Incidence of Infectious Complications in Highly Sensitized Renal Transplant Recipients Treated by Rituximab: A Case-Controlled Study

Background. Use of rituximab for various indications in renal transplantation is increasing. However, tolerance and complications associated with rituximab therapy remain controversial. Methods. We retrospectively analyzed severe infectious episodes during 2005 to 2007 in 38 renal transplant recipients treated with rituximab as induction therapy or for antibody-mediated rejection and compared this population with 26 highly sensitized renal transplant recipients who received comparable treatment but without rituximab. Results. Mean posttransplant follow-up was 25.5 +/- 11.5 and 34.6 +/- 16.4 months in the rituximab and control groups, respectively (P=0.01). A total of 84 severe infectious episodes occurred in 39 patients (rituximab 55.3% vs. controls 69.2% [NS]). Most frequent were bacterial infections (47.4% vs. 57.7%), followed by viral and fungal infections (10.6% vs. 15.4% and 7.9% vs. 7.7%, respectively), with no statistical difference between groups. Two patients died in each group. Three of these four deaths were related to infectious complications. Biologic parameters were similar in both groups. Serum creatinine levels were higher at months 3 and 12 in patients with severe infections, but we found no other difference between patients with or without infections. Specifically, rituximab was not associated with an increased risk of infection. Conclusions. In highly sensitized patients, rituximab therapy is not associated with an increased risk of severe infection.