title: Infliximab or rituximab for refractory Wegener's granulomatosis: long-term follow up. A prospective randomised multicentre study on 17 patients.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Hôpital Cochin, University Paris Descartes, Paris, France. mathilde.de-menthon@cch.aphp.fr
authors.forename: Mathilde
authors.initials: M
authors.lastname: de Menthon
authors.forename: Pascal
authors.initials: P
authors.lastname: Cohen
authors.forename: Christian
authors.initials: C
authors.lastname: Pagnoux
authors.forename: Matthias
authors.initials: M
authors.lastname: Buchler
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.forename: Frédérick
authors.initials: F
authors.lastname: Détrée
authors.forename: Martine
authors.initials: M
authors.lastname: Gayraud
authors.forename: Mehdi
authors.initials: M
authors.lastname: Khellaf
authors.forename: Christian
authors.initials: C
authors.lastname: Penalba
authors.forename: Bruno
authors.initials: B
authors.lastname: Legallicier
authors.forename: Luc
authors.initials: L
authors.lastname: Mouthon
authors.forename: Loïc
authors.initials: L
authors.lastname: Guillevin
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004351:Drug Resistance; D057915:Drug Substitution; D005260:Female; D005602:France; D014890:Granulomatosis with Polyangiitis / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069285:Infliximab; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D018570:Risk Assessment; D012307:Risk Factors; D000069283:Rituximab; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D007166:Immunosuppressive Agents; D000069283:Rituximab; D000069285:Infliximab