Campath alemtuzumab: Phase IV data

An open-label, U.S. Phase IV trial in 474 renal transplant recipients at high or low immunologic risk showed that a single 30 mg dose of alemtuzumab met the primary endpoint of a significantly lower rate of biopsy-confirmed acute rejection at both 6 (3% vs. 15%, p<0.001) and 12 months (5% vs. 17%, p<0.001) vs. conventional therapy. Additionally, the rate of biopsy-confirmed acute rejection in low-risk patients treated with alemtuzumab was significantly lower vs. conventional therapy at 3 years (10% vs. 22%, p=0.003), but there was no significant difference between treatment groups in high-risk patients (18% vs. 15%, p=0.63). Conventional therapy consisted of rabbit anti-thymocyte globulin for high-risk patients (n=139), and basiliximab for low-risk patients (n=335). All patients received mycophenolate mofetil and tacrolimus. Patients at a high risk for acute rejection were defined by a repeat transplant, a peak or current value of panel-reactive antibodies of >=20%, or being of African American descent. Data were published in the New England Journal of Medicine. ...