Purpose To study the clinical safety and adverse events (AEs) of Belimumab treatment in routine clinical practice in SLE patients.
Methods Retrospective observational study in which data from patients diagnosed of SLE according to SLICC 2012 criteria treated with intravenous Belimumab therapy (Initial: 3 doses 10 mg/kg IV every 14 days and maintenance dose: 10 mg/kg IV every 28 days) were collected. Analytical data of serological profile, clinical manifestations at the onset of the disease and at present, concomitant immunosuppressant and AEs (grouped in non-infectious, infectious, and infusion/hypersensitivity reactions) from July 2012 to September 2017 were collected.
Results A total of 15 patients [13 women (86.6%), median (SD) age 32 (8.34) and age at diagnosis 20.17 (11.5) years] were included. Median follow-up was 20 months (range, 1–61). Serologic Activity and clinical manifestation are shown on table 1.
Discontinuation of Belimumab therapy was observed in 4 patients after a 1, 16, 13, and 61 months of follow-up respectively. One patient discontinued voluntary after 61 months of treatment due to desire for pregnancy. The other three patients discontinued by itchy skin lesions, primary pulmonary hypertension and peripheral venous insufficiency.
21 AEs were reported (19 infectious and 2 non-infectious), and 18 occurred in patients with more than 12 months of follow-up. No infusion-related reactions were observed.
All patients received concomitant immunosuppressant therapy (hydroxychloroquine in 8, mycophenolate mofetil in 6, azathioprine in 4, and methotrexate in 2). 12 patients were receiving simultaneous glucocorticoid treatment. We observed a significant decrease in the mean daily prednisone dose over time (8.0 mg/day at the beginning to 5.3 mg/day at the end of study).
Conclusions In conclusion, our data confirm the safety of Belimumab therapy in SLE patients. Overall, 4 (20%) patients discontinued treatment due to AEs and in one additional patient (7%) treatment was stopped due to pregnancy. Reduction of disease activity was observed in 12 (80%) of our patients. Finally, the significant decrease of prednisone dose is associated to and additional reduction in steroid-related AEs and with an increase in patient’s quality of life.
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