Background/Purpose After the approval of belimumab for patients with systemic lupus erythematosus (SLE), the objective of this study is to describe the clinical outcomes associated with 6 months of belimumab treatment in clinical practice settings in Spain.

Methods OBSErve (GSK 200883) is a multi-center and retrospective study from community-based rheumatology practices with high experience in SLE treatment. All adult SLE patients in their practices who had received belimumab (10mg/kg) as part of routine care were identified for chart abstraction. Baseline date is the date of belimumab initiation. The activity of the disease was classified as mild, moderate and severe according the perception of the disease manifestations by the physician or based on SELENA-SLEDAI index. The primary clinical outcome measure is the overall clinical response, reported as change from baseline in SLE disease manifestations, 6 months after belimumab initiation based on physician subjective assessment. Reasons for premature treatment discontinuation were collected as secondary variable of safety, and information about steroid use and dosage within the first 6 months of belimumab therapy was collected as secondary variables of efficacy.

Results 64 eligible patient charts were included. The mean patient age was 42.7 years±12; 89% were female; 23% were diagnosed with SLE <5 years ago; 6%, 61% and 33% had mild, moderate and severe SLE respectively at baseline; 70% of patients had low C3 or C4, and 69% high anti-dsDNA at baseline. The most frequent reasons for initiating belimumab were an ineffective previous treatment regimen (78%), the intent to decrease steroid use (58%), and worsening patient condition (55%). The most frequent manifestation of SLE in these patients were musculoskeletal (arthritis=56.2%), Immunologic (low complement [C3, C4, or CH50]=53.13), Increased anti-dsDNA antibody levels=48.44%, and Mucocutaneous (Rash=26.56%). In general, belimumab appeared to be well-tolerated; two patients (3%) had discontinued belimumab within the first 6 months of therapy: one due to lack of efficacy, the other due to Pelvic inflammatory disease. After 6 months of belimumab therapy 72%, 52% and 27% of patients had an overall clinical improvement of >20%, >50% and >80% respectively. For the most frequent SLE manifestations, such as in arthritis (69%), low complements (47%), high anti-ds-DNA levels (48%), and fatigue (60%) a >50% improvement was observed. Additionally, the mean score of the SELENA-SLEDAI index decreased from 10.1 to 4.5 (p<0.0001) in the first 6 months. In 88% of the patients (n=57), a decrease SELENA-SLEDAI index was observed.

Oral steroids were used concomitantly in 95% of SLE patients at baseline. Patients had a mean reduction in steroid dose of 6.8mg/day from 14.8mg/day at baseline after 6 months of treatment with belimumab (p<0.0001). 75% of patients (n=57) experienced a reduction in steroid use during the 6 months.

Conclusion Among SLE patients treated with belimumab, clinical and serological improvement was observed in a majority of SLE patients over their first 6 months of routine treatment in a sample of clinical practices in Spain.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/evolution-of-patients-with-systemic-lupus-erythematous-treated-with-belimumab-in-clinical-practice-settings/