Antibody formation during intravenous and intramuscular therapy with Erwinia asparaginase*

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Abstract
Background Determination of the frequency of antibody formation during first and second exposure to Erwinia asparaginase after i.v. and i.m. administration. Procedure Thirty‐nine children with newly diagnosed acute lymphoblastic leukemia (ALL) were included in this prospective study. Antibodies were determined (ELISA method) in plasma from these patients on specific days during and after therapy with 30,000 IU/m2 i.v. or i.m. every day for ten days during the induction phase (first exposure). For 19 children, antibodies were measured in plasma during and after the re‐induction phase (second exposure) following treatment with 30,000 IU/m2 i.v. or i.m. twice a week for two weeks (Mondays and Thursdays). On the same days of therapy, enzyme activity (spectrophotometric method) and the concentration of asparagine (HPLC) was determined. Results During the first exposure, none of the patients developed anti‐Erwinia asparaginase antibodies. During the second exposure, one patient (1 of 8 patients) treated intravenously developed antibodies, which were associated with disappearance of enzyme activity and reappearance of asparagine. Three of eleven patients developed antibodies of pharmacokinetic importance after i.m. therapy. None of the children had any clinical symptoms of hypersensitivity. Conclusions The formation of antibodies and subsequently altered pharmacokinetics of Erwinia asparaginase seemed to be of importance only during a second period of asparaginase therapy. Med. Pediatr. Oncol. 2002;38:310–316.
Funding Information
  • The Aarhus University Research Foundation
  • The Institute for Clinical Experimental Research, University of Aarhus
  • The Danish Cancer Society
  • The M. Brogaard & Wife Foundation
  • The Gerda and Aage Haensch Foundation
  • The Beckett Foundation
  • The Danish Children's Cancer Foundation
  • The Anders Hasselbalch Foundation