EFFICACY AND SAFETY OF ANTI-SARS-CoV-2 VACCINATION IN PEOPLE WITH RMDs: RESULTS FROM A SYSTEMATIC LITERATURE REVIEW

BackgroundAs the third year of the pandemic begins, over 13 billion doses of anti-SARS-CoV-2 vaccines have been administrated worldwide and growing evidence on their efficacy and safety in people with RMDs has accrued.ObjectivesTo update our previous systematic literature review (SLR)[1] on efficacy and safety of anti-SARS-CoV-2 vaccination in people with rheumatic and musculoskeletal diseases (RMDs)MethodsA literature search according to the PICO framework was conducted on July 22, 2022 to identify references in seven databases published after June 1, 2021 (end date of previous SLR). Title and s were independently screened by 3 investigators (AA, AN and FK). Eligibility criteria were stricter in terms of requirement of the inclusion of control group or undertaking a multivariable analysis. However, for some outcomes (e.g., RMD flares), descriptive studies were also included due to the paucity of data. Data extraction and risk of bias (RoB) assessment were performed as in the previous SLR.ResultsOf 1583 references, 219 were included for full text assessment and 30 fulfilled the eligibility criteria. Recent studies confirmed that a full vaccination cycle was generally immunogenic, though the seroconversion rate and the anti-spike antibody (Ab) titre were lower in patients with RMDs compared to healthy controls. Vaccination was also able to induce neutralising antibodies (NAb) but the seroconversion rate and the neutralising activity were lower than in controls. Glucocorticoids, mycophenolate mofetil, rituximab and abatacept were negatively associated with Ab and NAb seroconversion. Two studies specifically investigating RTX-treated RMD patients identified an association between lower dose and longer period of time after the last RTX infusion before vaccination and higher likelihood of Ab seroconversion. The majority of breakthrough infections (B-INFs) were asymptomatic and, if symptomatic, mild to moderate. A higher number of vaccine doses was associated with a lower incidence and severity of B-INFs, although B-INF incidence rate was generally higher in the post-delta variant period. Higher disease activity was associated with higher likelihood of severe/critical B-INFs. Regarding safety, in general, patients with RMDs showed higher rates of mild AEs compared to the general population, however severe AEs were rare, if any. Disease flares have been observed in/reported by less than 10% of patients in the various cohorts and although often requiring treatment with glucocorticoids or change of the ongoing immunosuppressive therapy, hospitalization was generally not needed. Pre-vaccination colchicine prophylaxis seemed useful to prevent gout flares in the post-vaccination trimester.ConclusionOverall anti-SARS-CoV-2 vaccination is immunogenic and safe in patients with RMDs. However, careful and individualised assessment of the ongoing therapy and disease activity when planning the vaccination schedule is necessary to minimise the risk of reduced immunogenicity, post-vaccination disease flares and breakthrough infections.Reference[1]Kroon FPB, Najm A, Alunno A, Schoones JW, Landewé RBM, Machado PM, Navarro Compán V. Ann Rheum Dis. 2022;81(3):422-432Acknowledgements:NIL.Disclosure of InterestsNone Declared.

Eular Covid and Covax Registries' Update: Focus on Myositis

The EULAR COVID-19 registry, launched in March 2020, is an observational registry that captures physician-entered data on both adult and paediatric patients with a pre-existing rheumatic and musculoskeletal disease (RMD) and SARSCoV-2 infection. Data are entered voluntarily directly into the European data entry portal. In addition, as some countries were already collecting COVID-19 data, either within existing registries or in new COVID-19 registries (France, Germany, Greece, Italy, Portugal, Sweden and Switzerland), they were invited to share their data with the EULAR COVID-19 registry. EULAR data are then merged with data from the Global Rheumatology Alliance (GRA) for analysis. The aim of the EULAR-GRA COVID-19 registry is to collect, analyze, generate and disseminate information about COVID-19 and rheumatology to patients, physicians and other relevant groups to improve the care of patients with rheumatic disease. Later during the pandemic, patients with immune-mediated inflammatory diseases (including inflammatory RMDs) were excluded from SARS-CoV-2 vaccine clinical development programmes;therefore, questions regarding the safety, effectiveness and potential measures that may increase the safety and effectiveness of vaccination against SARS-CoV-2 were unanswered. Lack of data led to some contradictory advice from rheumatology organisations and healthcare professionals regarding some of these vaccination aspects. In order to contribute to more informed decisions by patients and healthcare professionals and more robust and homogeneous evidence-based recommendations from relevant organisations, EULAR decided to create a second registry to collect data and learn about vaccination outcomes in people with RMDs. At the 4th Global Conference on Myositis (GCOM), myositis-specific data from these two registries will be presented.

Covid-19 Vaccination and Guillain-Barre Syndrome: Analyses Using the National Immunoglobulin Database

Anti-viral vaccination has rarely been associated with Guillain- Barre syndrome(GBS). We performed a population-based study of NHS England data and a UK multicentre surveillance study to investigate the relationship between COVID-19 vaccination and GBS. We linked GBS cases from England's National Immunoglobulin Database(NID) with COVID-19 vaccina- tion data from December 2020-July 2021. GBS temporally associated within a 6-week risk window of any COVID-19 vaccine was identified. We prospectively collected incident UK GBS cases January- November 2021 regardless of vaccine exposure. The NID recorded 996 English GBS cases January-October 2021. A spike of cases above the 2016-2020 average occurred March-April 2021. 198 cases occurred within 6 weeks of first-dose COVID-19 vaccina- tion (0.618cases/ 100,000vaccinations: 176 ChAdOx1 nCoV-19, 21 tozinameran, 1 mRNA-1273). First-dose ChAdOx1 nCoV-19 accounted for the excess of 98-140 GBS cases with a peak 24 days post-vaccination. First-dose tozinameran and seconddose any vaccination showed no excess GBS risk. The UK multicen- tre surveillance dataset (121 patients) identified no phenotypic or demographic differences between vaccinelinked and unlinked cases. First-dose ChAdOx1 nCoV-19 vaccination is associated with excess GBS risk 0.576 (95%CI 0.481-0.691) cases/100,000 doses. No specific features are associated with vaccinationrelated GBS cases. The mechanism of immunogenicity of ChAdOx1 nCoV-19- warrants further study.

COVID-19 and the Challenges of Chemotherapy: The Failure Case of Hy-droxychloroquine in the Clinical Treatment of SARS-CoV-2 Infection

In December 2019, in Wuhan, China, an outbreak of a respiratory disease was reported, and the causative agent of which was discovered to be the new coronavirus. This disease spread rapidly around the world, and in March 2020, the WHO declared a state of pandemic. According to the WHO situation in October report, more than 41,570.883 were affected, and 1,134.940 deaths had occurred. Thus, the urgency to find therapeutic targets to prevent viral replication and a vaccine to protect against the disease became a great challenge for researchers around the world. A French group began using, in patients, a drug that had already been approved for human use, hy-droxychloroquine (HQ) alone or in combination with azithromycin. The use of a drug already approved by regulatory agencies can enable treatment strategies to be put in place rapidly;however, even though in vitro may indicate success, this is not always guaranteed. For HQ, some studies have shown a satisfactory response in patients, while in many others, the result was not positive and patients actually died. Furthermore, many adverse effects of HQ have been described. In this re-view, we will briefly discuss how this therapy became an option for the treatment of SARS-CoV-2 infection. We will address the use of HQ in different pathologies and COVID-19 specifically;de-scribing the doses used, as well as the main adverse effects. The take-home message is that more ef-forts are still required to conclude the efficacy of HQ against COVID-19, however, most of the studies carried out currently are showing that the use of HQ does not bring benefits during treatment of COVID-19.Copyright © 2021 Bentham Science Publishers.

Sars-Cov-2 Vaccine Safety in Adolescents with Inflammatory Rheumatic and Musculoskeletal Diseases and Adults with Juvenile Idiopathic Arthritis: Data from the Eular Covax Physicianreported Registry

Introduction/Background: There is a lack of data on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs) as they were excluded from initial vaccine trials. Vaccination guidance is based on data from adults with or CYP without RMDs. Description/Method: Our objective was to describe the safety of SARS-COV-2 vaccination in adolescents with inflammatory RMDs and adults with JIA. We described patient characteristics, flares, and adverse events in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology (EULAR) COVAX registry. Discussion/Results: Thirty-six adolescent cases were reported from 4 countries, mostly female (58%) with JIA (42%: 28% non-systemic JIA, 14% systemic JIA) and a median age of 15 [IQR: 14.5, 17]. Most were in remission (64%) or had minimal (22%) disease activity at the time of vaccination. Over half of the adolescent group (56%) reported early reactogenic-like AEs. One mild polyarthralgia flare and one serious AE of special interest (malaise) were reported. No CYP reported SARS-CoV-2 infection post-vaccination. No cases of paediatric inflammatory multi-system syndrome or myocarditis adverse events were reported. Seventy-four adult JIA cases were reported from 11 countries;73% were female with a median age of 26 [IQR: 23, 31]. Eight-five percent had ns-JIA and 15% had s-JIA. Almost two thirds (62%) reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three 20-30 year old females were diagnosed with SARS-CoV-2 post-vaccination;all fully recovered. Key learning points/Conclusion: In this observational registry dataset, SARS-CoV-2 vaccines appeared safe in adolescents with RMDs and adults with JIA, with a low frequency of disease flares, serious AEs, and SARS-CoV-2 re-infection seen in both populations.

Sars-Cov-2 Infection in 898 Patients with Sjogren's Syndrome: Characteristics Associated with Poor Outcomes

Objectives. To determine characteristics associated with a more severe COVID-19 outcome in people with Sjogren's disease (SJD). Methods. People with SJD and COVID-19 reported to two international registries (Sjogren Big Data Consortium and COVID-19 Global Rheumatology Alliance) from March 2020 to October 2021 were included. An ordinal COVID-19 severity scale was defined: (1) not hospitalized, (2) hospitalized with no ventilation, (3) hospitalized requiring non-invasive ventilation, (4) hospitalized requiring invasive ventilation, and (5) death. Odds ratios (OR) were estimated using a multivariable ordinal logistic regression model adjusted for age, sex, comorbidities and anti-rheumatic medications included as covariates. Results. A total of 898 people with SJD were included (825 (91.8%) women, mean age SARS-CoV-2 infection diagnosis: 55.5 years), including 652 patients with primary SJD and 246 with other associated systemic rheumatic diseases. 33.9% were hospitalized, 14.5% required ventilation, and 4.3% died. In the multivariable model, older age (OR 1.03, 95% CI 1.02 to 1.05), male sex (OR 1.81, 95% CI 1.10 to 2.92), two or more comorbidities (OR 2.99, 95% CI 1.92 to 4.67;vs none), baseline therapy with corticosteroids (OR 2.04, 95% CI 1.20 to 3.46), immunosuppressive agents (OR 2.09, 95% CI 1.30 to 3.38) and B-cell depleting agents (OR 5.38, 95% CI 2.77 to 10.47) were associated with worse outcomes (reference for all medications: hydroxychloroquine only). Conclusions. More severe COVID-19 outcomes in individuals with Sjogren's are largely driven by demographic factors and baseline comorbidities. Patients using immunosuppressants, especially rituximab, also experienced more severe outcomes.

FACTORS ASSOCIATED with SEVERE COVID-19 OUTCOMES in PATIENTS with IDIOPATHIC INFLAMMATORY MYOPATHY: RESULTS from the COVID-19 GLOBAL RHEUMATOLOGY ALLIANCE PHYSICIAN-REPORTED REGISTRY

Background: There is a paucity of data in the literature about the outcome of patients with idiopathic infammatory myopathy (IIM) who have been infected with SARS-CoV-2. Objectives: To investigate factors associated with severe COVID-19 outcomes in patients with IIM. Methods: Data on demographics, number of comorbidities, region, COVID-19 time period, physician-reported disease activity, anti-rheumatic medication exposure at the clinical onset of COVID-19, and COVID-19 outcomes of IIM patients were obtained from the voluntary COVID-19 Global Rheumatology Alliance physician-reported registry of adults with rheumatic disease (from 17 March 2020 to 27 August 2021). An ordinal COVID-19 severity scale was used as primary outcome of interest, with each outcome category being mutually exclusive from the other:a) no hospital-ization, b) hospitalization (and no death), or c) death. Odds ratios (OR) were estimated using multivariable ordinal logistic regression. In ordinal logistic regression, the effect size of a categorical predictor can be interpreted as the odds of being one level higher on the ordinal COVID-19 severity scale than the reference category. Results: Complete hospitalization and death outcome data was available in 348 IIM cases. Mean age was 53 years, and 223 (64.1%) were female. Overall, 167/348 (48.0%) people were not hospitalized, 136/348 (39.1%) were hospitalized (and did not die), and 45/348 (12.9%) died. Older age (OR=1.59 per decade of life, 95%CI 1.32-1.93), male sex (OR=1.63, 95%CI 1.004-2.64;versus female), high disease activity (OR=4.05, 95%CI 1.29-12.76;versus remission), presence of two or more comorbidities (OR=2.39, 95%CI 1.22-4.68;versus none), predni-solone-equivalent dose >7.5 mg/day (OR=2.37, 95%CI 1.27-4.44;versus no gluco-corticoid intake), and exposure to rituximab (OR=2.60, 95%CI 1.23-5.47;versus csDMARDs only) were associated with worse COVID-19 outcomes (Table 1). Conclusion: These are the frst global registry data on the impact of COVID-19 on IIM patients. Older age, male gender, higher comorbidity burden, higher disease activity, higher glucocorticoid intake and rituximab exposure were associated with worse outcomes. These fndings will inform risk stratifcation and management decisions for IIM patients.

CHARACTERISTICS ASSOCIATED with POOR COVID-19 OUTCOMES in PEOPLE with PSORIASIS and SPONDYLOARTHRITIS: DATA from the COVID-19 PSOPROTECT and GLOBAL RHEUMATOLOGY ALLIANCE PHYSICIAN-REPORTED REGISTRIES

Background: Some factors associated with severe COVID-19 outcomes have been identifed in patients with psoriasis (PsO) and infammatory/autoimmune rheumatic diseases, namely older age, male sex, comorbidity burden, higher disease activity, and certain medications such as rituximab. However, information about specifcities of patients with PsO, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), including disease modifying anti-rheumatic drugs (DMARDs) specifcally licensed for these conditions, such as IL-17 inhibitors (IL-17i), IL-23/IL-12 + 23 inhibitors (IL-23/IL-12 + 23i), and apremilast, is lacking. Objectives: To determine characteristics associated with severe COVID-19 outcomes in people with PsO, PsA and axSpA. Methods: This study was a pooled analysis of data from two physician-reported registries: the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), comprising patients with PsO/PsA, and the COVID-19 Global Rheumatology Alliance (GRA) registry, comprising patients with PsA/axSpA. Data from the beginning of the pandemic up to 25 October, 2021 were included. An ordinal severity outcome was defned as: 1) not hospitalised, 2) hospitalised without death, and 3) death. A multivariable ordinal logistic regression model was constructed to assess the relationship between COVID-19 severity and demographic characteristics (age, sex, time period of infection), comorbidities (hypertension, other cardiovascular disease [CVD], chronic obstructive lung disease [COPD], asthma, other chronic lung disease, chronic kidney disease, cancer, smoking, obesity, diabetes mellitus [DM]), rheumatic/skin disease (PsO, PsA, axSpA), physician-reported disease activity, and medication exposure (methotrexate, lefunomide, sulfasalazine, TNFi, IL17i, IL-23/IL-12 + 23i, Janus kinase inhibitors (JAKi), apremilast, glucocorticoids [GC] and NSAIDs). Age-adjustment was performed employing four-knot restricted cubic splines. Country-adjustment was performed using random effects. Results: A total of 5008 individuals with PsO (n=921), PsA (n=2263) and axSpA (n=1824) were included. Mean age was 50 years (SD 13.5) and 51.8% were male. Hospitalisation (without death) was observed in 14.6% of cases and 1.8% died. In the multivariable model, the following variables were associated with severe COVID-19 outcomes: older age (Figure 1), male sex (OR 1.53, 95%CI 1.29-1.82), CVD (hypertension alone: 1.26, 1.02-1.56;other CVD alone: 1.89, 1.22-2.94;vs no hypertension and no other CVD), COPD or asthma (1.75, 1.32-2.32), other lung disease (2.56, 1.66-3.97), chronic kidney disease (2.32, 1.50-3.59), obesity and DM (obesity alone: 1.36, 1.07-1.71;DM alone: 1.85, 1.39-2.47;obesity and DM: 1.89, 1.34-2.67;vs no obesity and no DM), higher disease activity and GC intake (remission/low disease activity and GC intake: 1.96, 1.36-2.82;moderate/severe disease activity and no GC intake: 1.35, 1.05-1.72;moderate/severe disease activity and GC intake 2.30, 1.41-3.74;vs remission/low disease activity and no GC intake). Conversely, the following variables were associated with less severe COVID-19 outcomes: time period after 15 June 2020 (16 June 2020-31 December 2020: 0.42, 0.34-0.51;1 January 2021 onwards: 0.52, 0.41-0.67;vs time period until 15 June 2020), a diagnosis of PsO (without arthritis) (0.49, 0.37-0.65;vs PsA), and exposure to TNFi (0.58, 0.45-0.75;vs no DMARDs), IL17i (0.63, 0.45-0.88;vs no DMARDs), IL-23/IL-12 + 23i (0.68, 0.46-0.997;vs no DMARDs) and NSAIDs (0.77, 0.60-0.98;vs no NSAIDs). Conclusion: More severe COVID-19 outcomes in PsO, PsA and axSpA are largely driven by demographic factors (age, sex), comorbidities, and active disease. None of the DMARDs typically used in PsO, PsA and axSpA, were associated with severe COVID-19 outcomes, including IL-17i, IL-23/IL-12 + 23i, JAKi and apremilast.

SARS-COV-2 VACCINE SAFETY in ADOLESCENTS with INFLAMMATORY RHEUMATIC and MUSCULOSKELETAL DISEASES and ADULTS with JUVENILE IDIOPATHIC ARTHRITIS

Background: There is a lack of data on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs. Objectives: To describe the characteristics and outcomes of adolescents with infammatory RMDs and adults with juvenile idiopathic arthritis (JIA) vaccinated against SARS-CoV-2. Methods: We described patient characteristics, fares, and adverse events in adolescent cases under 18 with infammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology (EULAR) COVAX registry. Results: Thirty-six adolescent cases were reported from 4 countries, the most frequent diagnosis was JIA (42%). Over half (56%) reported early reactogen-ic-like adverse events (AEs) experienced within 7 days of vaccination. One mild polyarthralgia fare and one serious AE (malaise) were reported. No CYP reported SARS-CoV-2 infection post-vaccination. In addition to the adolescent cases, eleven countries reported 74 adult JIA cases. Among these, 62% reported early reactogenic-like AEs and two fares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three 20-30 year old females were diagnosed with SARS-CoV-2 post-vaccination;all fully recovered. Conclusion: In this observational registry dataset, SARS-CoV-2 vaccines appeared safe in adolescents with RMDs and adults with JIA, with a low frequency of disease fares, serious AEs, and SARS-CoV-2 re-infection seen in both populations.

Managing risk and sexuality in the Covid-19 context

This text presents initial questions from the SEXVID national survey on sexual practices and risk management in the Covid-19 context. The category of risk management, taken from studies about management and health in relation to HIV/AIDS and practices of assemblage, with reference to studies of materialities, articulates heterogeneous elements involved in managing offline sexual encounters in the context of the pandemic. We focus on two questions: how does this management take place, especially in a political environment lacking public policies on prevention and risk, and what are the practical materialities that constitute this articulated assemblage of elements that justify or not the risk of contamination. We use scenes constructed from semi-structured interviews in the initial phase of the study to contextualize the central question and learn about the impact of the pandemic on the sexual experiences of part of the population. © 2022, Brazilian Anthropology Association. All rights reserved.

Unreachable The physical impossibility of digital displays

"Unreachable" is an artwork that explores the feelings caused by the absence of human closeness and social gathering, and the forced distancing imposed by the spread of the highly contagious virus COVID-19. Digital technologies allowed the continuity of some activities adapted to this new reality. Nevertheless, although we can see and hear through them, they do not fulfill the human need for touch nor replace the sensations of being physically close to other people and of live cultural and leisure moments. Through the display of images and videos that avoid the participants when they cross the minimum safety distance, this artwork addresses the feelings of the impossibility of physically reaching something important and meaningful through digital devices, even though these may simulate a sense of closeness. © 2021 Copyright held by the owner/author(s).

Managing the COVID-19 pandemic in a Portuguese School of Nursing: an experience report

Introduction: The COVID-19 pandemic, decreed by the WHO in March 2020, created enormous challenges. Our Institution was faced with the need to take measures to control the spread of the disease and keep the academic community safe, for which a comprehensive contingency plan was created so that the entire community felt involved and able to follow the proposed measures. Objectives: (I) Describe the process of building a contingency plan to respond to the COVID-19 pandemic situation in a Nursing School;(II) Describe the implementation of the contingency plan and its adequacy, depending on the evolution of the pandemic situation and (III) Describe the main challenges encountered and the corrective strategies adopted. Methodology: Experience report of the construction and implementation of the Institution's contingency plan. A Contingency Plan Team was appointed that created a plan following the guidelines of the various health regulatory authorities, structured in four topics: 1) organization of structures;2) training;3) organization of academic and work activities;4) follow-up and monitoring. In addition, several guiding documents for safe practices were also prepared, aimed at readjusting the teaching-learning process and the safety of employees. Results: 1) organization of structures: An isolation room was established in each building, Spaces were reorganized to ensure safe distances;antiseptics were distributed;Signals was adopted to make the path;internal dynamics and specific procedures changed. 2) training: Clarification sessions were organized with teachers and online training for students and non-teaching staff, and face-to-face training for cleaning staff and support teams. 3) organization of academic and work activities: plan the beginning and breaks according to the maximum amount of people in the same room, fixed the capacity of each classroom. 4) follow-up and monitoring: a case notification/registration process was created and spread the message for all community on the website and by email. Conclusions: The contingency plan has responded to the Institution's needs. It was dynamic and flexible, always be adjusted according to national norms/guidelines and in partnership with Local Health Authorities. The implemented changes proved to be effective and supported the entire school community, which started to integrate the new rules into their daily lives. The very low cases report of covid-19 with the beginning in our institution, seems to reveal the success of the implemented measures.