Use of belimumab in real-world in Spain: a scoping review about characteristics of SLE patients

Abstract

Abstract Background Belimumab was the first biological drug approved for Systemic Lupus Erythematosus (SLE). There is not a review focusing on all real-life experience with belimumab to date that could help to describe how this drug behaves in the Spanish clinical setting. Objective To describe the characteristics of SLE patients treated with belimumab added to standard of care in real-clinical setting in Spain. Methods We conducted a comprehensive scoping review of real-world data (RWD) according to PRISMA Scoping Reviews Checklist and the framework proposed by Arksey and O’Malley. PubMed and EMBASE were searched without language restriction and hand searches of relevant articles were examined. Results We included data from 222 patients treated with belimumab for SLE included in 19 RWD studies conducted in Spain. The mean age was 40.9 years, 84.2% were female, and baseline scores SELENA-SLEDAI ranged between 5.9 and 12. Lupus nephritis basal prevalence was of 2.7%. The main reason for belimumab initiation was previous treatments lack of efficacy (69.7%) and the most common laboratory abnormalities were hypocomplementemia (40.9%), ANA + (34.2%), and anti-DNA (33.3%). The addition of belimumab to standard therapy was associated with a reduction of daily glucocorticoids intake in 1.4–11.1 mg at 6 months. Belimumab discontinuation was observed in 18.6% of patients. Conclusion Our study helps to further explore the profile of SLE patients most likely to be treated with belimumab. Key Points• Scientific evidence in SLE provided by randomized controlled trials sometimes differs from the actual treatment of SLE patients in routine clinical practice.• There is a lack of published “real-world” data on SLE treatment with belimumab in Spain.• This scoping review intends to describe and analyze the clinical characteristics of SLE patients receiving belimumab in a real-life setting in Spain.• These “real-world” clinical experience can provide a more realistic view of the overall patterns of SLE care compared with clinical trials.