Efficacyandsafetyofbelimumabinpatientswith systemiclupus erythematosus: retrospective study

Aim

To evaluate the efficacy and safety profile of belimumab 10 mg/kg intravenously in patients with systemic lupus erythematosus (SLE).

Material and methods

In a retrospective study, 24 adult patients (19 females and 5 males, median age of 34 years) with SLE were treated with belimumab 10 mg/kg for 48 weeks. A primary end-point was response to treatment (a >4-point reduction in SELENA–SLEDAI score and no deterioration from baseline in BILAG and physician’s global assessment scales) in the full analysis set population. We also studied the efficacy of belimumab in patients with moderate to high disease activity, its impact on the immunological indices of activity and the steroid-sparing effect.

Results

At baseline, 12 patients had low disease activity and 12 patients presented with moderate to high activity of SLE. All patients received concomitant treatment with corticosteroids, hydroxychloroquine 200-400 mg daily and/or immunosuppressive agents. A response to belimumab treatment was achieved in 12 of 24 patients (50.0%) in the full analysis set population and 11 of 12 patients (91.7%) with moderate to high disease activity. Average SELENA-SLEDAI score in these groups of patients decreased from 6.1±4.3 to 1.9±2.1 (p<0.05) and from 9.2±3.6 to 2.6±2.5 (p<0.05), respectively. Immunological activity improved in 12 (63.2%) of 19 patients. In the full analysis set population, median dose of corticosteroids was reduced from 11.3 to 7.5 mg daily (p<0.05), while in patients with moderate to high disease activity, it was reduced from 17.5 to 10.0 mg daily (p<0.05). Immunosuppressive agents were discontinued in 5 (38.5%) of 13 patients. One patient developed serious adverse event (abcess) that did not require discontinuation of belimumab therapy.

Conclusion

Belimumab10 mg/kg reduced activity of SLE and had steroid-sparing effect and favorable safety profile.

Key words

Systemic lupus erythematosus, belimumab, efficacy, safety.