A BAFF/APRIL dual inhibitor for the treatment of systemic lupus erythematosus: a long-term, observational, real-world study.

BACKGROUND: This study evaluated the efficacy and safety of telitacicept (a B-cell inhibitor targeting B cell-activating factor [BAFF] and a proliferation-inducing ligand [APRIL]) in patients with systemic lupus erythematosus (SLE) in real clinical settings. METHODS: This was a long-term, single-center, observational study with a maximum observation point of 36 months. A total of 110 patients with SLE treated with telitacicept at Peking Union Medical College Hospital between May 2021 and October 2025 were retrospectively enrolled. The SLEDAI-2K score, SLE Responder Index-4 (SRI-4) response, serological parameters and glucocorticoid dose were evaluated. Subgroup analysis was performed for patients with renal involvement and hematologic involvement. Univariate and multivariate Cox regression and logistic regression analysis were used to explore the predictors of SRI-4 response. RESULTS: The mean duration of telitacicept treatment was 21.12 ± 13.29 months. After 2, 4, 6, 12, 18, 24, and 36 months of telitacicept treatment, 31%, 49%, 55%, 60%, 74%, 61%, and 65% of patients with SLE achieved SRI-4 response, respectively. The SLEDAI-2K score, immunoglobulin level, anti-dsDNA levels and glucocorticoid dose all decreased significantly at 6, 12, 18, 24, and 36 months, whereas complements 3 and 4 increased significantly. Additionally, The 24-hour urine protein, serum creatinine and serum albumin of patients with renal involvement were significantly improved, and the platelet count, hemoglobin and white blood cell count of patients with hematologic involvement were significantly increased. The incidence of adverse events was 34%, with infection accounting for 25.5%; no serious adverse events occurred. CONCLUSIONS: This real-world study demonstrated that telitacicept is both efficacious and safe and can effectively reduce disease activity and improve serological indices. It may therefore be a viable medicine for the treatment of SLE.