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Efficacy and safety of belimumab in primary Sjögren's syndrome: results of the BELISS open-label phase II study
  1. Xavier Mariette1,
  2. Raphaèle Seror1,
  3. Luca Quartuccio2,
  4. Gabriel Baron3,
  5. Sara Salvin2,
  6. Martina Fabris2,4,
  7. Frederic Desmoulins1,
  8. Gaétane Nocturne1,
  9. Philippe Ravaud3,
  10. Salvatore De Vita2
  1. 1Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France
  2. 2Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy
  3. 3Faculty of Medicine, AP-HP, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, INSERM, U738, University of Paris Descartes, Paris, France
  4. 4Institute of Clinical Pathology, University Hospital of Udine, Udine, Italy
  1. Correspondence to Dr Xavier Mariette, Service de Rhumatologie, Hôpital Bicêtre, 78 rue du Général Leclerc, Le Kremlin Bicêtre 94275, France; xavier.mariette{at}bct.aphp.fr

Abstract

Background Increased expression of B cell activating factor (BAFF or B lymphocyte stimulator) may explain the B cell activation characteristic of primary Sjögren's syndrome (pSS).

Objectives To evaluate the efficacy and safety of belimumab, targeting BAFF, in patients with pSS.

Methods Patients were included in this bi-centric prospective 1-year open-label trial if they fulfilled American European Consensus group criteria, were anti-Sjögren's syndrome A-positive and had current systemic complications or salivary gland enlargement, or early disease (<5 years), or biomarkers of B cell activation. They received belimumab, 10 mg/kg, at weeks 0, 2 and 4 and then every 4 weeks to week 24. The primary end-point, assessed at week 28, was improvement in two of five items: reduction in ≥30% in dryness score on a visual analogue scale (VAS), ≥30% in fatigue VAS score, ≥30% in VAS pain score, ≥30% in systemic activity VAS assessed by the physician and/or >25% improvement in any B cell activation biomarker values.

Results Among 30 patients included, the primary end-point was achieved in 18 (60%). The mean (SD) European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index decreased from 8.8 (7.4) to 6.3 (6.6) (p=0.0015) and EULAR) Sjögren's Syndrome Patient Reported Index from 6.4 (1.1) to 5.6 (2.0) (p=0.0174). The mean dryness, fatigue and pain VAS varied from 7.8 (1.8) to 6.2 (2.9) (p=0.0021), 6.9 (1.8) to 6.0 (2.2) (p=0.0606) and 4.6 (2.6) to 4.7 (2.4) (p=0.89), respectively. Salivary flow and Schirmer's test did not change.

Conclusions These encouraging results justify future randomised controlled trials of belimumab in a selected target population of pSS patients most likely to benefit from treatment.

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