The Relationship between Platelet to Lymphocyte Ratio and Platelet Indices with Disease Severity Level of Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is an episodic, chronic autoimmune inflammatory disease characterized by remission and flare phases. Laboratory parameters required to assess the severity of disease activity in SLE include platelet count and platelet indices. Several studies regarding the Platelet to Lymphocyte Ratio (PLR) and platelet indices on the severity of SLE patients remain inconsistent. This study aimed to evaluate the relationship between PLR value and platelet index with the degree of disease severity in SLE patients. This study used a retrospective analytic observational design in SLE patients from January 2016 to December 2019 at Dr. Sardjito Central Hospital. Disease severity was assessed using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score. Platelet to Lymphocyte Ratio (PLR) values and platelet indices were measured with a hematology analyzer. The data were analyzed using correlation, bivariate, multiple regression tests, and the ROC curve to determine the PLR cut-off. There were 55 SLE patients with high activity (SLEDAI 11-19; n=30(54,54%)) and very high activity (SLEDAI 20; n=25(45.45%)). There was a significant correlation (p <0.05) between the PLR value, platelet count, plateletcrit, and Mean Platelet Volume (MPV) with SLEDAI scores (p <0.05), but only the MPV variable was significant as an independent variable (p=0.0357). In the ROC curve, a cut-off PLR value of 124 was obtained with a sensitivity of 68.0%, specificity of 66.7%, likelihood ratio=2.04 (AUC=0.659 with p-value=0.035) to detect very high disease activity. Based on the PLR value, platelet count and plateletcrit negatively correlated with SLEDAI score but were related to the very high degree of thrombocytopenia in disease activity. The MPV value reflected the high platelet turnover, which had a positive correlation with the SLEDAI score. Patients with a PLR value ≤124 were 2.04 times more likely to have a SLEDAI score of 20, indicating potential use as a predictor of disease activity. The PLR value and platelet indices were significantly related to the degree of SLE activity.

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

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

AB0339 PREVALENCE AND ASSOCIATED FACTORS OF LOW BONE MINERAL DENSITY IN ADULTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Background:Patients with Systemic Lupus Erythematosus (SLE) are at risk of osteoporosis (OP) and fragility fractures (FFx) because of the disease or its treatments. We assessed the prevalence and risk factors for OP in patients with SLE.Objectives:Our objective is to determine the prevalence of bone mineral density (BMD) loss and fracture risk factors in SLE patients undergoing dual-energy X-ray absorptiometry (DXA).Methods:This is a cross sectional study conducted during the year 2020 in the Rheumatology and internal medicine departements in Taher Sfar hospital of Mahdia, Tunisia. We included patients aged ≥18 years with a diagnosis of SLE according to the 1997 ACR or 2012 SLICC criteria. Patients with renal or hepatic osteodystrophy, or receiving bisphosphonates were excluded from the study. The BMD values were measured by DXA. The T-score, Z-scores and BMD of the lumbar spine (LS) and femoral neck (FN) were determined. OP was defined as a value of the T-score less or equal to -2.5 SD for postmenopausal women and men aged more than 50 years old, and Z-scores less or equal to -2 for premenopausal women and men aged less than 50 years old.Results:Forty-six SLE patients were included. The mean age was 47.19±16.45 years [18-85], with a mean disease duration of 2.52±3.46 years [15days-15years]. The mean SLEDAI score was 5.34±4.82. As regards menstrual history of female patients: 56.5% were premenopausal, 43.5% were post-menopausal and 6% had premature menopause. 13% of our patients gave history of smoking. The mean BMI was 27.6 ± 6 kg/m2 [15-39.8]. FFx were diagnosed in 4 patients (9%) and the mean age of the first fracture was 45years. GCs were used in 65.2% of cases (30 patients). The mean daily dose of GCs was 10 mg/day and the mean cumulative dose was 20g. Calcium and Vitamin D intake was mentioned in 65.2% of cases (30 patients). The association of SLE with other rheumatic diseases was found in 14 of patients. The mean T-score at FN and LS were respectively 0.02±1.17 and -1.32±1.36. The mean Z-score at FN and LS were respectively 0.53±1.14 and -0.6±1.26. It was found that 17 patients (37% of cases) had OP, 12 had osteopenia (26%) and 17 patients (37%) had normal BMD. 37% of patients had OP at LS, 23.9% osteopenia at LS, 6.5% OP at FN and 21.7% osteopenia at FN. Low BMD was significantly correlated with increased age (p=0.01) and disease duration(p=0.05),post-menopausal status(p=0.04), higher BMI (p=0.004), musculoskeletal involvement (p=0.01), association to other rheumatic diseases (p=0.01), higher disease activity by SLEDAI score (p=0.05), higher Erythrocyte sedimentation Rate (p=0.01) and C-Reactive Protein (p=0.007), low serum complement C3 (p=0.009) and C4 (p=0.04) and cumulative doses of GCs (p=0.01).We found also that BMD at LS was mostly affected by GCs intake, BMI and CRP while BMD at FN was mostly affected by SLEDAI score, C3 and C4 (p<0.001 in all cases). Gender, history of smoking and cardiovascular comorbidities had no significant impact on BMD.Conclusion:OP is a common but unrecognised complication of SLE with increased frequency of both peripheral and vertebral FFx. Our study suggests a high risk profile for OP and FFx in SLE which seems to be associated with age, disease duration, post-menopausal status, BMI and GCs.References:[1]Dey, M., & Bukhari, M. (2018). Predictors of fracture risk in patients with systemic lupus erythematosus. Lupus, 27(9), 1547–1551.Disclosure of Interests:None declared

POS1452 DE NOVO LUPUS NEPHRITIS FOLLOWING THE INTRODUCTION OF BELIMUMAB

Background:Belimumab inhibits the activity of the soluble cytokine BLyS (B lymphocyte stimulator) and is recommended for use in moderate refractory systemic lupus erythematosus (SLE). A recent randomised controlled trial reported that Belimumab improves the outcomes for patients with lupus nephritis when used with standard therapy.Objectives:We present two cases of lupus nephritis that developed in SLE patients without pre-existing renal disease shortly after commencing treatment with Belimumab.Methods:Both patients are Afro-Caribbean females with similar immunological profiles, including ANA, dsDNA, anti-Sm, anti- Ro and anti-RNP antibodies. The first was 59 years old with a long standing diagnosis of SLE since 1996 that had required previous Cyclophosphamide for neuropsychiatric lupus. She was most recently taking Hydroxychloroquine, Mycophenolate and Prednisolone having previously failed with Azathioprine twice. Belimumab was commenced in February 2020 due to worsening arthritis, mouth ulcers, pleuritis and systemic features associated with a significant rise in her dsDNA and low complement. Her SLEDAI score was 13. After six months of treatment she developed proteinuria for the first time. Her urine protein creatinine ratio (uPCR) was measured at 205mg/mmol and a subsequent renal biopsy revealed features of active Class IV and V lupus nephritis. Belimumab was changed to Rituximab. Mycophenolate was stopped due to persistent neutropenia and Tacrolimus was introduced instead. After 5 months treatment her uPCR is now 33mg/mmol.The second patient was 37 years old with a recent diagnosis of SLE in 2018. She presented with inflammatory arthritis, oral and nasal ulcers, and cytopenia. She responded poorly to Azathioprine and was intolerant of Mycophenolate. Her most recent treatment was Hydroxychloroquine and Prednisolone. She was commenced on Belimumab in February 2020 due to active mucocutaneous and musculoskeletal features of lupus with a SLEDAI score of 12. The mucocutaneous features of lupus responded well but she developed proteinuria seven months later, and by November 2020 her uPCR was 149mg/mmol. Belimumab was switched to Rituximab and initially her uPCR continued to rise but it has now fallen to 43mg/mmol.Results:The occurrence of new lupus nephritis soon after the initiation of Belimumab monotherapy has been reported previously and our cases raise further concerns. A prospective observational study recently reported significantly increased rates of new lupus nephritis developing in patients receiving Belimumab in addition to standard care compared to those receiving standard treatment. An association between Belimumab and the development of de novo lupus nephritis has not yet been conclusively established but it would create a significant challenge in how Belimumab is used and consented for in SLE, especially if it becomes more widely used to treat lupus nephritis. The mechanism by which Belimumab may increase the risk of, or trigger, lupus nephritis is currently unclear but may result from increased activity in BLyS associated pathways following the blockade of the BLyS pathway.Conclusion:These two cases raise questions about the role of using Belimumab in patients at risk of developing lupus nephritis. We therefore recommend caution in its use and recommend active monitoring of renal parameters especially in patients with poor clinical and serological response to Belimumab.References:[1]Furie R, Rovin BH, Houssiau F, et al. Two-year, randomized, controlled trial of belimumab in lupus nephritis. N Engl J Med. 2020; 383(12):1117-28[2]Sjöwall C, Cöster L. Belimumab may not prevent lupus nephritis in serologically active patients with ongoing non-renal disease activity. Scand J Rheumatol. 2014; 43(5):428-30[3]Staveri C, Karokis D, Liossis SN. New onset of lupus nephritis in two patients with SLE shortly after initiation of treatment with belimumab. Semin Arthritis Rheum. 2017; 46(6):788-790[4]Parodis I, Vital EM, Hassan SU, et al. De novo lupus nephritis during treatment with belimumab. Rheumatology. 2020; keaa796Disclosure of Interests:None declared

AB0337 ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE IN SYSTEMIC LUPUS ERYTHEMATOSUS USING THE SLEQoL (SYSTEMIC LUPUS ERYTHEMATOSUS-SPECIFICQUALITY OF LIFE QUESTIONNAIRE)

Background:Patients withsystemic lupus erythematosus (SLE) have a better survival than decades ago. Nevertheless, they still experience a low health-related quality of life (HRQoL). The Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQoL) is one of the most widely used specific tools for measuring HRQoL in SLE.Objectives:The aim of our study is to assess the impact of the SLE in the HRQoL using the SLEQoL tool.Methods:This is a cross-sectional study during a period of the year 2020, including patients followed in the departments of Internal Medicine and Rheumatology in Mahdia, Tunisia. All patients were diagnosed with SLE based in ACR 1997/SLICC2012. The SLEQoL is composed of 40 items scored from 1 to 7, it includes six HRQoL domains: physical functioning (Items 1 to 6), activities (items 7 to 15), symptoms (items 16 to 23), treatment (items 24 to 27), mood (items 28 to 31) and self-image (items 32 to 40) with higher values corresponding to worse HRQoL.Results:Forty patients were enrolled. The age of the SLE patients (36 females/4 males) ranged from 11 to 87 years. The mean age was 47.75±17.59 years. The mean disease duration was 2.3 ±2.9 years. The mean SLEDAI score was 5.78±4.94. The main target organs involved were cutaneous, musculoskeletal, neurological, pulmonary, cardiovascular and renal in 85%, 82.5%, 32.5%, 17.5%, 15% and 7.5% of cases respectively. The biologic analysis showed the positivity of anti-nuclear antibodies in 97.5% of cases, low serum complement C3 and C4 in 20% and 32.5% of cases respectively. A biological inflammatory syndrome was found in 37.5% of cases and Anemia in 42.5%. 85% of SLE patients were treated by anti-malarial, 62.5% were treated by Glucocorticoids and 5% by Methotrexate. The mean SLEQoL global score was 77.92 ± 34.02 [40-153]. The means of different domains (physical functioning, activities, symptoms, treatment, mood and self-image) were respectively 12.1±6.49 [6-30]; 19.6±10.9 [9-49]; 16.4±8.1 [8-34]; 5.5±2.36 [4-14]; 9.6±5.4 [4-20]; 14.9±7.5 [9-36]. The most severely impacted domains were activities and symptoms. The less affected domains were treatment and mood. The SLEQoL global score was correlated with increased age (p=0.03), longer disease duration (p=0.05), SLEDAI score (p=0.02), visual analog scale of pain (p=0.04), musculoskeletal manifestations (p=0.04), cutaneous manifestations (p=0.05) and pulmonary manifestations (p=0.05). By analyzing biological tests of our patients, we found a correlation between the SLEQoL global score and Erythrocyte sedimentation rate [ESR] (p=0.05), Anemia (p=0.04), low serum complement C3 (p=0.02) and C4 (p=0.003). SLEQoL global score and its six domains were not correlated with gender, educational level nor marital status.Conclusion:Our study showed that HRQoL is impaired in patients with SLE. The most important predictors of low HRQoL were older age, longer disease duration, some clinical manifestations, biological activity disease indicators (ESR, anemia and low complement level) and the SLEDAI score.References:[1]Leong, K. P., Kong, K. O., Thong, B. Y. H., Koh, E. T., Lian, T. Y., Teh, C. L., et al (2005). Development and preliminary validation of a systemic lupus erythematosus-specific quality-of-life instrument (SLEQOL). Rheumatology, 44(10), 1267–1276.Disclosure of Interests:None declared

POS0769 VALIDATION OF THE SIMPLE INDEX FOR DISEASE ACTIVITY OF SYSTEMIC LUPUS ERYTHEMATOSUS IN CHINESE PATIENTS

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

Cytokine Profile in Juvenile Systemic Lupus Erythematosus

Background: Cytokines have an important role in immune system dysregulation in SLE because they act on the differentiation, maturation, and activation of several effector cells, culminating in inflammation and subsequent tissue damage.The aim of the work was to evaluate cytokine profile (IL2, IL10 and IL13) in children with SLE and their possible role in the pathogenesis of lupus nephritis. Methods: This is a cross sectional case-control study conducted on 60 children with SLE and 30 healthy children of matched age and sex served as a control group. The presence of lupus nephritis was confirmed by renal biopsy and histopathological examination. The SLE Disease Activity Index (SLEDAI) score for each patient was used to evaluate disease activity. Serum IL2, IL-10 & IL-13levels were measured using ELISA. Results: There was a significant increase in serum IL-10 levels in SLE patients compared to healthy controls and in patients with lupus nephritis compared to patients without lupus nephritis. Also, there were significant positive correlation between IL-10 and SLEDAI Score and between IL-10 and 24-hour urinary protein collection. There was no statistically significant difference in IL-2 levels in SLE patients compared to healthy controls. However, IL2 levels were significantly lower in active patients without lupus nephritis compared to active patients with lupus nephritis. There was no correlation between IL-2 and 24-hour urinary protein collection. The levels of IL13 were significantly higher in SLE patients compared to healthy controls and in patients with lupus nephritis compared to patients without lupus nephritis. There were significant positive correlations between Il 13 and SLEDAI Score and between IL-13and 24-hour urinary protein collection. Conclusions: Soluble IL10 and IL-13 could be used as a measure of disease activity. Further studies are needed to evaluate SLE pathophysiology including measurement of cytokine profile.

Serum Interleukin-26 Is a New Biomarker for Disease Activity Assessment in Systemic Lupus Erythematosus

ObjectiveInterleukin-26 (IL-26) has a unique ability to activate innate immune cells due to its binding to circulating double-stranded DNA. High levels of IL-26 have been reported in patients with chronic inflammation. We aimed to investigate IL-26 levels in patients with systemic lupus erythematosus (SLE).MethodsIL-26 serum levels were quantified by ELISA for 47 healthy controls and 109 SLE patients previously enrolled in the PLUS study. Performance of IL-26 levels and classical markers (autoantibodies or complement consumption) to identify an active SLE disease (SLE disease activity index (SLEDAI) score &gt; 4) were compared.ResultsIL-26 levels were significantly higher in SLE patients than in controls (4.04 ± 11.66 and 0.74 ± 2.02 ng/mL; p = 0.005). IL-26 levels were also significantly higher in patients with active disease than those with inactive disease (33.08 ± 21.06 vs 1.10 ± 3.80 ng/mL, p &lt; 0.0001). IL-26 levels correlated with SLEDAI score and the urine protein to creatinine ratio (uPCR) (p &lt; 0.001). Patients with high IL-26 levels had higher SLEDAI score, anti-DNA antibodies levels, and uPCR (p &lt; 0.05). They presented more frequently with C3 or C4 complement consumption. Lastly, IL-26 showed stronger performance than classical markers (complement consumption or autoantibodies) for active disease identification.ConclusionsOur results suggest that, in addition to classical SLE serological markers, the measurement of IL-26 levels may be a useful biomarker for active disease identification in SLE patients.

FC 034SAFETY AND EFFICACY OF INTRAVENOUS BELIMUMAB IN PATIENTS WITH LUPUS NEPHRITIS: A 6-MONTH OPEN-LABEL EXTENSION

Background and Aims Lupus nephritis (LN) is the most common severe manifestation of systemic lupus erythematosus (SLE), occurring in up to 40% of patients (pts) with SLE over their disease course, and resulting in 10–20% of pts progressing to end-stage kidney disease.1-3 The BLISS-LN (GSK Study BEL114054; NCT01639339) study demonstrated that the addition of intravenous (IV) belimumab (BEL) to standard therapy (ST) in pts with active LN significantly improved renal responses over 2 years compared with ST alone.4 Here we present additional safety and efficacy data from the 6-month open-label (OL) extension phase of BLISS-LN. Method In this OL phase, eligible completers of the Phase 3 BLISS-LN study (those who received BEL or placebo [PBO] through Week 100 and completed Week 104 assessments) received BEL 10 mg/kg IV plus ST every 28 days for 24 weeks. Endpoints at OL Week 28 included: safety; Primary Efficacy Renal Response (PERR; defined as urine protein:creatinine ratio [uPCR] ≤0.7; eGFR no more than 20% below OL baseline value or ≥60 ml/min/1.73m2; no rescue therapy); Complete Renal Response (CRR; defined as uPCR &lt;0.5; eGFR no more than 10% below OL baseline value or ≥90 ml/min/1.73m2; no rescue therapy); uPCR; eGFR; the proportion of pts with Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score &lt;4; Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI); and corticosteroid use. Analyses were based on observed data and summarised relative to the OL baseline (last available value measured prior to dosing on or before the date of the first OL treatment dose). Results Of 257 pts (57.4 % of pts in BLISS-LN double-blind [DB] study) screened and enrolled, 255 pts were treated (safety population: 123 pts switched from PBO to BEL; 132 pts remained on BEL). In total, 254 pts were included in the efficacy analyses (PBO to BEL: 122 pts; BEL to BEL: 132 pts). Mean (standard deviation) age was 35.9 (10.3) years. In total, 3.5% of pts withdrew from the OL phase, mainly due to adverse events (AE; 2.0%). Overall, 168/255 (65.9%) pts experienced ≥1 AE (76/123 [61.8%] PBO to BEL pts; 92/132 [69.7%] BEL to BEL pts); 49/255 (19.2%) pts had ≥1 treatment-related AE (25/123 [20.3%] PBO to BEL pts; 24/132 [18.2% ] BEL to BEL pts); 15/255 (5.9%) pts had ≥1 serious AE (5/123 [4.1%] PBO to BEL pts; 10/132 [7.6%] BEL to BEL pts); and 1 death was reported in the PBO to BEL group. The proportion of patients achieving PERR and CRR increased from OL baseline to OL Week 28 in both groups (Table). The median (interquartile range [IQR]) for uPCR and eGFR were maintained from OL baseline through to OL Week 28 (Table). The proportion of SLEDAI score &lt;4 responders in BEL to BEL group tended to increase from OL baseline to OL Week 28, and decrease in the PBO to BEL group (Table). SDI worsening (change &gt;0) was experienced by 7 (2.9%) pts (4 [3.3%] PBO to BEL; 3 [2.5%] BEL to BEL) compared with OL baseline. There was no appreciable change in the number of patients receiving average daily prednisone-equivalent doses of ≤5 mg or ≤7.5 mg from OL baseline to OL Week 28 (Table). Conclusion BEL was well tolerated as an add-on to ST, with no new safety signals. Efficacy among pts with LN randomised to BEL during the DB phase was maintained during the OL phase. Study funding GSK. Editorial assistance (GSK-funded): Olga Conn, PhD, Fishawack Indicia Ltd., part of Fishawack Health, UK.

MO277THE RATIO OF NEUTROPHIL TO LYMPHOCYTE AS A POTENTIAL MARKER OF CLINICOPATHOLOGICAL ACTIVITY FOR SYSTEMIC LUPUS ERYTHEMATOSUS

Background and Aims The ratio of neutrophils to lymphocytes (NLR) is a novel inflammatory factor that is elevated in systemic lupus erythematosus (SLE) and related to disease activity. However, the relationship between NLR and renal pathological manifestations in patients with lupus nephritis (LN) has not been studied. Method In this retrospective study, 240 SLE patients were recruited. 186 patients with renal involvement and 124 LN patients underwent renal biopsy. In the meanwhile, control groups included 125 chronic kidney disease (CKD) patients and 125 healthy volunteers. Patients with SLE disease activity 2000 (SLEDAI-2K) &gt;9 and ≤ 9 were defined as severely active and mildly active, respectively. Clinical parameters and pathological data were collected. The correlations between NLR and clinicopathological features were analyzed. Results The NLR of SLE group was significantly higher than that of the sex-age matched control groups. Patients with nephritis had higher NLR levels than those without nephritis [2.88(1.81,4.32) vs. 2.43(1.55,3.90), P=0.044; Figure 1]. Increased NLR was observed in severely active group compared to mildly active group [3.00(1.84,4.28) vs.2.36(1.61,3.51), P=0.020; Figure 1]. NLR was significantly positively related with SLEDAI score (r=0.131, P=0.043), Renal SLEDAI score (r=0.173, P=0.023), C-reactive protein (CRP; r=0.213, P=0.002), 24-hour urine protein (r=0.274, P&lt;0.001; Figure 2A), renal activity index (AI; r=0.192, P=0.033), cellular crescents (r=0.274, P=0.006) and tubular atrophy (r=0.226, P=0.011), and negatively correlated with serum albumin (r=-0.187, P=0.004; Figure 2A). Based on the receiver operating characteristic (ROC) curve, the best NLR cut-off value to predict severe activity and cellular crescents was 2.19 and 3.16, respectively. The ability of NLR to differentiate severely active from mildly active SLE was stronger than CRP and weaker than C3 (Figure 3A). The ability of NLR to predict cellular crescents was better than C3, but not superior to SLEDAI and RSLEDAI. Interestingly, the ROC fitted by NLR and RSLEDAI had a higher AUC and sensitivity [AUC=0.75(0.66,0.84), sensitivity=82.6%, specificity=63.6%; Figure 3B]. Conclusion NLR was a non-invasive and potential inflammatory factor to evaluate clinical and renal pathological activity in patients with SLE.