LAUSR

Background Glucocorticoids (GC) have been the mainstay treatment in giant cell arteritis (GCA) for decades. Recently tocilizumab and abatacept have been proven to be effective alternatives to glucocortiocids. However, not all GCA patients are eligible for a biologics. Objectives We aimed to evaluate the role of leflunomide (LEF) as a steroid sparing agent in GCA. Methods This prospective observational study included newly diagnosed GCA patients followed at least 48 weeks at a single secondary/tertiary rheumatology centre. Patients were treated with GC in line with the EULAR recommendations.1 In short, patients with uncomplicated GCA initially received oral methylprednisolone (MP) 32–48 mg qd, while those with ischaemic complications or large vessel disease first received MP 250 mg on 3 consecutive days intravenously, followed by oral MP. MP tapering was started 2–4 weeks after treatment initiation slowly to 4 mg qd which was continued for at least 6 months. At week 12, LEF 10 mg qd was recommended as an add-on therapy to those GCA patients without contraindications for it. The final decision to add LEF was patient dependent. Follow-up visits with predetermined clinical and laboratory tests were performed 4, 12, 24, 48, 96 and 144 weeks after diagnosis. In patients who relapsed during the MP tapering unscheduled visits were arranged and treatment was adjusted (GC dose was increased and LEF 10 mg or LEF dose increase to 20 mg or alternative steroid sparing agent in case of LEF ineffectiveness recommended). The number of relapses and a cumulative GC dose during follow-up were recorded. Results Between July 2014 and December 2016 we identified 76 (65.8% female, median (IQR) age 73.7 (66.1–78.8) years) new GCA cases with a follow-up of at least 48 weeks (median (IQR) 7551–104 weeks). 30/76 patients (39.5%) received LEF at W12 (“LEF” group), the others continued with GC only. During the follow-up 22 patients relapsed, 4 in “LEF” group (13.3%) and 18 (39.1%) in “GC only” group. The difference was statistically significant (p=0.02; NNT 3.9 (95%CI 2.2–17.4)). Furthermore, 17/30 GCA cases (56.7%) in “LEF” group managed to stop GC at W48 (with 1 relapse (5.9%) shortly afterwards), but none in GC only group. Patients tolerated LEF relatively well. Adverse events (AEs) were usually mild. 8/30 patients (26.7%) discontinued LEF (1 due to ineffectiveness and 7 due to one/more AEs – hair loss developed in 4/7 cases, diarrhoea in 2/7 patients, weight loss in 2/7 cases, and elevated transaminases in 1/7). The occurrence of infections requiring antibiotics and/or hospital admission was lower in LEF group compared to “GC only” group (10% vs. 26.5%). Conclusions We found in our prospective observational study in GCA a steroid sparing action and a rather good tolerability of LEF. Disclosure of Interest None declared