Dataset Information

Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus.

ABSTRACT:

Objectives

To investigate the impact of remission and lupus low disease activity state (LLDAS) on health-related quality of life (HRQoL) in systemic lupus erythematosus.

Methods

Short-Form 36 (SF-36), three-level EQ-5D (EQ-5D-3L) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials were used. Duration in remission/LLDAS required to reach a HRQoL benefit ≥ minimal clinically important differences (MCIDs) during and post-treatment was determined using quantile regression and generalized estimating equations.

Results

Patients (n = 1684) were assessed every fourth week (15 visits). Four cumulative (β = 0.60) or four consecutive (β = 0.66) visits in remission were required to achieve a benefit ≥MCID in SF-36 physical component summary (PCS) scores, and six cumulative (β = 0.44) or five consecutive (β = 0.49) for a benefit ≥MCID in mental component summary (MCS) scores. Eight cumulative (β = 0.30 for both) or eight consecutive (β = 0.32 for both) visits in LLDAS were required for a benefit in PCS/MCS ≥MCID, respectively. For EQ-5D-3L index scores ≥MCID, six cumulative (β = 0.007) or five consecutive (β = 0.008) visits in remission were required, and eight cumulative (β = 0.005) or six consecutive (β = 0.006) visits in LLDAS. For FACIT-Fatigue scores ≥MCID, 12 cumulative (β = 0.34) or 10 consecutive (β = 0.39) visits in remission were required, and 17 cumulative (β = 0.24) or 16 consecutive (β = 0.25) visits in LLDAS.

Conclusion

Remission and LLDAS contribute to a HRQoL benefit in a time-dependent manner. Shorter time in remission than in LLDAS was required for a clinically important benefit in HRQoL, and longer time in remission for a benefit in mental compared with physical HRQoL aspects. When remission/LLDAS was sustained, the same benefit was achieved in a shorter time.

SUBMITTER: Emamikia S

PROVIDER: S-EPMC9707321 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus.

Emamikia Sharzad S Oon Shereen S Gomez Alvaro A Lindblom Julius J Borg Alexander A Enman Yvonne Y Morand Eric E Grannas David D van Vollenhoven Ronald F RF Nikpour Mandana M Parodis Ioannis I

Rheumatology (Oxford, England) 20221101 12

<h4>Objectives</h4>To investigate the impact of remission and lupus low disease activity state (LLDAS) on health-related quality of life (HRQoL) in systemic lupus erythematosus.<h4>Methods</h4>Short-Form 36 (SF-36), three-level EQ-5D (EQ-5D-3L) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials were used. Duration in remission/LLDAS required to reach a HRQoL benefit ≥ minimal clinically important differences ...[more]

PMID: 35302581

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Project description:ObjectiveTo assess the impact of different disease activity patterns-long quiescent (LQ), chronically active (CA) and relapsing-remitting (RR)-on health-related quality of life (HRQoL) in a cohort of patients with systemic lupus erythematosus (SLE).MethodsA retrospective, monocentric analysis of prospectively collected data. Adult SLE outpatients were enrolled between 2017 and 2021.For each year of follow-up, three disease activity patterns were defined: LQ if at each visit clinical Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Activity Index (SELENA-SLEDAI)=0, Physician Global Assessment (PGA)=0; CA if at each visit clinical SELENA-SLEDAI >0, PGA >0; RR if patients presented active disease in at least one visit during the observation period, interspersed with periods of remission. These patterns were applied to the year and the 3 years before enrolment.At enrolment, each patient completed: Short Form 36 (SF-36), Lupus Impact Tracker, Functional Assessment of Chronic Illness Therapy (FACIT), Hospital Anxiety and Depression Scale (HADS). The correlation between disease patterns and Patient-Reported Outcomes was analysed.Results241 SLE patients were enrolled, of which 222 had complete clinical data for the 3-year period before enrolment. Both in the year and during the 3 years before enrolment, the most frequent disease pattern was the LQ (154/241 and 122/222 patients, respectively), followed by RR (53/241 and 92/222 patients, respectively) and CA (34/241 and 8/222 patients, respectively).At baseline, fibromyalgia, organ damage, age and daily glucocorticoid dose were associated with worse HRQoL.At the multivariable analysis, after adjusting for confounding factors, patients with LQ disease during the 3 years before enrolment presented a better physical HRQoL (SF-36 physical component summary, regression coefficient=3.2, 95% CI 0.51-5.89, p=0.02) and minor depressive symptoms (HADS-D, regression coefficient=-1.17, 95% CI -2.38 to 0.0.27, p=0.055), compared with patients with CA/RR disease.ConclusionA persistently quiescent disease may have a positive impact on patients' physical HRQoL and on depressive symptoms. However, this condition appears insufficient to obtain a significant improvement in mental health, fatigue and disease burden among patients with SLE.

Project description:ObjectivesAssociations between BMI and health-related quality of life (HRQoL) in SLE have been implied, but data are scarce. We determined the impact of overweight and obesity on HRQoL in a large SLE population.MethodsWe pooled cross-sectional baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (N = 1684). HRQoL was evaluated using the 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale and the European Quality of Life 5-dimension questionnaire (EQ-5D). Comparisons between BMI groups were conducted using the Mann-Whitney U test and adjustments using linear regression. Clinical relevance was determined by minimal clinically important differences (MCIDs).ResultsIn total, 43.2% of the patients had BMI above normal and 17.4% were obese. Overweight and obese patients reported worse SF-36 physical component summary (PCS), physical functioning, role physical, bodily pain and FACIT-Fatigue scores than normal weight patients. Divergences were greater than corresponding MCIDs and more prominent with increasing BMI. Despite no clinically important difference in SF-36 mental component summary scores across BMI categories, patients experienced progressively diminished vitality and social functioning with increasing BMI. In linear regression analysis, BMI above normal and obesity were associated with worse PCS (standardized coefficient β = -0.10, P < 0.001 and β = -0.17, P < 0.001, respectively), FACIT-Fatigue (β = -0.11, P < 0.001 and β = -0.16, P < 0.001) and EQ-5D (β = -0.08, P = 0.001 and β = -0.12, P < 0.001) scores, independently of demographic and disease-related factors. The impact of BMI on the PCS and FACIT-Fatigue was more pronounced than that of SLE activity.ConclusionPatients with SLE and BMI above normal experienced clinically important HRQoL diminutions in physical aspects, fatigue and social functioning. A survey of potential causality underlying this association is warranted.

Project description:Higher prevalence and worst outcome have been reported among people with systemic lupus erythematosus with non-European ancestries, with both genetic and socioeconomic variables as contributing factors. In Mexico, studies assessing the inequities related to quality of life for Systemic Lupus Erythematosus patients remain sparse. This study aims to assess the inequities related to quality of life in a cohort of Mexican people with SLE. This study included 942 individuals with SLE from the Mexican Lupus Registry (LupusRGMX) and two healthy control groups. Self-answered surveys were collected via the Research Electronic Data Capture platform between May 2021 and January 2023. Data was analyzed as a cross-sectional study. A random forest model was implemented to assess potential predictive variables. Permutation tests were performed to analyze the effect health providers had on diagnosis lag and quality of life's differences among socioeconomic levels. Partial correlation analysis between the number of patients and rheumatologists registered was also performed. Systemic Lupus Erythematosus participants had significantly lower quality of life than healthy people (p-values < 0.0001). Socioeconomic status, delay in diagnosis, and corticosteroid consumption were the factors that influenced QoL the most (RMSE = 9.53 with the importance variable validated); lower quality of life was associated with lower socioeconomic status (p-value < 0.0001). Disparities in health services were reflected in longer diagnosis time among people with public health providers (p-value = 0.0419). A significant association between diagnosed patients and available rheumatologists by geographical state was observed (ρ = 0.4, p-value = 0.0259), which can be translated into restricted access to specialists. Since most of our cohort exhibited low socioeconomic status, it is important to consider them as a vulnerable population; this study settles the necessity to deepen the effects of the socioeconomic disparities, allowing to design public policies and strategies aimed to reduce Systemic Lupus Erythematosus disparities, therefore improving quality of life of Mexican people with Systemic Lupus Erythematosus.

Project description:BackgroundSystemic lupus erythematosus (SLE) is a chronic autoimmune disease which impacts patients' lives. Many studies in high-income countries have focused on their health-related quality of life (HRQoL). However, evidence of awareness of SLE and HRQoL in low- and middle-income countries is lacking. Therefore, this study aimed to identify the determinants of HRQoL of SLE patients in Vietnam, a lower-middle income country.MethodsThis cross-sectional study was conducted at the National Hospital of Dermatology and Venereology in 2019. A pre-tested structured questionnaire was used to collect data. It consisted of Short Form-36 to assess HRQoL which comprised physical and mental component summaries, Multidimensional Scale of Perceived Social Support, Satisfaction with Life Scale, and Mental Adjustment to SLE. Multiple linear regression was used to identify the determinants of HRQoL.ResultsOne hundred thirty four patients with SLE participated in this study. The majority of the patients were women (n = 126, 94.0%). The mean age of all participants was 37.9 years old (standard deviation [SD] 12.5). Of 134 participants, 104 (77.6%) were married. Older patients were more likely to have a lower score of mental component summary (B=-0.45, 95% CI -0.73, -0.17). Patients with more children were more likely to have a lower score of physical component summary (B=-5.14, 95% CI -9.27, -1.00). Patients who felt more helplessness or hopelessness were more likely to have lower scores of physical and mental component summaries (B=-1.85, 95% CI -2.80, -0.90; B=-1.69, 95% CI -2.57, -0.81). Also, patients who felt more anxious were more likely to have a lower score of mental component summary (B=-1.04, 95% CI -1.77, -0.32). Patients who were more satisfied with their lives were more likely to have higher scores of physical and mental component summaries (B = 1.07, 95% CI 0.50, 1.64; B = 1.08, 95% CI 0.55, 1.61).ConclusionFactors associated with lower HRQoL in Vietnam were feelings of helplessness or hopelessness, and burdens of parenting roles. However, social support can contribute to a higher HRQoL, such as information support, self-support groups, and daycare services provided at the community level.

Project description:ObjectiveTo determine the independent impact of different definitions of remission and low disease activity (LDA) on damage accrual.MethodsPatients with ≥2 annual assessments from a longitudinal multinational inception lupus cohort were studied. Five mutually exclusive disease activity states were defined: remission off-treatment: clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI)-2K=0, without prednisone or immunosuppressants; remission on-treatment: cSLEDAI-2K score=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; low disease activity Toronto cohort (LDA-TC): cSLEDAI-2K score of ≤2, without prednisone or immunosuppressants; modified lupus low disease activity (mLLDAS): Systemic Lupus Erythematosus Disease Activity Index-2K score of 4 with no activity in major organ/systems, no new disease activity, prednisone ≤7.5 mg/day and/or maintenance immunosuppressants; active: all remaining visits. Only the most stringent definition was used per visit. Antimalarials were allowed in all. The proportion of time that patients were in a specific state at each visit since cohort entry was determined. Damage accrual was ascertained with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Univariable and multivariable generalised estimated equation negative binomial regression models were used. Time-dependent covariates were determined at the same annual visit as the disease activity state but the SDI at the subsequent visit.ResultsThere were 1652 patients, 1464 (88.6%) female, mean age at diagnosis 34.2 (SD 13.4) years and mean follow-up time of 7.7 (SD 4.8) years. Being in remission off-treatment, remission on-treatment, LDA-TC and mLLDAS (per 25% increase) were each associated with a lower probability of damage accrual (remission off-treatment: incidence rate ratio (IRR)=0.75, 95% CI 0.70 to 0.81; remission on-treatment: IRR=0.68, 95% CI 0.62 to 0.75; LDA: IRR=0.79, 95% CI 0.68 to 0.92; and mLLDAS: IRR=0.76, 95% CI 0.65 to 0.89)).ConclusionsRemission on-treatment and off-treatment, LDA-TC and mLLDAS were associated with less damage accrual, even adjusting for possible confounders and effect modifiers.

Project description:IntroductionA recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus (SLE) found reduction of antioxidants and substrates for energy generation. These metabolic alterations may underlie one of the most common features of SLE--fatigue. The metabolomic studies also noted reduced omega-3 fatty acids, which are powerful anti- oxidants. This deficiency may be causally related to oxidative stress, inflammation, disease activity, and fatigue in SLE. Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies. The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue, quality of life, and disease activity as part of a randomized clinical trial.MethodsFifty SLE patients recruited in outpatient clinics were randomized 1:1 to fish oil supplementation or olive oil placebo, and blinded to their treatment group. At baseline and after 6 months of treatment, RAND Short Form-36 (RAND SF-36), Fatigue Severity Scale (FSS), SLE Disease Activity Index (SLEDAI), and Physician Global Assessment (PGA) were completed; serum was also collected for soluble mediator analysis.ResultsThirty-two patients completed the study. PGA improved significantly in the fish oil group compared with the placebo group (p = 0.015). The RAND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends (p = 0.092 and 0.070). No clear difference was seen in FSS and SLEDAI (p = 0.350 and p = 0.417). Erythrocyte sedimentation rate and serum IL-12 were reduced (p = 0.008 and p = 0.058); while serum IL-13 was increased by fish oil supplementation (p = 0.033).ConclusionsIn this randomized, placebo-controlled 6-month trial, SLE patients randomized to fish oil supplementation demonstrated improvement in their PGA, RAND SF-36, and some circulating inflammatory markers.Trial registrationClinicalTrials.gov Identifier: NCT02021513 (registered 13 December 2013).

Dataset Information

Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus.

Objectives

Methods

Results

Conclusion

Publications

Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus.

Similar Datasets

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