Objectives To derive and validate a definition of low disease activity (LDA) for systemic lupus erythematosus (SLE) based on the SLE Disease Activity Score (SLE-DAS), in a real-life multicentre cohort of SLE patients. Methods Derivation was conducted using data from a monocentric cohort of SLE (Portugal), and validation was performed in a multicentre cohort (Italy, France, and Spain). The Lupus Low Disease Activity State (LLDAS) was used as comparator. We applied receiver operating characteristics (ROC) curve analysis against the LLDAS to determine the cut-off of SLE-DAS for LDA using bootstrap methodology. In a second step, we tested a definition of SLE-DAS LDA that included: (i) the statistically derived SLE-DAS upper threshold for LDA, and (ii) prednisone dose ≤7.5 mg/day. In the multicentre validation cohort, we assessed the classification performance of this SLE-DAS LDA definition. Results We included 774 patients, 300 in the derivation and 474 in the validation cohorts, respectively. In the derivation cohort, the optimal cut-off to identify patients in LLDAS was SLE-DAS ≤2.48, presenting an area under the curve (AUC) of 0.965 (95%CI 0.935–0.994). When applied to the multicentre validation cohort, the SLE-DAS LDA definition showed a sensitivity of 97.1% and a specificity of 97.7% for LLDAS and an almost perfect agreement (Cohen’s Kappa =0.933; p< 0.001). McNemar’s test found no significant differences between the two definitions (p= 0.092). Conclusion The SLE-DAS LDA is a validated, accurate, and easy-to-use definition for classifying SLE patients in LDA state.

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Background:In rheumatoid arthritis (RA), global disease activity is commonly assessed, from the patient’s and the physician’s perspective, through a 100mm VAS. Previous studies have commonly shown a considerable discrepancy between the patient’s and physician’s assessment.Objectives:This study aimed evaluating patient-physician discordance in the assessment of disease activity and to explore its determinants.Methods:Cross sectional study including RA patients (ACR/EULAR 2010 classification criteria), aged ≥ 18 years, followed in a single tertiary centre. Data were collected from the most recent evaluation including sociodemographic features, disease duration (years), disease activity (DAS 28 3V-PCR), tender and swollen joint count 0-28 (TJC and SJC), VAS-pain-patient, patient and physician global assessment (PGA and PhGA respectively), erythrocyte sedimentation rate (ESR), C-reactive protein (CPR), Health assessment questionnaire (HAQ) and EuroQol five-dimension scale (EQ5D). The discrepancy between patients and physicians (ΔPPhGA) was defined as PGA minus PhGA, and a difference > |20mm| was considered as “discordant”. A descriptive analysis was performed and variables described as proportions or means (+/- SD), as adequate. Correlation between ΔPPhGA and other variables was assessed through Pearson’s correlation and comparison between groups through t-test. Variables with p<0.05 or otherwise considered clinically relevant were included in multiple linear regression analysis to identify predictors for ΔPPhGA. A p≤0.05 was considered statistically significant.Results:In total, 467 patients with RA were included (81.2% female; mean age 63.9% ± 12.2 years). PGA and PhGA were discordant in 61.7% of the cases, the patient scoring higher than the physician in 95% of these cases. The proportion of concordance increased (p< 0.01) when considering only patients in remission (DAS 28 3V <2.6), (Graph 1). ΔPPhGA was moderately correlated with VAS-pain-patient (r = 0.59) and weakly correlated with SJC (r = -0.12), HAQ (r= 0.27), EQ5D (r = -0.28) and age (r = 0.21); all p<0.01. In multivariate analysis, VAS-pain-patient (β 0.74, 95% CI 0.62-0.88, p=0.00) and TJC (β 0.16, 95% CI 0.45-0.48, p=0.02) remained associated with a higher ΔPPhGA.Conclusion:Our study confirmed that a significant discrepancy between patients and physicians in the assessment of global disease activity is frequent in clinical practice, probably due to valorization of different parameters. This was much less pronounced among patients in remission. Higher VAS-pain-patient and TJC were independent predictors of greater discrepancy between patients and physician’s assessment.Disclosure of Interests:Luisa Brites: None declared, Flavio Costa: None declared, João Dinis de Freitas: None declared, Mariana Luis: None declared, Ana Rita Prata: None declared, Helena Assunção: None declared, LILIANA SARAIVA: None declared, Marlene Sousa: None declared, Ana Rita Cunha: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, Catia Duarte: None declared

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Background:The patent expiration of the original etanercept in Europe has facilitated the development of biosimilar products. Non-significant differences in efficacy and safety were noted in clinical trials which are not expected to influence clinical performance. Nonetheless, daily practice data should be gathered to support the claim for biosimilarity.Objectives:To compare the effectiveness and safety of original and biosimilar etanercept, in biological-Disease Modifying Antirheumatic Drug (bDMARD)-naïve patients.Methods:A retrospective multicenter non-interventional study, using data collected prospectively from Reuma.pt (The Rheumatic Diseases Portuguese Register) was done, including patients with: age ≥ 18 years old; diagnosis of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Spondyloarthritis (SpA) (axial or peripheral); active disease who initiated treatment with etanercept as first line of biological treatment after 2010. Kaplan-Meyer was used to calculate the persistence rate in treatment. Disease activity at baseline and follow-up data at 6, 12, 18 and 24 months of treatment was compared using the chi-square for categorical variables and t-student or Mann-Whitney tests for continuous variables. Reasons for discontinuing therapy were summarized using descriptive statistics. Statistical significance was assumed for 2-sided p-values >0.05.Results:We included 1694 patients (413 on biosimilar and 1280 on original etanercept) 864 with RA, 335 with PsA and 494 with SpA. The population’s baseline characteristics were not significantly different among both groups, except concomitant treatment in RA (higher use of conventional DMARDs in biosimilar group and higher use of NSAIDs in original group) and in SpA patients (higher use of corticosteroids in original group).At baseline, a higher joint count was found in patients treated with original etanercept with a statistical difference for swollen (p=0.03) and tender (p=0.01) joints count (SJC and TJC, respectively) in RA and in TJC in SpA patients (p=0.02). In RA patients, CDAI and SDAI were higher in patients who started original (p=0.03; p=0.04, respectively). Pain measured by visual analogic scale was higher in SpA patients treated with biosimilar (p=0.03).The 3-year PR was not significantly different between both treatment groups in RA, PsA and SpA (Figure1). In RA, PR in biosimilar was 72.6%, with a median time-on-drug (TOD) of 28.3 months; for original etanercept PR was 63.6%, with a median TOD of 27.4 months (p=0.566). In PsA patients, the PR for biosimilar was 70.6%, with a median TOD of 27.6 months, and in original drug 67.0%, with a median TOD of 28.1 months (p=0.743). In SpA patients, the PR were 78.4% for biosimilar (median TOD of 27.4 months) and 71.5% for original treatment (median TOD of 28.0 months (p=0.816)).Figure 1.Drug survival in biosimilar and original etanercept in Rheumatoid Arthritis, Psoriatic Arthritis and SpondyloarthritisIn RA patients, we did not find differences between the two treatment groups for the proportion of patients in remission or low disease activity by CDAI ≤10, SDAI≤11 or DAS28 <3.2 at 6, 12, 18 and 24 months of treatment. For PsA, no differences were found in the same timelines for DAPSA≤14, DAS28<3.2, BASDAI<4, ASDAS<2.1 or PsARC response. Also, in SpA patients, no differences were found in BASDAI<4, BASFI<4, ASDAS<2.1, ASDAS response and BASDAI response in all the timelines with the exception of BASDAI response at 18 months, which was achieved in fewer patients in biosimilar therapy (p=0.02).Overall, 535 (31.6%) patients stopped etanercept (428 patients on original and 107 patients on biosimilar). Discontinuations due to inefficacy were the most frequent, but there were no significant differences between both groups as for adverse events. Discontinuations due to “other reasons” were higher for the original group, both in RA (p=0.01) and in SpA (p=0.04).Conclusion:Biosimilar and original used as first-line biological treatment showed similar effectiveness and safety in our long-term cohort of patients with RA, PsA, and SpADisclosure of Interests:None declared