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OBJECTIVES: The study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC). METHODS: A systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years. RESULTS: For the 5-year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (-0.434; 95% CI -0.667 to -0.201; p<0.001). For the time to organ damage progression analysis (1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases 2 was greater in the SoC group compared with the belimumab group. CONCLUSIONS: PS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.
author list (cited authors)
Urowitz, M. B., Ohsfeldt, R. L., Wielage, R. C., Kelton, K. A., Asukai, Y., & Ramachandran, S