A Scandinavian two-center study of BMA 031 in steroid-resistant rejection of renal grafts.
BMA 031 (Behring Monoclonal Antibody) was given to 25 renal graft recipients with biopsy-proven steroid-resistant rejections. A dose of 50 mg of BMA 031 was given i.v. on 7 consecutive days concomitantly with a standard triple-drug regimen. No premedication was administered before the first BMA 031 dose. After the first dose, 7 patients experienced moderate fever (< 39 degrees C), 5 patients had high fever (> 39 degrees C), 4 patients had nausea/vomiting, 3 diarrhea, 1 headache, and 1 hypertension. 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 experienced re-rejections 3-46 days after the last BMA 031 dose, and were treated with methylprednisolone and/or rabbit antihuman thymocyte globulin. Seven patients lost their grafts within 1 year (28%), including 2 patients who died of infection with a functioning graft. BMA 031 seems to be a safe drug with only few mild side effects, and it effectively reverses steroid-resistant rejections. Re-rejections were frequent, but mostly reversible.
Pfeffer
P F
PF
National Hospital, Oslo, Norway.
Ohlman
S
S
Jakobsen
A
A
Fauchald
P
P
Leivestad
T
T
Tydén
G
G
Flatmark
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000945:Antigens, Differentiation, T-Lymphocyte / Q000276:immunology; D018801:CD2 Antigens; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000097:blood; D004231:Diuresis / Q000187:drug effects; D004351:Drug Resistance; D005260:Female; D005916:Globulins / Q000627:therapeutic use; D006084:Graft Rejection / Q000188:drug therapy* / Q000276:immunology; D006684:HLA-DR Antigens / Q000276:immunology; D006650:Histocompatibility Testing; D006801:Humans; D007223:Infant; D016030:Kidney Transplantation / Q000276:immunology*; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D011971:Receptors, Immunologic / Q000276:immunology; D013256:Steroids / Q000627:therapeutic use*; D013950:Thymus Gland / Q000276:immunology; D014019:Tissue Donors; D014020:Tissue Extracts / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D000945:Antigens, Differentiation, T-Lymphocyte; D018801:CD2 Antigens; D005916:Globulins; D006684:HLA-DR Antigens; D011971:Receptors, Immunologic; D013256:Steroids; D014020:Tissue Extracts; D003404:Creatinine; D008775:Methylprednisolone