Tofacitinib Versus Methotrexate in Treating Mucocutaneous and Musculoskeletal Lesions of Systemic Lupus Erythematosus: Real-World Results From the CSTAR Cohort XXXII.

Objective: This study aimed to evaluate and compare the efficacy and safety of tofacitinib versus methotrexate in the management of systemic lupus erythematosus (SLE) within a real-world cohort, with a particular focus on mucocutaneous and musculoskeletal involvement.

Methods: We conducted a retrospective analysis based on the Chinese SLE Treatment and Research Group (CSTAR) cohort. Patients with SLE presenting with active mucocutaneous or musculoskeletal involvement who initiated treatment with tofacitinib or methotrexate were included. The primary endpoint was the proportion of patients achieving resolution of mucocutaneous and musculoskeletal symptoms, as defined by the SLE Disease Activity Index 2000, at 3 months.

Results: A total of 109 patients were included in the study, with 44 assigned to the tofacitinib group and 65 to the methotrexate group. The tofacitinib group exhibited a numerically higher trend in resolution proportion for both mucocutaneous (3 months: 88.0% vs. 69.6%, p = 0.162; 6 months: 83.3% vs. 77.8%, p > 0.999) and musculoskeletal (100.0% vs. 84.6%, p = 0.555; 100.0% vs. 73.7%, p = 0.289) involvement compared with the methotrexate group. However, these differences did not reach statistical significance. Survival analysis revealed that tofacitinib was associated with a faster resolution of mucocutaneous (p = 0.043) involvement compared to methotrexate within a 6-month follow-up period. There was no significant difference in the incidence of adverse events between the two groups (2.3% vs. 3.1%, p > 0.999).

Conclusions: Tofacitinib may demonstrate superior effectiveness over methotrexate in the resolution of mucocutaneous involvement in SLE patients, primarily by achieving remission more rapidly, while maintaining a comparable safety profile.