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Tolerance and efficacy of rituximab and changes in serum B cell biomarkers in patients with systemic complications of primary Sjögren’s syndrome
  1. Raphaèle Seror1,
  2. Christelle Sordet2,
  3. Loic Guillevin3,
  4. Eric Hachulla4,
  5. Charles Masson5,
  6. Marc Ittah1,
  7. Sophie Candon6,
  8. Véronique Le Guern3,
  9. Achille Aouba7,
  10. Jean Sibilia2,
  11. Jacques-Eric Gottenberg1,*,
  12. Xavier Mariette1,*
  1. 1Department of Rheumatology, Hôpital Bicêtre, Assistance Publique–Hôpitaux de Paris, Université paris-Sud 11, INSERM U802, Le Kremlin Bicêtre, France
  2. 2Department of Rheumatology, Hôpital Hautepierre, Strasbourg, France
  3. 3Department of Internal Medicine, Hôpital Cochin, Université René-Descartes Paris 5, Assistance Publique–Hôpitaux de Paris, Paris, France
  4. 4Department of Internal Medicine, CHU de Lille, Lille, France
  5. 5Department of Rheumatology, CHU d’Angers, Angers, France
  6. 6Department of Immunology, Hôpital Necker, Assistance Publique–Hôpitaux de Paris, Paris, France
  7. 7Department of Hematology, Hôpital Necker, Université René-Descartes Paris 5, Assistance Publique–Hôpitaux de Paris, Paris, France
  1. Correspondence to:
    Professor X Mariette
    Service de Rhumatologie, Hôpital de Bicêtre, 78 rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France; xavier.mariette{at}


Objective: To investigate the safety and efficacy of rituximab (RTX) for systemic symptoms in patients with primary Sjögren’s syndrome (pSS), and changes in B cell biomarkers.

Patients and methods: The records of 16 patients with pSS according to the American European consensus group criteria were reviewed retrospectively.

Results: Patients, all women, had a median age of 58.5 (range 41–71) years and a disease duration of 9.5 (range 0–25) years. RTX was prescribed for lymphoma (n = 5), refractory pulmonary disease with polysynovitis (n = 2), severe polysynovitis (n = 2), mixed cryoglobulinaemia (n = 5), thrombocytopenia (n = 1) and mononeuritis multiplex (n = 1). The median follow-up duration was 14.5 (range 2–48) months. Three patients experienced adverse events, including one mild serum sickness-like reaction with the presence of human antichimeric antibodies. Efficacy of treatment was observed in 4 of 5 patients with lymphomas and in 9 of 11 patients with systemic involvement. Dryness was improved in only a minority of patients. Corticosteroid dose was reduced in 11 patients. RTX induced decreased rheumatoid factor, γ-globulin and β2-microglobulin levels, and the level of B cell activating factor of the tumour necrosis factor family (BAFF) increased concomitantly with B cell depletion. Five patients were re-treated, with good efficacy and tolerance, except for one with probable serum sickness-like reaction.

Conclusion: This study shows good efficacy and fair tolerance of RTX for systemic features. In addition, RTX allows for a marked reduction in corticosteroid use. Except for BAFF, the level of which increases, serum B cell biomarker levels decrease after taking RTX. Controlled trials should be performed to confirm the efficacy of RTX in pSS.

  • BAFF, B cell activating factor of the tumour necrosis factor family
  • FITC, fluorescein isothiocyanate
  • HACA, human anti-chimeric antibody
  • pSS, primary Sjögren’s syndrome
  • RTX, rituximab

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  • Published Online First 1 September 2006

  • * These authors contributed equally to this work.

  • Funding: This work was supported by grant Réseau de recherche clinique INSERM on Sjögren’s syndrome.

  • Competing interests: None.