Efficacy and safety of belimumab in systemic lupus erythematosus patients with severe lupus nephritis requiring renal replacement therapy.

BACKGROUND

Systemic lupus erythematosus is a chronic inflammatory autoimmune disease that has various manifestations. Lupus nephritis is a common and severe presentation, which results in increased morbidity and mortality. Belimumab added on standard therapy has been proved to induce disease remission and improve renal parameters. However, the use of belimumab has not been explored in patients requiring dialysis treatment.

METHODS

Seven patients diagnosed as SLE with renal involvement requiring dialysis, who received belimumab in addition to steroids or immunosuppressants were identified. Clinical and biological data were extracted from medical records and laboratory databases. Ten mg/kg belimumab was applied on day 1, 15, 29, and every 28 days thereafter for a total of 8 dose. Renal parameters including urine output and serum creatinine level, immunologic index including anti-ds-DNA antibody titer and complement level, and disease activity were documented to reveal the response to belimumab.

RESULTS

After belimumab therapy, all the 7 patients receiving dialysis therapy showed immunologic improvement. Disease activity significantly declined from 16.5 to 5.33 using SLEDAI-2K score. Apart from patient 7 on maintenance dialysis, 5 of 6 patients had increased urine output and were out of dialysis treatment. Patient 5 and 6 showed significant decrease in serum creatinine level. Only one pulmonary infection was documented.

CONCLUSIONS

Belimumab added to steroids or immunosuppressive agents was able to improve renal and immunologic parameters and decrease disease activity of SLE patients receiving dialysis treatment. The safety issue is promising with no severe adverse effect recorded. Further large, controlled, randomized clinical trials are required to confirm the results.