title: Recombinant human tumor necrosis factor receptor Fc fusion protein therapy in kidney transplant recipients undergoing OKT3 induction therapy.
abstract: 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.
authors.affiliation: Department of Surgery, University of Washington, Seattle 98195, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Novak
authors.forename: C M
authors.initials: CM
authors.lastname: Blosch
authors.forename: J D
authors.initials: JD
authors.lastname: Perkins
authors.forename: C L
authors.initials: CL
authors.lastname: Davis
authors.forename: D
authors.initials: D
authors.lastname: Barr
authors.forename: J P
authors.initials: JP
authors.lastname: McVicar
authors.forename: R S
authors.initials: RS
authors.lastname: Griffin
authors.forename: A L
authors.initials: AL
authors.lastname: Farrand
authors.forename: M
authors.initials: M
authors.lastname: Wener
authors.forename: C L
authors.initials: CL
authors.lastname: Marsh
mesh_terms: 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
chemical_list: D007141:Immunoglobulin Fc Fragments; D015850:Interleukin-6; D016853:Muromonab-CD3; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins