Recombinant human tumor necrosis factor receptor Fc fusion protein therapy in kidney transplant recipients undergoing OKT3 induction therapy.
BACKGROUND
Initial doses of OKT3 are associated with a cytokine-induced acute clinical syndrome (ACS). This study assessed the safety of a recombinant human tumor necrosis factor receptor fusion protein (TNFR:Fc) given to minimize 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. Patients were monitored after transplant for OKT3-ACS symptoms. Levels of cytokines, 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 patients (10/12) compared to controls (1/4) in the 3 months after transplant, but the etiology of this difference was unclear. There were no significant differences in cytokine profiles.


CONCLUSIONS
TNFR:Fc is well tolerated by renal transplant patients receiving OKT3 induction therapy and modestly decreases the symptoms associated with OKT3-ACS.
Novak
E J
EJ
Department of Surgery, University of Washington, Seattle 98195, USA.
Blosch
C M
CM
Perkins
J D
JD
Davis
C L
CL
Barr
D
D
McVicar
J P
JP
Griffin
R S
RS
Farrand
A L
AL
Wener
M
M
Marsh
C L
CL
D000208:Acute Disease; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000627:therapeutic use*; D015850:Interleukin-6 / Q000097:blood; D016030:Kidney Transplantation; D016853:Muromonab-CD3 / Q000009:adverse effects*; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D014184:Transplantation, Homologous
D007141:Immunoglobulin Fc Fragments; D015850:Interleukin-6; D016853:Muromonab-CD3; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins