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Abstract: TH-PO635

Efficacy and Safety of Belimumab in Refractory and Newly Diagnosed Patients with Active Lupus Nephritis: A Real-World Retrospective Observational Study

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Ma, Ying, Nephrology Hospital of the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
  • Lu, Wanhong, Nephrology Hospital of the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
  • Sun, Jiping, Nephrology Hospital of the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Background

Lupus nephritis (LN), the common manifestation of SLE, continues to be a principal cause of morbidity and mortality. According to 2024 KDIGO guideline, belimumab is recommended as adjunct therapy for active LN. However, the differences in its efficacy and safety between refractory and newly diagnosed active LN are unknown.

Methods

We enrolled active LN patients who initiated belimumab as adjunct therapy in our center between June 2021 and January 2024, and divided them into refractory group and newly diagnosed group according to previous immunosuppressive therapy. Patients were followed up for more than 3 months. Renal manifestation, serologic features, SLEDAI score and steroid dosage were recorded. Efficacy endpoints were complete renal response(CRR) and primary efficacy renal response(PERR)(see BLISS-LN).

Results

A total of 89 active LN patients were selected from 116 LN patients receiving belimumab in our database, among which 42 were in refractory group. At the initiation of belimumab, there is no statistical difference of age, gender, SLEDAI score, renal related markers(proteinuria, serum albumin, eGFR, renal histological classification), and serologic features(positive anti-dsDNA, C3, C4, etc.) between the two groups. Compared with newly diagnosed patients, refractory patients had significantly longer LN duration (P<0.001), lower B-lymphocyte count(P=0.001), and lower dosage of steroids(p=0.003) . During the follow-up period, serum albumin, eGFR, C3 and C4 increased, while SLEDAI score, proteinuria and steroids dosage decreased in both groups. The decrease in dosage of steroids were more prominent in newly diagnosed group, with the proportion of patients receiving>7.5 mg/d (prednisone-equivalent dose) steroids reduced from 97.8%(45/46) at initiation to 34.8%(16/46) at last visit. For the refractory active LN patients, the estimated probability of CRR at 3 months was 39.0% and the estimated probability of PERR at 3 months was 48.8%. They were all comparable to newly diagnosed patients by Log Rank test(p=0.137,p=0.623). No difference was found in adverse events rates(p=0.183), time to first renal flare(p=0.792) or RRE(p=0.701).

Conclusion

The add-on treatment with belimumab showed comparable efficacy and safety in refractory and newly diagnosed active LN patients.