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FRI0246 Serious infusion-related reactions after rituximab in patients with rheumatoid arthritis: data from the autoimmunity and rituximab registry
  1. J. H. Salmon1,
  2. P. Ravaud2,
  3. T. Bardin3,
  4. P. Cacoub4,
  5. A. Cantagruel5,
  6. B. Combe6,
  7. M. Dougados7,
  8. R.-M. Flipo8,
  9. B. Godeau9,
  10. L. Guillevin10,
  11. X. Le Loët11,
  12. E. Hachulla12,
  13. T. Schaeverbeke13,
  14. J. Sibilia14,
  15. I. Pane15,
  16. G. Baron16,
  17. X. Mariette17,
  18. J.-E. Gottenberg14 on behalf of french society of rheumatology
  1. 1Rheumatology, Hopital Maison Blanche CHU de Reims, Reims
  2. 2Epidemiology, Hopital Hotel Dieu, 75014 Paris
  3. 3Rheumatology, Hôpital Lariboisière
  4. 4Internal Medecine, Hopital Pitié-Salpétrière, Paris
  5. 5Rheumatology, CHU, Toulouse
  6. 6Rheumatology, Hopital Lapeyronie, Montpellier
  7. 7Rheumatology, Paris-Descartes University, Cochin Hospital, Paris
  8. 8Rheumatology, Hôpital Roger Salengro, CHRU de Lille, Lille
  9. 9Internal Medecine, CHU Henri Mondor, Créteil
  10. 10Internal Medecine, Hôpital Cochin, Paris
  11. 11Rheumatology, Rouen University Hospital & Inserm U905, Rouen
  12. 12Internal Medecine, Hôpital Claude Huriez, CHRU de Lille, Lille
  13. 13Rheumatology, CHU de Bordeaux, Bordeaux
  14. 14Rheumatology, CHU Hautepierre, Strasbourg
  15. 15Epidemiology, Dieu University Hospital Paris
  16. 16Epidemiology, Hopital Bichat
  17. 17Rheumatology, Rheumatology, Hôpital Bicêtre, INSERM U802, Université Paris-Sud 11, Paris, France

Abstract

Objectives To evaluate the prevalence of serious infusion-related reactions after rituximab (RTX) in a large prospective registry of patients with rheumatoid arthritis.

Methods The Autoimmunity and Rituximab registry (AIR) is an independent registry promoted by the French Society of Rheumatology that included 1983 patients with rheumatoid arthritis treated with rituximab and followed-up prospectively for seven years. An infusion-related reaction (IRR) was defined as occurring during or in the 24 hours following an infusion.

Results Overall, 45 IRR resulted in RTX discontinuation [2.2% of all patients with RA, 0.4% of all infusions]. These serious IRR occurred after the first cycle in 17 patients, the second cycle in 18, the third cycle in 7, the fourth cycle in 2 patients and after the fifth cycle in 1 patient. Serious IRR mainly occurred after the first infusion of the cycle (71% of the 45 IRR vs 39% after the second infusion). 32 patients (73%) had allergic or anaphylactic manifestations such as a skin rash (18 patients), a throat irritation (8 patients), an anaphylaxis (3 patients), a bronchospasm (2 patients) or an angioedema (1 patient), 5 (11%) hypertension, 3 patients (7%) fever, 4 patients (8.5%) other symptoms and 1 missing data. Among the 30 patients who had a serious IRR after the second or subsequent infusions, 15 (50%) had previously had a milder IRR requiring a transient interruption or a reduction in the infusion flow. There was no fatal infusion-related reaction, and all infusion-related reactions resolved after discontinuation of RTX and symptomatic treatment.

Conclusions The real life frequency of IRR resulting in RTX discontinuation is similar to that observed in clinical studies, approximately 0.5 %. Allergic manifestations were the most frequent. These reactions mainly occurred during the first two cycles, but nearly a quarter of them occurred after the 3d or subsequent cycles. Last, severe reactions had been preceded by a milder infusion reaction to a former infusion in 50% of patients

Disclosure of Interest: None Declared

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