title: A retrospective study on the efficacy and safety of intraveinous immunoglobulin (Tegeline®) in patients with chronic inflammatory demyelinating polyneuropathy.
abstract: OBJECTIVE
  To assess the efficacy and safety of intraveinous immunoglobulin (IV Ig) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) at 4, 7 and 12months.
  
  
  METHODS
  A national multicenter retrospective study was conducted by LFB Biotehcnologies in patients with CIDP who had received at least one cycle of a 5% polyvalent IV Ig, Tegeline(®), from LFB biomédicaments between 1995 and 2004. The primary endpoint was the efficacy of IV Ig at 4 months, which was defined as the responder rate based on the modified Rankin scale. Several secondary endpoints were assessed: safety and efficacy (i.e., responders according to the investigators' overall assessment of the patients' status) at 4, 7 and 12 months. The analysis was performed at 7 months only (due to missing data for 12 months and few patients).
  
  
  RESULTS
  A total of 26 patients were included who had received between 1 and 6 cycles of IV Ig (mean 3±2) with a median follow-up of 9.9 months. The responder rate at 4 months based on the modified Rankin scale was 52% (95% CI 0.313-0.722), whereas the responder rate with placebo reported in the literature (meta-analysis including results from van Schaik and an ICE study) is 18% (P<0.001). Responder patients at 4 months were still responders at 7 months. The overall safety of IV Ig was good, with adverse events of mild to moderate severity, which resolved without sequelae and were expected adverse events of IV Ig.
  
  
  CONCLUSIONS
  This retrospective study confirmed both the efficacy of IV Ig at 4 months in the treatment of chronic inflammatory demyelinating polyneuropathy and the favorable safety profile of the product.
authors.affiliation: CHU de Saint-Étienne, Saint-Étienne, France. Electronic address: robert.florence@yahoo.fr.
authors.forename: Florence
authors.initials: F
authors.lastname: Robert
authors.affiliation: CHU de Rennes, Rennes, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Edan
authors.affiliation: CHU d'Angers, Angers, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Nicolas
authors.affiliation: CHU de Marseille, Marseille, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Pouget
authors.affiliation: Hospices civils de Lyon, Lyon, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Vial
authors.affiliation: CHU de Saint-Étienne, Saint-Étienne, France.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Antoine
authors.affiliation: LFB biomédicaments, Les Ulis, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Puget
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D020277:Polyradiculoneuropathy, Chronic Inflammatory Demyelinating / Q000276:immunology / Q000628:therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D016756:Immunoglobulins, Intravenous