title: Efficacy of rituximab in systemic manifestations of primary Sjogren's syndrome: results in 78 patients of the AutoImmune and Rituximab registry.
abstract: OBJECTIVE
  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.
authors.affiliation: Service 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. jacques-eric.gottenberg@chru-strasbourg.fr
authors.forename: Jacques-Eric
authors.initials: JE
authors.lastname: Gottenberg
authors.forename: Gael
authors.initials: G
authors.lastname: Cinquetti
authors.forename: Claire
authors.initials: C
authors.lastname: Larroche
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.forename: Olivier
authors.initials: O
authors.lastname: Meyer
authors.forename: Edouard
authors.initials: E
authors.lastname: Pertuiset
authors.forename: Guy
authors.initials: G
authors.lastname: Kaplanski
authors.forename: Laurent
authors.initials: L
authors.lastname: Chiche
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Berthelot
authors.forename: Bruno
authors.initials: B
authors.lastname: Gombert
authors.forename: Philippe
authors.initials: P
authors.lastname: Goupille
authors.forename: Christian
authors.initials: C
authors.lastname: Marcelli
authors.forename: Séverine
authors.initials: S
authors.lastname: Feuillet
authors.forename: Jean
authors.initials: J
authors.lastname: Leone
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.forename: Charles
authors.initials: C
authors.lastname: Zarnitsky
authors.forename: Philippe
authors.initials: P
authors.lastname: Carli
authors.forename: Stephanie
authors.initials: S
authors.lastname: Rist
authors.forename: Philippe
authors.initials: P
authors.lastname: Gaudin
authors.forename: Carine
authors.initials: C
authors.lastname: Salliot
authors.forename: Muriel
authors.initials: M
authors.lastname: Piperno
authors.forename: Adeline
authors.initials: A
authors.lastname: Deplas
authors.forename: Maxime
authors.initials: M
authors.lastname: Breban
authors.forename: Thierry
authors.initials: T
authors.lastname: Lequerre
authors.forename: Pascal
authors.initials: P
authors.lastname: Richette
authors.forename: Charles
authors.initials: C
authors.lastname: Ghiringhelli
authors.forename: Mohamed
authors.initials: M
authors.lastname: Hamidou
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D000069283:Rituximab; D012859:Sjogren's Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab