Does leflunomide have a role in giant cell arteritis? An open-label study

Abstract

Glucocorticoid monotherapy has been the mainstay treatment of giant cell arteritis (GCA) for decades. We aimed to evaluate the role of leflunomide as a steroid-sparing agent in GCA. This open-label study included incipient GCA patients followed for at least 48 weeks at a single secondary/tertiary rheumatology centre. At the time of diagnosis, patients received glucocorticoids. At week 12 of follow-up, leflunomide 10 mg qd was recommended as an adjunctive therapy to all patients without contraindications. The decision to start the leflunomide was patient-dependent. The number of relapses, a cumulative glucocorticoid dose during follow-up and treatment-related adverse events (AE) were recorded and compared between glucocorticoid-only and leflunomide groups. Seventy-six patients (65.8% female, median (IQR) age 73.7 (66.1-78.8) years) were followed for a median (IQR) 96 (86-96) weeks. Thirty out of 76 (39.5%) patients received leflunomide at week 12 (leflunomide group); the others continued treatment with glucocorticoid (glucocorticoid-only group). During the first 48 weeks of follow-up, 22 patients relapsed, 4 (13.3%) in leflunomide group and 18 (39.1%) in glucocorticoid-only group. The difference was statistically significant (p = 0.02; NNT 3.9 (95% CI 2.2-17.4)). Furthermore, 17/30 (56.7%) patients in the leflunomide group managed to stop glucocorticoid at week 48 (with one relapse (5.9%) shortly afterwards). The cumulative glucocorticoid dose at the last visit was lower in the leflunomide group than in the glucocorticoid-only group (p = 0.01). Our findings indicate the steroid-sparing effect of leflunomide in GCA.

Efficacy and safety of tocilizumab in giant cell arteritis: a single centre NHS experience using imaging (ultrasound and PET-CT) as a diagnostic and monitoring tool

“…A meta-analysis suggests a modest effect for methotrexate and there are case series and an open non-randomised study of leflunomide. [25][26][27] We feel that TCZ retreatment should be permitted and even continued long term with aortic/large vessel disease. There is also a need to recruit TCZ unresponsive or post-TCZ flares to further clinical trials in GCA.…”

A new era for giant cell arteritis

“…Recently an open label study comparing leflunomide as adjunctive therapy to standard care and GCs alone found that three quarters of the leflunomide group had reduced relapse rate and decreased cumulative doses of GCs. Leflunomide needs further highlevel evidence to support its use in GCA [87].…”

European Headache Federation recommendations for neurologists managing giant cell arteritis

“…Use of anti-tumour necrosis factor (TNF) alpha therapy in GCA was disappointing [78]. Leflunomide has been investigated in an open-label prospective single centre study of 76 patients and shown some benefit in controlling disease, reducing the use of GC [79].…”