Objective The aim of this study was to assess the immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibody titers after the primary regimen of 2 doses. Methods Patients with RA with no seroconversion after 2 doses of SARS-CoV-2 vaccine and who received a third dose of either an mRNA or vector-based vaccine were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity, and T cell responses were assessed after the third dose. Results A total of 21 nonresponder patients were included. At the time of vaccination, 29% were receiving glucocorticoids and 85% biologic disease-modifying antirheumatic drugs (including 6 taking abatacept [ABA] and 4 taking rituximab [RTX]). The majority (95%) received the BNT162b2 vaccine and only one of them received the ChAdOx1 nCoV-19 vaccine. After the third dose, 91% of the patients presented detectable anti-SARS-CoV-2 IgG and 76% showed neutralizing activity. Compared to other treatments, ABA and RTX were associated with the absence of neutralizing activity in 4 out of 5 (80%) patients and lower titers of neutralizing antibodies (median 3, IQR 0-20 vs 8, IQR 4-128; P = 0.20). Specific T cell response was detected in 41% of all patients after the second dose, increasing to 71% after the third dose. The use of ABA was associated with a lower frequency of T cell response (33% vs 87%, P = 0.03). Conclusion In this RA cohort, 91% of patients who failed to seroconvert after 2 doses of SARS-CoV-2 vaccine presented detectable anti-SARS-CoV-2 IgG after a third dose. The use of ABA was associated with a lower frequency of specific T cell response.
BackgroundAdvances in rheumatology and new therapeutic options have certainly impacted patient survival, changing the age range, from youth to seniors. The differences between the age groups could influence the evolution of the disease and the adverse events (AEs) related to the treatments. There are few real-world data on the safety and efficacy of treatments in different age groups.ObjectivesTo evaluate the frequency of AEs and the survival of treatments according to the age in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS).MethodsRetrospective, observational, multicenter study of real-life data of patients included in the BIOBADASAR 3.0 registry; exposed and not exposed to original biological treatments (b-DMARDs), biosimilars, targeted synthetic drugs (ts-DMARDs). The unexposed group received treatment with conventional disease-modifying drugs (cDMARDs). A Kaplan-Meier and Log Rank Test analysis was performed to study AEs-free survival and treatment in different age groups (young people <25; young adults 25-34; mature adults 34-65; old adults >65). Factors related to treatment survival were evaluated using Cox regression models.Results5,297 patients were included, 80.3% female, mean age 43.7 years (SD 15.6) and median disease progression 14.3 [IQR 11.5]. RA 4658 (87.9%); APs 490 (9.25%) and EA 149 (2.8%). The main reason for treatment discontinuation was ineffectiveness, in 624 patients in the exposed group and in 53 (2.5%) patients in control group, followed by the presence of AEs in 352 (11.2%) and 83 (3.9%), respectively (p=0.001).A mean Charlson Score of 0.268 (SD 0.6) in the exposed group and 0.306 (SD 0.7) in the control group (p=0.095). Median EAs-free survival in the exposed group was 12.5 years [IQR 16.6] while in controls was 28 years [IQR 11], p<0.0001. Median AEs-free survival was 12 years (IQR 11) in young people, 11.5 years [IQR: 4.9] in young adults, 10 years [IQR: 3.25] in mature adults and 7.6 years [IQR: 6] in old adults with a difference statistically significant (p>0.017). The exposed group presented a median treatment survival in years of 11.25 years [IQR: 10] in young people; 12.5 years [IQR: 4.7] in young adults, 7.5 years [IQR: 12.1] in mature adults and 4.5 years [IQR: 1.14] in old adults (p>0.0001). Considering only the first line of treatment, a median survival of 11.5 years [IQR: 10] was evidenced in the age group <25; 12 years [IQR: 2.6] between 25-34 years old, 10 years [IQR: 12] in the group between 34-65 years old and 5.5 years [IQR: 1.14] in the group > 65 years old (p>0.004). (Figure 1). Considering the second line of treatment, the differences between the groups were not statistically significant (p=0.57). In the multivariate regression model for patients with RA, the factors with the greatest impact on treatment survival were female sex (HR 1.3, 95% CI 1.2-1.4), old age (HR 1.01, 95% CI 1.008-1.01), treatment with steroids (HR 1.19, 95% CI1.1-1.2) and longer disease duration (HR 1.01, 95% CI1.01 – 1.02).ConclusionIn the present study we were able to demonstrate a greater occurrence of AEs in old adults and mature adults compared to young people and young adults. Conversely, survival for b-DMARDs and ts-DMARDs were greater in youth and young adults. In patients with RA, female sex, corticosteroid therapy, old aged and longer disease duration were associated with treatment discontinuation.References[1]Souto A, et al. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and meta-analysis of drug registries and health care databases. Rheumatology (Oxford). 2016;55(3):523–34.[2]Ray D, et al. Immune senescence, epigenetics and autoimmunity. Clin Immunol. 2018 Nov;196:59-63. doi: 10.1016/j.clim.2018.04.002. Epub 2018 Apr 11.[3]Vela P, et al. Influence of age on the occurrence of adverse events in rheumatic patients at the onset of biological treatment: data from the BIOBADASER III register. Arthritis Res Ther. 2020 Jun 15;22(1):143. doi: 10.1186/s13075-020-02231-x.Disclosure of InterestsNone declared
Background:Work disability is an important outcome in the treatment of Spondyloarthritis (SpA) since this disease affects people in the most productive stage of life.Objectives:The aim of this study is to investigate the working status and the factors associated with work productivity loss (WPL) in patients with axial (axSpA) and peripheral SpA (pSpA).Methods:Patients with SpA according to ASAS criteria were included consecutively in this multicentric cross-sectional study. Evaluation of activity through a visual analogue scale (0-100), enthesitis (LEI), functional capacity (HAQ and BASFI), disease activity (DAS28 and BASDAI), health status (ASAS Health Index) and quality of life (ASQoL) were calculated. The Ankylosing Spondylitis Disease Activity Score (ASDAS) was recorded. The Work Productivity and Activity Impairment Spondyloarthritis (WPAI SpA) questionnaire was used to assess work productivity.Spearman’s correlation coefficient (ρ) was used to assess the correlation with the percentage of WPL.Results:274 patients with SpA were recruited, 129 (47.1%) with axSpA and 145 (52.9%) with pSpA. 56.6% were women and 33.2% stopped working due to the underlying disease.Among axSpA patients, 70% were radiographic and 30% non radiographic, mean age 45.5 (SD14) yrs, median disease duration 72 (IQR 36-144) months and diagnosis delay 20 (IQR 11-70) months. 45.7% were employed, median hours worked in the last week was 40 (IQR 25-45), median scores for absenteeism was 0% (IQR 0-2), presenteeism 30% (IQR 5-40), WPL 30% (IQR 10-52.5) and activity impairment 30% (IQR 10-50). A positive correlation was found between WPL and the following variables: HAQ (ρ:0.40, p<0.001), BASDAI (ρ:0.48, p<0.001), ASDAS (ρ:0.46, p<0.001), BASFI (ρ:0.59, p<0.001), ASQoL (ρ:0.60, p<0.0001), LEI (ρ:0.31, p:0.02) and ASAS health index (ρ:0.54, p<0.001).Among pSpA patients, mean age was 52.3 (SD13) yrs, median disease duration 60 (IQR 14-120) months and diagnosis delay 12 (IQR 3-24) months. 46.9% were employed, median hrs worked in the last week was 30 (IQR 14-40), absenteeism 0% (IQR 0-7), presenteeism 30% (IQR 2.5-58), WPL 30% (IQR 5-52) and activity impairment 20% (IQR 0-40). A positive correlation was found between WPL and: HAQ (ρ:0.49, p<0.001), ASDAS (ρ:0.58, p<0.001), ASQoL (ρ:0.57, p<0.0001), DAS28 (ρ:0.50, p<0.001), LEI (ρ:0.36, p:0.04) and ASAS health index (ρ:0.52, p<0.001). No statistically significant differences were found in absenteeism, presenteeism, WPL and activity impairment between axSpA and pSpA.Conclusion:Our study showed that WPL in this national cohort was 30% in both groups of patients and is associated with disease activity, enthesitis, health status, quality of life and functional ability.Disclosure of Interests:None declared
Background:The questionnaire “Assessment of Spondyloarthritis international Society Health Index” (ASAS HI) was developed to measure functionality and health status in patients with spondyloarthritis (SpA)1.Objectives:To describe the state of health measured by ASAS HI in Argentinian patients with SpA and to evaluate factors associated with poor health.Methods:Analytical, cross sectional, multicenter study. Patients with SpA according to ASAS criteria were consecutively included from 15 Argentinian centers. Statistical analysis: frequencies and percentages (%), mean and standard deviation (SD) or median and interquartile range (IQR). Bivariate analysis and logistic regression were performed to evaluate the factors associated with poor health status (ASAS HI > or equal to 12). Correlation with other parameters was evaluated by Spearman correlation.Results:We included 274 patients with a mean age 49 (SD 14) years, median disease duration 60 month (IQR 24-135), 155 (56.6%) of patients are male, 47% (n:129) axial SpA and 52.9 (n:145) peripheral SpA. One hundred and nine patients (43.4%) presented good health status, 117 (42.7%) had moderate state of health and 38 (13.9%) had poor health. In the bivariate analyses patients with ASAS health index greater than or equal to 12 (poor status), were older [54 (11) vs 48 (14), p: 0.01], had higher disease duration [11(IQR 57-192) vs 60 (IQR 24-120), p: 0.02], more hypertension [20 (52.6%) vs 67 (28.4%), p:0.004], more diabetes mellitus [10 (26.3%) vs 22(9.3%), p: 0.006], depression [6 (15.8%) vs 10 (4.2%), p:0.013], anxiety [8 (21%) vs (22 (9.3%),p:0.046], less years of education [9.8 (SD 3.5) vs 13 (SD 10), p:0.001], higher ASQol [12.6 (SD 4.6) vs 5.7 (SD4), p < 0.001], BASFI [7(SD2) vs 4(SD6), p: 0.001], DAS28 [4.71 (SD3.2) vs 2.8 (SD1),p: <0.001]. In the multivariate analyses the following variables were independently associated with poor health status: duration of disease, ASQol and DAS28. ASAS HI showed positive correlation with the following parameters: BASDAI (r:0.67, p< 0.001), HAQ (r:0.54, p< 0.001), ASDAS (r:0.67, p< 0.001), ASQol (r:0.80, p< 0.001), BASFI (r:0.72, p< 0.001) and DAS28 (0.56, p< 0.001).Conclusion:Poor health status is associated with disease activity, poor quality of life and functional activity. ASAS HI has a good correlation with other parameters to evaluate SpA, reinforcing the construct validity of this new tool.References:[1]Kiltz U,et al.Ann Rheum Dis2018;0:1–7.Disclosure of Interests:None declared
Introduction: the “Assessment of Spondyloarthritis International Society Health Index” (ASASHI) questionnaire was developed to globally measure function and health status in patients with spondyloarthritis (SpA). Cut-off points have been proposed to determine different health states that were poorly evaluated in real-life patients. Objectives: to describe the health status measured by ASAS-HI in Argentine patients with axial SpA (AxSpA) and peripheral SpA (SpAp) in daily practice and to evaluate the factors associated with poor health. Materials and methods: cross-sectional, analytical and multicenter study. Patients with SpAax and SpAp were consecutively included according to ASAS criteria, from 15 Argentine centers. Statistical analysis: descriptive statistics, bivariate and multivariate analysis (multiple logistic regression) were performed to evaluate the factors associated with poor health status (ASAS-HI≥12). To analyze the construct validity of the tool, Spearman correlation was performed between the ASAS-HI and other disease evaluation parameters. Results: 274 patients with SpA were included, with a mean age of 49 (± 14) years and a median duration of the disease of 62 months (p25-75: 24-135), 155 (56.6%) were male, 129 patients (47%) with AxSpA and 145 (52.9%) SpAp. According to the ASAS-HI, 119 patients (43.4%) had good health, 117 (42.7%) had moderate health and 38 (13.9%) had poor health. In patients with SpAp, the mean ASAS-HI value was 7 (p25-75: 3-10). The ASAS-HI positively correlated with: DAS28: rho: 0.5 (p <0.001) and HAQ: rho: 0.54 (p <0.001). The variable independently associated with poor health status was DAS28 (OR: 1.9, 95% CI 1.1-3.4, p: 0.029). In patients with AxSpA, the mean ASAS-HI value was 6 (p25-75: 2.75-10). The ASAS-HI showed correlation with: BASDAI: rho: 0.7 (p <0.001), ASDAS-ERS: rho: 0.7 (p <0.001), ASQoL: rho: 0.8 (p<0.001), BASFI rho: 0.75 (p <0.001) 0.001). The variable that was independently associated with poor health was the ASDAS-ERS (OR 6.6, 95% CI 2-22, p 0.002). Conclusion: poor health status was independently associated with higher disease activity in patients with AxSpA and SpAp. The ASAS-HI correlated with other parameters of the disease, which reinforces the construct validity of this new tool.
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