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.
Conclusion. 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.
- Safety and Efficacy of Rituximab in Systemic Lupus Erythematosus
- Benjamin Terrier - Hop Bicetre, AP HP, Le Kremlin Bicetre, FranceZahir Amoura - Assistance Publique – Hôpitaux de ParisPhilippe Ravaud - Hop Bichat Claude Bernard, AP HP, F-75877 Paris 18, FranceEric Hachulla - Claude Huriez Hosp, Lille, FranceRomain Jouenne - Hop Bicetre, AP HP, Le Kremlin Bicetre, FranceBernard Combe - Lapeyronie Hosp, Montpellier, FranceChristine Bonnet - Dupuytren Hosp, Limoges, FrancePatrice Cacoub - Assistance Publique – Hôpitaux de ParisAlain Cantagrel - Purpan Hosp, Toulouse, FranceMichel de Bandt - Robert Ballanger Hosp, Aulnay Sous Bois, FranceOlivier Fain - Jean Verdier Hosp, AP HP, Bondy, FranceBruno Fautrel - Assistance Publique – Hôpitaux de ParisPhilippe Gaudin - Hop Sud, Grenoble, FranceBertrand Godeau - Hop Henri Mondor, AP HP, F-94010 Creteil, FranceJean-Robert Harle - Concept Hosp, Assistance Publ Hop Marseille, Marseille, FranceArnaud Hot - Hop Edouard Herriot, Hosp Civils Lyon, Lyon, FranceJean-Emmanuel Kahn - Foch Hosp, Suresnes, FranceOlivier Lambotte - Hop Bicetre, AP HP, Le Kremlin Bicetre, FranceClaire Larroche - Assistance Publique – Hôpitaux de ParisJean Leone - Hop Robert Debre, Reims, FranceOlivier Meyer - Assistance Publique – Hôpitaux de ParisBeatrice Pallot-Prades - Bellevue Hosp, St Etienne, FranceEdouard Pertuiset - Rene Dubos Hosp, Pontoise, FrancePierre Quartier - Hop Necker Enfants Malad, AP HP, Paris, FranceThierry Schaerverbeke - Pellegrin Hosp, Bordeaux, FranceJean Sibilia - Hautepierre Hosp, Strasbourg, FranceAlexandre Somogyi - Ctr Hosp Intercommunal, St Germain En Laye, FranceMartin Soubrier - Gabriel Montpied Hosp, Clermont Ferrand, FranceEric Vignon - Hop Edouard Herriot, Hosp Civils Lyon, Lyon, FranceBrigitte Bader-Meunier - Assistance Publique – Hôpitaux de ParisXavier Mariette - Hop Bicetre, AP HP, Le Kremlin Bicetre, FranceJacques-Eric Gottenberg - Hautepierre Hosp, Strasbourg, FranceClub Rhumatismes Inflammation
- Arthritis and rheumatism, Vol.62(8), pp.2458-2466
- Wiley
- 9
- Pfizer Bristol-Myers Squibb Wyeth; Pfizer Vifor Pharma Schering-Plough; Merck & Company; Schering Plough Corporation Sanofi-Aventis GlaxoSmithKline Roche France; Roche Holding Amgen Abbott; Abbott Laboratories
- 99233949309311
- IGMM - Institut de Génétique Moléculaire de Montpellier
- English
- Journal article