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Background and Importance Systemic lupus erythematosus (SLE) is a rare disease with highly variable manifestations. New therapies such as belimumab appear to reduce cumulative organ damage and disease flares, improving patient’s quality of life.Aim and Objectives This study aimed to evaluate the effectiveness, safety and adherence of belimumab, supported by a mobile application for pharmacological follow-up.Material and Methods A descriptive, observational, retrospective, single-centre study was conducted including all SLE patients treated with belimumab between 2013 and 2024, excluding clinical trials. Demographic, clinical, and biochemical data were collected, while safety and adherence information were obtained through a mobile app developed by the Pharmacy Department. Evaluations were performed at weeks 24, 52, 104, 208, and at study completion. Statistical analyses were conducted using STATA v18.0. Qualitative variables were expressed as percentages (frequency) and quantitative variables as median (interquartile range).Results 46 patients without renal involvement were included, predominantly female (94.9%), with a mean age of 44.6(12,13) years. The Rheumatology Department prescribed most treatments (64.8%). Median treatment duration was 28.9 (40,21) months. Joint involvement (65.9%) and cutaneous symptoms (45.5%) were most frequent. Anti-dsDNA antibodies were positive in 91.1%. Before belimumab, 71.7% received hydroxychloroquine, 39.1% methotrexate, 26.1% azathioprine, 26.1% mycophenolate, 30.0% rituximab, and 17.4% cyclophosphamide.Baseline SLEDAI was 8.4 (4,15). At week 24, 78.6% achieved SLEDAI <4, increasing to 89.3% at week 52. Corticosteroid reduction was notable: 32.6% used ≤5 mg/day prednisone at baseline versus 78.3% at week 24 and 95.6% by week 208. Complement levels improved (C3 +9.3%; C4 +13.8%) and anti-dsDNA (-28.6%) and IgM (-19.1%) decreased at week 24, with sustained improvement through week 208.Patients provided informed consent to participate via a mobile app that issued medication reminders, recorded adverse reactions in real time, collected quality of life (EQ-5D-5L, 52.2%) and adherence (Morisky–Green, 60.9%) questionnaires, and allowed direct communication with pharmacists 24 hours. 100% patients adhered to the prescribed dosing schedule. The most frequent adverse events, all registered through the app, were recurrent infections (47.9%), headache (26.8%), and allergic reactions (14.1%).Conclusion and Relevance Belimumab effectively reduced SLE activity, corticosteroid dependence, and biochemical markers of organ damage. The mobile app improved adherence, quality of life assessment, and the detection and management of adverse reactions.Conflict of Interest No conflict of interest