Efficacy of leflunomide as a steroid-sparing agent in treatment of Indian giant cell arteritis patients: A 2-year follow-up study

Abstract

Objectives: To evaluate the effectiveness of leflunomide as a steroid-sparing agent among Indian patients with giant cell arteritis (GCA) and to assess the changes of "halo sign" within affected arteries, detected ultrasonographically, after remission.

Methods: In this prospective observational study, patients fulfilling American College of Rheumatology criteria for GCA and having halo sign in temporal artery ultrasound were treated with leflunomide and predefined tapering dose of prednisolone. Ultrasounds of temporal and axillary arteries were done at baseline and after remission were achieved.

Results: Twenty-two GCA patients were followed up for a median duration of 24 months (interquartile range, IQR: 18-33). All patients showed clinical improvement and steroids could be stopped in 17 out of 22 patients. Median time to achieve remission (symptom-free with normal inflammatory markers) was 3 (95% confidence interval [CI]: 2.4-3.6) months. Median time to achieve reduction to prednisolone dose <5 mg/d was 9 months (95% CI: 7-11). Prednisolone dose could be reduced in all patients while on leflunomide, suggesting steroid-sparing effect and a steroid-free remission could be achieved after a median of 14 months (95% CI: 9.4-18.6). Ultrasonographically, all patients showed improvement of halo signs, after 8 weeks (IQR 7.25-12). Seven patients experienced a clinical relapse after 12 months (IQR: 5-21) of initial remission. The predictors of relapse were duration of symptoms before initiation of immunosuppression therapy and delayed achievement remission by strict criteria.

Conclusion: This study showed efficacy and safety of leflunomide as a steroid-sparing agent in Indian GCA patients.

Keywords: giant cell arteritis; halo sign; leflunomide; steroid-sparing agent; ultrasound.