[Basiliximab following penetrating risk-keratoplasty--a prospective randomized pilot study].
BACKGROUND
Until now cyclosporin A (CSA) and mycophenolate mofetil (MMF) are the only available systemic immunosuppressants for patients undergoing risk keratoplasty. Basiliximab is a chimeric monoclonal interleukin 2-receptor antibody, which inhibits T-cell proliferation. Basiliximab is approved for the treatment in patients after kidney transplantation. The aim of this study was to prove the efficacy and safety of Basiliximab after penetrating risk keratoplasty.


METHODS
20 patients undergoing risk keratoplasty received as postoperative medication fluocortolon 1 mg/kg/d (tapered off within three weeks) and prednisolone acetate eye-drops 5x/d (tapered off within five months). In addition, 10 patients received 20 mg basiliximab immediately following surgery and four days postoperatively. 10 patients in the control group received oral CSA adapted to the blood-trough level (120-150 ng/mL) for six months.


RESULTS
After a mean follow-up time of 477 +/- 263 days 4 patients of the basiliximab group showed corneal immune reactions (2 irreversible), while no side effects were observed. In the CSA group 2 immune reactions occurred (1 irreversible). In 2 CSA-treated patients the CSA administration had to be stopped due to side effects.


CONCLUSIONS
Basiliximab has a lower efficacy in preventing immune reactions after risk keratoplasty than CSA. However, the side effect profile of basiliximab is more favourable than that of CSA.
Birnbaum
F
F
Augenklinik, Universitätsklinik Freiburg. florian.birnbaum@uniklinik-freiburg.de
Jehle
T
T
Schwartzkopff
J
J
Sokolovska
Y
Y
Böhringer
D
D
Reis
A
A
Reinhard
T
T
D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000077552:Basiliximab; D017024:Chemotherapy, Adjuvant; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis* / Q000209:etiology* / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015948:Keratoplasty, Penetrating / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab