Rituximab as induction therapy after renal transplantation: a randomized, double-blind, placebo-controlled study of efficacy and safety.

Abstract

We evaluated the efficacy and safety of rituximab as induction therapy in renal transplant patients. In a double-blind, placebo-controlled study, 280 adult renal transplant patients were randomized between a single dose of rituximab (375 mg/m(2)) or placebo during transplant surgery. Patients were stratified according to panel-reactive antibody (PRA) value and rank number of transplantation. Maintenance immunosuppression consisted of tacrolimus, mycophenolate mofetil and steroids. The primary endpoint was the incidence of biopsy proven acute rejection (BPAR) within 6 months after transplantation. The incidence of BPAR was comparable between rituximab-treated (23/138, 16.7%) and placebo-treated patients (30/142, 21.2%, p = 0.25). Immunologically high-risk patients (PRA >6% or re-transplant) not receiving rituximab had a significantly higher incidence of rejection (13/34, 38.2%) compared to other treatment groups (rituximab-treated immunologically high-risk patients, and rituximab- or placebo-treated immunologically low-risk (PRA ≤ 6% or first transplant) patients (17.9%, 16.4% and 15.7%, p = 0.004). Neutropenia (<1.5 × 10(9) /L) occurred more frequently in rituximab-treated patients (24.3% vs. 2.2%, p < 0.001). After 24 months, the cumulative incidence of infections and malignancies was comparable. A single dose of rituximab as induction therapy did not reduce the overall incidence of BPAR, but might be beneficial in immunologically high-risk patients. Treatment with rituximab was safe.

• Authors: M W F van den Hoogen, E G Kamburova, M C Baas, E J Steenbergen, S Florquin, H J P M Koenen, I Joosten, L B Hilbrands
• Journal: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons (Am J Transplant) Vol. 15 Issue 2 Pg. 407-16 (Feb 2015) ISSN: 1600-6143 [Electronic] United States
• PMID: 25612493 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Chemical References

• Antibodies, Monoclonal, Murine-Derived
• Immunosuppressive Agents
• Rituximab

Topics

• Adult
• Antibodies, Monoclonal, Murine-Derived (therapeutic use)
• B-Lymphocytes (pathology)
• Biopsy
• Double-Blind Method
• Female
• Graft Rejection (epidemiology, pathology, prevention & control)
• Humans
• Immunosuppressive Agents (therapeutic use)
• Incidence
• Kidney (pathology)
• Kidney Transplantation
• Male
• Middle Aged
• Remission Induction
• Rituximab
• Treatment Outcome