Methyl-prednisolone plus methotrexate-based regime vs prednisone-based standard of care for giant cell arteritis: a propensity score study

Abstract

Objectives Treatment of giant cell arteritis (GCA) still requires substantial exposure to glucocorticoids (GC), which are associated with significant toxicity. This study compares the efficacy and safety of the GC-only standard of care (SOC) with a regimen combining intravenous methyl-prednisolone (IVMP) pulses, methotrexate (MTX) and lower-doses of prednisone, in newly diagnosed patients with GCA. Methods A usual clinical practice study was conducted in three Spanish academic hospitals. 151 patients diagnosed with GCA were treated with SOC-prednisone (40–60 mg/d) or with IVMP (125–500 mg/d x3) followed by lower-dose prednisone (≤30 mg/d) and MTX (IVMP/MTX), with a follow-up of 2 years. A propensity score was used to adjust for baseline differences in the multivariate analyses. Results 79 (52.3%) patients received SOC-prednisone and 72 (47.7%) IVMP/MTX. The clinical characteristics at baseline were similar in both groups. 100% patients achieved remission after a median time of 4 weeks, without differences between groups. Relapse rates were also similar. Patients receiving IVMP/MTX had significantly lower cumulative GC doses and reached prednisone ≤5 mg/d faster than SOC patients (mean 13.8 vs 56.5 weeks; p< 0.001). Patients in the IVMP/MTX group were less likely to suffer any GC-related adverse effect (adjusted OR 0.35, 95%CI 0.14–0.85; p= 0.021). Conclusions The combination IVMP/MTX with lower-dose prednisone is as effective as the SOC in inducing remission and preventing relapses in GCA. The IVMP/MTX scheme significantly reduces GC exposure and GC-associated adverse effects. IVMP/MTX could be a potential GC-sparing strategy, especially in patients with GCA at higher risk of GC toxicity.