395. Randomized Prospective Trial of Depleting Antibody Induction in Kidney and Pancreas Transplantation: Infectious Complications
Session: Poster Session: Hospital-acquired and Transplant Infections
Friday, October 30, 2009: 12:00 AM
Room: Poster Hall A
Background: Increased risk of infectious complications (ICs) after kidney (K) and pancreas (P) transplant (Tx) is a major concern when using lymphocyte depleting antibody induction agents such as alemtuzumab (Alem) and rabbit anti-thymocyte globulin (rATG).
Methods: We conducted a prospective, randomized trial comparing single dose Alem (30 mg) to alternate day rATG (1.5 mg/kg) induction in adult KTx and PTx patients (pts). Maintenance therapy was tacrolimus, mycophenolic acid, and risk stratification to determine early steroid elimination. Infection prophylaxis was given for fungal (1 month KTx; 2 month PTx), pneumocystis (12 month), and CMV (3 months; 6 months for primary CMV exposure). ICs were graded according to NIH Clinical Toxicity Criteria (CTCAE version 3.0).
Results: Between 2/1/05 and 8/31/08 (median follow-up 24 months), 222 pts were enrolled (113 randomized to Alem,109 to rATG induction). Demographics were similar between groups and 52 pts (23%) were age >60. Overall pt, KTx, and PTx survival rates were 95%, 90%, and 85%, respectively, and were comparable between groups (p=NS). Incidence of biopsy proven acute rejection (BPAR) was lower in the Alem (16%) vs rATG group (26%, p= 0.03). A total of 125 ICs occurred in Alem vs 154 ICs in rATG pts (p=NS). Of 113 Alem pts, 61 (54%) developed ICs compared to 81 (74%, p=.002) in the rATG group. Grade 2 (moderate) ICs occurred in 62 (55%) Alem vs 75 (69%, p=.04) rATG pts. Grade 3 (serious) ICs occurred in 52 (46%) Alem vs 75 (69%,p=.0007) rATG pts, whereas Grade 4 (life-threatening) ICs occurred in 8 (7%) Alem vs 1 (1%, p=.04) rATG pts. There was 1 Grade 5 (death) IC in each group. The incidence of polyoma (BK) viral infection was 1.8% in Alem vs 8% (p=.03) in rATG pts. CMV viremia occurred in 9 (8%) Alem vs 19 (17%, p=.04) rATG pts, and was more frequent with D+/R- (23%) and D+/R- (15%) serostatus. 11 fungal infections occurred in each group. Pts >60 did not exhibit a higher risk of infection, whereas the presence of BPAR increased the overall risk of ICs from 41% to 72% (p<.001).
Conclusion: Alem is associated with a lower incidence of BPAR and ICs compared to rATG induction regardless of pt age.
William Doares, PharmD1, Alan Farney, MD, PhD1, Lois Hart, BS1, Jeffrey Rogers, MD1, Robert Stratta, MD1 and  R. J. Stratta, None..
W. Doares, None..
A. C. Farney, None..
J. Rogers, None..
L. Hart, None., (1)Wake Forest Univ. School of Medicine, Winston-Salem, NC