AB0620 EFFICACY AND SAFETY OF TOCILIZUMAB IN GIANT CELL ARTERITIS: A MONOCENTRIC REAL-LIFE EXPERIENCE

Abstract

Background/Purpose : Tocilizumab (TCZ) has recently been shown to be effective and safe for the treatment of patients with giant cell arteritis (GCA). Here we describe our real-life experience with TCZ in a large cohort of GCA patients from a single Italian Centre. Methods : GCA patients, diagnosed according to the 1990 ACR criteria, followed-up at our Large Vessel Vasculitis Clinic and treated with TCZ were included. We retrospectively evaluated demographic features, disease characteristics, reasons for TCZ introduction and discontinuation, concomitant therapies and response to treatment. For each patient we also evaluated potential eligibility for GiACTA trial. For statistical comparisons non-parametric tests were used. Results : 34 patients (28 women, mean age 71.3+/-10 years) were included. Table 1 summarizes GCA clinical features, tools for GCA diagnosis (imaging and/or biopsy), and reasons for TCZ introduction. Mean disease duration before TCZ introduction was 23+/-31.3 months. Only 11 patients met both GiACTA inclusion and exclusion criteria at TCZ introduction. 26 patients were followed up for 3 months, 22 for 6 months and 15 for 12 months. Mean prednisone (PDN) dose at TCZ introduction was 23.23+/-13.84 mg. Mean PDN dose was 8.41+/-7.10 mg (p < 0.001) at month 3, 4.95+/-5.63 mg (p = 0.02) at month 6, and 2.66+/-2.7 mg (p = 0.05) at month 12. PDN was stopped in 9 patients (2 at month 3, 5 at month 6, 2 at month 12) due to optimal disease control with TCZ alone. At TCZ introduction 4 patients were already on methotrexate (MTX). MTX was subsequently stopped in 2 patients (1 at month 3, 1 at month 6) due to disease control. TCZ was temporarily held offin 2 patients due to zoster reactivation and in 2 patients due to mild bacterial infections, and definitively stopped after 2 months (when PDN dose was still high) in 2 patients due to severe bacterial infections. No patient experienced severe neutropenia or liver enzymes elevation. In no case TCZ was judged inefficient. Conclusion : Our data confirm TCZ is highly effective in GCA treatment and has a significant steroid-sparing effect. In our real-life retrospective study TCZ was also shown to be a safe option in patients with relapsing or refractory GCA.