AB1229 SAFETY OF BIOSIMILAR ETANERCEPT IN THE TREATMENT OF RHEUMATIC DISEASES: DATA FROM THE MEXICAN ADVERSE EVENTS REGISTRY (BIOBADAMEX)

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with high morbidity and disability that affects all aspects of quality of life (QoL). (1) LupusPRO is a disease-targeted patient-reported outcome tool for the measurement of health and non-health related quality of life (HRQoL and Non-HRQoL) in SLE patients. (2) Objectives: To translate, cross-culturally adapt, and validate the LupusPRO v.1.8 into the Arabic Language. Methods: LupusPRO v.1.8 was translated into Arabic following the forward-backward translation guideline. (3) The Arabic version of LupusPRO was subsequently applied to 107 Egyptian SLE patients. To assess test-retest reliability, the Arabic LupusPRO was completed on two occasions, two weeks apart. Validation was performed against the Arabic version of Medical Outcomes Study Short Form (SF-36), the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index (SDI). Discriminant validity of Arabic LupusPRO was evaluated against the SF-36 (item 1), while the conceptual framework was evaluated by the confirmatory factor analysis (CFA). Results: The study included 107 patients, 95% of whom were women. Their median age was 32 (range:18-55) years. Arabic LupusPRO’s Cronbach’s alpha ranged from 0.71 to 0.98 except for the social support domain (0.65). Test-retest reliability ranged from 0.83 to 0.98. Convergent validity with corresponding domains of the SF-36 was satisfactory. Criterion validity showed a weak and non-significant correlation of lupusPRO domains with SDI except for physical domain and significant weak correlation with SELENA-SLEDAI (Table1). Discriminant validity showed acceptable results against the SF-36 (item 1). The CFA showed good model fit indices for the hypothesized item-to-scale relationships (CFI =0.988, TLI = 0.987, and RMSEA=0.062), with most of item-to-scale loadings greater than 0.9. Conclusion: The Arabic version of LupusPRO v1.8 is a reliable and valid tool for measuring QoL(HRQoL and Non-HRQoL) in Arabic-speaking SLE patients. References: [1]Mcelhone K, Abbott J, Teh L-SJL. A review of health- related quality of life in systemic lupus erythematosus. Lupus 2006;15(10):633-43. [2]Jolly M, Pickard AS, Block JA, et al. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Semin Arthritis Rheum. 2012;42(1):56–65. [3]Beaton D, Bombardier C, Guillemin F, Ferraz M. Guidelines for the Process of Cross-Cultural Adaption of Self-Report Measures. Spine. 2001;25:3186-91. Disclosure of Interests: None declared