RESUMEN
OBJECTIVES: To compare efficacy and tolerance of infliximab versus rituximab to treat refractory Wegener's granulomatosis (WG), and clarify their respective indications. METHODS: Patients with systemic WG refractory to, or intolerant to steroids and consecutive immunosuppressant lines, including oral cyclophosphamide, were randomly assigned to receive infliximab or rituximab and their ongoing regimen. The primary endpoint was partial (PR) or complete remission (CR) at month 12. The secondary endpoint was the occurrence of adverse events. Long-term follow-up data were subjected to post-hoc analysis. RESULTS: Between 2004 and 2007, 9 infliximab and 8 rituximab patients were included. At M12, we observed 2 infliximab and 4 rituximab CR, 1 infliximab and 1 rituximab PR, 5 infliximab and 2 rituximab failures and 2 deaths (NS). Post-hoc analysis was conducted after 30.6±15.4 months of follow-up. Among the 15 survivors, 2 infliximab patients and 1 rituximab patient relapsed. Among 5 infliximab non-responders, 4 were successfully switched to rituximab. During follow-up, one patient from each group died. Over the long term, 10/17 (59%) patients responded to rituximab, 1 to infliximab, 2 to other strategies and 2 died. Despite the 2 deaths, tolerance of both drugs was considered acceptable in terms of WG severity before treatment and previous treatment lines. CONCLUSIONS: Our observations demonstrate the usefulness of infliximab and/or rituximab to obtain remission of refractory WG with a trend at M12 favouring rituximab. During long-term follow-up, rituximab was better able at obtaining and maintaining remission.