Background/Purpose: Large-scale clinical trials have demonstrated the clinical efficacy of belimumab in patients with systemic lupus erythematosus (SLE). We examined clinical outcomes associated with 12 months of belimumab treatment in clinical practice settings in the United States (US).

Methods: This is a multi-center retrospective chart review from community-based rheumatology practices that treated >10 SLE patients annually and had >5 yrs of practice experience (OBSErve; GSK117295). Physicians randomly identified adult SLE patients who had received ≥8 infusions of belimumab as part of their usual care. Data were collected for the 6 months prior to belimumab initiation (baseline), for the first 6 months after initiation and for Months 6–12; data included demographics, disease characteristics, disease activity assessment scores (where available), and concomitant medications. The primary outcome measure was physician impression of change in SLE disease manifestations.

Results: This interim analysis at 12 months included 384 patients (female: 89.8%; mean age: 41.8 [standard deviation: 12.3] years; Caucasian: 51.6%; African-American: 25.5%; Hispanic: 16.7%; Other: 6.3%) enrolled by 60 rheumatologists from 21 states. During the 6–12 month follow-up period, 43 patients (11.2 %) discontinued belimumab. The most common reasons for discontinuation were patient request (37.2%), medication not effective (27.9%), lack of patient compliance (20.9%), disease progression (18.6%), loss of insurance/reimbursement (7.0%) and loss to follow-up or death (7.0%).

During Months 0–6, physicians’ impression of change in SLE disease showed improvements of <20%, ≥20%, ≥50% and ≥80% in 10.7%, 88.3%, 47.1% and 11.2% of patients, respectively; no change was reported for 0.5% of patients, and 0.5% were considered to have worsened. Continued improvements were observed during Months 6–12 when improvements of <20%, ≥20%, ≥50% and ≥80%, beyond those observed at Month 6, were reported in 16.1%, 70.8%, 30.2% and 10.2% of patients, respectively; no change was reported for 9.9% of patients and 3% were considered to have worsened.

Overall, 297/384 patients (77.3%) received concomitant steroids at baseline; 104/297 patients (35.0%) were able to discontinue steroids altogether at 12 months. The mean steroid dose (prednisone equivalent) among steroid users at baseline and 12 months was 19.4 mg/day and 8.4 mg/day, respectively. During the 12 month period, 6 patients initiated steroid treatment.

For the 96 (25%) patients with SELENA-SLEDAI scores at 12 months, mean score was 12.5 at baseline, 6.0 at 6 months, and 5.1 at 12 months (59.2% reduction from baseline). From baseline to 12 months, mean Physician Global Assessment scale scores improved by 58.7% (n=100) and Patient Global Assessment scale scores improved by 61.5% (n=78).

Conclusion: Overall, physicians reported continued improvement in clinical outcomes and reduction in steroid use over 12 months of treatment with belimumab 10 mg/kg plus usual care, among patients receiving ≥8 belimumab infusions.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/12-month-outcomes-associated-with-belimumab-in-patients-with-systemic-lupus-erythematosus-in-clinical-practice-settings-the-observe-study/