title: Efficacy of belimumab and targeting of rheumatoid factor-positive B-cell expansion in Sjögren's syndrome: follow-up after the end of the phase II open-label BELISS study.
abstract: OBJECTIVE
  Belimumab, a monoclonal anti-B lymphocyte Stimulator (BLyS) antibody, appeared effective in Sjögren's syndrome (SS) in the phase II open-label 52-week BELISS study. Herein, the follow-up after the end of the BELISS study and suspension of the drug was reported in order to further verify the efficacy of belimumab in SS.
  
  
  METHODS
  13 SS patients were followed after the end of the belimumab treatment. The patients were all female, aged 54±15 years; all the patients presented anti-SSA and/or anti-SSB positivity. Composite scores for SS disease activity were collected at month 6 and month 12 after the end of the trial. The changes of IgG, IgA, IgM immunoglobulin serum levels, and rheumatoid factor (RF) level were reported. BLyS serum levels were also analysed. Statistics for paired comparisons were used.
  
  
  RESULTS
  ESSDAI score increased from 3.5±3.7 at week 52 (end of the trial) to 7.0±5.7 at month 12 after the end of the trial (p=0.003). RF level increased from 31.0 (8.0-224.6) IU/ml at week 52 to 69 (11-666) IU/ml at month 12 after the end of the trial (p=0.008). IgM level increased from 131.9±73.6 mg/dl at week 52 to 165±84.6 mg/dl at month 12 after the end of the trial (p=0.04). A significant increase of serum BLyS levels also increased from 1304 (667-3835) pg/ml at week 52 to 2882 (1353-6178) pg/ml twelve months after belimumab suspension (p=0,04).
  
  
  CONCLUSIONS
  Targeting BLyS by belimumab appears effective in SS, with the inhibition of RF-positive B cell proliferation.
authors.affiliation: Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S. Maria della Misericordia, Udine, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Quartuccio
authors.affiliation: Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S. Maria della Misericordia, Udine, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Salvin
authors.affiliation: Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S. Maria della Misericordia, Udine, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Corazza
authors.affiliation: Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S. Maria della Misericordia, Udine, Italy.
authors.forename: Saviana
authors.initials: S
authors.lastname: Gandolfo
authors.affiliation: Institute of Pathology, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S. Maria della Misericordia, Udine, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Fabris
authors.affiliation: Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero-Universitaria S. Maria della Misericordia, Udine, Italy. devita.salvatore@aoud.sanita.fvg.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Vita
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D053264:B-Cell Activating Factor / Q000037:antagonists & inhibitors*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood; D008875:Middle Aged; D012217:Rheumatoid Factor / Q000097:blood*; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000276:immunology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D053264:B-Cell Activating Factor; D007075:Immunoglobulin M; C505719:TNFSF13B protein, human; C511911:belimumab; D012217:Rheumatoid Factor