Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry.
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.
Terrier
Benjamin
B
Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris, and Paris 11 University, Le Kremlin Bicêtre, France.
Amoura
Zahir
Z
Ravaud
Philippe
P
Hachulla
Eric
E
Jouenne
Romain
R
Combe
Bernard
B
Bonnet
Christine
C
Cacoub
Patrice
P
Cantagrel
Alain
A
de Bandt
Michel
M
Fain
Olivier
O
Fautrel
Bruno
B
Gaudin
Philippe
P
Godeau
Bertrand
B
Harlé
Jean-Robert
JR
Hot
Arnaud
A
Kahn
Jean-Emmanuel
JE
Lambotte
Olivier
O
Larroche
Claire
C
Léone
Jean
J
Meyer
Olivier
O
Pallot-Prades
Béatrice
B
Pertuiset
Edouard
E
Quartier
Pierre
P
Schaerverbeke
Thierry
T
Sibilia
Jean
J
Somogyi
Alexandre
A
Soubrier
Martin
M
Vignon
Eric
E
Bader-Meunier
Brigitte
B
Mariette
Xavier
X
Gottenberg
Jacques-Eric
JE
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
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab