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Background/Aims Post COVID-19 syndrome (PCS) is an emerging cause of morbidity and poor quality of life in COVID-19 survivors. We aimed to assess the prevalence, risk factors, outcomes, and association with disease flares of PCS in patients with autoimmune rheumatic diseases (AIRDs) and non-rheumatic autoimmune diseases (nrAIDs), both vulnerable groups understudied in the current literature using data from the 2nd COVID-19 Vaccination in Autoimmune Diseases (COVAD) global multicentre patient self-reported e-survey. Methods The survey was circulated from February to July 2022 by the international COVAD Study Group (157 collaborators from 106 countries), and demographics, comorbidities, AIRD/nrAID status, COVID-19 history, vaccination details, and PROMIS physical and mental function were recorded. PCS was defined as symptom resolution time >90 days following acute COVID-19. Predictors of PCS were analysed using regression models for the different groups. Results 7666 total respondents completed the survey. Of these, 2650 respondents with complete responses had positive COVID-19 infection, and 1677 (45.0% AIRDs, 12.5% nrAIDs, 42.5% HCs) completed the survey >90 days post acute COVID-19. Of these, 136 (8.1%) had PCS. Prevalence of PCS was higher in AIRDs (10.8%) than healthy controls HCs (5.3%) (OR: 2.1;95%CI: 1.4-3.1, p=0.002). Across the entire cohort, a higher risk of PCS was seen in women (OR: 2.9;95%CI: 1.1-7.7, p=0.037), patients with long duration of AIRDs/ nrAIDs (OR 1.01;95%CI: 1.0-1.02, p=0.016), those with comorbidities (OR: 2.8;95%CI: 1.4-5.7, p=0.005), and patients requiring oxygen supplementation for severe acute COVID-19 (OR: 3.8;95%CI: 1.1- 13.6, p=0.039). Among patients with AIRDs, comorbidities (OR 2.0;95%CI: 1.08-3.6, p=0.026), and advanced treatment (OR: 1.9;95%CI: 1.08-3.3, p=0.024), or intensive care (OR: 3.8;95%CI: 1.01-14.4, p=0.047) for severe COVID-19 were risk factors for PCS. Notably, patients who developed PCS had poorer PROMIS global physical [15 (12-17) vs 12 (9-15)] and mental health [14 (11-16) vs 11 (8-14)] scores than those without PCS. Conclusion Individuals with AIRDs have a greater risk of PCS than HCs. Associated comorbid conditions, and advanced treatment or intensive care unit admission for severe COVID-19 confer a higher risk of PCS. It is imperative to identify risk factors for PCS for immediate multidisciplinary management in anticipation of poor physical and mental health.
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Background/Aims Flares following COVID-19 vaccination are an emerging concern among patients with rare rheumatic disease like idiopathic inflammatory myositis (IIMs), whereas data and understanding of this is rather limited. We aimed to study the prevalence, characteristics and determinants of IIM flares following COVID-19 vaccination. Methods CoVAD (COVID-19 Vaccination In Autoimmune Diseases) surveys are global patient self-reported e-surveys from 109 countries conducted in 2021 and 2022. Flares of IIM were defined by 4 definitions;a. patient self-reported, b. physician and immunosuppression (IS) denoted, c. sign directed (new erythematous rash, or worsening myositis or arthritis), d. MCID worsening of PROMISPF10a score between the patients who had taken both surveys. Descriptive statistics and multivariate regression were used to describe the predictors of flare. Cox-regression analysis was used to differentiate flares by IIM subtypes. Results Among the 1,278 IIM patients, aged 63 (50-71) years, 276 (21.5%) were dermatomyositis, 237 (18.5%) IBM, 899 (70.3%) were female and most were Caucasian (80.8%). Flares of IIM were seen in 123/1278 (9.6%), 163/1278 (12.7%), 112/1278 (8.7%), and 16/96 (19.6%) by definitions a-d respectively with median time to flare being 71.5 (10.7- 235) days. Muscle weakness (69.1%), and fatigue (56.9%) were the most common symptoms of flare. The predictors of self-reported flare were: inactive/disease in remission prior to first dose of vaccine (OR=4.3, 95%CI=2.4-7.6), and anxiety disorder (OR=2.2, 95%CI=1.1-4.7). Rituximab use (OR=0.3, 95%CI=0.1-0.7) and IBM (OR=0.3, 95%CI=0.1-0.7) were protective. Physician defined flares were seen more often in females, mixed ethnicity, and those with asthma, ILD, and anxiety disorder (OR ranging 1.6-7.0, all p<0.05). Notably, overlap myositis (OM) had higher HR for flare compared to polymyositis (HR=2.3, 95%CI=1.2-4.4, p=0.010). Conclusion Nearly one in ten individuals with IIM develop flares after vaccination, more so among women, those with overlap myositis, and inactive disease prior to vaccination. Formal definition of flares in IIM is needed.
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Background: Idiopathic inflammatory myopathies are a group of rare systemic autoimmune rheumatic diseases with substantial heterogeneity. We aimed to investigate gender differences in patient-reported outcomes and treatment regimens of people with idiopathic inflammatory myopathies. Method(s): This international, patient-reported, e-survey was conducted worldwide. We used data from the COVID-19 vaccination in autoimmune disease (COVAD) study, a large-scale, international, self-reported e-survey assessing the safety of COVID-19 vaccination in patients older than 18 years with autoimmune rheumatic diseases, including idiopathic inflammatory myopathies. The COVAD study was conducted in more than 80 health-care centres, including hospitals, clinics, and universities located in more than 50 countries worldwide and on social media platforms, such as Facebook and Twitter. The COVAD e-survey was open between April 1, 2021, and Dec 31, 2021. We extracted survey data regarding demographics;autoimmune rheumatic disease diagnosis;autoimmune multimorbidity (three or more autoimmune rheumatic disease diagnoses for each patient);current corticosteroid or immunosuppressant use;and patient-reported outcomes, including fatigue and pain Visual Analogue Scale (VAS), and PROMIS short form-physical function 10a (PF-10a). Gender was reported by participants with three options (men, women, or do not wish to disclose). Patient-reported outcomes and corticosteroid or immunosuppressant use were compared between men and women. Participants with inclusion body myositis were analysed separately due to the substantial difference in treatment and disease outcomes compared with other idiopathic inflammatory myopathy subtypes. Factors affecting each patient-reported outcome were determined using multivariable analysis. Finding(s): The survey data were extracted on Aug 31, 2021, and 1202 complete responses from participants with idiopathic inflammatory myopathies were analysed. Five patients who did not wish to disclose gender were excluded. 845 (70.6%) of the remaining 1197 were women. Women were younger than men (median 58 years [IQR 48-68] vs 69 years [58-75];p=0.00010). Autoimmune multimorbidity was more common in women than in men (94 [11.1%] of 845 vs 11 [3.1%] of 352;p<0.0001). Corticosteroid use was similar in men and women with idiopathic inflammatory myopathies (except for inclusion body myositis), whereas the distribution of immunosuppressants was different, with higher hydroxychloroquine use in women (131 [18.3%] of 717 vs 11 [6.9%] of 159 in men;p=0.0082). The median fatigue VAS was significantly higher in women than in men (5 [IQR 3-7] vs 4 [2-6];p=0.0036), whereas the gender difference in pain VAS (median 3 [IQR 1-5] in women vs 2 [0-4] in men;p=0.064) and PROMIS PF-10a scores (38 [31-45] vs 39 [30-47];p=0.29) was non-significant. There were no significant differences in patient-reported outcomes and treatment in participants with inclusion body myositis. The multivariable analysis of idiopathic inflammatory myopathies (except for inclusion body myositis) revealed that female sex, residence in high-income countries, a diagnosis of overlap myositis, and autoimmune multimorbidity were independent risk factors for higher fatigue VAS. Interpretation(s): Women with Idiopathic inflammatory myopathies frequently have autoimmune multimorbidity and increased fatigue compared with men, calling for greater attention and further research on targeted treatment approaches. Funding(s): None.Copyright © 2022 Elsevier Ltd
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Background. Significant gaps are present in the evidence of the spectrum and severity of COVID-19 infection in idiopathic inflammatory myopathies (IIMs). Patients with IIMs typically require immunosuppressive therapy, may have multiple disease sequelae, and frequent comorbidities, and thus may be more susceptible to severe COVID-19 infection and complications. The possibility of attenuated immunogenicity and reduced efficacy of COVID-19 vaccines due to concomitant immunosuppressive medication is a major concern in these patients, and there is little data available on COVID-19 vaccine breakthrough infections (BI) in IIMs Methods. We developed an extensive patient self-reporting electronic-survey (COVAD survey) featuring 36 questions to collect respondent demographics, SAID details, COVID-19 infection history, COVID-19 vaccination details, 7-day post vaccination adverse events and patient reported outcome measures using the PROMIS tool. After pilot testing, validation, translation into 18 languages on the online platform surveymonkey.com, and vetting by international experts, the COVAD survey was circulated in early 2021 by a multicenter study group of >110 collaborators in 94 countries. BI was defined as COVID-19 infection occurring more than 2 weeks after receiving 1st dose of a COVID-19 vaccine. We analysed data from the baseline survey for descriptive and intergroup comparative statistics based on data distribution and variable type. Results. Data from 10,900 respondents [42 (30-55) years, 74% females, 45% Caucasians] were analysed. Most were HCs (47%), followed by SAIDs (42%) and IIMs (11%). All respondents included in the final analysis had received a single dose of the vaccine and 69% had received 2 primary doses. Pfizer (39.8%) was the most common vaccine received, followed by Oxford/AstraZeneca (13.4%), and Covishield (10.9%). IIM patients were older, had a higher Caucasian representation and higher Pfizer uptake than other SAIDs, and HC. A higher proportion of IIM patients received immunosuppressants than other SAIDs. After adjustment for covariates, COVID-19 severity and BIs were comparable among patients with IIMs, SAIDs, and HCs, except for all-cause hospitalisation prior to vaccination (IIMs vs. HCs, OR=2.5, 95%CI 1.1-5.8) and COVID-19 cases prior to vaccination (IIMs vs. SAIDs, OR=0.6, 95%CI 0.4-0.8, and IIMs vs HCs, OR=0.4, 95%CI 0.3-0.5). BIs in IIMs were uncommon, with only 17 (1.4%) patients reporting BIs, of whom 13 were on immunosuppressants, and 3 required hospitalisation. Unvaccinated individuals with IIMs were at 4.6 (95%CI 2.7-8.0) times higher odds for developing COVID-19, and the 2nd vaccine dose had a protective effect on BI occurrence (Figure 1). Conclusion. IIMs patients reported fewer COVID-19 prior to vaccination than SAIDs and HCs, but had higher odds of all-cause hospitalisation than HCs. Vaccination protected patients with IIMs against COVID-19. COVID-19 breakthrough infections were uncommon in IIMs, with a similar symptom profile, disease duration, and severity in comparison to patients with SAIDs and HCs.
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Borges et al. have recently reported the first case of a dermatomyositis onset in close association with established coronavirus disease 2019 (COVID-19). Similarly, we report a patient who, on the contrary, had COVID-19 following early established dermatomyositis. We report prospectively the outcome of her disease.
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COVID-19 , Dermatomyositis , COVID-19/complications , Dermatomyositis/complications , Female , HumansABSTRACT
Objectives: To determine the main risk factors associated with COVID-19 in SLE patients. Methods: The Reuma CoV Brazil is a multicenter, observational, prospective cohort designed to monitor immune-mediated rheumatic diseases patients during SARS-CoV-2 pandemic in Brazil. SLE adult patients according to SLE SLICC criteria classification (2012), with and without (control group-CG) COVID-19 diagnosis were matched. Demographic data, managing of COVID-19, comorbidities, clinical characteristics (disease activity: Patient Report Outcomes-PROs, Physician Global Assessment and SLEDAI-2 K)were collected. Results: From May 2020 to January 2021, 604 SLE patients were included, 317 (52.4%) with COVID-19 and 287 (47.6%) in the CG. Both groups were homogeneous and comparable regarding sex and comorbidities. SLE patients with COVID-19 declared a lower level of social isolation (49.5% vs. 61.9%;p = 0.002), worked more commonly in health professions (10.4% vs. 3.5%;p = 0.002), presented more frequently joint (32.5% vs. 22.0%;p = 0.004) and hematological manifestations (18.0% vs. 11.5%;p = 0.025). SLEDAI-2 K did not differ among groups prior and after COVID-19 infection. However, considering the mean duration of COVID-19 symptoms (12.1 ± 8.8 days), infected patients had more severe disease activity's PROs after resolution of COVID-19 symptoms (2.9 ± 2.9 vs. 2.3 ± 2.6;p = 0.031). The hospitalization rate was 20.5% (n = 65), of whom 23 (7.2%) needed intensive care unit and 14 (4.4%) patients died. Hypertension [5,26 (1,9714,07);p = 0.001] and recently cyclophosphamide pulses [39,21 (4,17-368,53);p = 0.001] were associated with hospitalization and patients who received telemedicine medical care presented 72% less chance of hospitalization [0.28 (0.09-0.83);p = 0.023). Conclusion: COVID-19 was associated with a lower level of declared social isolation and more severe disease activity perception after SARS-CoV-2 infection according to PROs. Hypertension and cyclophosphamide were associated with hospitalization and telemedicine can be a useful tool for SLE patients with COVID-19. These data should be considered to perform public health policy and national guidelines to manage SLE patients during the pandemic, as well as to prioritize some special groups for the immunization program.