Background/Purpose: Systemic lupus erythematosus (SLE) is an autoimmune disease with multi-organ involvements and recurrent relapses. The objectives of treatment include ensuring long-term patient survival, preventing disease relapses and organ damage. Belimumab(BEL) is a humanized monoclonal antibody that targets B-Cell Activating Factor of the TNF Family(BAFF) and has been approved as the first antibody to treat SLE. Tofacitinib(TOFA) functions as an inhibitor of Janus kinase (JAK). Previous study demonstrated the safety and efficacy of TOFA in treating mucocutaneous involvement and arthritis in lupus. TOFA showed the potential efficacy to faster reach BICLA (BILAG-based Composite Lupus Assessment) response than belimumab in patients with mild to moderate SLE. However, the long-term effect of TOFA versus BEL in maintenance therapy of SLE remains unknown.We conducted this study to compare efficacy and safety of TOFA and BEL in 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. A total of 51 patients treated with TOF and 102 patients treated with BEL were enrolled through propensity score matching. 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: 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%, p ＞0.999; 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: 21.43% vs. 17.74%, p = 0.773; 12 months: 25% vs. 30.65%, p＝0.626). A gradual decline in C3 levels in the TOF group, while the BEL group showed a physiological increase over time. C4 levels increased within the first 6 months but gradually returned to baseline by 12 months in both groups. The glucocorticoid dosage curves for both groups exhibited a descending trend. Four patients in the TOF group and one patient in the BEL group reported adverse events during the one-year follow-up.

Conclusion: Tofacitinib demonstrated potentially comparable effects to belimumab in the maintenance treatment of SLE, both drugs can aid in tappering off glucocorticoid.

Fig.1. Study flow chart. Abbreviations: BEL, belimumab; CSTAR, the Chinese Systemic Lupus Erythematosus Treatment and Research group; CTX, cyclophosphamide; TOF, tofacitinib.

Fig.2. Relapse rate of TOF versus BEL within 6 months and 12 months. (A-C) Comparison of total relapse rates, relapse rates of SACQ sungroup, relapse rates of SQCQ sungroup between TOF and BEL within 6 months. Numbers represent percentages of all patients (%). (D-F) Comparison of total relapse rates, relapse rates of SACQ sungroup, relapse rates of SQCQ sungroup between TOF and BEL within 12 months. Numbers represent percentages of all patients (%). Abbreviations: SACQ, serologically active clinical quiescence. SQCQ, serologically quiescent clinical quiescent.

Fig.3. Change of GC dosage(prednisone equivalent) regarding the effectiveness of TOF versus BEL

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/tofacitinib-versus-belimumab-in-maintenance-therapy-of-systemic-lupus-erythematosus-a-real-world-study-of-the-cstar-cohort/