title: Efficacy and safety of belimumab in primary Sjögren's syndrome: results of the BELISS open-label phase II study.
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).
  
  
  OBJECTIVE
  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.
authors.affiliation: Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France.
authors.forename: Raphaèle
authors.initials: R
authors.lastname: Seror
authors.affiliation: Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Quartuccio
authors.affiliation: Faculty of Medicine, AP-HP, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, INSERM, U738, University of Paris Descartes, Paris, France.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Baron
authors.affiliation: Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Salvin
authors.affiliation: Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy Institute of Clinical Pathology, University Hospital of Udine, Udine, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Fabris
authors.affiliation: Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Desmoulins
authors.affiliation: Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France.
authors.forename: Gaétane
authors.initials: G
authors.lastname: Nocturne
authors.affiliation: Faculty of Medicine, AP-HP, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, INSERM, U738, University of Paris Descartes, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Vita
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D005221:Fatigue / Q000188:drug therapy / Q000209:etiology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007638:Keratoconjunctivitis Sicca / Q000188:drug therapy / Q000209:etiology; D008875:Middle Aged; D012859:Sjogren's Syndrome / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy / Q000209:etiology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C511911:belimumab