Phase II trial of copper zinc superoxide dismutase (CuZnSOD) in treatment of Crohn's disease.

Bovine CuZnSOD was used during an 8-year period as an anti-inflammatory drug in 26 patients with severe Crohn's disease, usually after failure of corticotherapy, or when this drug was avoided because of side-effects or abscesses. This was a Phase II trial during which doses, routes of administration and concomitant therapies were progressively modified. The acceptability was excellent with the free enzyme. We obtained 19/26 very good short term responses, and 82% good results on long term evolution. The efficacy of SOD as an anti-inflammatory drug in Crohn's disease needs to be confirmed by controlled trials.