Recombinant human tumor necrosis factor receptor Fc fusion protein therapyin kidney transplant recipients undergoing OKT3 induction therapy

Background. Initial doses of OKT3 are associated with a cytokine-induced ac ute clinical syndrome (ACS). This study assessed the safety of a recombinan t human tumor necrosis factor receptor fusion protein (TNFR:Fc) given to mi nimize OKT3-ACS symptoms in renal allograft recipients undergoing induction therapy. Methods. Sixteen patients were randomized into treatment or control groups. Treated patients received TNFR:Fc 1 hr before OKT3 on days 0 and 3. Patien ts were monitored after transplant for OKT3-ACS symptoms. Levels of cytokin es, serum creatinine, and C-reactive protein were followed. Results Patients receiving TNFR:Fc had lower OKT3-ACS symptoms as measured by a scoring system. There was a higher incidence of infection in treated p atients (10/12) compared to controls (1/4) in the 3 months after transplant , but the etiology of this difference was unclear. There were no significan t differences in cytokine profiles. Conclusions. TNFR:Fc is well tolerated by renal transplant patients receivi ng OKT3 induction therapy and modestly decreases the symptoms associated wi th OKT3-ACS.