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PT4:05 Tofacitinib versus belimumab in maintenance therapy of systemic lupus erythematosus: a real-world CSTAR cohort study

lupusscimed · 2026-03-01 · canonical JSON source

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Objectives Systemic lupus erythematosus (SLE) is a complicated autoimmune disease characterized by recurrent relapses. Belimumab (BEL) is a humanized monoclonal antibody and has been approved as the first biologics to treat SLE in controlling disease activity and reducing flares. Tofacitinib (TOF) functions as an inhibitor of Janus kinase (JAK) and showed positive efficacy in treating mucocutaneous involvement and arthritis in lupus. However, as a relatively new treatment for SLE, additional evidence and comparative studies are needed to establish its efficacy and safety. This study aimed to compare the efficacy and safety of tofacitinib versus belimumab in the maintenance therapy of SLE.Methods We conducted a real-world, multicenter, retrospective cohort study based on the Chinese SLE Treatment and Research Registry (CSTAR). Maintenance therapy was defined as treatment after achieving a clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI) score of zero and treated with glucocorticoid (GC) at a dose of less than 0.3mg/kg of body weight per day. Propensity score matching was used to minimize the bias of sex, age, SLEDAI scores and GC dose at baseline. The primary endpoint was the 12-month disease relapse rate, as defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI Flare Index (SFI).Results A total of 51 patients treated with TOF and 102 patients treated with BEL were enrolled through propensity score matching. There were no significant differences in baseline demographic, clinical, or therapeutic characteristics after matching. No statistically significant difference in relapse rates were observed between the TOF group and the BEL group within 6 and 12 months (19.61% vs. 18.63%; 25.49% vs. 29.41%, p = 0.704). Subgroup analysis of the serologically active clinical quiescence (SACQ) patients also showed no significant difference between two groups (6 months: 23.08% vs. 19.67%, p = 0.775; 12 months: 23.08% vs. 26.23%).Abstract PT4:05 Table 1Abstract PT4:05 Figure 1–5Conclusions Tofacitinib showed potentially comparable effects to belimumab in the maintenance treatment of SLE, both drugs can aid in tapering off glucocorticoid.