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Extended report
Tolerance and short term efficacy of rituximab in 43 patients with systemic autoimmune diseases
  1. J-E Gottenberg1,
  2. L Guillevin3,
  3. O Lambotte2,
  4. B Combe4,
  5. Y Allanore5,
  6. A Cantagrel6,
  7. C Larroche7,
  8. M Soubrier8,
  9. L Bouillet9,
  10. M Dougados10,
  11. O Fain11,
  12. D Farge12,
  13. X Kyndt13,
  14. O Lortholary14,
  15. C Masson15,
  16. B Moura16,
  17. P Remy17,
  18. T Thomas18,
  19. D Wendling19,
  20. J-M Anaya20,
  21. J Sibilia21,
  22. X Mariette1,
  23. for the Club Rhumatismes et Inflammation (CRI)
  1. 1Service de Rhumatologie, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France
  2. 2Service de Médecine Interne, Hôpital de Bicêtre
  3. 3Service de Médecine Interne, Hôpital Cochin, Paris
  4. 4Service d’Immuno-Rhumatologie, Hôpital Lapeyronie, Montpellier, France
  5. 5Service de Rhumatologie A, Hôpital Cochin, Paris
  6. 6Service de Rhumatologie, Centre Hospitalier Universitaire (CHU), Rangueil, Toulouse, France
  7. 7Service de Médecine Interne, Hôpital Avicenne, Bobigny, France
  8. 8Service de Rhumatologie, CHU Gabriel Montpied, Clermont-Ferrand, France
  9. 9Service de Médecine Interne, CHU de Grenoble, Grenoble, France
  10. 10Service de Rhumatologie B, Hôpital Cochin, Paris
  11. 11Service de Médecine Interne, Hôpital Jean Verdier, Bondy, France
  12. 12Service de Médecine Interne, Hôpital Saint-Louis, Paris
  13. 13Service de Nephrologie et Médecine Interne, CHU de Valenciennes, Valenciennes, France
  14. 14Service de Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, Paris
  15. 15Service de Rhumatologie, CHU d’Angers, Angers, France
  16. 16Service de Rhumatologie, Hôpital Ambroise Paré, Boulogne, France
  17. 17Service de Nephrologie, Hôpital Henri Mondor, Créteil, France
  18. 18Service de Rhumatologie, CHU Saint-Etienne, Saint-Etienne, France
  19. 19Service de Rhumatologie, CHU Jean Minjoz, Besançon, France
  20. 20Unidad de Reumatología CIB, Universidad Pontificia Bolivariana, Medellin, Colombia
  21. 21Service de Rhumatologie, Hôpital Hautepierre, Strasbourg, France
  1. Correspondence to:
    Professor Xavier Mariette
    Service de Rhumatologie, Hôpital de Bicêtre, 78 rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France; xavier.mariettebct.ap-hop-paris.fr

Abstract

Objective: To assess the tolerance and efficacy of rituximab in patients with various autoimmune diseases seen in daily rheumatological practice.

Methods: 866 rheumatology and internal medicine practitioners were contacted by email to obtain the files of patients treated with rituximab for systemic autoimmune diseases. Patients with lymphoma were analysed if the evolution of the autoimmune disease could be evaluated.

Results: In all, 43 of 49 cases could be analysed, including 14 with rheumatoid arthritis (RA), 13 with systemic lupus erythematosus (SLE), six with primary Sjögren’s syndrome (pSS), five with systemic vasculitis, and five with other autoimmune diseases. Rituximab was prescribed for lymphoma in two patients with RA and two with pSS. In the 39 other cases, rituximab was given because of the refractory character of the autoimmune disease. The mean follow up period was 8.3 months (range 2 to 26). There were 11 adverse events in 10 patients and treatment had to be discontinued in six. Efficacy was observed in 30 patients (70%): RA 11, SLE 9, pSS 5, vasculitis 2, antisynthetase syndromes 2, sarcoidosis 1. The mean decrease in corticosteroid intake was 9.5 mg/d (range 0 to 50) in responders. Seven patients experienced relapse after mean 8.1 months (5 to 15). Three patients died because of refractory autoimmune disease.

Conclusions: Despite absence of marketing authorisation, rituximab is used to treat various refractory autoimmune diseases in daily rheumatological practice. This study showed good tolerance and short term clinical efficacy, with marked corticosteroid reduction in patients with SLE, pSS, vasculitis, and polymyositis.

  • ACR, American College of Rheumatology
  • ANCA, antineutrophil cytoplasmic antibodies
  • DAS28, 28 joint disease activity score
  • MALT, mucosa associated lymphoid tissue
  • MC, mixed cryoglobulinaemia
  • pSS, primary Sjögren’s syndrome
  • RA, rheumatoid arthritis
  • SLE, systemic lupus erythematosus
  • SLEDAI, SLE disease activity index
  • autoimmunity
  • primary Sjögren’s syndrome
  • systemic lupus erythematosus
  • systemic vasculitis
  • rituximab

https://doi.org/10.1136/ard.2004.029694

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