Real-World Effectiveness of Intravenous Belimumab on Clinical Outcomes in Patients With Systemic Lupus Erythematosus in Saudi Arabia: The OBSErve Observational Study.

Abstract

Purpose: To describe intravenous (IV) belimumab's clinical effectiveness in patients with systemic lupus erythematosus (SLE) in real-world practice in Saudi Arabia.

Patients and methods: This retrospective, observational OBSErve study (GSK Study 215349) analyzed medical record data for adults with SLE receiving IV belimumab. Index date was the date of belimumab initiation. The primary endpoint was overall clinical response per physician judgement (categorized as worse, no improvement, improvement of <20%, 20-49%, 50-79%, ≥80%) at 6 months post-index. The secondary endpoints included changes from index in Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score and corticosteroid dose at 6 months post-index; and healthcare resource utilization (HCRU) 6 months pre- and post-index.

Results: Of 47 patients enrolled, 44 patients completed ≥6 months of IV belimumab treatment and were included in the analysis. Most patients were female (91.5%) and the mean (standard deviation [SD]) age was 33.1 (8.1) years. At 6 months post-index, overall physician-assessed clinical improvements of ≥20% and ≥50% were reported for 97.7% (n=43) and 79.5% (n=35) of patients, respectively; 2.3% (n=1) of patients had no improvement, and no patient worsened. Mean SELENA-SLEDAI score decreased by 7.8 points during the 6 months post-index. Mean (SD) corticosteroid dose decreased from 10.2 (7.5) mg/day at index to 6.2 (3.4) mg/day at 6 months post-index. Reductions in unscheduled physician office and emergency room visits were observed during the post-index versus pre-index periods.

Conclusion: Real-world data from patients with SLE treated with IV belimumab in Saudi Arabia demonstrated clinical improvements and reductions in corticosteroid dose and HCRU. Although the low number of patients and lack of a control group limit interpretation, the similar findings to the other OBSErve studies support the effectiveness of belimumab for patients with SLE in Saudi Arabia.