A SCANDINAVIAN 2-CENTER STUDY OF BMA 031 IN STEROID-RESISTANT REJECTION OF RENAL GRAFTS

BMA 031 (Behring Monoclonal Antibody) was given to 25 renal graft reci pients with biopsy-proven steroid-resistant rejections. A dose of 50 m g of BMA 031 was given i.v. on 7 consecutive days concomitantly with a standard triple-drug regimen. No premedication was administered befor e the first BMA 031 dose. After the first dose, 7 patients experienced moderate fever (<39-degrees-C), 5 patients had high fever (>39-degree s-C), 4 patients had nausea/vomiting, 3 diarrhea, 1 headache, and 1 hy pertension. These reactions were seen only after the first dose except for 1 patient who developed urticaria on days 3-4. All the rejection episodes were reversed or partially reversed. Twenty-one patients expe rienced re-rejections 3-46 days after the last BMA 031 dose, and were treated with methylprednisolone and/or rabbit antihuman thymocyte glob ulin. Seven patients lost their grafts within 1 year (28%), including 2 patients who died of infection with a functioning graft. BMA 031 see ms to be a safe drug with only few mild side effects, and it effective ly reverses steroid-resistant rejections. Re-rejections were frequent, but mostly reversible.