scholarly journals POS0747 MAPPING THE NATIONWIDE CLINICAL PROFILE AND PATTERNS OF CARE OF SLE IN BRAZIL – FINDINGS FROM THE MACUNAÍMA STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 625.2-626
Author(s):  
M. Abreu ◽  
O. Monticielo ◽  
V. Fernandes ◽  
A. Cristovão Maiorano ◽  
F. Dos Santos Beserra ◽  
...  

Background:Systemic lupus erythematosus (SLE) is an autoimmune disease with wide clinical variability. Brazil has vast regional diversity, both from an ethnic and socio-cultural point of view.Objectives:To map the clinical profile of SLE in Brazil and explore how this distribution is associated with regional disparities.Methods:This cross-sectional study (GSK Study 207353) evaluated 300 Brazilian patients ≥18 years old with SLE (American College of Rheumatology [ACR] criteria, 1997) who had been under SLE care for ≥1 year. Five SLE reference teaching facilities were selected, one in each of the following Brazilian regions: North (NO), Northeast (NE), Midwest (CO), Southeast (SE), and South (SU). Each region included 60 patients. Clinical and demographic characteristics, and patterns of care were measured through questionnaires completed by physicians or nurses. The SLE Disease Activity Index (SLEDAI) score described disease activity and the Systemic Lupus International Collaborating Clinics/ACR Damage Index (SDI) described damage accrual. To assess the potential association between regional disparities and clinical outcomes, a hospitalisation profile was described. A bootstrapping approach of logistic regression was used to explore potential factors associated with hospitalisation.Results:Overall, 92.3% of patients were female, with a mean (standard deviation; SD) age of 41.8 (12.7) years and a mean (SD) disease duration of 11.8 (7.9) years. Overall, 161 (53.7%) patients were of Latino origin; in the NO this proportion was 88%. White patients predominated in the SU (58.3%); and black patients in the SE (31.7%). The mean (SD) number of years of schooling was 11.3 (4.6), and was highest in the NO (14.2 [3.6]) and lowest in the SU (9.0 [4.0]; p<0.001). With regard to the distribution of the SLE clinical profile according to ACR criteria, arthritis was found in 221 patients and predominated in all regions (mean 73.7%), with a lower prevalence in the CO (40%; p<0.001; Figure 1A). The mean (SD) SLEDAI score was 4.33 (5.39) at the time of interview. The main contributing factors to disease activity, according to SLEDAI, were complement consumption (18%), arthritis (15.3%), and alopecia (15%). The SDI scale was scored for cataracts (15%), proteinuria (8.7%), and thrombosis (7.3%). Among the associated comorbidities, hypertension was predominant in the NO (35%; p=0.001). Smoking predominated in the SU (23%; p<0.001); obesity (27%; p=0.059) and dyslipidemia (35%; p=0.023), in the SE. Regarding patterns of care (Figure 1B), antimalarials were most frequently prescribed in the SE (88.3%) and the SU (91.7%). Corticosteroids prevailed in the NO (96.7%). The mean (SD) time between home and care facility was 4.5 (12.6) hours. Patients in the NO reported the longest transport time to reach the care facility (11.5 [25.4] hours; p<0.001). The hospitalisation rate during the study period was 21.3% across all regions, with no statistical difference between centres (p=0.651). Reasons for hospitalisation included disease activity (36 [12%]), infection (19 [6.3%]), surgery (10 [3.3%]), and management of clinical morbidities (6 [2.0%]). Hospitalisation was associated with ethnicity (p<0.016), occupational status (p<0.001), age (p=0.02), and the use of hydroxychloroquine (HCQ) or chloroquine (CQ; p<0.001).Conclusion:This nationwide study highlights ethnic, social, and patterns-of-care disparities among Brazilian patients with SLE. The modelling shows evidence that such disparities contribute to the divergent clinical spectrum observed in Brazil.Funding:GSKFigure 1.Distribution of the A) Brazilian SLE clinical profile according to the ACR Classification Criteria and B) Brazilian prescriptive profile for SLE treatment according to the use of immunosuppressive drugs, biological agents, and corticosteroids during the study (12 months)ANA, antinuclear antibodyAcknowledgements:Medical writing assistance was provided by Helen Taylor, Fishawack Indicia Ltd., UK, part of Fishawack Health, and was funded by GSK.Disclosure of Interests:Mirhelen Abreu Grant/research support from: GSK, Amgen, Biogen, Libbs, Odirlei Monticielo Speakers bureau: GSK, AbbVie, UCB, Roche, Novartis, Consultant of: GSK, AbbVie, Janssen, Vander Fernandes Speakers bureau: Janssen, Novartis, Roche, AbbVie, Pfizer, Grant/research support from: Novartis, GSK, Pfizer, Alexandre Cristovão Maiorano: None declared, Fernando dos Santos Beserra: None declared, Flavia Lamarao Employee of: GSK, Nathalie David Shareholder of: GSK, Employee of: GSK, Bruna de Veras Employee of: GSK, Blanca Bica: None declared, Domingos Sávio Nunes de Lima Grant/research support from: GSK, Marta Maria das Chagas Medeiros: None declared

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 999.1-999
Author(s):  
M. Abreu ◽  
O. Monticielo ◽  
V. Fernandes ◽  
A. Cristovão Maiorano ◽  
F. Dos Santos Beserra ◽  
...  

Background:Lupus nephritis (LN) is one of the most serious organic manifestations of systemic lupus erythematosus (SLE). Ethnicity can contribute to disparities in the prevalence and disease activity of LN.Objectives:To assess the prevalence of LN in Brazilian patients with SLE and to determine factors associated with LN activity across the country.Methods:This cross-sectional study (GSK Study 207353) was carried out through face-to-face interviews and review of medical records (12-month study period). Adult patients with SLE (American College of Rheumatology [ACR] criteria, 1997) were included. Five SLE reference teaching centres were selected: North (NO), Northeast (NE), Midwest (CO), Southeast (SE), and South (SU). Patients with another disease whose morbidity surpassed SLE were excluded. LN was defined as reported in the medical record or history of confirmed renal biopsy; disease activity by pre-defined changes in SLE Disease Activity Index (SLEDAI) or the patient’s kidney disease during the study. Activity was assessed during (T0), 6 months before (T6), and 12 months before (T12) the interview. Systemic Lupus International Collaborating Clinics/ACR Damage Index score mapped damage accrual. Two pairings were performed, aiming to discriminate factors associated with LN and its activity, respectively. Matching technique was used to select similar individuals based on propensity scores, obtained from a logistic regression model. A bootstrapping method explored characteristic variables associated with the risk of progressing to LN.Results:Overall, 300 Brazilian patients with SLE were included in the study. Two groups were paired: LN group (N=150) and non-LN group (N = 141). The prevalence of LN in the paired sample (N=291) was 51.5%, with a disparity between centres (p<0.001; Figure 1A). Most patients were female (LN: 92.7%; non-LN: 94.3%) and the mean (standard deviation [SD]) age for the LN and non-LN groups was 39.46 (11.86) and 43.96 (12.18), respectively. History of serositis was associated with the presence of LN (42 [28.0%] vs 21 [14.9%] non-LN; p=0.010). Type IV histological class predominated in both groups, with no disparity between centres. Social disparities were noted between groups. Non-active workers prevailed among the LN group (115 [76.7%] vs 98 [69.5%] for non-LN, p=0.024).When pairing for disease activity at T12, 73 (50.3%) patients with LN (N=145) had active disease. There was regional disparity in terms of disease activity (Figure 1B), with a predominance of active LN in the NO (28 [68.3%]) and SU (16 [55.2%], p=0.026). Type IV histological class was the component most associated with active LN (active: 32 [43.8%]; non-active: 11 [15.3%], p<0.001). Variation in SLEDAI during the study period discriminated between active and non-active LN. The mean (SD) SLEDAI score at T12 was substantially higher in those with active LN compared with non-active LN (7.18 [4.83] vs 2.47 [4.63], p<0.001). As for the pattern of care, corticosteroids users prevailed in those with active LN (62 [84.9%] vs 45 [62.5%] for non-active LN, p=0.004). There was no disparity in the use of immunosuppressants, with the exception of cyclophosphamide use, noted among 16 (21.9%) patients with active LN and 6 (8.3%) patients with non-active LN (p=0.041). Psychotropic or anticonvulsant use was higher in patients with non-active LN (32 [44.4%] vs 17 [23.3%] patients with active LN, p=0.012). Consultation with a neurologist was verified in 15 (20.8%) patients with non-active LN and 6 (8.2%) with active LN (p=0.055). Hospitalisation occurred in 17 patients with non-active (23.6%) and active (23.3%) LN.Conclusion:Disparities in the prevalence of LN and its activity were evident between the regions across Brazil, highlighting differences in clinical factors, regional factors, and patterns of care.Funding:GSKFigure 1.Prevalence of A) LN among regional centres, comparing them to disease activity profile and prescriptive practice, and B) Active and non-active LN according to prescriptive practiceCQ, chloroquine; HCQ, hydroxychloroquine*At T12Acknowledgements:Medical writing assistance was provided by Helen Taylor, Fishawack Indicia Ltd., UK, part of Fishawack Health, and was funded by GSK.Disclosure of Interests:Mirhelen Abreu Grant/research support from: GSK, Amgen, Biogen, Libbs, Odirlei Monticielo Speakers bureau: GSK, AbbVie, UCB, Roche, Novartis, Consultant of: GSK, AbbVie, Janssen, Vander Fernandes Speakers bureau: Janssen, Novartis, Roche, AbbVie, Pfizer, Grant/research support from: Novartis, GSK, Pfizer, Alexandre Cristovão Maiorano: None declared, Fernando dos Santos Beserra: None declared, Flavia Lamarao Employee of: GSK, Nathalie David Shareholder of: GSK, Employee of: GSK, Bruna de Veras Employee of: GSK, Blanca Bica: None declared, Domingos Sávio Nunes de Lima Grant/research support from: GSK, Marta Maria das Chagas Medeiros: None declared


Author(s):  
Seravina Adila Izzati ◽  
Ovi Sofia ◽  
Cesarius Singgih Wahono ◽  
Nadia Artha Dewi ◽  
Ovi Sofia

Introduction: Lupus retinopathy and posterior uveitis are complications due to systemic lupus erythematosus which can threaten the vision. The presence of posterior segment manifestation is suggestive of high disease activity. The aim of this study is to identify posterior segment manifestation (Lupus Retinopathy and Posterior Uveitis) in SLE patient and their correlation with SLE disease activity using The Mexican-SLEDAI (MEX-SLEDAI) score.                                                                                                                                                                Methods: This was an analytical observational study with cross-sectional design, conducted from August to October 2020 and involved 114 SLE patients in Dr. Saiful Anwar General Hospital. We calculated MEX-SLEDAI score to assess SLE disease activity. All participant that met inclusion criteria underwent ophthalmology examinations using a portable slit-lamp, head indirect ophthalmoscope, and fundus finding were documented using portable fundus imaging.   Result: Lupus retinopathy (LR) presents in 25/114 (21.9%) and posterior uveitis (PU) occurs in 2/114 (1.8%) SLE patients. The mean age of patient with LR, PU, and without retinopathy were 32.92; 37.00; and 31.08 years respectively. The posterior segment findings were hemorrhages, cotton wool spots, hard exudates, and vasculitis reflecting vascular damage. The most common manifestation found in retina was cotton wool spot. The mean of MEX-SLEDAI score of SLE patient with LR (7.200 ± 3.905) and SLE patient with PU (3.500 ± 2.121) was higher than the mean of SLE patient without LR and PU (2.871 ± 2.534). There was a significant association between LR and MEX-SLEDAI score (p=0.000). An insignificant association between PU and MEX-SLEDAI score was found (p=0.353)   Conclusion There is a significance correlation between lupus retinopathy and SLE disease activity based on MEX-SLEDAI scores. The mean of MEX-SLEDAI score in SLE patients with lupus retinopathy was higher than SLE with posterior uvetis and SLE without posterior segment manifestations.


Lupus ◽  
2020 ◽  
Vol 29 (3) ◽  
pp. 344-350
Author(s):  
S Selvananda ◽  
Y Y Chong ◽  
R J Thundyil

Objective Systemic lupus erythematosus (SLE) is a complex multi-systemic autoimmune disease with variable levels of activity that may wax and wane within the same patient over the years. In view of the scarcity of data about lupus in the East Malaysian population, we aimed to study the disease activity and damage index in patients with SLE hospitalized in a tertiary center in Sabah, East Malaysia. Methods We retrospectively studied all patients with SLE admitted from 1 January 2013 to 31 December 2015. Demographic data, clinical features, treatment received, SLEDAI and SLICC/ACR (Systemic Lupus International Collaborating Clinics/American College of Rheumatology) criteria and outcomes were collected. Results There were 108 patients studied whereby 88.9% were females. They had a mean age of 31.4 ± 11.02 years at admission and were multiethnic in origin. The mean number of ACR criteria for SLE was 5.03 ± 1.5 at the time of diagnosis. There were 158 hospitalizations during the 3 years. The main causes of hospitalization were flare of SLE (66.5%), infection (57.6%), renal biopsy (15.5%) and others (11.4%). Active nephritis (65%), cutaneous (44.4%) and hematological involvement (40.2%) were the three commonest manifestations. There was concurrent flare of SLE and infection in 41.1% of the admissions. The mean SLEDAI score at admission was 10.8 ± 7.20, with a mean SLEDAI of 9.3 ± 6.9 in those without damage and 11.9 ± 7.21 in those with damage ( p-value = 0.026). The median SLICC score was 1 with a mean of 0.93 ± 1.07. There were nine deaths (5.6%) during the study period and all patients were females. Compared with those who survived, they had a significantly higher SLEDAI score of 15.80 ± 8.2 ( p-value = 0.0207) and a SLICC score of 2.70 ± 1.6 ( p-value <0.001). Conclusion SLE is more common among the indigenous population of Sabah, the Kadazan-Dusun, which has not been shown before this study. Disease characteristics were, however, similar to reports from the Asia-Pacific region. Acute flare of SLE and infection remained the main causes of admission and readmissions and was present in 44.4% of the mortalities in our cohort.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 638.2-639
Author(s):  
C. C. Mok ◽  
L. Y. Ho ◽  
K. L. Chan ◽  
J. Meenakshi

Objectives:To validate the SIMPLE index for systemic lupus erythematosus (SLE) disease activity assessment in Chinese patients.Methods:Adult patients (age ≥18 years) who fulfilled the 2013 SLICC criteria for SLE and were followed in the Rheumatology clinics of Tuen Mun Hospital, Hong Kong were recruited in a cross-sectional study. Participants were invited to complete the SIMPLE questionnaire before seeing doctors on the same day. The two laboratory results were supplemented by research nurses. Physicians, who were blinded to the SIMPLE results, were asked to complete disease activity assessment by the SELENA-SLEDAI and physicians’ global assessment (PGA) after consultation. Correlation was made between the SIMPLE score and the SLEDAI/PGA scores by Spearman’s rank correlation test. Receiver operating characteristic (ROC) analysis was performed to find the best cut-off SIMPLE score that predicted a clinical SLEDAI score of 1-6 (mild SLE activity) and ≥7 (moderate/severe activity).Results:364 SLE patients were studied (94% women; age 45.4±13.4 years; disease duration 13.2±8.0 years). The proportion of patients having a history of neuropsychiatric and renal disease that required immunosuppressive therapies was 9.3% and 56%, respectively. At the time of questionnaire completion, 69 (19%) patients had SLEDAI ≥6 and 192 (53%) had SLEDAI 1-5. The mean SLEDAI was 3.04±2.85 and PGA score was 0.62±0.55. A total of 161 (44%) had SDI score ≥1. The mean SIMPLE index was 26.0±12.9. SIMPLE index correlated significantly with SLEDAI (ρ=0.76; p<0.001) and PGA score (ρ=0.48; p<0.001). ROC analysis showed that a SIMPLE index of >27 points best predicted a clinical SLEDAI score of 1-6 (area under the curve [AUC] 0.78[0.73-0.84]; sensitivity 0.75; specificity 0.71), and >36.8 points best predicted a clinical SLEDAI score of ≥7 (AUC 0.87[0.69-1.00]; sensitivity 0.88, specificity 0.85).Conclusion:SIMPLE shows a good correlation with SELENA-SLEDAI and PGA. It is a simple tool that enables patients to self-report disease activity and communicate with the health care team more efficiently.Disclosure of Interests:None declared


2021 ◽  
Vol 15 (1) ◽  
pp. 35-39
Author(s):  
Sadaf Andleeb ◽  
Tafazzul-E-Haque Mahmud ◽  
Aflak Rasheed ◽  
Muhammad Shahid Mehmood ◽  
Iram Gull ◽  
...  

Background: Early diagnosis and effective treatment in systemic lupus erythematosus (SLE) has very crucial role. Anti dsDNA is very important diagnostic tool and activity marker in SLE. This study aimed to determine the association of anti dsDNA antibodies titer with non-renal manifestations of systemic lupus erythematosus and systemic lupus erythematosus disease activity index (SLEDAI). Patients and methods: It was a cross-sectional study and was carried out at Department of Rheumatology and Immunology, Tertiary Care Hospital, Lahore from Feb 2021 to May 2021. The study involved 69 male and female patients satisfying the systemic lupus international collaborating clinics (SLICC) classification criteria. Questions regarding different symptoms were asked and disease activity parameters were noted excluding renal parameters. Anti-dsDNA titers were measured from standard laboratory using immunofluorescence technique and were correlated with SLEDAI score. A written informed consent was obtained from every patient. Results: The mean age of the patients was 30.7±10.2 years while the mean duration of disease 1.94±2.65 years. We observed a female predominance among these patients with male to female ratio of 1:7.6. There were fifty-four (78.3%) patients with active disease. The mean anti-dsDNA levels were significantly higher in patients with active disease (315.73±481.68 vs. 78.46±113.64 IU/mL; p-value=0.003). There was a significantly strong positive correlation between anti-dsDNA levels and SLEDAI score (r=0.358; p-value=0.006). When compared, significant difference was observed in mean anti-dsDNA titers in patients with chronic cutaneous manifestations (p-value=0.040), lymphopenia (p-value= 0.012), pleurisy/pericarditis (p-value= 0.024) and leukopenia <3000/mm3 (p-value= 0.001). Conclusion: Anti-dsDNA antibodies titers are remarkably increased in patients with non-renal manifestations of systemic lupus erythematosus particularly with chronic cutaneous manifestations and leukopenia and positively correlate with disease activity status and SLEDAI score.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1053.2-1054
Author(s):  
C. Moriano ◽  
J. Calvo ◽  
I. Rua-Figueroa ◽  
E. Diez Alvarez ◽  
C. Bermúdez ◽  
...  

Background:The mortality in Systemic Lupus Erythematosus (SLE) varies largely across different countries most probably due to social, healthcare and ethnic differences.Objectives:To analyze the causes and identify predictive factors of mortality of SLE in Spain in the present century.Methods:We performed a cross-sectional and retrospective study analyzing data from the RELESSER cohort (Spanish Registry of Systemic Lupus Erythematosus of the Spanish Society of Rheumatology). We included all patients diagnosed with SLE since the year 2000 and recorded sociodemographic, clinical and serological variables, comorbidities and treatments, as well as indicators of disease activity, damage and severity. The characteristics of the deceased patients were compared with those of the survivors, and variables with clinical significance or statistical significance were grouped into multivariate models to determine which ones were independently associated with the outcome of the disease.Results:A total of 2004 patients were included, 88.6% female, the mean age at diagnosis was 38.3 (± 15.3) years, with a mean delay in diagnosis of 28.9 (± 52.6) months. Up to 2.84% of the individuals had died. The leading cause of death was SLE activity (n=16), followed by infections (n=14), vascular events (n=7) and cancer (n=6). The mean age of death was 54.68 (± 20.13) years, and neither age, sex nor delay in diagnosis was independently associated with mortality. The presence of nephritis, depression, severe infections, organ damage (SLICC/ACR DI) or disease activity (SLEDAI), as well as the use of cyclophosphamide, rituximab or high doses of corticosteroids, were predictors of mortality in our cohort. Antimalarial treatment and skin manifestations were linked to improved survival.Conclusion:In the RELESSER cohort, clinical factors, co-morbidities, as well as therapeutic attitudes were associated with a significant increase in mortality in SLE. Interestingly, depression was independently associated to mortality. The activity of the disease and infections continue to be the main causes of death at the beginning of the 21st century amongst our patients.Disclosure of Interests:Clara Moriano: None declared, Jaime Calvo Grant/research support from: Lilly, UCB, Consultant of: Abbvie, Jansen, Celgene, Iñigo Rua-Figueroa: None declared, Elvira Diez Alvarez: None declared, Cristina Bermúdez: None declared, Francisco J López-Longo Grant/research support from: AbbVie and GSK, Speakers bureau: AbbVie, Actelion, Bristol Myers Squibb, GSK, MSD, Pfizer, Roche, and UCB Pharma, María Galindo-Izquierdo: None declared, Alejandro Olive: None declared, Eva Tomero Muriel: None declared, Antonio Fernandez-Nebro: None declared, Mercedes Freire González: None declared, Olaia Fernández- Berrizbeitia: None declared, Ana Pérez Gómez: None declared, Esther Uriarte Isacelaya: None declared, Carlos Marras Fernandez Cid: None declared, Carlos A. Montilla-Morales: None declared, Gregorio Santos Soler: None declared, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD, M. Rodíguez-Gómez: None declared, Paloma Vela-Casasempere: None declared, Alina Boteanu: None declared, J. Narváez: None declared, Victor Martinez Taboada: None declared, Blanca Hernández-Cruz Speakers bureau: Abbvie, Lilly, Sanofi, BMS, STADA, José Luis Andreu: None declared, José A Hernandez Beriain: None declared, Lorena Expósito: None declared, Raúl Menor-Almagro: None declared, Mónica Ibañez Barceló: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Carles Galisteo: None declared, Enrique Raya: None declared, Víctor Quevedo Vila: None declared, Tomas Vazquez Rodriguez: None declared, Jesus Ibañez: None declared, Jose M Pego-Reigosa: None declared


Lupus ◽  
2021 ◽  
pp. 096120332110345
Author(s):  
Stefan Vordenbäumen ◽  
Alexander Sokolowski ◽  
Anna Rosenbaum ◽  
Claudia Gebhard ◽  
Johanna Raithel ◽  
...  

Objective Hypomethylation of CD40-ligand (CD40L) in T-cells is associated with increased disease activity in systemic lupus erythematosus (SLE). We therefore investigated possible associations of dietary methyl donors and products with CD40L methylation status in SLE. Methods Food frequency questionnaires were employed to calculate methyl donor micronutrients in 61 female SLE patients (age 45.7 ± 12.0 years, disease duration 16.2 ± 8.4 years) and compared to methylation levels of previously identified key DNA methylation sites (CpG17 and CpG22) within CD40L promotor of T-cells using quantitative DNA methylation analysis on the EpiTYPER mass spectrometry platform. Disease activity was assessed by SLE Disease Activity Index (SLEDAI). Linear regression modelling was used. P values were adjusted according to Benjamini & Hochberg. Results Amongst the micronutrients assessed (g per day), methionine and cysteine were associated with methylation of CpG17 (β = 5.0 (95%CI: 0.6-9.4), p = 0.04; and β = 2.4 (0.6-4.1), p = 0.02, respectively). Methionine, choline, and cysteine were additionally associated with the mean methylation of the entire CD40L (β = 9.5 (1.0-18.0), p = 0.04; β = 1.6 (0.4-3.0), p = 0.04; and β = 4.3 (0.9-7.7), p = 0.02, respectively). Associations of the SLEDAI with hypomethylation were confirmed for CpG17 (β=-32.6 (-60.6 to -4.6), p = 0.04) and CpG22 (β=-38.3 (-61.2 to -15.4), p = 0.004), but not the mean methylation of CD40L. Dietary products with the highest impact on methylation included meat, ice cream, white bread, and cooked potatoes. Conclusions Dietary methyl donors may influence DNA methylation levels and thereby disease activity in SLE.


Lupus ◽  
2021 ◽  
pp. 096120332110050
Author(s):  
Rory C Monahan ◽  
Liesbeth JJ Beaart-van de Voorde ◽  
Jeroen Eikenboom ◽  
Rolf Fronczek ◽  
Margreet Kloppenburg ◽  
...  

Introduction We aimed to investigate risk factors for fatigue in patients with systemic lupus erythematosus (SLE) and neuropsychiatric symptoms in order to identify potential interventional strategies. Methods Patients visiting the neuropsychiatric SLE (NPSLE) clinic of the Leiden University Medical Center between 2007–2019 were included. In a multidisciplinary consensus meeting, SLE patients were classified as having neuropsychiatric symptoms of inflammatory origin (inflammatory phenotype) or other origin (non-inflammatory phenotype). Fatigue was assessed with the SF-36 vitality domain (VT) since 2007 and the multidimensional fatigue inventory (MFI) and visual analogue scale (VAS) since 2011. Patients with a score on the SF-36 VT ≥1 standard deviation (SD) away from the mean of age-related controls of the general population were classified as fatigued; patients ≥2 SD away were classified as extremely fatigued. Disease activity was measured using the SLE disease activity index-2000. The influence of the presence of an inflammatory phenotype, disease activity and symptoms of depression and anxiety as measured by the hospital anxiety and depression scale (HADS) was analyzed using multiple regression analyses corrected for age, sex and education. Results 348 out of 371 eligible patients filled in questionnaires and were included in this study . The majority was female (87%) and the mean age was 43 ± 14 years. 72 patients (21%) had neuropsychiatric symptoms of an inflammatory origin. Fatigue was present in 78% of all patients and extreme fatigue was present in 50% of patients with an inflammatory phenotype vs 46% in the non-inflammatory phenotype. Fatigue was similar in patients with an inflammatory phenotype compared to patients with a non-inflammatory phenotype on the SF-36 VT (β: 0.8 (95% CI −4.8; 6.1) and there was less fatigue in patients with an inflammatory phenotype on the MFI and VAS (β: −3.7 (95% CI: −6.9; −0.5) and β: −1.0 (95% CI −1.6; −0.3)). There was no association between disease activity and fatigue, but symptoms of anxiety and depression (HADS) associated strongly with all fatigue measurements. Conclusion This study suggests that intervention strategies to target fatigue in (NP)SLE patients may need to focus on symptoms of anxiety and depression rather than immunosuppressive treatment.


2010 ◽  
Vol 38 (1) ◽  
pp. 60-63 ◽  
Author(s):  
DOMINIQUE IBAÑEZ ◽  
DAFNA D. GLADMAN ◽  
ZAHI TOUMA ◽  
MANDANA NIKPOUR ◽  
MURRAY B. UROWITZ

Objective.Adjusted mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; AMS) measures lupus disease activity over time. Our aim was to determine optimal visit frequency for calculating AMS.Methods.Patients followed monthly for 12 consecutive visits were included. AMS was calculated using all of the SLEDAI 2000 (AMSGOLD using all 12 visits), only quarterly visits (AMS3, using visits 3 months apart), semiannual visits (AMS6, using first, middle, and last visits only), and annual visits (AMS12, using only the first and last visits). Comparisons of AMS3, AMS6, and AMS12 with AMSGOLD are made using descriptive statistics.Results.Seventy-eight patients were included (92% women, mean age at SLE diagnosis 30.1 yrs and at study start 46.2 yrs). The mean (SD) AMSGOLD for the entire year was 2.05 (1.66), for AMS3 1.99 (1.65), for AMS6 2.12 (1.87), and for AMS12 2.08 (1.83). Mean (SD) of the absolute differences with AMSGOLD: for AMS3 0.29 (0.33), for AMS6 0.45 (0.59), and for AMS12 0.61 (0.58). Differences that were < 0.5 were considered minimal while those ≥ 1 were deemed important. Comparing AMSGOLD to AMS3, 82% of the differences were minimal and 3% were important. When comparing to AMS6, 68% were minimal and 10% were important, while comparing to AMS12, 50% were minimal and 21% were important.Conclusion.Usual clinic visits occurring quarterly offer a good estimation of disease activity over a 1-year period and are preferred over semiannual and annual visits.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 597-598
Author(s):  
R. Van Vollenhoven ◽  
R. Furie ◽  
K. Kalunian ◽  
S. Navarra ◽  
J. Romero-Diaz ◽  
...  

Background:Type I interferons and other inflammatory mediators derived from plasmacytoid dendritic cells (pDCs) are implicated in systemic lupus erythematous (SLE) pathology. BIIB059 is a humanized monoclonal antibody that targets blood dendritic cell antigen 2 (BDCA2), a pDC-specific receptor. The binding of BIIB059 to BDCA2 leads to rapid internalization of BDCA2 from the surface of pDCs and subsequent inhibition of interferon, cytokine, and chemokine production. In Part A of the 2-part, phase 2 LILAC study (NCT02847598), BIIB059 significantly reduced SLE activity, as evidenced by reduced total active joint count (primary endpoint) and higher SLE Responder Index (SRI-4)1 response (a secondary endpoint) versus placebo.2Objectives:To evaluate SRI-4 response for BIIB059 versus placebo at Week 24 in SLE participant subgroups.Methods:Enrollment in LILAC Part A was open to adults fulfilling ≥ 4 of 11 revised 1997 ACR criteria for classification of SLE, with ≥ 4 tender and ≥ 4 swollen joints, active skin disease, and positive lupus antibodies. Participants were randomized to receive either BIIB059 450 mg or placebo subcutaneously every 4 weeks for 20 weeks (with an additional dose at Week 2). SRI-4 response at Week 24 was analyzed in subgroups, though analyses were limited by small sample sizes and were not powered for statistical testing.Results:In LILAC Part A, 64 and 56 participants were dosed with BIIB059 450 mg and placebo, respectively. At week 24, SRI-4 response rate was observed in favor of BIIB059 regardless of the baseline disease activity, such as SLEDAI-2K <10 versus ≥10, presence of BILAG-2004 grade A or B arthritis, oral corticosteroid usage, positivity for anti-ds DNA autoantibody and/or complement status, with point estimates for least-squares mean differences as well as corresponding 95% CIs consistently favoring BIIB059 (Figure 1). The incidence of adverse events in the overall study population was similar between the placebo and BIIB059 groups.2Conclusion:BIIB059 treatment was associated with greater SRI-4 response rate, consistent among different subgroups of baseline disease activity as measured by SLEDAI-2K and BILAG-2004, glucocorticoid dosage, and serology. These findings provide additional evidence of the potential benefit of BIIB059 for the treatment of patients with active SLE.References:[1]Furie RA, et al. Arthritis Rheum. 2009;61(9):1143-1151. 2. Furie RA, et al. Arthritis Rheumatol. 2020;72(suppl 10). Abstract 0935.Acknowledgements:This study was sponsored by Biogen (Cambridge, MA, USA). Writing and editorial support was provided by Excel Scientific Solutions (Fairfield, CT, USA); funding was provided by Biogen.Disclosure of Interests:Ronald van Vollenhoven Consultant of: AbbVie, AstraZeneca, Biotest, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Lilly, Medac, Merck, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Arthrogen, Bristol Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, UCB, Richard Furie Consultant of: Biogen, Grant/research support from: Biogen, Kenneth Kalunian Consultant of: AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, Equillium, Genentech, Gilead, ILTOO, Janssen, Nektar, Roche, Viela, Grant/research support from: Lupus Research Alliance, Pfizer, Sanford Consortium, Sandra Navarra Speakers bureau: Astellas, Johnson & Johnson, Novartis, Pfizer, Consultant of: Biogen, Grant/research support from: Biogen, Juanita Romero-Diaz Consultant of: Biogen, Boehringer Ingelheim, Victoria Werth Consultant of: AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Gilead, GlaxoSmithKline, Janssen, Kyowa Kirin, Resolve, Viela, Grant/research support from: Biogen, Celgene, Gilead, Janssen, Viela, XIAOBI HUANG Shareholder of: Biogen, Employee of: Biogen, HUA CARROLL Shareholder of: Biogen, Employee of: Biogen, Cristina Musselli Shareholder of: Biogen, Employee of: Biogen, Catherine Barbey Shareholder of: Biogen, Employee of: Biogen, NATHALIE FRANCHIMONT Shareholder of: Biogen, OMass Therapeutics, Employee of: Biogen


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