Addition of Leflunomide to Prednisone Fails to Improve Remission in Takayasu Arteritis: Study
China: Researchers have found in a clinical study that adding leflunomide (LEF) to prednisone was safe and well tolerated but did not significantly improve clinical remission rates in patients with Takayasu arteritis (TAK) compared with placebo plus prednisone. The findings suggest that leflunomide does not provide additional benefit over standard prednisone therapy for inducing remission in TAK.
The findings come from the Takayasu Arteritis Clinical Trial in China (TACTIC), a multicenter, randomized, double-blind, placebo-controlled study published in BMC Medicine. The study was led by Ying Sun from the Department of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, China, along with colleagues.
Takayasu arteritis is a rare chronic inflammatory disease affecting the aorta and its major branches, often requiring prolonged treatment with glucocorticoids. While leflunomide has shown promise in previous observational studies, evidence from randomized clinical trials has been limited. The TACTIC trial was designed to determine whether adding leflunomide to prednisone could improve treatment outcomes.
The multicenter trial enrolled 116 patients across six centers in China between December 2016 and November 2022. Participants were randomized 1:1 to receive either leflunomide (20 mg/day) or placebo for 24 weeks, alongside prednisone (0.6 mg/kg/day) with tapering initiated from week four.
The primary endpoint was clinical remission at week 24. Secondary endpoints included time to remission, prednisone dose, disease recurrence, imaging outcomes, and safety. Patients who achieved remission entered a 28-week extension phase and received leflunomide through week 52, while non-responders in the leflunomide arm discontinued the study.
The trial revealed the following findings:
- At 24 weeks, clinical remission was achieved in 81.5% of patients receiving leflunomide plus prednisone and 78.9% of those receiving placebo plus prednisone, with no statistically significant difference between the groups.
- Sensitivity analyses confirmed that adding leflunomide did not significantly improve the primary endpoint of clinical remission.
- Post hoc analyses suggested that leflunomide may offer greater benefit in selected subgroups, including women, patients aged 40 years or younger, those with refractory disease, patients with systemic symptoms, and those with imaging type II disease.
- Patients treated with leflunomide required a slightly lower average prednisone dose by week 24 compared with the placebo group.
- Adverse events were reported in 24.5% of patients receiving leflunomide versus 39.3% of those receiving placebo.
- Serious adverse events occurred in six patients in the leflunomide group and four patients in the placebo group.
- One death was reported during the trial, occurring in the placebo group.
The researchers concluded that although the trial did not meet its primary endpoint, the findings indicate that leflunomide remains a potential alternative treatment option for Takayasu arteritis, particularly in selected patient populations. They noted that further studies are needed to identify which patients are most likely to benefit from the therapy.
Reference:
Sun, Y., Kong, X., Dai, X. et al. Efficacy of leflunomide in active Takayasu arteritis: a randomized double-blind placebo-controlled trial subtitle: Takayasu arteritis clinical trial in China (TACTIC). BMC Med (2026). https://doi.org/10.1186/s12916-026-05009-1
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