scholarly journals POS0786 UNMET TREATMENT NEEDS IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): A CROSS-SECTIONAL ASSESSMENT OF DISEASE ACTIVITY IN SLE PATIENTS DURING THEIR LAST VISIT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 646.1-646
Author(s):  
O. Gioti ◽  
K. Chavatza ◽  
G. Belevonis ◽  
S. Koutsoviti ◽  
C. Katsimpari ◽  
...  

Background:The current goal of treatment in SLE is remission or low disease activity (LDA) and prevention of flares, achieved with the lowest possible dose of glucocorticoids. Nevertheless, in current clinical practice a significant number of patients still has active disease.1,2Objectives:To assess the current disease activity state of SLE patients during their most recent visit in two centers (Department of Rheumatology in “Asklepieio” Hospital and Rheumatology Unit in “Attikon” Hospital, both in Athens, Greece).Methods:Cross-sectional study of patients with a diagnosis of SLE for at least one year. Patients were divided into four groups: 1) Remission off-therapy: SLE Disease Activity Index (SLEDAI)=0 without prednisone or immunosuppressive drugs (IS), 2) Remission on-therapy: SLEDAI=0, prednisone dose ≤5mg/day and/or IS (conventional and biologic, maintenance phase), 3) LDA: SLEDAI ≤4, prednisone dose ≤7.5mg/day and/or IS (maintenance phase), 4) Active disease: SLEDAI >4 and/or prednisone dose >7.5mg/day and/or IS (induction phase).2 Hydroxychloroquine was allowed in all groups.Results:205 patients were included [95.1% female, mean (SD) age 48.4 (14.9) years and median disease duration (IQR) 6.2 (12.6) years]. A history of lupus nephritis and neuropsychiatric SLE was present in 16.6% and 17.1% of our patients, respectively, and 39% of patients had SLICC/ACR damage index (SDI) > 0. At last visit, remission off-therapy and remission on-therapy was present in 8.3% (n=17) and 15.1% (n=31) of our patients, respectively. Seventy-five patients (36.6%) had LDA, whereas 82 patients (40%) had active disease. More than 85% (86.3%) of patients were in treatment with hydroxychloroquine and 64.4% were receiving immunosuppressive drugs. Regarding glucocorticoids, 50.2% (n=103) were treated with prednisone dose ≤7.5mg/day and over 40% (42.4%, n=87) did not receive prednisone at all. A SLEDAI score 0 and 1-4 was achieved in 24.4% and 42.9% of patients, respectively, but only 3.9% had a SLEDAI > 8, indicative of high disease activity.Conclusion:Although the majority of our patients were treated with hydroxychloroquine and glucocorticoids in acceptable levels of daily dose, four out of ten patients in our practice have active disease during their last visit. Achieving treatment goals in SLE patients remains a challenge for future novel therapies.References:[1]Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis 2019; 78: 736–745.[2]Ugarte-Gil MF, Wojdyla D, Pons-Estel GJ, et al. Remission and Low Disease Activity Status (LDAS) protect lupus patients from damage occurrence: data from a multiethnic, multinational Latin American Lupus Cohort (GLADEL). Ann Rheum Dis 2017; 76: 2071–2074.Disclosure of Interests:None declared

2019 ◽  
Vol 46 (10) ◽  
pp. 1299-1308 ◽  
Author(s):  
Manuel F. Ugarte-Gil ◽  
Daniel Wojdyla ◽  
Guillermo J. Pons-Estel ◽  
Rosana Quintana ◽  
José A. Gómez-Puerta ◽  
...  

Objective.To determine the predictors of remission and low disease activity state (LDAS) in patients with systemic lupus erythematosus (SLE).Methods.Three disease activity states were defined: Remission = SLE Disease Activity Index (SLEDAI) = 0 and prednisone ≤ 5 mg/day and/or immunosuppressants (maintenance dose); LDAS = SLEDAI ≤ 4, prednisone ≤ 7.5 mg/day and/or immunosuppressants (maintenance dose); and non-optimally controlled state = SLEDAI > 4 and/or prednisone > 7.5 mg/day and/or immunosuppressants (induction dose). Antimalarials were allowed in all groups. Patients with at least 2 SLEDAI reported and not optimally controlled at entry were included in these analyses. Outcomes were remission and LDAS. Multivariable Cox regression models (stepwise selection procedure) were performed for remission and for LDAS.Results.Of 1480 patients, 902 were non-optimally controlled at entry; among them, 196 patients achieved remission (21.7%) and 314 achieved LDAS (34.8%). Variables predictive of a higher probability of remission were the absence of mucocutaneous manifestations (HR 1.571, 95% CI 1.064–2.320), absence of renal involvement (HR 1.487, 95% CI 1.067–2.073), and absence of hematologic involvement (HR 1.354, 95% CI 1.005–1.825); the use of immunosuppressive drugs before the baseline visit (HR 1.468, 95% CI 1.025–2.105); and a lower SLEDAI score at entry (HR 1.028, 95% CI 1.006–1.051 per 1-unit decrease). These variables were predictive of LDAS: older age at entry, per 5-year increase (HR 1.050, 95% CI 1.004–1.098); absence of mucocutaneous manifestations (HR 1.401, 95% CI 1.016–1.930) and renal involvement (HR 1.344, 95% CI 1.049–1.721); and lower SLEDAI score at entry (HR 1.025, 95% CI 1.009–1.042).Conclusion.Absence of mucocutaneous, renal, and hematologic involvement, use of immunosuppressive drugs, and lower disease activity early in the course of the disease were predictive of remission in patients with SLE; older age was predictive of LDAS.


2021 ◽  
Author(s):  
Jorge Medina Castillo ◽  
Nayeli Nicté López Villa

Abstract Objetives. To determine the correlation between prolactin levels and disease activity classified based on the Mexican lupus erythematosus disease systemic activity index (MEX SLEDAI).Methods. In this cross-sectional observational study, serum prolactin, age, sex, treatment, as well as manifestations of active disease were determined. Disease activity was evaluated using the Mexican Systemic Lupus Erythematosus Activity Index (MEX-SLEDAI). The correlation of MEX-SLEDAI with prolactin was determined using the Spearman correlation coefficient. The significance of differences between continuous variables was determined with the non-paired Student’s t test and the significance of differences between categorical variables was determined with Chi-square test.Results. 55 patients were included, 10 (18.1%) had MEX-SLEDAI ≥ 7 and 45 (81.8%) less than 7. A positive correlation was found with a Spearman rho 0.387 (p = 0.004) between the MEX-SLEDAI and the levels serum prolactin. Subjects with active disease and hyperprolactinemia had 80% manifestations at the renal level (p = 0.001).Conclusion. There is significant correlation between prolactin levels and disease activity. Hyperprolactinemia were detected in patients with renal activity as well as those with MEX-SLEDAI ≥ 7.


2018 ◽  
Vol 56 (2) ◽  
pp. 109-115 ◽  
Author(s):  
Lucia Mazur-Nicorici ◽  
Victoria Sadovici-Bobeica ◽  
Maria Garabajiu ◽  
Minodora Mazur

Abstract Introduction. The aim of the research was the study of the adherence to treatment in patients with systemic lupus erythematosus. Methods. Cross-sectional study including 132 consecutive patients with systemic lupus erythematosus (SLICC, 2012 classification criteria). We collected clinical and socio-demographic data, socio-economic status; we assessed SLEDAI-2k disease activity, and estimated the adherence to treatment by Morisky questionnaire. Results. Our results demonstrated that low adherence to treatment in patients with systemic lupus erythematosus was in only 11.36% of patients, while 43.18% and 45.46% of the patients were scored as moderate and high adherence, respectively. A moderate/high adherence to treatment was associated to a high level of education (r = −0.51, p < 0.05, 95% CI = −0.25 to −0.66), low disease activity (r = 0.38, p < 0.05, 95% CI = 0.25 to 0.53) and low indices of physician global assessment (r = −0.31, p<0.05, 95% CI = −0.23 to −0.71). The sub-analysis of the adherence to each drug demonstrated that the highest adherence was to treatment with glucocorticosteroids – 92.85%, followed by hydroxychloroquine and aspirin – 92.15% and 89.79%, respectively. Conclusion. In our cohort, the adherence to treatment was high in 45.46%, moderate in 43.18% and low in only 11.36% cases. High adherence to treatment was associated to low disease activity. The adherence was positively influenced by the age at the onset of the disease and a high educational level.


2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Elena Elefante ◽  
Chiara Tani ◽  
Chiara Stagnaro ◽  
Viola Signorini ◽  
Alice Parma ◽  
...  

Abstract Background Remission or the lowest possible disease activity is the main target in the management of systemic lupus erythematosus (SLE). Anyway, conflicting data are present in the literature regarding the correlation between physician-driven definitions and patient perception of the disease. The objective of this study is to evaluate the relationship between the definition of lupus low disease activity state (LLDAS) and patient’s health-related quality of life (HRQoL). Methods This is a cross-sectional, monocentric study. Adult SLE patients were included. For each patient, demographics, disease duration, medications, comorbidities, organ damage, active disease manifestations and SELENA-SLEDAI were assessed. Patients have been categorised as follows: LLDAS, remission and active disease. Each patient completed the following patient-reported outcomes (PROs): SF-36, LIT, FACIT-Fatigue and SLAQ. A SLAQ score < 6 (25° percentile of our cohort) was used as the cut-off value to define a low disease activity state according to patient self-evaluation. Results We enrolled 259 consecutive SLE patients (mainly female and Caucasian, mean age 45.33 ± 13.14 years, median disease duration 14 years). 80.3% were in LLDAS, of whom 82.2% were in remission; 19.7% were active. No differences emerged for any of the PROs used between the LLDAS and the active group. Considering the LLDAS subgroup, we identified 56 patients with a subjective low disease activity (SLAQ < 6) and we defined them as “concordant”; the remaining 152 patients in LLDAS presented a subjective active disease (SLAQ ≥ 6) and were defined “discordant”. Discordant patients presented more frequently ongoing and past joint involvement (p < 0.05) and a diagnosis of fibromyalgia (p < 0.01); furthermore, they were more likely to be on glucocorticoid therapy (p < 0.01). Discordant patients showed a significantly poorer HRQoL, assessed by all PROs (p < 0.0001). Conclusions Joint involvement, glucocorticoid therapy and comorbid fibromyalgia resulted to be the most important variables determining the poor concordance between patient and physician perspective on the disease.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 595.1-595
Author(s):  
M. Dall’era ◽  
T. Hermes ◽  
M. Eaddy ◽  
A. Ogbonnaya ◽  
E. Farrelly ◽  
...  

Background:Lupus nephritis (LN) is a common and severe manifestation of systemic lupus erythematosus (SLE) affecting 50% of SLE patients and leading to end-stage kidney disease (ESKD) in up to 30% of patients with LN.1 Previous studies have reported higher healthcare costs in patients with SLE that develop LN compared to patients without LN.2-5 These studies captured overall treatment costs associated with LN, regardless of disease activity or severity, and were conducted in small patient populations.Objectives:The aim of this study was to assess the real-world economic implications of achieving low disease activity compared to active disease or ESKD in a large LN population.Methods:This study was a retrospective observational analysis of patients with LN within Optum’s health plan identified with ICD9 or ICD10 codes to have LN between January 1, 2015, and December 31, 2019. Patients were ≥18 years of age and had ≥2 months of follow-up data available. Patients were followed until death, loss to follow-up, or December 31, 2019. Low disease activity was defined by evidence of glucocorticoid doses ≤5 mg/day, evidence of mycophenolate mofetil (MMF) doses ≤2 g/day, and no use of cyclophosphamide for ≥6 consecutive months. Follow-up time that could not be defined as low disease activity was defined as active disease periods, except for periods with evidence of ESKD. Healthcare payer costs for medical and pharmacy services were compared between periods of low disease activity, active disease, and ESKD. A univariate generalized estimating equation model accounting for interdependence was used to compare differences in costs between periods of active and low disease activity.Results:A total of 21,251 patients with LN met study criteria with a mean follow-up time of 31.0 months. The mean age was 60.3 years; 86.9% of patients were female and 35.2% of patients were non-White race. Low disease activity was evident in 51.3% of patients with a mean duration of 27.5 months. Mean monthly medical costs were $2,523 during periods of low disease activity and $4,777 during periods of active disease. After factoring in pharmacy costs, mean monthly total costs were $3,584 during periods of low activity and $6,612 during periods of active disease (P<0.001). The mean monthly costs of ESRD were $18,084 for medical and $3,760 for pharmacy.Conclusion:Achieving low disease activity in patients with LN is associated with reduced economic burden to healthcare payers, with monthly medical costs averaging $2,254 less and total monthly costs averaging $3,028 less than costs during periods of active disease.References:[1]Parikh SV et al. Update on Lupus Nephritis: Core Curriculum 2020. Am J Kidney Dis. 2020;76(2):265-281.[2]Bartels-Peculis L et al. Treatment patterns and health care costs of lupus nephritis in a United States payer population. Open Access Rheumatol. 2020;12:117-124.[3]Furst DE et al. Medical costs and healthcare resource use in patients with lupus nephritis and neuropsychiatric lupus in an insured population. J Med Econ. 2013;16(4):500-509.[4]Li T et al. Long-term medical costs and resource utilization in systemic lupus erythematosus and lupus nephritis: a five-year analysis of a large Medicaid population. Arthritis Rheum. 2009;61(6):755-763.[5]Pelletier EM et al. Economic outcomes in patients diagnosed with systemic lupus erythematosus with versus without nephritis: results from an analysis of data from a US claims database. Clin Ther. 2009;31(11):2653-2664.Disclosure of Interests:Maria Dall’Era Speakers bureau: Consulting agreement with Aurinia for Advisory Boards and educational lectures, Tim Hermes Shareholder of: Aurinia Pharmaceuticals Inc., Employee of: Aurinia Pharmaceuticals Inc., Michael Eaddy Consultant of: Aurinia Pharmaceuticals Inc., Augustina Ogbonnaya Consultant of: Aurinia Pharmaceuticals Inc., Eileen Farrelly Consultant of: Aurinia Pharmaceuticals Inc., Paola Mina-Osorio Shareholder of: Aurinia Pharmaceuticals Inc., Employee of: Aurinia Pharmaceuticals Inc.


2019 ◽  
Vol 11 (2) ◽  
Author(s):  
Ryan Ardian Saputro ◽  
Santi Andayani ◽  
Stefanie Yuliana Usman ◽  
Laniyati Hamijoyo

Background: Systemic Lupus Erythematosus (SLE) is an autoimmune disease with heterogeneous clinical manifestations including fatigue. Previous studies aimed at proving the relationship between fatigue and SLE disease activity showed conflicting results. In 2015, Asia Pacific Lupus Collaboration (APLC) developed low disease activity criteria, named Lupus Low Disease Activity State (LLDAS). Patients who spend more time in LLDAS have significantly lower morbidity. This study aimed to evaluate the association between disease activity based on LLDAS and fatigue.    Methods: This is a analytical cross-sectional study. Subjects were SLE patients at rheumatology clinic in Dr. Hasan Sadikin Hospital, Bandung during June-January 2018. Subjects were evaluated based on LLDAS criteria and divided into 2 groups: LLDAS and non-LLDAS. Fatigue status of the subjects was assessed with Fatigue Severity Scale (FSS). Results: A hundred and thirty-three subjects were included in this study, divided into 63 subjects in LLDAS group and 60 subjects in non-LLDAS group. Nineteen subjects (30.2%) in LLDAS group had fatigue and 39 subjects (65%) in non-LLDAS had fatigue. There was a significant association between LLDAS and fatigue (p< 0.001). Nonetheless, fatigue level in LLDAS group was still high since disease activity was not the only factor related to fatigue. Fatigue may be a distinct clinical manifestation of neuropsychiatric lupus and may be independent of lupus disease activity Conclusions: There was a significant association between LLDAS and fatigue showed by lower fatigue level was found in the LLDAS group than in the non-LLDAS group.   Keywords: Systemic lupus erythematosus, disease activity, Lupus Low Disease Activity State, fatigue


2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Rosalie Magro ◽  
Andrew A. Borg

Systemic Lupus Erythematosus (SLE) is a multisystemic autoimmune disorder. The aim of this study was to characterise the SLE patients living in Malta in order to estimate the prevalence and incidence of SLE and characterise the clinical presentation as well as identify any unmet needs. 107 SLE patients who fulfilled SLICC classification criteria were identified. These were invited to participate in the study by means of an interview, blood and urine tests, and filling of the following questionnaires: Fatigue Severity Scale (FSS), visual analogue scale (VAS) for fatigue, Hospital Anxiety and Depression Scale (HADS), VAS for pain, Pittsburgh Sleep Quality Index (PSQI), and modified Health Assessment Questionnaire (mHAQ). The estimated prevalence of SLE in Malta is 29.3 patients per 100,000 and the estimated incidence is 1.48 per 100,000 per year. 93.5% of SLE patients were female, and the mean age at diagnosis was 33.1 years. 60.8% were overweight or obese and body mass index (BMI) had a significant positive correlation with daily dose of prednisolone (R=0.177, p=0.046). 20.7% and 3.3% had a moderate and high disease activity, respectively, as measured by SLEDAI-2K. Disease activity had a significant positive correlation with functional disability measured by mHAQ (R=0.417, p<0.001). 56.5% had an abnormal level of fatigue (FSS >3.7) and 57.6% had a high level of anxiety (HADS ≥8). This study has identified a number of unmet needs of SLE patients, including obesity, uncontrolled disease activity, fatigue, and anxiety.


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