RESUMEN
OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: TCZ was effective and well tolerated in Japanese patients with GCA and may be an effective treatment option combined with glucocorticoids.