Methylprednisolone plus MTX-based regime vs prednisone-based standard of care for GCA: a propensity score study.

Abstract

Treatment of GCA still requires substantial exposure to glucocorticoids (GCs), 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 methylprednisolone (IVMP) pulses, MTX and lower doses of prednisone, in newly diagnosed patients with GCA. A usual clinical practice study was conducted in three Spanish academic hospitals. One hundred and fifty-one patients diagnosed with GCA were treated with SOC prednisone (40-60 mg/d) or with IVMP (125-500 mg/d ×3) 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. Seventy-nine (52.3%) patients received SOC prednisone and 72 (47.7%) IVMP/MTX. The clinical characteristics at baseline were similar in both the groups. Hundred percent patients achieved remission after a median time of 4 weeks, without differences between the 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). 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.