Health-related quality of life in patients with systemic lupus erythematosus: a Spanish study based on patient reports

[EN] Introduction and objectivesSystemic lupus erythematosus (SLE) is a disease that significantly affects the quality of life and welfare of patients. SLE patients can be classified into multimorbidity levels using Clinical Risk Groups (CRGs) to help to incorporate predictive models of health needs. The goal of this study was to correlate CRGs with health-related quality of life (HR-QoL) and costs in SLE patients.MethodsA questionnaire was administered to SLE patients in four hospital centers of the Valencian Community (Spain) between October 2015 and March 2016. The factors studied included HR-QoL (EQ-5D-5L and VAS), disease activity (SLAI/SELENA), damage (SLICC/ACR), and severity (IGK).ResultsThe patients (N=190, 92.06% female, age (mean SD) 47.23 +/- 13.43years) were sorted according to health status in nine CRGs. We found that most SLE patients (>70%) were in CRGs 5 and 6. The main HR-QoL issues in these patients were related to mobility, ability to perform usual activities, and pain/discomfort. The scores (mean +/- SD) for EQ-5D-5L and VAS were 0.74 +/- 0.25 and 65.67 +/- 23.52, respectively. We found that the age of the patients negatively affected their HR-QoL (r=-0.266). SLE direct costs per patient increased with each CRG group, representing 71.92% of the total costs, while indirect costs were highly variable. The average cost per patient with SLE amounted to Euro8432.85 (year 2014).Conclusions Patients' quality of life is related with age, disease activity, damage, and severity. Age was the parameter which most affects HR-QoL. 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Survival of jak inhibitors: real-word data from the biobadaser III registry

Background JAK inhibitors (JAKi) have been recently authorized in the European Union. JAKi long-term performance in the clinical practice setting still needs to be assessed. Drug survival reflects a drug’s effectiveness, safety, and tolerability; thus, it is an important measurement for real-world studies. Objectives To describe the pattern of use of JAKi in real-world dataset, and to analyze the drug survival as a group (tofacitinib+baricitinib). Methods Information was obtained from BIOBADASER III, an ongoing observational longitudinal multicenter cohort of patients with rheumatic diseases treated with biologic or targeted synthetic (b/ts) DMARDs in Spain. All subjects with current or previous JAKi use were included and followed until September 2018. Clinical characteristics of the patients were analyzed. Drug survival (overall, and for biologic-naive and biologic-experienced patients) was determined using Kaplan-Meier analysis. Results 149 patients, 75.2% women, were treated with JAKi, receiving a total of 152 cycles of treatment (50.7% tofacitinib, 49.3% baricitinib; 3 patients had both). The most frequent diagnosis was rheumatoid arthritis (RA, 92.6%), and there is a small number of off-label uses (6%), depicted at Table 1. Use on psoriatic arthritis is scarce (1.3%). Concomitant use of methotrexate (MTX) was registered in 68 patients (45.6%). Previous use of bDMARDs was high (n=124, 81.6%); drug survival rate for biologic-experienced patients was 81.7% and 78.7% at 6 and 12 months. None of the JAKi treatments in biologic-naive patients (n=18, 18.4%) were discontinued during follow-up. Pooled survival rate of JAKi was 85.0% and 82.5% at 6 and 12 months (Figure 1). Discontinuation was seen in 19 treatments (12.5%); the reasons were inefficacy (n=15, 9.9%) or adverse events (n=4, 2.6%). Conclusion The current use of JAKi in Spain is mainly in RA and as 2nd line after bDMARDs. The use of JAKi in psoriatic arthritis is still scarce and a small group of patients are treated off-label. Less than half use combination therapy with MTX. Overall survival of JAKi is superior to 80% at 12 months. A longer follow-up is needed to continue analyzing the survival of JAKi in a real-world context

Impact of age on the appearance of adverse eventsat the beginning of biological treatment: data from the BIOBADASER 3.0 registry

Background: Currents medical advances are allowing patients with chronic arthritis to live to advanced ages. Although the risks of biological therapies in elderly patients have been previously evaluated, data are scarce since they are mainly derived from clinical trials, in which elderly populations are often underrepresented or event excluded (patients up to 75 years old). In addition, comparisons between such studies are difficult in the absence of a consensus in defining the groups’ age. Objectives: To evaluate the impact of age on the appearance of adverse events (AE) in patients with rheumatic diseases (rheumatoid arthritis -RA-, ankylosing spondylitis -AS- and psoriatic arthritis -PsA) at the start of biological treatment. Methods: Multicenter prospective study in a real-world setting. Information was obtained from BIOBADASER, a national safety registry of patients with rheumatic diseases treated with biologics or targeted synthetic disease modifying anti-rheumatic drugs. For this analysis, all patients included in this registry since 2000 and diagnosed with RA, AS or PsA were included, and classified into four categories according to age at initiation of biologic treatment: young ( 75 years-old). Data collected included: 1) patient’s data 2) data on treatment and 3) data on AE. Proportions, means and standard deviations were used to describe the population. Poisson regression model was carried out to explore factors associated with the appearance of AEs. Crude and adjusted incidence rate ratios (IRRs) were calculated. Results: A total of 2531 patients were included: 1154 RA (45.59%), 680 PsA (26.87%), and 697 AS (27.54%). Age groups: there were 64 young patients (2.52%), 2166 adults (85.57%), 243 elderly adults (9.6%), and 58 very elderly adults (2.29%). Comorbidities increased with age, while smoking rates decreased. Methotrexate use was similar in all age groups (53.99% in the total sample), but corticosteroid treatment increased with age (young 27.7%, adults 47%, elderly adults 64.36% and the very elderly 70.21%). 77.87% received anti-TNF treatment, and 22.13% other biological drugs. Poisson regression model showed an increased probability of suffering a first adverse event with increasing age regardless of the disease (IRR for AS: 1.04 (0.87-1.26); IRR for PsA: 1.08 (0.92-1.28)). Other factors associated with higher IRR were sex (being woman), type of biological treatment (TNF inhibitors), concomitant therapy (methotrexate), smoking, comorbidities (Charlson Index) and time of evolution of rheumatic disease. No differences were found between pathologies. Conclusion: A mix of clinical and patient factors seem to explain the appearance of a first AE after biological therapy initiation, with age being one of those explanatory variables

Changing pattern of the use of biologic disease modifying antirheumatic drugs in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

Background: During the last 15 years, the comprehensive understanding of the safety, effectiveness, expanding access, and availability of new biologic disease-modifying antirheumatic drugs (bDMARDs) has likely contributed to the pattern of use of these compounds in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Objectives: To assess changes in the baseline characteristics of patients who underwent biological therapy from 2007 to 2018 in a real world setting. Methods: Data were obtained from BIOBADASER, the Spanish registry of biologics. Recorded data is obtained from routine clinical practice. Patients diagnosed with RA, PsA and AS and who started biological treatment from 2007 to 2018 were included. Sociodemographic and clinical variables, as well as first bDMARD used, were stratified by the starting year period (2007-2009; 2010-2012; 2013-2015; 2016-2018) and compared using Anova and Chi-square tests. Results: 6943 patients (2827 RA patients, 1274 PsA and 1261 AS) were included in this analysis (Table 1). Patient age at the beginning of the first biologic was significantly higher during the period 2016-2018 than in 2007-2009 (48.3 vs 50.6). Disease duration until the use of biologics decreased from 8.6 to 8.1 years. In RA patients, disease activity, as assessed by DAS28 at the start of the biological treatment, was significantly higher in the 2007-2009 period than in the last period analyzed (5.1 vs 4.7). The use of TNF inhibitor as a first option also changed significantly (94.6% vs 58.5%). Regarding comorbidities, the number of rheumatic patients treated with biologics and a past history of cancer (1.8% vs 3.7%), ischemic heart disease (1.8% vs 3.1%), hypercholesterolemia (13.6% vs 26.1%), or hypertension (21.7% vs 23.7%) has increased significantly. Conclusion: Our data show that during the last decade the pattern of use of biologics in patients with rheumatic diseases has changed. Nowadays these compounds are used in older patients, with shorter disease duration, with lower disease activity in RA, and with more comorbidities