Evaluation of the efficacy and safety of belimumab and telitacicept in patients with systemic lupus erythematosus: results from a retrospective, observational study

Abstract

This investigation aimed to evaluate the efficacy and safety of belimumab and telitacicept in active systemic lupus erythematosus (SLE) and to explore potential predictors within a treat-to-target paradigm. 101 individuals were retrospectively enrolled at Guangdong Provincial People's Hospital between January 2021 and December 2023, receiving either belimumab (n = 50) or telitacicept (n = 51) in conjunction with standard therapy for more than 24 weeks. Key clinical endpoints were evaluated, with lupus low disease activity state (LLDAS) as the primary outcome. Multivariate analysis was employed to investigate factors associated with failure to attain LLDAS. Baseline characteristics were balanced in both groups after propensity score-based inverse probability of treatment weighting. At 24 weeks, the rates of attainment of LLDAS were 54.86% in the telitacicept group and 33.13% in patients receiving belimumab (p = 0.048). A larger proportion of patients receiving telitacicept attained prednisone dosages of ≤ 7.5 mg/day (p = 0.012). Improvements in complement C4 levels and the occurrence of severe hypogammaglobulinemia were more pronounced among patients receiving telitacicept, with no differences in SLE Responder Index 4, DORIS remission, and renal response. Treatment with telitacicept (OR = 0.80, p = 0.032) and elevated levels of complement C3 (OR = 0.63, p = 0.003) were associated with a decreased risk of failing to achieve LLDAS. No severe adverse events were documented in both groups. Both belimumab and telitacicept displayed satisfactory effectiveness and safety profiles. Our findings imply telitacicept may offer potential benefits associated with the early attainment of LLDAS and reduced glucocorticoid exposure. Restricted by the observational design, the findings require further validation in prospective studies.

Keywords: Belimumab; IPTW; LLDAS; Systemic lupus erythematosus; Telitacicept.

Fig. 1

Protocol flowchart of the study design

Fig. 2

The standardized mean differences before and after propensity score-based inverse probability of treatment weighting

Fig. 3

Clinical outcomes between belimumab and telitacicept treatment after IPTW. A SRI-4 response at 4, 12, and 24 weeks. B Attainment of LLDAS at 4, 12, 24, and 52 weeks. C Analysis of lack of LLDAS attainment at 24 weeks. D Attainment of DORIS remission at 4, 12, and 24 weeks. E Changes in SLEDAI-2 K scores from baseline to 24 weeks. F Changes in PGA from baseline to 24 weeks. (*p < 0.05, **p < 0.01) IPTW, inverse probability of treatment weighting; SRI-4, systemic lupus erythematosus responder index; LLDAS, lupus low disease activity state; DORIS, definition of remission in SLE; SLEDAI-2 K, systemic lupus erythematosus disease activity index 2000; PGA, physician’s global assessment

Fig. 4

Glucocorticoid dosages and serological indicators changes from baseline after IPTW A Changes in glucocorticoid dosages from baseline to 24 weeks after IPTW. B Attainment of low glucocorticoid dosages of ≤ 5 mg/day or ≤ 7.5 mg/day at week 24 after IPTW. C–F Changes in levels of anti-dsDNA, C3, C4, and serum IgG from baseline to 24 weeks after IPTW. G Frequency of hypogammaglobulinemia between belimumab and telitacicept treatment after IPTW. (*p < 0.05, **p < 0.01) C3, complement C3; C4, complement C4; IgG Immunoglobulin G

Fig. 5

Treatment outcomes in lupus nephritis between belimumab and telitacicept treatment after IPTW. A Changes in UPCR from baseline to 24 weeks after IPTW. B–D PR, CR, and PERR at 12 and 24 weeks between belimumab and telitacicept treatment groups after IPTW. UPCR, urinary protein to creatinine ratio; PR, partial response; CR, complete response; PERR, primary efficacy renal response