Real-world treatment patterns and outcomes in moderate-to-severe SLE: findings from the Spanish SPOCS cohort

Abstract

OBJECTIVE: This analysis describes disease activity, organ damage and health-related quality of life (HRQoL) in patients with active SLE and moderate-to-severe disease activity from the Spanish SLE Prospective Observational Cohort Study (SPOCS) cohort. METHODS: SPOCS (NCT03189875) is a multicentre, prospective, observational cohort that followed-up adults with SLE every 6 months for up to 3 years. Disease activity was assessed using SLE Disease Activity Index 2000 (SLEDAI-2K) and Physician Global Assessment. Remission and Lupus Low Disease Activity State (LLDAS) definitions were therapeutic objectives; organ damage by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI); HRQoL by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Patient Health Questionnaire-8 (PHQ-8) and EuroQol 5-Dimension 5-Level (EQ-5D-5L). Patients were recruited from 18 Spanish sites (2017-2019). RESULTS: 99 patients were enrolled. At baseline, median (IQR) SLEDAI-2K was 8 (7-12); 45% of patients had organ damage (mean (SD) SDI 1.1 (1.6)). Remission was achieved by 13% at 6 months and at 24 months; sustained remission occurred in 9%. 24% achieved LLDAS at 6 months and ?22% thereafter; 8% maintained LLDAS for ?70% of follow-up. Median SLEDAI-2K declined to 4 at 6 months. New or worsening organ damage occurred in 11%, 8% and 12% of patients at 12, 24 and 36 months, respectively; mean SDI (SD) increased to 1.8 (2.0) by 36 months. Musculoskeletal, cutaneous, neuropsychiatric and renal systems were most frequently involved. HRQoL remained poor: 60%-75% had depressive symptoms (PHQ-8 ?5), 35%-50% moderate-to-severe depression (PHQ-8 ?10), mean FACIT-F ?30 (indicating persistent severe fatigue) and mean EQ-5D-5L index 0.70-0.75. Pain/discomfort affected up to 76% and anxiety/depression up to 66% of participants. CONCLUSIONS: In Spanish clinical practice, sustained remission and low disease activity state remain uncommon in moderate-to-severe SLE. Nearly half had organ damage at baseline, with continued accrual and impaired HRQoL. These findings highlight ongoing challenges in achieving lasting disease control and underscore the need for broader adoption of treat-to-target approaches to improve outcomes and prevent irreversible organ damage in this patient population. TRIAL REGISTRATION NUMBER: NCT03189875.