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- Dey, Mrinalini, et al.
(författare)
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COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus
- 2023
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Ingår i: Journal of Clinical Medicine. - : MDPI. - 2077-0383. ; 12:24
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The safety profile of COVID-19 vaccination is well documented, but hesitancy among people with immune-mediated inflammatory diseases, often immunocompromised, remains high, partially due to a scarcity of data on safety over a longer term. We herein aimed to assess delayed adverse events (DAEs) occurring >7 days after COVID-19 vaccination in systemic lupus erythematosus (SLE) versus other rheumatic autoimmune diseases (rAIDs), non-rheumatic AIDs (nrAIDs), and healthy controls (HCs).METHODS: Self-reported data were captured within the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 online survey, which comprised >150 centres and responses from 106 countries, between February and June 2022. Logistic regression analysis adjusting for important confounders (age, sex, ethnicity) was used to compare groups.RESULTS: Of 7203 eligible individuals, 882 (12.2%) patients had SLE, 3161 (43.9%) patients had rAIDs, 426 (5.9%) patients had nrAIDs, and 2734 (38.0%) were HCs. SLE patients had a median age of 39 years (IQR: 31-50); 93.7% were women. SLE patients reported, more frequently, major DAEs (OR: 1.6; 95% CI: 1.2-2.0; p = 0.001) and hospitalisation (OR: 2.2; 95% CI: 1.4-3.4; p < 0.001) compared to HCs, severe rashes (OR: 2.4; 95% CI: 1.3-4.2; p = 0.004) compared to people with rAIDS, and hospitalisation (OR: 2.3; 95% CI: 1.1-4.9; p = 0.029) as well as several minor DAEs compared to people with nrAIDs. Differences were observed between vaccines in terms of frequency of major DAEs and hospitalisations, with the latter seen more frequently in patients receiving the Moderna vaccine. People with SLE with no autoimmune multimorbidity less frequently reported overall minor DAEs compared to SLE patients with comorbid nrAIDs (OR: 0.5; 95% CI: 0.3-1.0; p = 0.036).CONCLUSION: Hospitalisations post-vaccination were more frequent in SLE patients than in HCs. Monitoring of SLE patients following COVID-19 vaccination can help in identifying DAEs early, informing patients about expected DAEs, and supporting patients, especially those with autoimmune multimorbidity.
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| 3. |
- Fornaro, M., et al.
(författare)
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MULTIMORBIDITY AND PROMIS HEALTH OUTCOMES IN PATIENTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES : DATA FROM A LARGE, GLOBAL E-SURVEY (COVAD STUDY)
- 2023
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Ingår i: Annals of the Rheumatic Diseases. - : HighWire Press. - 0003-4967 .- 1468-2060. ; 82:Suppl. 1, s. 942-943
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Prevalence of comorbidities and their impact on health outcomes in Idiopathic inflammatory myopathies (IIMs) is limited.Objectives: This study aimed to explore the prevalence of multimorbidity in patients with IIMs, other autoimmune rheumatic diseases (AIRDs) and Healthy controls (HCs). We further explore the impact of comorbidities on patients’ physical, mental, and social health assessed by the Patient-Reported Outcome Measurement Information System (PROMIS instruments).Methods: Data for this study were acquired from the COVAD 2 e-survey hosted by a study group consisting of 167 collaborators in 110 countries. Basic multimorbidity (BM) was defined as the co-occurrence of two or more comorbidities in an individual, while complex multimorbidity (CM) signified the co-occurrence of 3 or more chronic conditions affecting 3 or more different organ systems. PROMIS global physical health (PGP), mental health (PGM), fatigue 4a (F4a) and physical function short form (SF10) were analysed using descriptive statistics and linear regression models. Hierarchical Clustering on Principal Components was performed to outline the grouping.Results: Of 10740 complete respondents, 1558 IIMs, 4591 AIRDs and 3652 HCs were analysed. Individuals with IIMs exhibited high burden of any comorbidity (OR: 1.62 vs AIRDs and 2.95 vs HCs,p<0.01), BM (OR 1.66 vs AIRDs and 3.52 vs HCs,p<0.01), CM (OR: 1.69 vs AIRDs and 6.23 vs HCs,p<0.01), and mental health disorders (MHDs) (OR 1.33 vs AIRDs and 2.63 vs HCs,p<0.01).IIM patients with comorbidities (and MHDs) had worse physical function (low PGP, PGM, SF10 and higher F4a scores, all p<0.001). Worse physical function (PGP) was predicted by age (0.35; 0.030), active disease (-1.51; <0.001), BM (-1.11; <0.001), and MHDs (-1.47; <0.001). PGM was impacted by age (0.51; 0.004), active disease (-1.34, <0.001), BM (-0.75; 0.001) and MHDs (-2.22; <0.001). Determinants of SF10a were age (-3.86; <0.001), active disease (-7.03, <0.001), female (2.85, <0.001), BM (-2.95; <0.001) and MHDs (-2.37; <0.001). Fatigue (F4a) was impacted by age (-0.96, <0.001), active disease (1.45, <0.001), country human development index (0.95; 0.036), BM (1.11; <0.001); and MHDs (2.17; <0.001).Four distinct clusters (Figure 1A, Table 1) were identified i.e., cluster 0: lower burden of comorbidities and good health status; cluster 1: older patients, whit higher burden of comorbidities and poor health status, cluster 2: patients with higher prevalence of MHDs, lower PGP and PGM; and higher F4a scores; and lastly Cluster 3 that comprised older patients with an average burden of comorbidities and overall good health status according to PROMIS scores.Dermatomyositis, anti-synthetase syndrome, necrotizing autoimmune myopathy were similarly represented in all clusters, whilst inclusion body myositis and polymyositis were more predominant in clusters 1 (40.6% and 17.2%) and 3 (32 % and 17.5%), while overlap myositis was more represented in cluster 2 (25.6%) and 0 (32.7%) (Figure 1B).Conclusion: Patients with IIMs have a higher burden of comorbidities that adversely impact physical and mental health, calling for optimized approaches for holistic patient management.
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| 4. |
- Gupta, L., et al.
(författare)
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COMORBIDITIES, COMPLEX MULTIMORBIDITY AND PROMIS HEALTH OUTCOMES AMONGAUTOIMMUNE RHEUMATIC DISEASES : DATA FROM THE COVAD STUDY
- 2023
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Ingår i: Annals of the Rheumatic Diseases. - : HighWire Press. - 0003-4967 .- 1468-2060. ; 82:Suppl. 1, s. 555-556
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Comorbidities have a profound impact on the QoL of patients living with autoimmune rheumatic diseases (AIRDs). Unfortunately, global data on the burden of comorbidities and its impact on health outcomes in this vulnerable group is scarce.Objectives: We studied the prevalence, distribution and clustering of comorbidities and multimorbidity among patients with AIRDs and healthy controls (HCs) and its impact on health outcomes, utilizing data from the ongoing 2nd COVAD study.Methods: The COVAD study is a global e-survey that embodies patient voice while empowering collaborators and young researchers. The study group of 157 physicians across 106 countries from February-June 2022 captured details of AIRDs, autoimmune and non-autoimmune comorbidities, and validated patient reported outcomes. Human Development Index (UNDP 2021-22) of country of residence was taken as a surrogate marker for socioeconomic status (SES).Basic multimorbidity (BM), Complex multimorbidity (CM), Autoimmune multimorbidity (AM) are defined as the co-occurrence of ≥2 non-rheumatic comorbidities, ≥3 non-rheumatic chronic conditions affecting ≥3 different organ systems [1] and ≥3 autoimmune diseases (AIDs) in an individual respectively.PROMIS global physical health (PGP), mental health (PGM), fatigue 4a (F4a) and physical function short form (SF10) scores were calculated for the different groups and compared using descriptive statistics, linear regression and cluster analysis (hierarchical followed by K means).Results: Of 17,612 total respondents, 6149 (62.7%) had underlying AIRDs and 3652 (37.3%) were HCs, with female (80.8%) and Caucasian (53.9%) predominance in the former.All types of multimorbidity were more frequent in AIRDs than HCs, including any comorbidity (77.1% versus 25.0%; OR: 2.9; 2.7-3.2), BM (21.0% vs 6.2%; 4.0; 3.4-4.6), and CM (3.1% vs 0.5%; 6.4; 3.9-10.4), and with prevalence increasing with age (p<0.001) (Figure 1A, B). Comorbidity prevalence was the highest among Americans and Australians (72% each).Patients with AIRDs had poorer health outcomes than HCs, including lower PGP, PGM, SF10, F4a scores (all p<0.001). Among AIRDs, those with comorbidities had lower physical function and PROMIS scores (PGP, PGM, and SF10), and reported fatigue more often (all p<0.001).Female gender, and underlying BM and AM particularly predisposed patients to worse physical health (lower PGP, lower SF10a) and mental health outcomes (lower PGM). While advanced age (-1.815; <0.001), and lower SES (0.871; 0.027) specifically predicted poorer physical function (lower SF10a). Fatigue (higher F4a) was seen more frequently among women (1.711; <0.001), and those with BM (1.142; 0.002); AM (1.768; 0.011), and higher SEC (0.478; 0.016).Cluster analysis of patients with AIRDs revealed 2 clusters (Figure 1C 1D); cluster 1 with low PGP, PGM, SF10 and high F4a; cluster 2 with high PGP, PGM, SF10 and low F4a. The clusters differed predominantly based on the frequency of comorbidities; any comorbidity (59.7% vs 41.8%; p<0.001), BM (28.5% vs 14.7%; 0.001); CM (4.5% vs 1.9%; <0.001), and AM (10.0% vs 4.0%; <0.001).Conclusion: Comorbidities complicate three-quarters of individuals living with AIRDs, and have an outsized impact on self-reported physical function, perceived fatigue, and QoL. Substantial regional differences call for further exploration of key drivers of this important aspect to allow optimized multidisciplinary and holistic care in anticipation of poorer outcomes.Reference: [1]Harrison C, Britt H, Miller G, Henderson J. Examining different measures of multimorbidity, using a large prospective cross-sectional study in Australian general practice. BMJ Open. 2014 Jul 1;4(7):e004694.
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| 5. |
- Olsson, E. Kihlgren, et al.
(författare)
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BREAKTHROUGH SARS-COV-2 INFECTION IN FULLY VACCINATED PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS : RESULTS FROM THE COVID-19 VACCINATION IN AUTOIMMUNE DISEASE (COVAD) STUDY
- 2023
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Ingår i: Annals of the Rheumatic Diseases. - : HighWire Press. - 0003-4967 .- 1468-2060. ; 82:Suppl. 1, s. 540-541
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Although 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).Objectives: This 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).Methods: The 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.Results: A 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).Conclusion: COVID-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.
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