title: Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry.
abstract: OBJECTIVE
  A number of open-label studies have suggested the potential benefit of rituximab (RTX) in systemic lupus erythematosus (SLE). However, in 2 recent randomized controlled trials (RCTs) of RTX, the primary end points were not met. We undertook this study to evaluate the safety and efficacy of RTX in off-trial patients with SLE seen in regular clinical practice.
  
  
  METHODS
  We analyzed prospective data from the French AutoImmunity and Rituximab (AIR) registry, which includes data on patients with autoimmune disorders treated with RTX.
  
  
  RESULTS
  One hundred thirty-six patients received treatment for SLE. The mean +/- SD score on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) version of the SLE Disease Activity Index (SLEDAI) was 11.3 +/- 8.9 at baseline. Severe infections were noted in 12 patients (9%), corresponding to a rate of 6.6/100 patient-years. Most severe infections occurred within the first 3 months after the last RTX infusion. Five patients died, due to severe infection (n = 3) or refractory autoimmune disease (n = 2). Overall response was observed in 80 of 113 patients (71%) by the SELENA-SLEDAI assessment. Efficacy did not differ significantly between patients receiving RTX monotherapy and those receiving concomitant immunosuppressive agents (who had higher baseline disease activity). Articular, cutaneous, renal, and hematologic improvements were noted in 72%, 70%, 74%, and 88% of patients, respectively. Among responders, 41% experienced a relapse of disease, with a response in 91% after retreatment with RTX.
  
  
  CONCLUSIONS
  Data from the AIR registry show a satisfactory tolerance profile and clinical efficacy of RTX in patients with SLE. The contrasting results with those from recent RCTs leave open the question of the therapeutic use of RTX in SLE. Additional controlled studies with new designs are needed to define the place of RTX in the therapeutic arsenal for SLE.
authors.affiliation: Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris, and Paris 11 University, Le Kremlin Bicêtre, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Terrier
authors.forename: Zahir
authors.initials: Z
authors.lastname: Amoura
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.forename: Romain
authors.initials: R
authors.lastname: Jouenne
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
authors.forename: Christine
authors.initials: C
authors.lastname: Bonnet
authors.forename: Patrice
authors.initials: P
authors.lastname: Cacoub
authors.forename: Alain
authors.initials: A
authors.lastname: Cantagrel
authors.forename: Michel
authors.initials: M
authors.lastname: de Bandt
authors.forename: Olivier
authors.initials: O
authors.lastname: Fain
authors.forename: Bruno
authors.initials: B
authors.lastname: Fautrel
authors.forename: Philippe
authors.initials: P
authors.lastname: Gaudin
authors.forename: Bertrand
authors.initials: B
authors.lastname: Godeau
authors.forename: Jean-Robert
authors.initials: JR
authors.lastname: Harlé
authors.forename: Arnaud
authors.initials: A
authors.lastname: Hot
authors.forename: Jean-Emmanuel
authors.initials: JE
authors.lastname: Kahn
authors.forename: Olivier
authors.initials: O
authors.lastname: Lambotte
authors.forename: Claire
authors.initials: C
authors.lastname: Larroche
authors.forename: Jean
authors.initials: J
authors.lastname: Léone
authors.forename: Olivier
authors.initials: O
authors.lastname: Meyer
authors.forename: Béatrice
authors.initials: B
authors.lastname: Pallot-Prades
authors.forename: Edouard
authors.initials: E
authors.lastname: Pertuiset
authors.forename: Pierre
authors.initials: P
authors.lastname: Quartier
authors.forename: Thierry
authors.initials: T
authors.lastname: Schaerverbeke
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.forename: Alexandre
authors.initials: A
authors.lastname: Somogyi
authors.forename: Martin
authors.initials: M
authors.lastname: Soubrier
authors.forename: Eric
authors.initials: E
authors.lastname: Vignon
authors.forename: Brigitte
authors.initials: B
authors.lastname: Bader-Meunier
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.forename: Jacques-Eric
authors.initials: JE
authors.lastname: Gottenberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000707:Anaphylaxis / Q000139:chemically induced; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D002648:Child; D005260:Female; D005602:France; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000628:therapy*; D008181:Lupus Nephritis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012042:Registries; D000069283:Rituximab; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab