A multicentre, large-scale, observational study of tocilizumab in patients with giant cell arteritis in Japan.

Abstract

In clinical trials, tocilizumab (TCZ) is efficacious in patients with giant cell arteritis (GCA). This study evaluated the real-world tolerability and effectiveness of TCZ in Japanese patients with GCA. In this multicentre, prospective, phase 4, large-scale, observational study, patients with GCA (with no TCZ treatment 6 months before the study) were recruited from 71 centres across Japan. Patients received subcutaneous TCZ 162 mg weekly (observation period, 52 weeks). Of the 117 patients (female, 70.1%; mean age, 74.2 years; mean disease duration, 1.4 years; treated for new-onset GCA, 71.8%; presence of large-vessel lesions [LVLs], 61.5%; previous immunosuppressant use, 28.2%; glucocorticoids at baseline, 95.7% [mean: 22.4 mg/day]), 38.5% reported adverse events. The most common adverse events of special interest were neutropenia and leukopenia (7.7%), followed by serious infection (6.0%). The relapse-free proportion was 85.0%; relapse after remission, 6.0%; and no remission, 9.0%. At the last observation, 94.2% of relapse-free patients received a concomitant glucocorticoid dose of <10 mg/day. Fatigue, headache, neck pain and absence of LVLs were positively associated with the relapse. TCZ was effective and well tolerated in Japanese patients with GCA and may be an effective treatment option combined with glucocorticoids.