Safety of rituximab in rheumatoid arthritis: A long-term prospective single-center study of gammaglobulin concentrations and infections |
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| Authors: | Anne Isvy Marine Meunier Camille Gobeaux-Chenevier Emilie Maury Julien Wipff Chantal Job-Deslandre André Kahan Yannick Allanore |
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| Affiliation: | 1. Service de rhumatologie A, hôpital Cochin, AP–HP, université Paris Descartes, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France;2. Department of clinical chemistry, hôpital Cochin, AP–HP, université Paris Descartes, 75014 Paris, France;3. Inserm U1016, institut Cochin, université Paris Descartes, 75014 Paris, France;1. Service de rhumatologie, université Paris-Descartes, hôpital Cochin, Paris, France;2. EA 4490, service de rhumatologie, CHU de Lille, Lille, France;3. Inserm U1059, service de rhumatologie, CHU de Saint-Étienne, Saint-Étienne, France;1. Medical Affairs, Roche Servicios S. A., Central America and the Caribbean;2. Research Unit, Hospital San Juan de Dios, CCSS, Costa Rica;3. School of Pharmacy, Universidad de Costa Rica, Costa Rica;4. Rheumatology Department, Hospital Max Peralta, CCSS, Costa Rica;5. Marbella Research Center, Panama;6. Rheumatology Department, Hospital San Juan de Dios, CCSS, Costa Rica;7. Centro de Atención e Investigación en Reumatología y Afines (CAIRA), Costa Rica;8. School of Medicine, Universidad de Costa Rica, Costa Rica;9. Rheumatology Department, Hospital Docente Padre Billini, Dominican Republic;10. Rheumatology Chair, Universidad Pedro Henríquez Ureña, Dominican Republic;11. School of Medicine, Universidad de San Carlos de Guatemala, Guatemala;12. Rheumatology Department, Hospital General de Enfermedades, IGSS Guatemala, Guatemala;13. IGSS Guatemala, Guatemala;14. Rheumatology Department, Complejo Hospitalario Dr. Arnulfo Arias Madrid, CSS Panamá, Panama;15. America Medical Center, Panama;1. Département de rhumatologie, centre hospitalier universitaire de Saint-Étienne, Saint-Étienne, France;2. LBTO, Inserm U1059, université Jean-Monnet, Saint-Étienne, France;1. Division of Cardiovascular-Thoracic Surgery, Ann & Robert H. Lurie Children''s Hospital of Chicago, Chicago, Ill;3. Division of Cardiology, Ann & Robert H. Lurie Children''s Hospital of Chicago, Chicago, Ill;2. Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill;4. Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Ill |
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| Abstract: | ![]()
ObjectiveRituximab seems well tolerated in patients with rheumatoid arthritis (RA). However, variations in the gammaglobulin profile that might increase the infection risk have been reported. Here, our objective was to evaluate gammaglobulin concentrations and the infection risk in patients receiving rituximab therapy for RA in everyday practice.MethodsProspective single-center observational study of 65 patients with refractory RA (median age, 59 years; range, 26–83) treated with rituximab 1 g twice 15 days apart, with or without a further 1-g dose at least 6 months later depending on the clinical response. Gammaglobulins were assayed before each rituximab dose.ResultsThe median cumulative rituximab dose was 4 g (1–16) and the median time to retreatment was 8 months (6–16). Rituximab therapy significantly improved the DAS-28 score. The gammaglobulin concentration decreased significantly between the first and last rituximab dose (from 11.6 g/L [5–26] to 8.2 g/L [3–20], a ?2.6 g/L difference; P < 0.05). The decrease was larger in the 24 patients with cumulative rituximab doses greater than 5 g than in the 41 other patients (difference of ?4 vs ?2.7 g/L; P < 0.05). Three patients experienced severe infections, two in the high-dose group and one in the other group (P = 0.5).ConclusionThese data obtained in everyday practice constitute further evidence that rituximab is well-tolerated in patients with RA. Rituximab therapy was associated with a decrease in gammaglobulin concentrations that was greater in patients receiving higher cumulative doses. |
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