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BackgroundThe exact pathogenesis of fibromyalgia (FM) syndrome is unclear. However, different infections including hepatitis C virus, Human immunodeficiency virus and Lyme disease have already been implicated with the development of FM after their acute phase[1]. Imbalance between pro-inflammatory and anti-inflammatory cytokines has been suggested as a possible mechanism that facilitates the neuropathic pain[2].ObjectivesTo investigate the incidence of FM syndrome among convalesced individuals following hospitalization for Acute Coronavirus Disease-2019 (COVID-19) and to identify possible risk factors.MethodsWe performed a cross-sectional study on patients who were discharged after COVID-19 hospitalization from the Sheba Medical Center, Israel, between July 2020 to November 2020. A phone interview was performed consisting of the following questionnaires: the Fibromyalgia Survey Diagnostic Criteria Questionnaire, Sense of Coherence Questionnaire to evaluate resilience, and the Subjective Traumatic Outlook Questionnaire to assess the associated psychological aspects of the trauma. The incidence of post-COVID FM was calculated and regression models were performed to identify predictors.ResultsThe study population consisted of 198 eligible patients who completed the phone interview. The median age was 64 (52-72) and 37% were women. The median follow-up was 5.2 months (IQR 4.4-5.8). The incidence of FM was 15% (30 patients) and 87% (172 patients) had at least one FM-related symptom. Female gender was significantly associated with post-COVID FM (OR 3.65, p=0.002). In addition, high median Subjective Traumatic Outlook scores and low median Sense of Coherence scores were both significantly associated with post-COVID FM (OR 1.19, p<0.001 and OR 0.92, p<0.001, respectively).ConclusionFM is highly prevalent among COVID-19 convalescent patients. Our finding suggests that a significant subjective traumatic experience and a low resilience are highly associated with post-COVID FM.References[1]Buskila D, Atzeni F, Sarzi-Puttini P. Etiology of fibromyalgia: the possible role of infection and vaccination. Autoimmun Rev. 2008;8: 41-43. https://doi.org/10.1016/j.autrev.2008.07.023[2]Amital M, Ben-Shabat N, Amital H, Buskila D, Cohen AD, Amital D. COVID-19 associated hospitalization in 571 patients with fibromyalgia—A population-based study. PLoS ONE. 2021:16: e0261772. https://doi.org/10.1371/journal.pone.0261772Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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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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BackgroundAlthough studies have quantified adherence to medications among patients with rheumatic diseases (RD) during the COVID-19, lack of direct pre-pandemic comparison precludes understanding of impact of the pandemic.ObjectivesOur objective was to evaluate the effect of the COVID-19 pandemic on adherence to disease modifying drugs (DMARDs) including conventional synthetic (csDMARDs) and targeted synthetic (tsDMARDs).MethodsWe linked population-based health data on all physician visits, hospital admissions, and all dispensed medications, regardless of payer in British Columbia from 01/01/1996 to 3/31/2021. We identified prescriptions for csDMARDs (including methotrexate, hydroxychloroquine) and tsDMARDs, namely anti-TNFs (including infliximab, etanercept, adalimumab) and rituximab using drug identification numbers among indicated individuals with RD. We defined March 11, 2020, as the ‘index date' which corresponded to the date that mitigation measures for the COVID-19 pandemic were first introduced. We assessed adherence as proportion days covered (PDC), calculated monthly in the 12 months before and 12 months after the index date. We used interrupted time-series models, namely segmented regression to estimate changes and trends in adherence before and after the index date.ResultsOur analysis showed that the mean PDCs for all included DMARDs stayed relatively steady in the 12 months before and after mitigation measures were introduced (see Table 1). Adherence was highest among anti-TNFs, methotrexate, and azathioprine. Anti-TNFs were on a downward trajectory 12 months prior to the index date. Interrupted time-series modeling demonstrated statistically significant differences in the trends in PDCs post- vs. pre-mitigation measures for all anti-TNFS (slope [∂]: 1.38, standard error [SE]: 0.23), infliximab (∂: 1.35, SE: 0.23), adalimumab (∂: 0.82, SE: 0.25), and etanercept (∂: 1.07, SE: 0.25) (see Figure 1a). Conversely, the csDMARDs were on a flatter trajectory, and methotrexate (∂: -0.53, SE: 0.16), leflunomide (∂: 0.43, SE: 0.08), mycophenolate (∂: -1.26, SE: 0.48), cyclophosphamide (∂: 0.29, SE: 0.05), minocycline (∂: 0.04, SE: 0.02), chloroquine (∂: 0.02, SE: 0.00) showed statistically significant changes in estimated PDC trajectory after mitigation measures were introduced (see Figure 1b).ConclusionThis population-based study demonstrates that messaging and pandemic mitigation measures did not affect adherence to DMARDs.Table 1.Mean PDC 1 year before and after mitigation measures for the COVID-19 pandemic were introduced.MedicationMean PDC (%) 12 months before index dateMean PDC (%) 12 months after index datecsDMARDsmethotrexate28.926.8azathioprine21.819.5sulfasalazine16.214.9leflunomide14.313.0cyclosporine13.711.5hydroxychloroquine10.59.6mycophenolate4.52.9antimalarials4.43.9penicillamine3.53.4cyclophosphamide1.50.7chlorambucil1.20.4minocycline1.10.9gold0.50.2chloroquine0.10.0tsDMARDsanti-TNFs52.149.2infliximab41.838.3adalimumab40.336.8etanercept31.828.9rituximab3.42.9REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundFor patients with autoimmune rheumatic diseases, the Covid-19 pandemic carried some implications in addition to those faced by the general population. In particular, the question whether these patients are at increased risk of contracting Covid-19 or have an unfavourable disease course has been and is a matter of concern.In autumn 2020, the population of the Vinschgau valley in South Tyrol, northern Italy was still largely spared from infection with SARS-CoV-2. Accordingly, incidence of the disease in the upcoming winter was anticipated to be high.ObjectivesThis prospective observational study aimed at characterizing Covid-19 infections in a population of patients with inflammatory arthritis (IA) residing in the Vinschgau valley. The study was conceived as companion project to an analogously designed prospective cohort study in the general population of the Vinschgau valley, the CHRIS Covid-19 study.MethodsBetween september and december 2020, IA patients (i.e. previously diagnosed rheumatoid arthritis [RA], psoriatic arthritis [PsA] or peripheral spondyloarthritis [SpA]) residing in the Vinschgau valley (n=394 based on national healthcare system database) were contacted. Those who consented to participate in the study underwent a clinical baseline visit including TJC, SJC, VAS and assessment of RAID, PsAID9 or BASDAI (range 0-10, respectively). In addition, a Covid-19 screening questionnaire was administered. Then, active and/or past infection with SARS-CoV-2 were determined by nasopharyneal swab (PCR) and serum antibody test. In positively tested subjects, Covid-19 disease severity was graded according to WHO criteria (range 0-8, with 0 = no evidence of infection and 8 = death). Patients were followed-up with regular telephone interviews including Covid-19 screening questionnaire and RAID/PsAID/BASDAI for up to 12 months.Results111 patients (72 RA, 29 PsA, 10 SpA) were enrolled (see Table 1 for demographics and comorbidities).A total number of 19 PCR-confirmed SARS-CoV-2 infections in 17 patients (10 RA, 7 PsA) were observed. Mean ± standard deviation 7-day incidence (incident cases/study population) was 0.003 ± 0.007.Fatigue, fever, anosmia and sore throat (present in 57.9%, 47.4%, 42.1% and 36.8% of infections, respectively) were the most frequent symptoms. Median (min-max) disease severity was 2 [1-4]. Two infections led to hospitalization, in one case oxygen supply was necessary. Four infections were asymptomatic (Figure 1).One patient died during follow-up due to pre-existing non-small cell lung cancer.Median absolute difference between post- and pre-infection disease activity was 0.4 and -0.8 for RAID and PsAID, respectively (both markedly below the minimal clinically important difference of 3 and 3.6 points, respectively).ConclusionIncidence of Covid-19 in the analysed cohort of patients with IA was low. Symptoms and comorbidities of SARS-CoV-2-positive IA patients reflected those known from the general population. Covid-19 seemed to have no relevant impact on IA disease activity. Comparison of these preliminary data with those of the general population is planned.Figure 1.Spectrum of clinical symptoms reported by study patients during infection with SARS-CoV-2[Figure omitted. See PDF]Table 1.Demographic data and selected comorbidities of study patients. Age and body mass index (BMI) are given in means ± standard deviation, female sex and comorbidities are given in n (% of column totals).TotalSARS-CoV-2 positiveHospitalized111172Age at inclusion (years)59.7 ± 9.462.5 ± 10.076.3 ± 9.0BMI at inclusion (kg/m2)27.9 ± 17.126.1 ± 3.330.5 ± 1.6Female sex76 (68.5)10 (58.8)1 (50)Active smokers22 (19.8)1 (5.9)0 (0)Arterial hypertension44 (39.6)8 (47.1)2 (50)Diabetes mellitus4 (3.6)1 (5.9)1 (50)Hyperlipidemia27 (24.3)2 (11.8)1 (50)Cardiac arrhythmias12 (10.8)2 (11.8)1 (50)History of cancer5 (4.5)1 (5.9)0 (0)Chronic bronchitis4 (3.6)1 (5.9)0 (0)Asthma3 (2.7%)0 (0)0 (0)Hospitalized in previous 12 months21 (18.9)3 (17.6)0 (0)Surgery with general anaesthesia in previous 12 months11 (9.9)2 (11.8)0 (0)Ack owledgementsThe authors thank Elena Cannavò and the CHRIS study team, whose support was of invaluable importance for the conduction of the study.Disclosure of InterestsNone Declared.
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BackgroundIgA vasculitis (IgAV) is a rare autoimmune disease affecting small vessels. It is well established that the incidence is higher in children (3 to 26 per 100,000 children/year,) [1] than in adults (0.1 to 1.8 per 100,000 individuals/year) [1]. However others epidemiological data and impact of the COVID-19 on IgAV remain overlooked [2].ObjectivesTo collect and analyze epidemiological data on IgAV in both adults and children in France.MethodsWe conducted an observational study using a national database called "BNDMR” [3] (Banque Nationale de Données Maladies Rares) on IgA vasculitis (code ORPHA761), which gathered patients managed in the French rare disease expert network. The incidence was estimated from the date of diagnosis, and we calculated the median annual incidence over the period 2010-2022. We specifically assessed the north/south gradient (latitude of the residence higher/lower than the median of the latitudes), the seasonality, and the impact of the COVID-19 pandemic compared to other patients reported within the same period and addressed in the same expert centers used as controls.ResultsDuring this 12-year period, 1988 patients with IgAV were reported (1498 children;490 adults). The male to female ratio was 1.57 for adults and 1.05 for children. The median IgAV annual incidence was 15 cases/year [IQR 9-30] and 82 cases/year [IQR 72-86] for adult and children cases respectively. Time to diagnosis was less than 1 month for both. Compared with other patients reported in the same expert centers, IgAV was more frequently reported in the southern part of France than in the north (OR 4.88 [95% confidence intervals: 4.17 - 5.74] in adults and OR 1.51 [1.35 - 1.68] in children). IgAV was also more frequently observed in winter than during the rest of the year in both adults (OR 1.60 [1.39 - 1.82]) and children (OR 1.22 [1.01 - 1.48]). The incidence of IgAV decreased during the COVID-19 pandemic period (from March 2020 to September 2022) in children (OR 0.62 [0.47 - 0.81]) but not in the adult population (OR 0.90 [0.76 - 1.06]).ConclusionOur study confirms the winter seasonality and sex ratio in IgAV [4,5], but suggests that the incidence or the reporting of IgAV decreased in children during the COVID19 pandemia, possibly due to barrier measures [6]. The observed north/south gradient need confirmation. The main limitation of this study is a possible IgAV under-reporting as this study rely only on cases addressed in expert centers.References[1]Audemard-Verger A, Pillebout E, Guillevin L, Thervet E, Terrier B. IgA vasculitis (Henoch-Shönlein purpura) in adults: Diagnostic and therapeutic aspects. Autoimmun Rev. 2015;14(7):579-585. doi:10.1016/j.autrev.2015.02.003[2]Deshayes S, Moulis G, Pillebout E, Aouba A, Audemard-Verger A. Positive predictive value of hospital discharge diagnosis code to identify immunoglobulin A vasculitis in France: A validation study. Eur J Intern Med. 2017;43:e18-e19. doi:10.1016/j.ejim.2017.05.025[3]Jannot AS, Messiaen C, Khatim A, Pichon T, Sandrin A, BNDMR infrastructure team. The ongoing French BaMaRa-BNDMR cohort: implementation and deployment of a nationwide information system on rare disease. J Am Med Inform Assoc. 2022;29(3):553-558. doi:10.1093/jamia/ocab237[4]Piram M, Maldini C, Biscardi S, et al. Incidence of IgA vasculitis in children estimated by four-source capture-recapture analysis: a population-based study. Rheumatology (Oxford). 2017;56(8):1358-1366. doi:10.1093/rheumatology/kex158[5]Gardner-Medwin JMM, Dolezalova P, Cummins C, Southwood TR. Incidence of Henoch-Schönlein purpura, Kawasaki disease, and rare vasculitides in children of different ethnic origins. Lancet. 2002;360(9341):1197-1202. doi:10.1016/S0140-6736(02)11279-7[6]Kaya Akca U, Atalay E, Cuceoglu MK, et al. Impact of the COVID-19 pandemic on the frequency of the pediatric rheumatic diseases. Rheumatol Int. 2022;42(1):51-57. doi:10.1007/s00296-021-05027-7Figure.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundPatients with autoimmune inflammatory rheumatic diseases are at higher risk for coronavirus disease (COVID)-19 hospitalization and worse clinical outcomes compared with the general population. However, data on the association between COVID-19 outcomes and gout, or gout-related medications are still lacking.ObjectivesWe aimed to compare COVID-19 related clinical outcomes in gout vs. non-gout patients.MethodsWe conducted a retrospective cohort study using the electronic health record-based databases of Seoul National University hospital (SNUH) from January 2021 to April 2022 mapped to a common data model. Patients with gout and without gout were matched using a large-scale propensity score (PS) algorithm. The clinical outcomes of interest were COVID-19 infection, severe COVID-19 outcomes defined as the use of mechanical ventilation, tracheostomy or extracorporeal membrane oxygenation, and death within 30 days of COVID-19 diagnosis. The hazard ratio (HR) for gout vs. non-gout patients derived by Cox proportional hazard models were estimated utilizing a 1:5 PS-matched cohort.Results2,683 patients with gout and 417,035 patients without gout were identified among the patients who visited SNUH. After 1:5 PS matching, 1,363 gout patients and 4,030 non-gout patients remained for the analysis. The risk of COVID-19 infection was not significantly different between patients with gout and those without gout (HR 1.07 [95% CI 0.59-1.84]). Within the first month after the COVID-19 diagnosis, there was also no significant difference in the risk of hospitalization (HR 0.57 [95% CI 0.03-3.90], severe COVID-19 outcomes (HR 2.90 [95% CI 0.54-13.71]), or death (HR 1.35 [95% CI 0.06-16.24]).ConclusionPatients with gout did not have an increased risk of COVID-19 infection or worse clinical outcomes. Updates of temporal trends of COVID-19 outcomes in gout patients are yet warranted as new SARS-CoV-2 variants emerge.References[1]Shin YH, et al. Autoimmune inflammatory rheumatic diseases and COVID-19 outcomes in South Korea: a nationwide cohort study. Lancet Rheumatol. 2021 Oct;3(10):e698-e706.[2]Topless RK, et al. Gout and the risk of COVID-19 diagnosis and death in the UK Biobank: a population-based study. Lancet Rheumatol. 2022 Apr;4(4):e274-e281.[3]Xie D, et al. Gout and Excess Risk of Severe SARS-CoV-2 Infection Among Vaccinated Individuals: A General Population Study. Arthritis Rheumatol.2023 Jan;75(1):122-132.Table 1.Clinical outcomes of COVID-19 infection in patients with goutOutcomesUnmatched populationPopulation with PS stratification using 10 strata1:5 PS matched populationHazard ratio (95% CI)p-valueHazard ratio (95% CI)p-valueHazard ratio (95% CI)p-valueCOVID-19 infection1.68 (1.03-2.57)0.031.20 (0.72-1.87)0.461.07 (0.59-1.84)0.82Hospitalization due to COVID-191.92 (0.32-6.05)0.391.63 (0.26-5.77)0.540.57 (0.03-3.90)0.66Severe COVID-19 infection4.72 (1.44-11.28)<0.014.22 (1.17-12.21)0.022.90 (0.54-13.71)0.20Death due to COVID-191.15 (0.07-5.18)0.900.77 (0.04-3.81)0.821.35 (0.06-16.24)0.84Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundThe COVID-19 pandemic caused concerns whether patients with rheumatic musculoskeletal disease (RMD) treated with conventional (cs) or biologic (b) disease modifying drugs (DMARDs) and/or prednisolone exhibit an adequate immune response to the applied SARS-CoV2 vaccines.ObjectivesWe established the DECODIR study to assess and compare the efficacy of the SARS-CoV2 vaccines administered as part of the national vaccine roll-out: BNT162b2 vaccine (Pfizer/BioNTech) and mRNA-1273 vaccine (Moderna). The vaccines were offered as two doses four weeks apart;followed by a booster vaccination six months later. This national regimen included inflammatory rheumatic patients regardless of their respective anti-inflammatory treatment. We used patients' SARS-CoV2 IgG serum level as proxy for vaccination response (1).MethodsThe study was conducted as a longitudinal prospective cohort study. Patients with rheumatoid arthritis (RA), spondyloarthropathies (SpA) or psoriatic arthritis (PsA) receiving their outpatient treatment at the Danish Hospital for Rheumatic Diseases, Sonderborg, and monitored in the Danish DANBIO registry, were included.Blood samples, Disease activity and treatment information (cs/bDMARD, prednisolone) were collected at baseline (i.e. prior to vaccination), after six weeks, six and twelve months. SARS-CoV-2 IgG levels in serum were assessed by ELISA (Thermo-Fischer), and manufacturer's cut-off (>=10 EliA U/mL) selected as definition of sufficient IgG response. Antibody response was measured and compared at all four time points.Associations between antibody response, age, gender, disease (RA/PsA/SpA), treatment (none, cs/bDMARD or prednisolone) and disease activity were tested using proportional odds regression and bootstrapped tests of medians. Results were reported using mean, median (IqR) and bootstrapped 95% confidence interval (CI) of the median.ResultsA total of 243 patients were included at baseline and all were followed-up after six weeks;data from 233 patients were available at six months and for 229 patients at twelve months' follow-up. Those 229 patients had completed the national vaccination programme.The measurements performed 6 months after baseline demonstrated a per se decrease of IgG levels for the whole study population (median of 2.08 EliA U/mL at 6 months vs. 16 EliA U/mL at 6 weeks). The final measurements performed after twelve months demonstrated a significant increase of IgG levels. Thus, the completed vaccination programme, was followed by a significant increase in IgG levels (median of 100 EliA U/mL at twelve months vs. 16.5 EliA U/mL at six months, p < 0.001).Sufficient response rates were now recorded in all treatment scenarios, also in patients treated with prednisolone or combination of csDMARD and bDMARD. These two groups were at 6 months characterized by significant lower response rates, when compared with patients without any DMARD treatment.ConclusionCompleted vaccination programme defined as two doses plus booster vaccination resulted in a sufficient vaccination response as measured by IgG levels regardless of RA treatment.It is noteworthy that IgG levels increased markedly in patients treated with a combination of cs/bDMARD or oral prednisolone, who had low IgG levels (below manufacturer's cut-off >=10 EliA U/mL) after 6 months. Our results strongly support the efficacy of the complete vaccination programme including the 3rd booster vaccine in patients with inflammatory rheumatic diseases.Figure 1.Serum IgG-levels at baseline, 6 weeks, 6 months and 12 months;stratified by antirheumatic treatment. (Box plot showing median and interquartile range).[Figure omitted. See PDF]Reference[1]Schreiber K. et al. Reduced Humoral Response of SARS-CoV-2 Antibodies following Vaccination in Patients with Inflammatory Rheumatic Diseases— an Interim Report from a Danish Prospective Cohort Study. Vaccines 2022, 10(1), 35;https://doi.org/10.3390/vaccines10010035AcknowledgementsWe acknowledge all patients contributing to the DANBIO registry.The Danish Rheumatologic Biobank is a knowledged for handling and storage of biological material.Lab chieftechnician Charlotte Drachmann is acknowledged for her assistance.Disclosure of InterestsChristine Graversgaard: None declared, Karen Schreiber Speakers bureau: Lilly, UCB, Henning Jakobsen: None declared, Randi Petersen: None declared, Anders Bo Bojesen: None declared, Niels Steen Krogh: None declared, Bente Glintborg Grant/research support from: Pfizer, AbbVie, BMS, Sandoz, Merete Lund Hetland: None declared, Oliver Hendricks Speakers bureau: Pfizer, Lilly, Novartis.
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BackgroundMultisystem Inflammatory Syndrome in Children (MIS-C) is one of the most feared complications following SARS-CoV2 infection in children and adolescents. Few multinational multicenter studies from Latin America have been published.ObjectivesTo describe the clinical presentation, management, and outcomes of MIS-C in Latin America.MethodsObservational, prospective and retrospective, multicenter study to gather information from 84 participating centers across 16 Latin American countries, between August January 1, 2020 and June 30, 2022.ResultsOf the 1,239 reported cases of MIS-C, 84.2% were previously healthy. The most frequent clinical manifestation in our studied population was abdominal pain (N=804, 64.9%), followed by conjunctival injection (N=784, 63.3%). The median days of fever at the time of hospital admission was 5 and a significant number of subjects required admission to an intensive care unit (N=589, 47.8%). A total of 538 (47.2%) patients had an abnormal initial echocardiogram. Most of the subjects (N= 1,096, 88.7%) were treated with intravenous immunoglobulin (IVIG), while 76.7% (N= 947) were treated with steroids, of which 10.6% (N= 100) did not receive IVIG. The death rate attributed to MIS-C was 4.88%, with a rate of 3.39% for those initially diagnosed with MIS-C and 8.85% for those whose admission diagnosis was not MIS-C (P= 0.00001).ConclusionOne of the most significant findings from our study was the death rate, especially in those not initially diagnosed with MIS-C, in whom it was higher. This highlights the importance of increasing awareness and making an earlier diagnosis of MIS-C in Latin America.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundInflammatory rheumatic diseases are a debilitating disease affecting the joints and periarticular structures and leading, more or less rapidly, to cartilage and bone destruction. It is a major source of chronic pain and physical, psychological, and social disability, it affect approximately 1% of the world's population [1]. For more than 20 years, biotherapies have revolutionized the treatment of these inflammatory diseases and have largely contributed to the improvement of their prognosis [2]. Adherence to biologic therapies conditions the effectiveness of the treatments then the improvement of patients' quality of life [3].ObjectivesTo evaluate and compare adherence to biologic disease-modifying antirheumatic drugs (bDMARDs) according to the route of administration and the molecule used (Infliximab, Tocilizumab, Etanercept, Adalimumab, Certolizumab, and Golimumab) in patients with inflammatory rheumatic diseases.MethodsThis is a descriptive cross-sectional study with repeated data collection, bi-centric carried out in the rheumatology departments and outpatient clinics at Charles Nicolle Hospital and Rabta Hospital in Tunis and conducted over a period of 01 year and 02 months between 02/02/2021 and 30/04/2022. 71 adult patients with rheumatoid arthritis, spondyloarthritis or juvenile idiopathic arthritis were recruited, their adherence rate in the last 3 months before inclusion should be ≥80%. The collection of socio-demographic, clinical and therapeutic data was established with the help of a pre-established form, from medical files completed by questioning the patients during a direct interview or through a telephone communication. Adherence rate was calculated by determining the ratio of treatments cures (number of biologic injections taken during a year divided by the number of annual biologic injections prescribed).ResultsWithin the study population, adherence was estimated at 85.9%;in the group of patients using intravenous biotherapy was 82.1% (Infliximab 86%, Tocilizumab 75% p=0.04) and in the group of patients using subcutaneous treatment was 89.9% (Golimumab 94%, Etanercept 92%, Certolizumab 89%, Adalimumab 87% p=0.3). Adherence to biologic therapy was significantly higher in the subcutaneous group than in the intravenous group (p=0.01). The causes of poor adherence presented by the patients in this study were: stock-outs of biological treatment and delay in renewal by the national health insurance (CNAM) in thirty-eight cases (54%p<0.001), intercurrent infections in thirty-three cases (46% p=0.005) and the COVID 19 pandemic and its consequences in thirty patients (42%,p=0.28).ConclusionAdherence to biologic treatment is influenced by the route of administration, drugs type, intercurrent infections and drugs availability. All this factors must be treated to improve therapeutic adherence then the efficiency of the biologic therapy which conditions the preservation of physical capacities and an improvement in the quality of life.References[1]Adhésion médicamenteuse et représentations des patients atteints de rhumatisme inflammatoire chronique sous biothérapie: étude ADREP'RI.: 84. Betegnie AL.[2]2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. Singh JA, Saag KG, Bridges SL, Akl EA et al. janv 2016;68(1):1‑26.[3]Adherence to biologic DMARD therapies in rheumatoid arthritis. Expert Opin Biol Ther. Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L. sept 2010;10(9):1367‑78.[4]Adherence of rheumatoid arthritis patients to biologic disease-modifying antirheumatic drugs: a cross-sectional study. Mena-Vazquez N, Manrique-Arija S, Yunquera-Romero L, Ureña-Garnica I, Rojas-Gimenez et al.. Rheumatol Int [Internet]. oct 2017 [cité 30 oct 2022];37(10):1709‑18.[5]Adherence to Anti-Tumor Necrosis Factor Therapy Administered Subcutaneously and Associated Factors in Patients with Rheumatoid Arthritis. Salaffi F, Carotti M, Di Carlo M, Farah S, Gutierrez M. J Clin Rheumatol. déc 2015;21(8):419‑25.Acknowledgements:N L.Disclosure of InterestsNone Declared.
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BackgroundAlthough many studies have been conducted on COVID-19 in recent years, there are still unanswered questions regarding breakthrough infections (BTIs), particularly in patients with systemic lupus erythematosus (SLE).ObjectivesThis study aimed to determine the occurrence of breakthrough COVID-19 infections in patients with SLE versus other autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs).MethodsThe study was based on data from the COVAD questionnaire which amassed a total of 10,783 complete responses from patients with SLE, AIRD, or nrAIRD, and HCs. After exclusion of individuals who were unvaccinated, those who received one vaccine dose only, and those with uncertain responses regarding the vaccine doses, a total of 9,595 patients formed the study population of the present investigation. If a COVID-19 infection occurred after the initial two vaccine doses and at least one booster dose (at least three doses in total, herein termed full vaccination), it was considered a BTI. Data were analysed using multivariable regression models. Statistically significant results were denoted by p values <0.05.ResultsA total of 7,016/9,595 (73.1%) individuals were fully vaccinated. Among those, 1,002 (14.2%) reported at least one BTI, and 166 (2.3%) reported at least two BTIs. Among SLE patients, 867/1,218 (71.2%) were fully vaccinated. Among fully vaccinated SLE patients, 137 (15.8%) reported at least one BTI while 28 (3.2%) reported at least two BTIs. BTI frequencies in fully vaccinated SLE patients were comparable to those of other AIRDs (OR: 1.0;95% CI: 0.8–1.3;p=0.447) and nrAIDS (OR: 0.9;95% CI: 0.6–1.3;p=0.856) but higher compared with HCs (OR: 1.2;95% CI: 1.0–1.6;p=0.022).For SLE patients with three vaccine doses, 113/137 (82.5%) reported at least one BTI while the corresponding number for four vaccine doses was 24/137 (17.5%). Compared with HCs (OR: 10.6;95% CI: 1.2–93.0;p=0.032) and other AIRDs (OR: 3.5;95% CI: 1.08–11.5;p=0.036), SLE patients showed higher frequencies of hospitalisation.AID multimorbidity was associated with a 15-fold increased risk for a need of advanced treatment for COVID-19 (OR: 15.3;95% CI: 2.6–88.2;p=0.002).ConclusionCOVID-19 BTIs occurred in nearly 1 every 6th fully vaccinated patient with SLE, and 20% more frequently in this patient population compared with fully vaccinated HCs. Moreover, BTIs in SLE patients were more severe compared with BTIs in HCs or patients with AIRDs other than SLE, resulting in a greater need for hospitalisation. AID multimorbidity contributed to a more severe COVID-19 BTI requiring advanced management. These insights call for greater attention to vaccination in the vulnerable group of SLE patients, with appropriate risk stratification towards optimised vaccination strategies.Figure 1.Survival analysis across patients with SLE, AIRDs, or nrAIDs, and HCs. SLE: systemic lupus erythematosus;AIRD: autoimmune rheumatic disease;nrAID: non-rheumatic autoimmune disease;HC: healthy control.[Figure omitted. See PDF]AcknowledgementsThe authors thank all survey respondents, as well as patient associations and all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsEmelie Kihlgren Olsson: None declared, Naveen Ravichandran: None declared, Elena Nikiphorou Speakers bureau: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly., Consultant of: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly., Grant/research support from: EN holds research grants from Pfizer and Lilly., Julius Lindblom: None declared, Sreoshy Saha: None declared, Syahrul Sazliyana Shaharir: None declared, Wanruchada Katchamart: None declared, Phonpen Akarawatcharangura Goo: None declared, Lisa Traboco: None declared, Yi-Ming Chen: None declared, Kshitij Jagtap: None declared, James B. Lilleker Speakers bureau:
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BackgroundFatigue is a difficult subject for both physicians and patients. It is barely addressed during consultations and can therefore burden patient-physician-relations. To improve communication regarding fatigue, we developed a checklist that includes suggestions for evaluating possible causes for fatigue. In this analysis, we describe our study population and report first results 3 and 6 months after using the checklist.ObjectivesThe aims of our study are to validate the use of our newly developed fatigue checklist and to demonstrate that addressing fatigue in daily clinical practice and offering possible interventions can improve fatigue.MethodsWe recruited n=110 SLE patients with fatigue from our university hospital-based lupus reference centre in Duesseldorf. Fatigue was measured using the FSS (Fatigue Severity Scale). Our checklist included signs of depression and anxiety using the PHQ-4 (Patient Health Questionnaire), BMI (body mass index), physical activity, anemia, hypothyroidism and vitamin D deficiency. For each applicable cause, we listed possible interventions for free selection by the treating physician, such as replacement therapy (vitamin D, vitamin B12, iron, folic acid, erythropoietin), physical activity programs and psychosomatic consultations that were discussed with the patients. We re-evaluated our patients after 3 (T1) and 6 months (T2).ResultsBaseline characteristics of patients are summarized in Table 1.Table 1.BMI=body mass index, TSH=thyroidea stimulating hormone, PHQ4=patient health questionnaire (cut-off >3 points), HAQ=health assessment questionnaire, IMET= Index for measuring restrictions on social participation (higher scores point towards more restrictions on social participation), FSS=fatigue severity scale (≥4 points equal severe fatigue)N = 110n (%)Mean (SD)Age (years)49.0 (12.34)Female sex99.0 (90.0)BMI (kg/m2)25.9 (5.55)Disease duration (years)19.1 (10.05)TSH (µIU/ml)1.5 (1.05)25-OH-Vitamin D (ng/ml)39.5 (15.35)Haemoglobin (g/dl)13.0 (1.64)Sports activities>4h/week6.0 (5.5)2-4h/week18.0 (16.4)1-2h/week16.0 (14.5)<1h/week28.0 (25.5)No sport42.0 (38.2)Depression (PHQ4 score)2.3 (1.63)Anxiety (PHQ4 score)2.0 (1.71)Functional status (HAQ score)0.8 (0.49)Participation (IMET score)2.8 (2.31)Fatigue (FSS score)5.3 (1.35)After 3 and 6 months, we re-evaluated 83 patients and saw a significant reduction in fatigue measured by the FSS score (T1: mean difference estimate 0.367 and p-value <0.001;T2: mean difference estimate 0.305;p-value <0.005).Figure 1.Comparing FSS-Scores from T0, T1 and T2[Figure omitted. See PDF]ConclusionThe preliminary analysis of our study shows for the first time that incorporation of a checklist procedure into the management of patients with fatigue may improve short-term outcome after 3 and 6 months of observation. The improvement of symptoms documented in our study occurred even though the suggested exercise program and psychosomatic counseling sessions were not available for use during the current observation period because of the COVID-19 pandemic. At present, the mechanisms behind the observed effect remain unclear. Our ongoing analysis will clarify whether an additional effect on fatigue will occur after all suggested interventions resulting from the use of the checklist have been executed. Finally, it will demonstrate whether the incorporation of our checklist into routine clinical practice is capable to reduce fatigue over a prolonged time period.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the cause of coronavirus disease 2019 (COVID-19), has affected millions of people globally. It is a very contagious disease with various clinical manifestations. However, even in asymptomatic patients, it is believed that this virus exposure induces cryptic antibodies as in symptomatic patients. This current study aims to assess the prevalence of SARS-CoV-2 seropositivity by detecting the antibodies specific to the receptor-binding domain (SRBD) of SARS-CoV-2 in the pre-vaccine population in Bali. We assessed specific antibody titers against trimeric spike glycoprotein (S) of SARS-CoV-2 using Roche Elecsys Anti-SARS-CoV-2 S immunoassay in the serum of 510 pre-vaccine subjects without a previous documented history of SARS-CoV-2 infection. The average age was 35.53 years with 56.7% of the subjects being male. Among 510 subjects, 190 (37.3%) subjects were detected to have SARS-CoV-2 SRBD antibody or be seropositive. The range of the antibody titer was zero to 250 U/mL with the average being 44.3 U/mL. The number of subjects who had anti-SARS-Cov-2 SRBD titer above 132 U/mL was 76 (14.9%);it was the minimal antibody titer needed to donate plasma for plasma convalescent therapy. This study revealed a pre-vaccination population, without a history of COVID-19 infection, with seropositivity to SARS-CoV-2, which indicates the underdiagnosis of COVID-19, especially in asymptomatic individuals.
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BackgroundPatients with rheumatic diseases may present more severe SARS-CoV-2 infection compared to the general population. However, in some studies, hospitalization and mortality due COVID-19 were lower in patients with axial spondyloarthritis (axSpA) compared to other rheumatic diseases.ObjectivesTo 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.MethodsPatients ≥18 years old from the SAR-COVID national registry with diagnosis of AxSpA (ASAS criteria 2009) and RA (ACR/EULAR criteria 2010) 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, treatments and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS)[1]: ambulatory [1], mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death [8].Statistical analysisDescriptive statistics. Chi[2] or Fischer test and Student T or Mann-Whitney as appropriate. Poisson generalized linear model.ResultsA 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. More than a third of the patients were in remission. 43.9 % presented comorbidities, arterial hypertension being the most frequent. At 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. Although the differences were not significant, patients with RA presented more frequently cough, dyspnea, and gastrointestinal symptoms, while those with axSpA reported more frequently odynophagia, anosmia, and dysgeusia. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All of the patients with axSpA were admitted to the general ward, while 26.6% of those with RA to 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 to 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).ConclusionPatients with EspAax did not present complications from SARS-CoV-2 infections and none of them died due COVID-19.Reference[1]World Health Organization coronavirus disease (COVID-19) Therapeutic Trial Synopsis Draft 2020.Figure 1.Outcomes and severity of SARS-CoV-2 infection in patients with axSpA and RA.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsAndrea Bravo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Tatiana Barbich Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carolina Isnardi Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretati n, or writing the report. They do not have access to the information collected in the database., Gustavo Citera Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Emilce Edith Schneeberger Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Rosana Quintana Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Pisoni Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Mariana Pera Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Edson Velozo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Dora Aida Pereira Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Paula Alba Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Juan A Albiero Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Jaime Villafañe Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Hernan Maldonado Ficco Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Veronica Sa io Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Santiago Eduardo Aguero Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Romina Rojas Tessel Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Maria Isabel Quaglia Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., María Soledad Gálvez Elkin Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access tothe information collected in the database., Gisela Paola Pendon Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carolina Aeschlimann Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Gustavo Fabian Rodriguez Gil Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Malena Viola Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Romeo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carla Maldini Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Silvana Mariela Conti Grant/research support from: SAR-COVID is a multi-sponsor re istry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Rosana Gallo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Leticia Ibañez Zurlo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Maria Natalia Tamborenea Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Susana Isabel Pineda Vidal Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Debora Guaglianone Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Jonatan Marcos Mareco Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Goizueta Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Elisa Novatti Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Fernanda Guzzanti Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Gimena Gómez Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Karen Roberts Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of t em participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Guillermo Pons-Estel Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database.
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BackgroundCOVID-19 comes with a significant medical risk for patients with inflammatory rheumatic diseases, with an increased risk of infection and severe outcomes[1]. The vulnerability of rheumatologic patients might also affect their quality of life[2], for example by keeping up protective measures (masking, restriction of social contacts, etc.) while the general Swiss public no longer does so.ObjectivesThe aim of this study was to better understand the health-related burden of COVID-19 among patients with inflammatory rheumatic diseases and to investigate factors contributing to a different perception of the burden of COVID-19.MethodsWe included all patients registered in the Swiss Clinical Quality Management (SCQM) registry with rheumatoid arthritis (RA), axial spondylarthritis (axSpA), psoriatic arthritis (PsA), undifferentiated arthritis, polymyalgia rheumatica or giant cell arteritis who answered the questionnaire in the mobile My-SCQM app between the 4.11 and 11.12.2022. The questionnaire contained questions about the extent to which the pandemic is affecting patients' personal and social lives. We performed descriptive analysis on the whole population and also in subgroups according to 5 treatment groups, assigned in the following order: rituximab > JAK-inhibitors > other b/tsDMARDs > csDMARDs > none of these treatments. This means that someone taking e.g., both a JAKi and a csDMARD will be assigned to the JAKi category.ResultsThe questionnaire was answered by 1357 individuals with a median age of 57 years. 63% of participants were female. 33% are living in a household with children. 36% were diagnosed with RA, 34% with axSpA, 22% with PsA and 8% with another inflammatory rheumatic disease. A total of 100 patients were prescribed csDMARDs, 94 JAKi, 18 rituximab, 695 other b/tsDMARDs, and 450 patients received none of these treatments (Table 1). 10% of patients feel their general lives are affected by COVID-19 at a level of more than 7 out of a 10 scale. 3% of the participants report that COVID-19 impacts their social environment (family and friends) as a potentially dangerous disease at a level of more than 7 out of 10 scale. After being vaccinated against COVID-19, 33% of patients report no fear of the disease, however, 27% of participants still state that their anxiety against the virus remained unchanged. There is a trend towards persistence of fear in those taking rituximab (35%) compared to the participants in other groups (26% and 20% respectively in csDMARDs and JAKi takers). More than half of the population still wear masks, and rituximab users are the most likely to wear them (72% of these individuals still do), followed by individuals on JAKi (65%) (Figure 1).ConclusionOur study revealed that after around two years of the COVID-19 pandemic, the burden of COVID-19 in patients with inflammatory rheumatic diseases in Switzerland is generally low, although it appears higher in patients with JAKi and rituximab, and that for a minority the quality-of-life still remains impacted.References[1]Conway, R., et al., SARS–CoV-2 Infection and COVID-19-19 Outcomes in Rheumatic Diseases: A Systematic Literature Review and Meta-Analysis. 2022. 74(5): p. 766-775.[2]Goldman, J.D., et al., COVID-19-19 in immunocompromised populations: implications for prognosis and repurposing of immunotherapies. 2021. 9(6).Table 1.Basic characteristics of study population.VariableLevelOverallRituximabJAKiOther b/tsDMARDscsDMARDsNone of the aboveUnclearn13571894695100161289Gender (%)Men508 (37.4)3 (16.7)19 (20.2)291 (41.9)39 (39)63 (39)93 (32)Age (median)57595956595558Diagnosis Group (%)RA498 (36.7)18 (100)67 (71.3)188 (27)69 (69)33 (20.5)123 (42.6)axSpA462 (34)011 (11.7)270 (38.8)10 (10)87 (54)84 (29)PsA296 (21.8)011 (11.7)187 (26.9)15 (15)19 (11.8)64 (22)RZA/PMR13 (1)003 (0.4)07 (4.3)3 (1)UA88 (6.5)05 (5.3)47 (6.8)6 (6)15 (9.3)15 (5.2)Figure 1.Participants' description of their current situation concerning COVID-19 (YES/NO option per criteria): a. overall b. by treatment group.[Figure omitted. See PDF]Acknowledgements:NIL.Di closure of InterestsChristoph Blapp: None declared, Shekoofeh Yaghmaei Employee of: AstraZeneca, Adrian Ciurea: None declared, Almut Scherer: None declared, Marco Kuster Employee of: AstraZeneca, Kim Lauper Speakers bureau: Pfizer, Viatris and Galapagos, Consultant of: Pfizer, Grant/research support from: Eli-Lilly.
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Long-tailed macaque (Macaca fascicularis is one of the most common primates in Indonesia. In Sleman, Yogyakarta, Indonesia, the long-tailed macaque is habituated in Merapi Forest. The study aims to estimate the long-tailed macaque population and re-identification of groups. Moreover, we will observe the social structures that probably changed because of the interruption of interaction with visitors after the closure of the Tlogo Muncar area during the COVID-19 pandemic. The estimation population study was done using the concentration method. The long-tailed macaque group in Tlogo Muncar consists of three groups: Waterfalls, Mosque, and Joglo Trubus. The study was also identifying the alpha male of each group. The dataset obtained was processed using Microsoft Excel and analyzed descriptively. The results show that the estimated long-tailed macaque population in Tlogo Muncar area is 282 individuals. Alpha male identification of each group found alpha males in the Waterfall Group characterized by a lump on the left eyelid and a wound on the left hand. The alpha male of the Mosque Group is marked by a lump on his left eyelid with maxillary prognathism, while the alpha male of the Joglo Trubus Group has transverse scratches on the nose. The results showed an increase in the long-tailed macaque population in Tlogo Muncar area from 201 individuals in 2021 to 282 individuals in 2022. The increase of ecological pressure perhaps caused the rise in population number in 2022 during the closure of the area, to which the adult female responded by increasing their reproduction rate. The reopening of Tlogo Muncar after the Covid-19 pandemic has increased feed availability and attracted monkeys to forage outside the forest.
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BackgroundIn COVID-19 severe disease course such as need of intensive care unit (ICU) as well as development of mortality is mainly due to cytokine storm.ObjectivesIn this study, we aimed to evaluate the high dose intravenous anakinra treatment response and outcome in patients with severe and critical COVID-19 compared to standard of care.MethodsThis retrospective observational study was carried out at a tertiary referral center. The study population consisted of two groups as follows;the patients receiving high dose intravenous anakinra (anakinra group) between 01.09.2021 and 01.02.2022 and the patients treated with standard of care (SoC, control group) as historical control group who were hospitalized between 01.07.2021 and 01.09.2021.ResultsAfter the propensity score 1:1 matching 79 patients in anakinra and 79 patients in SoC matched and included into the analysis. Mean±SD patient age was 67.4±16.7 and 67.1±16.3 years in anakinra and SoC group, respectively (p=0.9). Male gender was 38 (48.7 %) in anakinra and 36 (46.2 %) SoC (p=0.8). Overall, ICU admission was in 14.1 % (n=11) and 30.8 % (n=24) (p=0.013;OR: 6.2), intubation in 12.8 % (n=10) and 16.7 % (n=13) patients (p=0.5), 14.1 % (n=11) and 32.1 % (n=25) patients died in anakinra and control group, respectively (p=0.008;OR: 7.1)ConclusionIn our study mortality was lower in patients receiving anakinra compared to SoC. Intravenous high dose anakinra is safe and effective treatment in patients with severe and critical COVID-19.Table 1.Baseline clinical and laboratory features of patients receiving standard of care (SoC) and Anakinra before and after propensity score (PS) matchingBefore PS matchingAfter PS matchingVariablesAnakinra (n=148)SoC (n=114)p value (OR)Anakinra (n=78)SoC (n=78)p value (OR)Age (years) (mean±SD)66.8±1763.1±170.0967.4±16.767.1±16.30.9Gender, male (n, %)78 (52.7)45 (39.5)0.033 (4.5)38 (48.7)36 (46.2)0.8Duration of hospitalization (days) (median, IQR)11 (12)9 (7.3)0.027.5 (9)11 (8)0.01Comorbidities (n, %) Diabetes mellitus41/146 (28.1)39 (34.2)0.318 (23)31 (39.7)0.025 (5) Hypertension84/143 (58.7)64 (56)0.730 (61.5)50 (64)0.7 Coronary heart disease27/143 (19)24 (21)0.718 (23)20 (25.6)0.7 Heart failure18/143 (12.6)23 (20)0.114 (18)20 (25.6)0.24 Chronic renal failure31 (21)6 (5.3)<0.001 (13.06)15 (19)6 (7.7)0.035 (4.5) Chronic obstructive lung disease23/144 (16)19 (16.7)0.914 (18)15 (19)0.8 Dementia15/117 (12.8)2 (1.8)0.001 (10.4)3/61 (5)2 (2.6)0.5 Malignancy16/146 (11)8 (7)0.39 (11.5)6 (7.7)0.4 Immunosuppressive usage18/146 (12.3)2 (1.8)0.001 (10.08)5 (6.5)2 (2.6)0.2Disease severity (n, %) NIH score 3 (severe)57 (38.5)68 (59.6)0.001 (11.5)48 (61.5)44 (56.4)0.5 NIH score 4 (critical)91 (61.5)46 (40.4)30 (38.5)34 (43.6) mcHIS score (mean±SD)3.4±1.22.64±1.5<0.0012.9±13.1±1.30.2PS: Propensity score, SoC: Standard of care, OR: Odds ratio, SD: Standard deviation, IQR: Interquartile range, mcHIS: Modified Covid hyperinflammatory syndrome score, NIH: National Institute Health, ALT: Alanin aminotransferase, AST: Aspartate aminotransferaseTable 2.Outcomes of patients receiving SoC and Anakinra before and after PS matchingBefore PS matchingAfter PS matchingVariables (n, %)Anakinra (n=148)SoC (n=114)p value (OR)Anakinra (n=78)SoC (n=78)p value (OR)Pneumothorax3/134 (2.2)00.25*2/73 (2.7)00.5*Myocardial infarction3/132 (2.3)6 (5.3)0.32/72 (2.8)2/56 (3.6)1Pulmonary embolism4/134 (3)11 (9.6)0.034 (4.8)*3/73 (4.1)7 (9)0.3*Intensive care unit60 (40.5)25 (22)0.001 (10.2)11 (14.1)24 (30.8)0.013 (6.2)Intubation54 (36.5)13 (11.4)<0.001 (21.3)10 (12.8)13 (16.7)0.5Mortality56 (37.8)27 (23.7)0.015 (5.96)11 (14.1)25 (32.1)0.008 (7.1)PS: Propensity score, SoC: Standard of care, OR: Odds ratioREFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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The objectives of this research include: (1) examining and analyzing the effect of capital structure, profitability, dividend payments and inflation on the value of mining companies;(2) examining and analyzing the moderating role of Good Corporate Governance (GCG) on the effect of capital structure, profitability, dividend payment and inflation on the value of mining companies listed on the IDX. The population of this study is all mining sector companies listed on the IDX for the period 2014-2020. The purposive sampling method is used as the sampling technique. The total population is 49 companies and the number of samples that meet the criteria are 44 companies. The research period is 7 years, so the total number of observations is 308 data (pooled data). The Moderated Regression Analysis (MRA) is used as the analysis method. The result is as follow: (1) capital structure has a negative significant effect on firm value;(2) profitability has a positive significant effect on firm value;(3) dividend payment has no significant effect on firm value;(4) inflation has a negative significant effect on firm value;(5) GCG has a moderating effect on the influence of capital structure, profitability and inflation on firm value, with the type of Quasi Moderating, whereas on the influence of dividend payments on firm value, it was the type of Pure Moderating.
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As a susceptible demographic, elderly individuals are more prone to risks during sudden disasters. With the exacerbation of aging, new challenges arise for urban disaster reduction and prevention. To address this, the key is to establish a community-scale resilience assessment framework based on the aging background and to summarize factors that influence the resilience level of communities. This approach is a crucial step towards seeking urban disaster prevention and reduction from the bottom up, and serves as an important link to enhance the capacity of urban disaster reduction. This paper explores community resilience evaluation indicators under the background of aging, builds a community resilience evaluation index system based on the Pressure–State–Response, uses the entropy weight method to weigh the indicators, and carries out a resilience evaluation of 507 communities in the main urban area of Changchun. The empirical results indicate significant spatial differentiation of community resilience in the main urban area of Changchun. Moreover, the regional development is unbalanced, showing a spatial distribution pattern of weakness in the middle and strength in the periphery. The ring road network highlights the difference between the new and old urban areas. The high contribution indexes of community resilience in the main urban area of Changchun were concentrated on disaster relief materials input, community self-rescue ability, and disaster cognition ability. Finally, strategies to improve community resilience are proposed from the perspectives of stress, state, and response, emphasizing community residents' participation, conducting disaster prevention and reduction training, and improving community response-ability.
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One of the key indicators to measure the sustainability and resilience of a city during a public health crisis is how well it can meet the daily needs of its residents. During the COVID-19 lockdown in Shanghai in 2022, e-commerce shopping and delivery became the most important method for ensuring the city's material supplies. This article uses the distribution data of a fresh e-commerce platform's pre-warehouse and static population distribution data to establish a basic material supply system evaluation model for the city and explore its resilience potential. Focusing on the central urban area of Shanghai, this study uses a population heat map with geographic coordinates to reflect the static distribution of residents and obtains the distribution data of the e-commerce pre-warehouses. Using kernel density analysis, the relationship between the pre-warehouses and the residents' needs is established. Through analysis, it was found that the supply capacity of fresh food in different areas of Shanghai during the lockdown could be categorized as insufficient, adequate, or excessive. Based on these three categories, improvement strategies were proposed. Finally, this article suggests establishing a scientific supply security system to promote urban sustainability and prepare for future challenges.
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After the outbreak of the COVID‐19 pandemic, the media abounded with stories of people ‘fleeing city‐centres' and ‘finding refuge in the countryside'. A recurrent argument is that the shift towards remote work has prompted individuals to reconsider their living situation and envisage the possibility of relocating further away from their workplace. The aim of this study is to examine the patterns of out‐migration from the Stockholm inner city during the COVID‐19 pandemic, as well as the characteristics of out‐migrants. We use Swedish register data to compare the trends for the first year of the COVID‐19 pandemic (2020) and the 5 years preceding it (2015–2019). Our study shows that, similar to other large cities across the world, individuals moved out of the inner city of Stockholm to a higher degree in 2020 than during the years preceding the pandemic. The majority of movers relocated to the Stockholm suburbs, which experienced a substantial increase in inflows from the Stockholm inner city. Yet a number of smaller municipalities, including traditional tourist destinations, also received more residents from the Stockholm inner city in 2020. Although it remains to be seen whether the increase in out‐migration from the Stockholm inner city observed in 2020 will be a long‐term trend, the paper discusses the policy implications of inner city out‐migration, from the perspective of both the sending and the receiving locations.