.ConclusionThis study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Induction of immunogenicity occurred in different vaccine regimens. Only 3.5% of individuals had COVID-19 infection with no difference between the types of vaccines evaluated. Future analyzes to explore the association of the effect of immunosuppressive medication, as well as the impact of booster doses and longer follow-up on clinical outcome will be performed.References[1]Mason A, et al. Lupus, vaccinations and COVID-19: What we know now. Lupus. 2021;30(10):1541-1552.[2]Furer V, Eviatar T, Zisman D, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: A multicentre study. Ann Rheum Dis. 2021;80(10):1330-1338.[3]Izmirly PM, Kim MY, Samanovic M, et al. Evaluation of Immune Response and Disease Status in SLE Patients Following SARS-CoV-2 Vaccination. Arthritis Rheumatol. Published online 2021.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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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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Introduction: Fontan patients have decreased exercise capacity. The COVID-19 pandemic exacerbated the variable adherence to hospital-based physical activity programs, which improve exercise capacity and attenuate the expected decline in aging Fontan patients. A positive pediatric exercise capacity trajectory has been reported to predict better adult Fontan outcomes. We designed and implemented a reimbursable 12-month, home-based, individualized physical activity program for Fontan patients utilizing a telemedicine model. Method(s): Eligible participants must be able to complete a cardiopulmonary exercise test (CPET) and demonstrate ability to adhere to a 12-month exercise prescription. Assent and consent are obtained. CPET and informal surveys of physical activity self-efficacy are completed at enrollment and graduation. An individualized exercise prescription is provided, with focus on skeletal and respiratory muscle strength training and aerobic activities. Participants receive a Garmin © device to monitor adherence. A cardiologist, nurse coordinator, and exercise physiologists comprise the team and regularly communicate with participants, starting with weekly check-ins that gradually space out to monthly as participants gain confidence. Result(s): Since program initiation, 9 participants have completed the program and 3 remain active. For the 9 graduates, all scheduled in-person and telehealth visits were completed. At completion of the 12-month program compared to baseline, there was no difference in maximal or submaximal oxygen consumption (VO2), peak heart rate, or oxygen saturation, but there was a significant increase in systolic blood pressure (144 +/- 16 vs 162 +/- 15, p-value 0.004) and minute ventilation (68.8 +/- 19.3 vs 76.8 +/- 22.1, p-value 0.012) at peak exercise. Per subjective report, all graduates had increased confidence related to exercise. There were no adverse events in any participant. Conclusion(s): A novel, home-based, 12-month individualized physical activity program using telemedicine was successfully implemented, with no adverse events. A larger study is needed to better assess change in VO2 and other qualitative and quantitative parameters, although the lack of decline in exercise capacity is encouraging.
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Introduction. There are few studies that evaluated the response to Covid- 19 vaccines, in primary Sjogren's Syndrome (pSS) and none evaluated ChAdOx1 n-Cov19 (AstraZeneca/Fiocruz). The aim of this study was to evaluate the efficacy and safety of the ChAdOx1 n-Cov19, a viral vector vaccine, in pSS compared to healthy control (HC). Methods. Patients with pSS >18 years, classified according to ACR/EULAR 2016 were included. Neutralizing antibodies against the Receptor Binding Domain - RBD portion of the Spike protein of SARS-CoV-2 (IgGS) were measured by chemiluminescence (Abbott), before the first dose (D0) and 28 days after the second dose (D28*). The test is considered reactive if >50 AU/ml. Results. Sixty pSS patients and 62 HC were recruited from a single center (HUCAM-UFES, Vitoria, ES, Brazil). The HC group was homogeneous for sex (92% women) and younger than HC (47+/-11 vs. 39+/-13, p<0.05). In the pSS group, 45.2% were anti-Ro positive, mean ESSDAI was 3.2, 83.3% were using DMARD or immunosuppressant/biological therapy, 31.9% were in high immunosuppression. The frequency of mild adverse events (AE) was similar in both two groups. No serious AE, hospitalizations or death were reported. There was no difference between the PGA ("Patient's Global Assessment") after vaccination (4.5 vs.5, p=0.903). Among seronegative individuals at baseline, the seroconversion rate (100% vs. 89%, p=0.02) was lower, and geometric mean titers (GeoMean IgG-S) was similar in pSS=696.9(CI95%237.6 -2,043) compared to HC=1,986(CI95%1,463-2,697;p=0.316). However, in those with high immunosuppression, the seroconversion (71%, p=0.001) and GeoMean titers were lower 229.4 (CI95%14.64-3,594, p=0.004). Patients in moderate to high disease activity (ESSDAI >=5) showed lower seroconversion (60%, p=0.006) and Geomean titers 31.7 (CI95%0.06-15.4;p=0.004). Conclusions. ChAdOX1 vaccine is safe and induced high GeoMean neutralizing antibodies titers and seroconversion rate in pSS patients similar to HC. Immunossuppression therapy and disease activity decreased the immune response to the vaccine.
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Background: Patients with autoimmune infammatory diseases (AID) have been prioritized for urgent vaccination to mitigate COVID-19 risk. However, few studies in the literature assessed the immunogenicity and safety of the COVID-19 vaccine in patients with AID. Objectives: In this context, the present study aims to evaluate the immunogenic-ity and safety of the vaccine against COVID-19 in patients with AID. Methods: These data are from 'Safety and efficacy on COVID-19 Vaccine in Rheumatic Disease'-SAFER study, a Brazilian multicentric prospective phase IV study to evaluate COVID-19 Vaccine in AID, in the real-life, in Brazil. Immunogenicity and adverse events (AE) from a single center were assessed, after 2 doses of ChAdOx1 (Oxford/AstraZeneca), 8 weeks of interval, in patients with AID and healthy controls (HC). Inclusion criteria were age ≥ 18 years and fulflling criteria according to international classifcation for AID. Exclusion criteria: pregnancy, previous severe AE to any vaccine, other immunosuppression causes. Stratifcation of post-vaccination AE was performed using a diary, flled out daily and returned at the end of 28 days for each dose. Participants were followed up through blood collection for measurement of IgG antibodies against SARS-CoV-2 spike receptor-binding domain by chemiluminescence (SARS-CoV-2 IgG II Quant assay, Abbott Laboratories, Abbott Park, IL, USA) at baseline and 28 days after the second dose. The seropositivity was defned for titers ≥50 AU/mL. Quantitative analyses were presented as observed frequency, percentage, central tendency, and variability measurements. The sample's normal distribution was verifed through the Shapiro-Wilk test. The Kruskal-Wallis test and the post-hoc Dwass-Steel-Critchlow-Fligner pairwise comparisons test were used to compare the IgG-S titers between the groups through the evaluation period. Categorical data were addressed using the Fisheŕs exact or Chi-squared (χ2) test. An alpha level of 5% signifcance was used in all analyses. Results: A total of 377 volunteers with AID and 50 HC were included in the study. Patients with spondyloarthritis (N=64), systemic lupus erythematosus (N=63), rheumatoid arthritis (N=61), primary Sjögren's syndrome (N=61), vasculitis (N=31), systemic sclerosis (N=14), inflammatory myopathy (N=9), Crohńs disease (N=49), ulcerative colitis (N=11) and other systemics AID (N=12) were evaluated. Both groups had female predominance (73.5% vs. 74.0%, p=0.937) and were homogeneous for age (43.5 vs. 41.7,p=0.308). The seroconversion among those not reactive (IgG-S negative at baseline) (46 HC and 191 AID), 28 days after second dose was 97.1% for spondyloar-thritis (p=0.425), systemic lupus erythematosus 88.2% (0.006), rheumatoid arthritis 93.5% (0.158), primary Sjögren's syndrome 92.6% (0.133), systemic sclerosis or inflammatory myopathy 47.1% (0.001), inflammatory bowel disease 100% (0.999) and vasculitis 80% (0.006), while in healthy control was 100%. In comparison with HC, there was a statistically significant difference in IgG-S titles only in systemic sclerosis or inflammatory myopathy (1.694 AU/ml vs. 3.719 AU/ml;p=0.006). Both groups only presented mild AE. Pain at the injection (85.7% vs. 78.4%, p=0.239), headache (67.3% vs. 53.8, p=0.074) and fatigue (59.2% Vs. 46.2%, p=0.089) were more common in HC than AID. Overall, reactions like arthralgia (52.6 vs. 22.4%, p<0.001), hematoma (14.1 vs. 4.1%, p=0.05), cutaneous rash (9.5 vs. 0%, p=0.024) were more frequent in AID. Most participants related that they felt safer after receiving a COVID-19 vaccination, and 52.4% did not reported a worse patient global assessment (PGA) index. Conclusion: In conclusion, our data indicated that ChAdOx1 vaccine is safe and induced high titers and seroconversion rate in AID. More severe AID, such as vasculitis, systemic lupus erythematosous, and systemic sclerosis and myositis showed a lower seroconversion rate. Further analysis will explore the association between immunossupressant and reactivity, and booster dose.
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Background and Purpose: We sought to investigate the impact of COVID-19 pandemic on number of acute stroke patients admitted to Japanese primary stroke centers (PSCs). Methods: The Japan Stroke Society and the MHLW registry of mechanical thrombectomy for acute ischemic stroke conducted a national annual survey of hospitalization volumes for acute ischemic stroke, intracranial cerebral hemorrhage, and subarachnoid hemorrhage in PSCs. Number of acute stroke patients was defined as sum of three stroke subtypes admitted within 7 days after the onset. Monthly acute stroke volumes were compared between 2019 and 2020, among COVID-19 waves, and regional infectious rates. Results: The stroke volume data was completed in 530 PSCs. The annual acute stroke volume was declined 2.5% from 179,893 in 2019 to 174,385 in 2020. Number of acute stoke patients was declined during COVID-19 expanding periods (1 wave, Mar-May;2 wave Jul-Aug;3 wave NovDec), whereas it was increased in the other months. The mean decline rate of stroke volumes from 2019 to 2020 was greater in 125 PSCs located in prefectures with high estimated SARS-CoV 2 infected rate (more than 2,300 per million people) than in 405 PSCs of the other regions (-4.6±15.4% vs -0.1±20.0%, P=0.008), especially during COVID-19 expanding periods (-8.2±17.9% vs -3.1±21.3%, P=0.009). Conclusions: Acute stroke volumes were declined in 2020 from 2019 in Japanese PSCs, especially during COVID-19 expanding periods and in highly infected regions. The overwhelmed health care system and infection control practices may have associated with decline of number of acute stroke patients during COVID-19 pandemic.