AB0494 Early Clinical Experiences with Belimumab in Polish Patients with Systemic Lupus Erythematosus

Background Belimumab is a monoclonal antibody, inhibitor of soluble B-cell activating factor, that is used in the adjuvant treatment of adult patients with active seropositive systemic lupus erythematosus (SLE) [1]. Belimumab was approved in Poland in 2011. Objectives To analyze the influence of belimumab therapy on the severity of SLE (expressed as SLEDAI score) and glucocorticoid (GC) use in Polish patients qualified to Early Access Program (EAP). Methods Recruitment to EAP was started in April 2012 in 8 Polish tertiary rheumatology centers. A total of 23 subjects were enrolled. The data of 22 patients (mean age 38.5±8.7 years, 18 women) with at least 3-month follow-up were analyzed. Median time elapsed between the diagnosis of SLE and the enrollment was 7 years (range: 1-39 years). Median SLEDAI score at baseline equaled 13.5 points (range: 6-32 points), and median baseline prednisone equivalent amounted to 11 mg (range: 5-35 mg). Results Median SLEDAI score at 3 months (7 points, range: 3-14 points) was significantly lower than the respective baseline value (p