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Efficacy of rituximab in systemic manifestations of primary Sjögren's syndrome: results in 78 patients of the AutoImmune and Rituximab registry
  1. Jacques-Eric Gottenberg1,
  2. Gael Cinquetti2,
  3. Claire Larroche3,
  4. Bernard Combe4,
  5. Eric Hachulla5,
  6. Olivier Meyer6,
  7. Edouard Pertuiset7,
  8. Guy Kaplanski8,
  9. Laurent Chiche8,
  10. Jean-Marie Berthelot9,
  11. Bruno Gombert10,
  12. Philippe Goupille11,
  13. Christian Marcelli12,
  14. Séverine Feuillet13,
  15. Jean Leone14,
  16. Jean Sibilia1,
  17. Charles Zarnitsky15,
  18. Philippe Carli16,
  19. Stephanie Rist17,
  20. Philippe Gaudin18,
  21. Carine Salliot17,
  22. Muriel Piperno19,
  23. Adeline Deplas20,
  24. Maxime Breban21,
  25. Thierry Lequerre22,
  26. Pascal Richette23,
  27. Charles Ghiringhelli24,
  28. Mohamed Hamidou25,
  29. Philippe Ravaud26,
  30. Xavier Mariette27,
  31. for the Club Rhumatismes et Inflammations and the French Society of Rheumatology
  1. 1Service de Rhumatologie, Centre National de Références des Maladies Auto-Immunes Systémiques Rares, Hôpitaux Universitaires de Strasbourg, Immunorhumathologie Moléculaire, INSERM UMR S 1109, Université de Strasbourg, Strasbourg, France
  2. 2Service de Médecine Interne et Maladies Infectieuses, HIA Legouest, Metz, France
  3. 3Service de Médecine interne, CHU Avicenne, Bobigny, France
  4. 4Service d'Immunorhumathologie, CHU Montpellier, Montpellier, France
  5. 5Service de Médecine interne, CHU Lille, Lille, France
  6. 6Service de Rhumatologie, Hôpital Bichat, Paris, France
  7. 7Service de Rhumatologie, CH Pontoise, Pontoise, France
  8. 8Service de Médecine interne, Hôpital de la conception, Marseille, France
  9. 9Service de Rhumatologie, INSERM U957, CHU Nantes, Nantes, France
  10. 10Service de Médecine Polyvalente - Rhumatologie, CH de La Rochelle, La Rochelle, France
  11. 11Service de Rhumatologie, CHU Tours, Tours, France
  12. 12Service de Rhumatologie, CHU de Caen, Caen, France
  13. 13Service de Pneumologie, Hôpital Saint Louis, Paris, France
  14. 14Service de Médecine Interne, Hôpital Debré, Reims, France
  15. 15Service de Rhumatologie, Groupe Hospitalier du Havre, Le Havre, France
  16. 16Service de Médecine Interne, HIA Sainte-Anne, Toulon, France
  17. 17Service de Rhumatologie, CHR Orléans, Orléans, France
  18. 18Service de Rhumatologie, CHU Hôpital Sud, Grenoble, Echirolles, France
  19. 19Service de Rhumatologie, CHU Lyon Sud France,
  20. 20Service de Rhumatologie, CH Niort, Niort France
  21. 21Service de Rhumatologie, CHU Ambroise Paré, Boulogne Billancourt, France
  22. 22Service de Rhumatologie, CHU Rouen, Rouen, France
  23. 23Service de Rhumatologie, Hôpital Lariboisière, Paris, France
  24. 24Service de Médecine Interne, Hôpital Saint André, Bordeaux, France
  25. 25Service de Médecine Interne, CHU de Nantes, Nantes, France
  26. 26INSERM U738, Département d'Epidémiologie, Biostatistiques et Recherche Clinique, Hôtel Dieu, Centre d'épidémiologie clinique, Paris, France
  27. 27Service de Rhumatologie, Université Paris Sud, AP-HP, Hôpitaux Universitaires Paris Sud, Paris, France
  1. Correspondence to Professor Jacques-Eric Gottenberg, ImmunoRhumatologie Moléculaire, Service de Rhumatologie, INSERM UMR_S 1109, Université de Strasbourg, Centre National de Référence des Maladies Auto-Immunes, Hôpital Hautepierre, 1 Avenue Molière, 67000 Strasbourg 67098, France;


Objectives To evaluate the efficacy and safety of rituximab in patients with primary Sjögren's syndrome (pSS).

Methods The AutoImmune and Rituximab registry has included 86 patients with pSS treated with rituximab, prospectivey followed up every 6 months for 5 years.

Results Seventy-eight patients with pSS (11 men, 67 women), who already had at least one follow-up visit, were analysed. Median age was 59.8 years (29–83), median duration of disease was 11.9 years (3–32). Indications for treatment were systemic involvement for 74 patients and only severe glandular involvement in four patients. The median European Sjögren's Syndrome disease activity index (ESSDAI) was 11 (2–31). 17 patients were concomitantly treated with another immunosuppressant agent. Median follow-up was 34.9 months (6–81.4) (226 patient-years). Overall efficacy according to the treating physician was observed in 47 patients (60%) after the first cycle of rituximab. Median ESSDAI decreased from 11 (2–31) to 7.5 (0–26) (p<0.0001). Median dosage of corticosteroid decreased from 17.6 mg/day (3–60) to 10.8 mg/day (p=0.1). Forty-one patients were retreated with rituximab. Four infusion reactions and one delayed serum sickness-like disease resulted in rituximab discontinuation. Three serious infections (1.3/100 patient-years) and two cancer-related deaths occurred.

Conclusions In common practice, the use of rituximab in pSS is mostly restricted to patients with systemic involvement. This prospective study shows good efficacy and tolerance of rituximab in patients with pSS and systemic involvement.

  • Sjøgren's Syndrome
  • Autoimmunity
  • Autoimmune Diseases

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