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A randomised double blind trial versus placebo does not confirm the benefit of α-interferon in polyneuropathy associated with monoclonal IgM
  1. XAVIER MARIETTE,
  2. JEAN-CLAUDE BROUET
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr
  1. SYLVIE CHEVRET
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr
  1. JEAN-MARC LEGER
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr
  1. PIERRE CLAVELOU
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr
  1. JEAN POUGET
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr
  1. JEAN-MARC VALLAT
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr
  1. CHRISTOPHE VIAL
  1. Service d'Immuno-Hèmatologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France
  2. Dèpartement de Biostatistique et Informatique Mèdicale, Hôpital Saint-Louis, Paris, France
  3. Service de Neurologie, Hôpital Pitiè-Salpétriëre, Paris, France
  4. Service de Neurologie, Hôpital Fontmaure, Chamaliëres, France
  5. Service de Neurologie, Hôpital de la Timone, Marseille, France
  6. Service de Neurologie, Hôpital Dupuytren, Limoges, France
  7. Service de Neurologie, Hôpital Wertheimer, Lyon, France
  1. Professor Jean-Claude Brouet jc.brouet{at}chu-stlouis.fr

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The peripheral neuropathy associated with a monoclonal anti-MAG IgM is considered as a specific entity.1-3 The clinical features are different from those seen with monoclonal IgG or IgA, with sensory loss and ataxia more often found. A causal link between the monoclonal IgM and the development of neuropathy is suggested by the antibody activity of the IgM to nerve polypeptides or glycolipids,3-7 the detection of IgM deposits on the myelin sheaths of patients' nerve biopsies,2 8 9 and the induction of the neuropathological process through the transfer of the anti-MAG IgM in animal models.10 11 The low rate (30%) of clinical improvement with chlorambucil (CLB) or plasma exchange in such patients justifies the search for new therapeutic strategies.12 13

In a previous phase II open clinical trial randomly comparing intravenous immunoglobulins (IVIg) and α-interferon (α-IFN), we concluded that IVIg was inefficient but that α-IFN produced a significant clinical improvement in eight out of 10 patients at 6 months and in seven of them at 12 months.14 The mechanism of action of α-IFN was unclear as the concentration of the monoclonal IgM as well as the titre of anti-MAG antibody were unchanged. As the improvement with α-IFN was mainly related to an improvement of sensory symptoms, most of them being subjective, we designed a multicentre, prospective, randomised double blind study of α-IFN versus placebo.

Patients included in this study had to fulfill all the following criteria: (1) have had stable or progressive neuropathy for at least 3 months; (2) show the presence of a serum monoclonal IgM with anti-MAG …

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