Background: Neuropsychiatric SLE (NPSLE) causes significant morbidity and mortality and is often excluded from randomized controlled trials. Rituximab (RTX) is recommended by European guidelines for the treatment of NPSLE but evidence is based on small case series of <50 patients. Objectives: To describe the baseline characteristics and early clinical outcomes of NPSLE involvement in a real-world RTX-treated cohort. Methods: Patients recruited to the British Isles Lupus Assessment Group Biologics Register (BILAG-BR) and starting treatment with RTX 2010-2023 were included. Patients with active NPSLE at baseline were defined as scoring A or B in the neuropsychiatric (NP) domain of the BILAG-2004 or a positive score in a NP domain of the SLEDAI-2K. Some improvement (SI) was defined as reduction of NP-BILAG to C or D and/or resolution of NP-SLEDAI-2K score. X2 and Wilcoxon rank sum tests were used to compare baseline characteristics between those with NPSLE and the non-NPSLE RTX-treated cohort. Statistical analysis was performed using Stata IC (V14). Results: 1779 patients were recruited to the BILAG-BR during the study period. 1311 received RTX and 146 of these had active NPSLE at baseline. 28 were excluded due to insufficient follow up data. 86% (102/118) of the NPSLE cohort were female, median (IQR) age 41 (30-52) and disease duration was 4 (2-9) years. 48/118 (41%) were administered concomitant immunosuppressants, 42/118 (36%) intravenous steroid pulses and 94/116(80%) oral steroids. Median baseline prednisolone dose was 15 (9-20) mg. Compared to those without NP involvement, NPSLE patients had more damage at baseline (median SDI 1 [0-1]), previous NPSLE (69% Vs 14%) and were more likely to exhibit disease activity (BILAG A/B) in >1 domain (86% Vs 55%) (Table 1). SI was seen in 77/109 (71%) and 60/81 (74%) of NPSLE patients at 6 and 12 months respectively. Median prednisolone dose was 10 (6.1-15) mg and 8 (5-20) mg at 6 and 12 months. Conclusion: This is the largest reported cohort of rituximab-treated NPSLE-treated patients. Rituximab appears effective in the treatment of moderate-severe NPSLE and is associated with lower steroid dose at 6 months. NPSLE is often seen in the context of active multisystem disease, in those with existing damage and previous NP involvement. REFERENCES: NIL. Acknowledgements: The British Isles Lupus Assessment Group Biologics Register (BILAG-BR) consortium. Disclosure of Interests: Mia Rodziewicz Medical Research Council Clinical Training Fellow based at the University of Manchester supported by the North West England Medical Research Council Fellowship Scheme in Clinical Pharmacology and Therapeutics, which is funded by the Medical Research Council (award reference MR/N025989/1), Roche Pharma, Eli Lilly and Company Limited, UCB Pharma, Novartis, the University of Liverpool and the University of Manchester, Sarah Dyball Consulting work for Novartis, Medical Research Council Clinical Training Fellow based at the University of Manchester supported by the North West England Medical Research Council Fellowship Scheme in Clinical Pharmacology and Therapeutics, which is funded by the Medical Research Council (award reference MR/N025989/1), Roche Pharma, Eli Lilly and Company Limited, UCB Pharma, Novartis, the University of Liverpool and the University of Manchester, Trixy David: None declared, Emily Sutton: None declared, Ben Parker Honoraria from Astra Zeneca, Abbvie and Roche, Consulting fees from GSK, UCB, BMS, Merck Serono, Astra Zeneca, Il-TOO, Eli Lily, Abbvie, Vifor and Fresenius-Kabi., Grant support from GSK, Astra Zeneca and Genzyme/Sanofi., Ian N. Bruce GSK, Astra Zeneca, UCB, GSK, UCB, BMS, Merck Serono, Astra Zeneca, IL-TOO, Eli Lily, GCK, Janssen, Astra Zeneca.Table 1Baseline characteristics of rituximab-treated patients recruited to the BILAG-BRActive NPSLEn=118Non-NPSLE cohortn=1167p valueAge, years41 (30-52)41 (29-51)0.827Female gender102 (86)1033/1149 (90)0.227Disease duration4 (2-9)4 (1-10)0.982BMI25 (23-31)26 (22-30)0.694Ever smoked34/94 (36)269/687 (39)0.444Previous NPSLE81/118 (69)139/1032 (13)<0.001Baseline SLICC damage index score1 (0-2)0 (0-1)<0.001Ancestry*White73/109 (67)595/1049 (57)0.039Black22 (20)164 (16)0.178South Asian6 (5)87 (14)0.048East Asian8 (9)61 (10)0.742Other4 (4)73 (7)0.156Hydroxychloroquine use ever105/118 (89)957/1167 (82)0.061Number of previous immunosuppressants2 (1-3)2 (1-3)0.400Concomitant immunosuppressantsMycophenolate mofetil27/115 (23)272/1109 (25)0.803Cyclophosphamide13 (11)77 (7)0.075Azathioprine5 (4)55 (5)0.772Prednisolone94/116 (81)790/1093 (72)0.069Baseline prednisolone dose, mg15 (10-25)10 (7.5-20)0.093BILAG A or BConstitutional23/115 (20)90/973 (9)Mucocutaneous47 (41)414 (43)Musculoskeletal43 (37)372 (38)Cardiorespiratory27 (23)182 (16)Gastroenterological9 (8)42 (4)Ophthalmological9 (8)28 (3)Renal37 (32)367 (38)Haematological8 (7)44 (5)Global numerical BILAG25 (19-34)14 (10-22)<0.001Active disease in >1 BILAG domain†101/118 (86)642/1161 (55)<0.001NP BILAG scoreA47 (47)-B52 (53)-NP SLEDAI-2KSeizure6 (5)-Psychosis10 (9)-Organic brain syndrome17 (15)-Cranial nerve disorder6 (5)-Lupus headache31 (27)-Cerebrovascular accident10 (9)-Global SLEDAI-2K14 (6-20)8 (5-12)<0.001NP neuropsychiatric. Data presented as n (%) and median (IQR) as appropriate. †BILAG A or B. *Compared to all other ancestries.

Background: Rates of clinical response to medical therapies may be suboptimal in patients with SLE, and furthermore such responses may be discordant with patient reported outcomes. Objectives: To compare the proportion of active SLE patients with a response to therapy at 12 months using clinician assessment and patient reported outcomes. To investigate discordant outcomes between health-related quality of life (HR-QoL) and clinical response of patients with moderate-severe SLE in the UK. Methods: Patients with active disease (1xBILAG A or 2xBILAG B) commencing rituximab (RTX), belimumab or a standard of care medication (SoC) for SLE in the BILAG-BR were analysed over 12 months. Major clinical response (MCR) was defined as no BILAG-A or BILAG-Bs at follow-up, SLEDAI-2K ≤4 and prednisolone ≤7.5mg daily. Significant improvement (SI) was defined as ≤1 BILAG-B at follow-up, reduction in SLEDAI-2K and reduced daily prednisolone (less than baseline dose, ≤10mg daily if baseline dose 10-20mg, and ≤15mg if baseline dose ≥20mg). Data from the short form-36 (SF-36) were used to calculate mental (MCS) and physical component scores (PCS). Minimum clinically important difference in MCS and PCS was defined as 2.5. In patients with a SI, discordance between PCS and MCS was assessed using multivariate logistic regression. Missing data were imputed using random forest in R V4.2.2 (package: missForest V.1.5). Results: 782 patients with SLE (Female=705 [90.2%], median age [IQR]: 39.7 [31.0-49.7] years; RTX=595, belimumab=95, SOC=92) with active SLE and sufficient follow up data were recruited between 2010-2022. Ancestry was 443 (56.7%) White, 128 (16.4%) Black, 97 (12.4%) South Asian and 37 (4.7%) Chinese/ East Asian. 679 (86.8%) patients were taking prednisolone at baseline (median dose [IQR]: 8 [5-12] mg daily). At 12 months, MCR was achieved in 106 (13.6%), and a further 279 (35.7%) demonstrated SI. Patients with SI at 12 months showed greater mean (SD) improvements their MCS (3.2 [8.5] vs 1.3 [8.4], p=0.0016) and PCS (6.1 [7.5] vs 3.3 [6.0], p<0.0001), compared to those without SI. Of those who achieved SI, MCS improved in 235 (56.5%) and PCS in 311 (74.8%). The association of clinical factors with discordance of disease activity with MCS and PCS measures are described in Table 1. Discordant MCS was associated with lower baseline SLEDAI-2K score, East-Asian ancestral background, higher baseline SLICC-damage index and higher socio-economic deprivation. Discordant PCS was associated with lower baseline steroid dose, and belimumab therapy. Conclusion: We found significant discordance between clinical response and change in HR-QoL in this moderate severe SLE population. Almost half of patients achieving SI fail to demonstrate a clinically significant improvement in their psychological wellbeing. Several factors may help identify patients with discordant outcomes and could be targeted to support more holistic care for patients with SLE. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: Sarah Dyball Novartis, UCB, Mia Rodziewicz UCB, Emily Sutton: None declared, Ben Parker Eli Lilly, Roche, Fresenius-Kabi, AbbVie, Genzyme/Sanofi, GSK, Ian N. Bruce AstraZeneca, GSK, UCB, AstraZeneca, Eli Lilly, GSK, Merck Serono, UCB, ILTOO, Genzyme/Sanofi, GSK, Roche, UCB, Novartis.Table 1The association of clinical variables with discordance between achievement of significant clinical improvement with mental and physical component score improvement in multivariate analysis. Data presented as adjusted OR (95% CI) *compared to White ancestral background; † English indices of deprivation 2019 decile: 1= most deprived, 10= least deprivedSF-36Mental Component Score, OR (95% CI)SF-36Physical Component Score, OR (95% CI)Female0.54 (0.28, 1.05)1.53 (0.67, 3.51)Ancestry*Black1.19 (0.65, 2.20)0.91 (0.45, 1.82)South Asian1.07 (0.58, 2.00)1.22 (0.63, 2.37)East Asian2.40 (1.01, 5.67)1.40 (0.54, 3.61)Baseline SLEDAI-2K score0.95 (0.92, 0.98)0.99 (0.95, 1.02)Baseline SLICC-damage index1.18 (1.00, 1.42)1.17 (0.97, 1.42)English indices of deprivation decile†0.92 (0.85, 1.00)0.96 (0.88, 1.05)Baseline steroid dose (per mg)1.00 (0.97, 1.02)0.97 (0.94, 1.00)Therapy (VS SoC)Rituximab0.73 (0.35, 1.50)2.08 (0.84, 5.16)Belimumab1.00 (0.42, 2.39)3.49 (1.26, 9.68)

Background SLE more commonly affects non-White populations who suffer higher disease activity and greater damage accrual. Objectives To describe differential response of patients with moderate-severe SLE in the UK by ethnic background. Methods Patients commencing rituximab (RTX), belimumab or a standard of care medication (SoC) for SLE in the BILAG-BR were analysed over 12 months. Major clinical response (MCR) was defined as a SLEDAI-2K ≤4 at 12 months. Deprivation was measured using English indices of deprivation 2019 decile (EID, 1= most deprived, 10=least). MCR was compared using multivariate logistic regression (reference group: White background; adjusted for age, gender and EID). Missing data were imputed using random forest in R V4.2.1 (package: missForest V.1.5). Results 1601 SLE patients (Female=1447 [90.4%], median age [IQR]: 39.9 [31.0-50.6] years) commenced therapy from September 2010-September 2022 (RTX: N=1177, belimumab: N=193, SOC: N=231). 905 (56.5%) were White, 233 (14.6%) were Black, 197 were Indo-Asian, 81 (5.1%) were Chinese/ East Asian, and 60 were of Multiple-Mixed background and 125 (7.8%) preferred not to say. 1,364 (85.2%) patients were taking glucocorticoids (GC) at baseline (median dose [IQR]: 7 [4.5-11.1] mg daily).MCR was achieved in 901 (56.3%) patients at 12 months. Black patients had a higher SLEDAI-2K score at baseline compared with white individuals (Figure 1). Black, East-Asian/ Chinese patients, and Multiple-Mixed ethnic background patients received a higher GC dose at baseline (Table 1). Black, Indo-Asian and Multiple-Mixed background patients were more likely to be in a lower EID.In patients receiving RTX, Black (adjusted OR 0.36 [95%CI 0.25-0.52]) and Indo-Asian (0.42 0.18-0.96)) patients were less likely to achieve MCR. In patients receiving belimumab, Black (0.65 [0.44-0.96]) and Indo-Asian patients (0.29 [0.09-0.93]) were also less likely to have an MCR. Absolute reduction in SLEDAI-2K was similar for each ethnic group. Conclusion Although absolute reduction in disease activity was similar across ethnic backgrounds, obtaining a MCR following treatment was lower in Black and Indo-Asian patients, in part reflecting higher baseline disease activity, but not explained by level of social deprivation; an observation not confined to a single treatment. There is a need for investigation into the drivers of these inequitable outcomes and reappraisal of treat-to-target strategies in these populations. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests Sarah Dyball: None declared, Mia Rodziewicz: None declared, Emily Sutton: None declared, Ben Parker: None declared, Ian N. Bruce Speakers bureau: GSK, Astra Zeneca, Janssen, Consultant of: GSK, Astra Zeneca, Aurinia, Lilly, Grant/research support from: GSK, Astra Zeneca, Janssen.Table 1Demographic and clinical data by ethnic background. Data presented as median (IQR) or N (%), with respective p values computed with chi2 or Kruskall–Wallis testWhiteBlackIndo-AsianChinese/ East AsianMultiple/ Mixedp-value(N=905)(N=233)(N=197)(N=81)(N=60)Age (years)43.9 (33.5-54.4)39.2 (30.1-47.6)36.2 (27.2-43.2)32.3 (25.0-39.2)35.0 (27.5-45.6)<0.001Female816 (90.2)220 (94.4)168 (85.3)74 (91.4)57 (95.0)0.035Disease duration (years)5.92 (2.90-11.8)6.68 (3.31-11.3)5.54 (2.73-9.93)4.95 (2.74-8.20)7.23 (4.11-10.2)0.0854Deprivation Decile (EID)5.00 (4.00-7.00)4.00 (2.00-5.00)4.00 (2.00-6.00)5.00 (3.00-7.00)4.00 (2.75-6.25)<0.001Renal involvement (ever)301 (33.3)119 (51.1)123 (62.4)60 (74.1)39 (65.0)<0.001Therapy0.0808SoC125 (13.8)28 (12.0)41 (20.8)9 (11.1)5 (8.3)Rituximab677 (74.8)165 (70.8)134 (68.0)63 (77.8)50 (83.3)Belimumab103 (11.4)40 (17.2)22 (11.2)9 (11.1)5 (8.3)Current pulse steroids291 (32.2)68 (29.2)77 (39.1)20 (24.7)10 (16.7)<0.001Current steroid dose (mg)5.00 (2.00-8.50)7.50 (4.00-12.0)6.00 (3.50-10.0)10.0 (5.50-18.0)8.50 (5.00-15.3)<0.001Figure 1Mean SLEDAI-2K at baseline, 3, 6 and 12 months, in A) Rituximab (n=1089), B) Belimumab (n=179) and C) SoC (n=208) treated patients

Background Patients with systemic lupus erythematosus (SLE) are known to have an increased mortality and risk of certain cancers compared to the general population. Objectives We aimed to characterise the all-cause mortality rate (MR) and the incidence of cancer in SLE patients receiving biologic and standard of care (SoC) therapies. Methods Patients recruited to the BILAG-BR 2010-2021 were included. Demographic and clinical data were recorded at recruitment. Mortality and malignancy data were collected from study centres, the UK Office of National Statistics and the National Cancer Register. Cox regression models were used to estimate the hazard ratios (HRs) of mortality and cancer in biologic-treated patients compared to SoC. Mortality models were adjusted for age, gender, co-morbidity, SLICC damage index (SDI) and hydroxychloroquine (HCQ) use. The standardised mortality ratio (SMR) and standardised incidence ratio (SIR) were calculated using death and cancer rates for the general UK population. Results During follow-up, (1463 patients with 5,962 person years [pys]), 32 incident cancers occurred in 31 individuals, a median (IQR) of 1.31 (0.63-3.36) years after registration. The overall incidence was 6.0 (3.8-7.6) per 1000 pys. Compared to the UK general population, the SIR (95% CI) was 1.21 (0.85-1.72). Using SoC as the comparator, the age and gender adjusted HR was 1.49 (0.57-3.92) for rituximab and 2.47 (0.57-10.58) for belimumab. Across the whole cohort, associated risk factors (table 1), included age at recruitment (HR 1.05 [1.02-1.08]) and male sex (HR 2.68 [1.13-6.41]).Following registration, 54 deaths occurred after a median of 1.8 (0.8-3.3) years. Crude MR was 9.15 (7.0-11.9) per 1000 pys. The SMR was 4.74 (3.63-6.19). The most common causes of death were infection (22, 40.7%), SLE (11, 20.3%) and cancer (6, 11.1%). MR was 3.3 (1.3-8.9) per 1000 py in the SoC, 11.3 (8.5-15.0) in the rituximab and 2.5 (0.4-17.9) in the belimumab group. Risk factors included age at recruitment (HR 1.07 [1.05-1.09]) and SDI (HR 1.34 [1.08-1.67]. HCQ use was protective (HR 0.30 [0.14-0.65]). In multivariate analysis, compared to SoC, risk was similar in rituximab (HR 2.36 [0.69-8.10) and belimumab groups (HR 1.41 [0.14-14.14]). Conclusion Although overall numbers are low, mortality rate and incidence of cancer appears to be broadly similar in SoC, rituximab and belimumab treated patients. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests Mia Rodziewicz: None declared, Sarah Dyball: None declared, Emily Sutton: None declared, Stephen McDonald: None declared, Ben Parker: None declared, Ian N. Bruce Speakers bureau: GSKAstra ZenecaJanssenConsultant of: GSKAstra ZenecaAuriniaLillyGrant/research support from: GSKAstra ZenecaJanssen.Table 1Risk factors associated with risk of cancer and death in a cohort of patients with moderate-severe SLECancerDeathHazard ratio (HR) (95% CI)Adjusted HR* (95% CI)HR (95% CI)Adjusted HR**(95% CI)Age at recruitment (per year)1.07 (1.04-1.09)1.05 (1.02-1.08)1.07 (1.05-1.09)1.04 (1.02 -1.07)Male sex3.51 (1.57-7.86)2.68 (1.13-6.41)2.06 (1.01-4.22)1.48 (0.54 -4.05)Disease duration1.02 (0.99-1.05)-1.01 (0.98-1.03)-SLICC damage index score at baseline (per unit increase)1.20 (0.96-1.49)-1.58 (1.39-1.81)1.37 (1.11-1.68)SLEDAI at baseline (per unit increase)0.99 (0.93-1.05)-1.01 (0.97-1.06)-Smoking ever1.46 (0.69-3.06)-1.49 (0.79-2.81)-Previous cancer2.81 (1.15-6.85)2.05 (0.81-5.22)3.29 (1.58-6.82)2.03 (0.83-5.02)Myocardial infarction2.57 (0.61-10.80)-5.33 (2.26-12.55)0.93 (0.22-4.00)Diabetes mellitus0.59 (0.08-4.34)-3.85 (1.79-8.25)1.63 (0.53-4.98)Hypertension2.21 (1.05-4.67)1.45 (0.67-3.13)1.81 (1.00-3.26)0.73 (0.32-1.67)Ethnicity2.68 (1.20-5.99)1.77 (0.68-4.58)1.85 (1.05-3.26)0.96 (0.41-2.23)Prednisolone dose at baseline (per mg)0.99 (0.94-1.03)-0.98 (0.94-1.02)-Previous:Hydroxychloroquine0.84 (0.32-2.18)-0.33 (0.18-0.60)0.31 (0.15-0.69)Mycophenolate mofetil0.82 (0.39-1.69)-1.16 (0.66-2.07)-Cyclophosphamide1.30 (060-2.83)-1.1 (0.65-2.14)-*Adjusted for age, sex, previous cancer, hypertension and ethnicity**Age, sex, previous cancer, myocardial infarction, diabetes mellitus, hypertension, white ethnicity and HCQ use

BackgroundPatients with systemic lupus erythematosus (SLE) are thought to be at greater risk of severe COVID-19 illness and associated complications due to a combination of inherent aberrant immune responses, immunosuppressive medications and co-morbidities.ObjectivesTo review COVID-19 infections, hospitalisation and recovery in a real-world cohort of patients with moderate to severe SLE and high immunosuppressant use.MethodsThe British Isles Lupus Assessment Group Biologics Registry (BILAG-BR) is a national prospective registry of lupus patients from the UK (2010-21) requiring significant immunosuppressive therapies. Patients from the BILAG-BR were invited to complete a paper or online questionnaire which consisted of 17 questions to assess prior COVID-19 infection and their recovery during the COVID-19 pandemic. Questionnaires were completed between 9th Oct 2021 and 7th Jan 2022. Responses were linked with data collected in the BILAG-BR. Mortality data were collected from study centres and the Office of National Statistics from Dec 2019-Jan 2022.ResultsData were collected from the first 202/1268 patients to respond. Patients were predominately female (186, 92.1%), had a median age of 51 (IQR 38-61) years and were from 37 UK centres. Previous therapy included rituximab (165, 81.7%), belimumab (33, 16.3%) and cyclophosphamide (54, 26.7%). In the past 12 months, over two thirds of patients (138, 68.3%) had received oral prednisolone (current median dose 5mg [IQR 5-8mg] daily), and almost a third had received parental steroids (60, 29.7%).Self-reported COVID-19 diagnosis occurred in 48 (23.8%) patients, of whom 20 reported a positive test. Eleven (55%) patients reported testing positive for COVID-19 after being vaccinated. Median reported recovery was 80% (IQR 60-100%), with subjective full recovery reported in 30% of patients (6/20) who had received a positive test. Of the 20 patients who tested positive for COVID-19, 5 were receiving belimumab, 1 tocilizumab, and in the prior 12 months, 2 had received cyclophosphamide and 4 rituximab.Of all respondents, three individuals were hospitalised with COVID-19, and one required an ICU admission. Of those hospitalised, two patients were unvaccinated prior to COVID-19 infection, and the other patient had received rituximab and cyclophosphamide prior to vaccination. Four/1387 patients registered in the BILAG-BR were confirmed to have died from COVID-19 since the beginning of the pandemic.ConclusionIn this cohort of moderate-to-severe SLE patients there was a low incidence of COVID-19 infection. Despite this, full recovery from PCR or lateral flow test proven COVID-19 infection was seen in only a third of patients. This raises concerns over the potential risk of long COVID in patients with SLE and warrants further investigation.AcknowledgementsSubmitted on behalf of the BILAG-biologics registerDisclosure of InterestsSarah Dyball Grant/research support from: UCB and Eli Lilly, Mia Rodziewicz Grant/research support from: UCB, Emily Sutton: None declared, Ben Parker Speakers bureau: Eli Lilly and Roche, Consultant of: Fresenius-Kabi and AbbVie, Grant/research support from: Genzyme/Sanofi and GSK, Ian N. Bruce Speakers bureau: AstraZeneca, GSK and UCB, Consultant of: AstraZeneca, Eli Lilly, GSK, Merck Serono, UCB and ILTOO, Grant/research support from: Genzyme/Sanofi, GSK, Roche and UCB

Background:Despite unprecedented drug development in SLE, the paucity of approved therapies remains a significant challenge. Recent trials have highlighted the need for minimising heterogeneity within SLE populations; however, there is concern this results in the recruitment of patients that are not representative of the SLE population.Objectives:Our aim was to apply published trial eligibility criteria to patients with non-renal SLE in a large UK-wide register to quantify how accurately these clinical trials represent a real-world cohort.Methods:A literature review of all major published double-blinded randomised phase III trials in non-renal SLE was performed (n=12). Inclusion and exclusion criteria common across the majority of clinical trials were applied to all patients recruited to the BILAG-BR (BILAG biologics register) starting either biological therapy or standard of care (SOC). We applied available data to common inclusion criteria including age ≥18 years, ACR 1997 SLE classification criteria, positive anti-dsDNA or ANA antibodies, active disease (defined as a BILAG A in 1 domain or a BILAG B in ≥2 domains, or a SLEDAI ≥6); and common exclusion criteria including restricted medication rules, active renal or neurological SLE (defined as a BILAG A in either domain), a history of hepatitis B or C, a history of malignancy (excluding basal cell carcinoma), CKD stage 4 or 5, a UPCR ≥100mg/mmol, and cytopenias (defined as neutrophils <1.0 x109/L, platelets <10 x109/L or Hb <70g/L). Baseline variables were compared using chi-squared test.Results:As of July 2018, 837 patients were recruited to the BILAG-BR starting either SOC (n=125) or a biologic therapy (n=712). The commonest biologic and SOC therapy was rituximab (n=662, 93%) and mycophenolate (n=64, 51%) respectively. Patients taking SOC were more likely to have inactive disease, as well as having higher steroid doses and less exposure to previous cyclophosphamide or B cell therapy. In the biologic and SOC groups, 476 (67%) and 71 (57%) respectively met all inclusion criteria (table 1). One or more exclusion criteria were met by 324 (46%) of the biologics group and 46 (37%) of the SOC group. As such, 562 (67%) patients were not eligible to enrol in a clinical trial. The patients not eligible to participate were similar in age (P=1.0), gender (P=0.7) and ethnicity (p=0.5) to those who were eligible. Median disease duration was longer in patients eligible to participate (2.9 vs. 5.1 years, p<0.01).Table 1.Patients from the BILAG-BR who meet eligibility criteria for major SLE clinical trialsInclusion criteriaBiologic (n=712)SOC (n=125)P valueAge ≥18 years7061220.1Meet ACR criteria for SLE6751160.4Antibody positive567990.9Active disease62697<0.01Total meeting all inclusion criteria476710.03Exclusion criteriaBiologic (n=712)SOC (n=125)P valueSteroids >40mg prednisolone98<0.001Active CNS SLE3971.0Active renal SLE138280.4Hepatitis B or C2010.2Malignancy5250.2Cyclophosphamide <90 days before entry370<0.01B cell therapy <1 year before entry500<0.01CKD 4/ 52230.7UPCR ≥100mg/mmol92201.0Low blood counts2510.1Pregnancy310.6Total number of patients excluded324460.1TotalNOT*eligible for clinical trial(n)562/837 (67%)1.0Conclusion:In a large national register of SLE patients, we found that two thirds of patients would not be eligible for recruitment to clinical trials using published inclusion and exclusion criteria. These results suggest that clinical trial recruits are not fully representative of the target disease population. This limits the generalisability of clinical trial results and supports the need for evidence from real world studies to fully understand the effectiveness of new therapies.Disclosure of Interests: :Sarah Dyball: None declared, Sophie Collinson: None declared, Emily Sutton: None declared, Eoghan McCarthy: None declared, Ben Parker Grant/research support from: GSK and Sanofi Genzyme, Consultant of: GSK, AstraZenaca, UCV, Abbvie, Pfizer, BMS, Celltrion, Ian N. Bruce Grant/research support from: Genzyme Sanofi, GSK, and UCB, Consultant of: Eli Lilly, AstraZeneca, UCB, Iltoo, and Merck Serono, Speakers bureau: UCB

Background and aims The anti-CD20 agent rituximab (RTX) is generally reserved for the treatment of refractory SLE. Whist response is variable no clear predictors of early response have been confirmed. We aimed to explore factors that predict early response to RTX in a nationwide cohort of patients receiving their first RTX course. Methods The BILAG-BR has recruited patients with refractory SLE starting RTX in the UK since Sept 2010. For this analysis we included patients who received RTX up to November 2015, had active disease at baseline, and had disease activity indices reported at baseline and 6 months. Response was defined as improvement of all active BILAG 2004 systems with no worsening in other systems or SLEDAI-2K; and no increase in glucocorticoid dose at 6 months. Results In 197 patients (90.36% females) 99 (50.8%) responded at 6 months. In a multivariable model with imputation for missing variables, concomitant IV cyclophosphamide and higher baseline oral glucocorticoid dose were associated with better response. A higher baseline global BILAG-2004 score was associated with lower rates of response (Table 1). Conclusions Early response to RTX in refractory SLE was associated with use of concomitant cyclophosphamide, higher glucocorticoid doses and lower baseline disease activity. Serology and demographic factors did not predict response. Understanding how concomitant therapy improves longer-term responses and identifying novel biomarkers of response will improve patient selection and overall outcomes for patients receiving this therapy.

Background: Children and young adults with JIA have increased levels of poor oral hygiene and dental decay [1].Periodontitis and types of arthritis are linked by similar components of blood cytokine profiles.Good dental health can be directly affected in JIA patients due to physical limitations in upper limb movements making brushing and flossing teeth difficult.An important factor in oral care is good dental hygiene and access to dental health practitioners.NHS advice is that all children should be reviewed by a dentist annually and be offered both sealant of their teeth and fluoride varnish at the appropriate time.Our aim was to establish if our patients had any barriers to accessing dental care.Methods: All patients (age 18 and under) diagnosed with JIA in the paediatric rheumatology clinic over a period of 3 months were asked to complete a dental care questionnaire.Parents completed the questionnaire for their children if necessary.Data were analysed using Excel.Results: 30 questionnaires were completed.Demographics were M:F 1:1.3, all children were diagnosed with JIA, average age 10.5 years with range 2-18.27 children were registered with an NHS dentist with the exception of one child with a private dentist.26 children had seen a dentist at least annually and one child in the past 2 years. 2 children, one aged 16, were not registered with a dentist because their parents didn't think it was important.11 children had 25 fillings in total, 9 of these children were not supervised during dental hygiene.13 children admitted to drinking sugary drinks daily and had 16 dental fillings.None of the children admitted to smoking.Conclusions: Whilst our audit showed that most children were registered with a dentist and were reviewed annually, only 1 child had been offered sealant and fluoride varnish.The NHS advises that children with chronic medical conditions can be seen either by their NHS dentist or by the local Community specialist dental service which can be accessed by referral from their rheumatology department or NHS dentist.None of the children were seen by the specialist dental service.We have developed an information leaflet informing parents and children with JIA of the importance of dental health explaining the benefits of both sealant and fluoride for teeth.