Efficacy of the anti-TNF-alpha antibody infliximab against refractory systemic vasculitides: an open pilot study on 10 patients.

Abstract

Evidence indicates that tumour necrosis factor (TNF) is a major agent in the pathogenesis of vasculitis. We studied the short-term effect of anti-TNF-alpha antibody in systemic vasculitis patients refractory to steroids and immunosuppressive agents. Ten patients refractory to corticosteroids and at least one immunosuppressant and who had persistently active disease or a new flare were included. Seven had Wegener's granulomatosis, two had rheumatoid arthritis-associated vasculitis and one had cryoglobulinaemia with mean duration of 9.1, 21.5 and 17 yr. They received infliximab (5 mg/kg) on days 1, 14, 42 and then every 8 weeks. Immunosuppressants were stopped between days 0 and 42 for eight patients, while the steroid dose was maintained or lowered. The treatment response was evaluated clinically with the Birmingham Vasculitis Activity Score 2000 (BVAS). Complete or partial remission was observed in all patients. The mean BVAS at entry was 9.1 (range 4-15) and had declined to 1.9 (range 0-4) by day 42 and 1.3 (range 0-4) at 6 months; BVAS of 0 was recorded for four patients on day 42 and for five at 6 months. The only adverse effect was cutaneous eruption in two patients. Anti-TNF-alpha successfully induced prompt symptomatic responses in patients with systemic vasculitis not responding to conventional treatment. Infliximab was well tolerated during the short-term follow-up.