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Objective To describe the experience of belimumab in Systemic Lupus Erythematosus (SLE) patients between 2013 and 2023 in a Portuguese Single Center Cohort. Methods Patients who were treated with belimumab were included. Retrospective patients' clinical charts review to demographic data, clinical manifestations, serological characteristics, previous infections and treatments, clinical and serological response to belimumab, time on belimumab, reasons to stop treatment and adverse events. SPSS was used to statical analysis. Results Twenty-eight Caucasian patients with SLE were treated with belimumab between 2013 and 2023 in our center, 27 (96,4%) female and 1 male (3,6%). Age at diagnosis was in average 25,0+/-9,5 years old, age first treatment with belimumab was 36,4+/-9,1 and disease duration before belimumab 10,8+/-6,1 years. Seventeen patients started intravenous belimumab and 2 of them switch to subcutaneous when it became available in our country. Eleven patients started subcutaneous. When belimumab was started constitutional involvement was present in 18 (64,3%), mucocutaneous 20 (71,4%), musculoskeletal 19 (67,9%), serositis 6 (21,4%), vasculitis 6 (21,4%), neurological 3 (10,7%) and renal 12 (42,9%). In average patients had 3 active SLE organ involvement. Four patients stopped belimumab before 3 months due to severe infection (2 patients), severe alopecia (1) and lost to follow-up (1). The patients with severe infection after belimumab had higher burden of immunosuppression and previous severe infections. From the patients who did more than 3 months of treatment, 19 (82,6%) had clinical response and 15 (65,2%) had serological response. In average, patients who responded were on belimumab treatment for 28,4+/-15,24 months. Time to first flare after belimumab was on average 15,5+/-10,6 months, and just 1 patient stopped belimumab after the first flare. Eight patients who responded, stopped belimumab due to lost of efficacy (3 patients), prolonged remission (2), patient's choice (1), depressive symptoms (1) and need to treat other concomitant disease (1). Minor infections occurred but none led to belimumab suspension. Conclusions Our cohort experience with belimumab add-on treatment led to clinical response in SLE patients in 82,6% of the patients. Early severe infections happened in patients with previous higher immunosuppression and severe infections burden.
Faria et al. (Fri,) studied this question.