Abstract

Background Little is known about the patient related outcomes and disease activity in systemic lupus erythematosus. Damage and impact are issues that have not been associated with activity in lupus previously. Objectives In a large cohort of systemic lupus erythematosus (SLE) patients, to evaluate the association between a Patient Acceptable Symptom State (PASS) and three different domains of the disease: activity, damage and impact of SLE on patients’ lives Methods Cross-sectional study of 1,364 SLE (ACR 97 Criteria) patients from the Spanish Society of Rheumatology Lupus Registry (RELESSER). Patients were clinically assessed by the physicians, who collected data about demographics, clinical manifestations, laboratory features and therapies. SLE activity was assessed by using the SLEDAI (SLE Disease Activity Index). The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) was used to measure damage accrual. The impact of SLE on patients’ lives was evaluated by using the Lupus Impact Tracker (LIT). The PASS question “Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?” was answered in a dichotomized way: yes/no. Measures of central tendency and spread were used to describe responses and T-test was used to evaluate the independence between PASS and the other questionnaires and indices. Results Mean age (years) ± S.D. of the 1,364 patients included in the study was 49.9 ± 13.3; 90.3% were female and 94.9% were Caucasian. In the total of patients, 979 (71.8%) were in PASS. Patients in PASS had significantly lower activity (SLEDAI Score) than those not in PASS (2.4 ± 3.2 vs. 3.0 ± 3.9, respectively; p=0.007). The SLICC/ACR DI was significantly lower in the group of patients in PASS compared to those without PASS (0.64 ± 1.1 vs. 0.81 ± 0.21, respectively; p=0.022). SLE had a significantly lower impact on patients in PASS in comparison to those without PASS (LIT Score: 8.47 ± 7.5 vs. 19.8 ± 8.34, respectively; p=0.001). Conclusion In the largest observational European Registry of SLE patients, PASS was associated with other domains of the disease: activity, damage and impact on patients’ life. PASS is a simple and reliable patient-reported outcome that can be a useful tool to evaluate patients’ well-being. Disclosure of Interests Tomas Vazquez Rodriguez: None declared, Inigo Rua Figueroa: None declared, Victor Del Campo Perez: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Francisco J Lopez-Longo: None declared, Maria Galindo-Izquierdo: None declared, Jaime Calvo-Alen: None declared, Antonio Fernandez-Nebro: None declared, Juan Ovalles: None declared, Pilar Rubio Munoz: None declared, Eva Tomero Muriel: None declared, Coral Mourino Rodriguez: None declared, Esther Uriarte Isacelaya: None declared, Angela Pecondon-Espanol: None declared, Mercedes Freire Gonzalez: None declared, Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Marian Gantes Mora: None declared, Monica Ibanez Barcelo: None declared, Carlos A. Montilla-Morales: None declared, Jose M Pego-Reigosa: None declared

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