Impact of belimumab on glucocorticoid intake in newly diagnosed systemic lupus erythematosus

Abstract

Background and objectives

Systemic lupus erythematosus (SLE) is an autoimmune disease with unknown etiology. For newly diagnosed SLE, there are few studies analyzing whether the use of belimumab can reduce the dose of glucocorticoids while maintaining disease remission. To explore this, we conducted this single-center, real-world setting study, based on a prospective cohort.

Methods

Newly diagnosed SLE taking Belimumab and standard-of-care (SoC) treatment were consecutively enrolled from July 2021 to December 2023 in a prospective manner. Disease assessments (SLE Responder Index 4 (SRI-4) response (a composite indicator to evaluate the efficacy of belimumab in RCTs), SLEDAI-2K) were conducted regularly. Patients were followed up for at least 12 months. Matched patients with SoC alone were enrolled after propensity score matching. Difference examination and generalized estimated equations were conducted.

Results

A total of 31 patients were enrolled in Belimumab group. SRI-4 response rate was 87.10% at 12 months. Serological parameters (anti-dsDNA and C3/C4), SLEDAI-2K and daily prednisone intake were improved overall. Compared with SoC group, SRI-4 rate and the trends of complement C4, SLEDAI-2K during follow up was similar in two groups. Trends of complement C3 (13.16 (4.14–22.18), P = 0.004), anti-dsDNA titer (−60.29 (−103.95 to −16.63), P = 0.007) and prednisone intake (−18.59 (−26.88 to −10.30), P = 0.000) were more significantly in Belimumab group. Belimumab group had significantly lower cumulative prednisone intake with overall well-tolerance.

Conclusion

Our data supported that prompt initiation of add-on Belimumab should be considered to control the disease and facilitate GC tapering/discontinuation, without prior failure to one or more conventional drugs.