Background and aims Clinical trials have demonstrated a safety profile of belimumab in SLE patients. Safety of belimumab under daily clinical practice is less well known. Our objective was to investigate safety of belimumab in patients with active SLE in daily clinical practice.

Methods We included patients with diagnosis of SLE (ACR criteria) treated at Medicarte IPS from March 2015 to October 2016. Medicarte is a referral centre for the integral medical care and pharmaco-surveillance of patients under biologic therapies in 13 cities in Colombia. Clinical information was obtained from electronic records. Adverse events (AE) were carefully evaluated during treatment.

Results Thirty three patients (all female) with active SLE were included. Mean age was 38.0±11.8 years, and mean disease duration was 10.6±9.2 years. Main refractory manifestations were musculoskeletal (100%), renal (45%), and mucocutaneous (42%). Background medications included MMF (87%), antimalarials (84%), MTX (72%), azathioprine (39%) and RTX (33%). Mean follow-up under belimumab treatment was 7.9±5.6 cycles. Mean prednisone doses were 12.0±11 mg/d. Only 8 (24%) out of 33 patients developed any AE. With a mean exposure time of 5.72 months, AE incidence rate, expressed as events per 100 p/months was 4.2 (Figure 1). The most common AE were: infusion reactions (3), urinary (2), and respiratory infections (1), herpes zoster (1) and mild pancytopenia (1). None of the patients stopped belimumab due AE

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Figure 1

Conclusions Belimumab was safe in clinical practice setting; only a few number of mild side AE were recorded. None of the patients discontinued belimumab treatment due AE.