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

Bovine Cu Zn SOD was used during an 8 year period as an antiinflammatory drug in 26 patients with severe Crohn's disease (CDAI 300) usually after failure of corticotherapy or when this drug was discontinued because of side effects or infection. This was a phase II trial during which doses routes of administration and concomitant therapies were progressively modified. We obtained 73% good short term responses (judged upon CDAI and anatomic healing) and 82% positive results on long term evolution (the criteria were: i CDAI lower than 100 in between relapses, ii complete healing or notable improvement of lesions, iii no surgery needed, iv return to work. The acceptability was excellent with the free enzyme. Since the above described experience, published in Free Radical Biology and Medicine (1989, 7: 145-151), we used always the same treatment schedule (SOD 8 mg/day associated with Desferroxamine--500 mg subcutaneous every 2 days). The follow-up during the 87-89 period showed that 12 are in good health without any relapse, 9 experienced one or more relapses, and showed good responses upon resumption of treatment, 5 failed to respond to treatment, all part of the initial group on which SOD treatment had already failed, and among whom 3 were lost for follow-up before 1987, and two others took up another SOD treatment which also failed. 3 new patients (2 females, 1 male) were treated since then, and all 3 had positive results (one with disappearance of ileocoecal mass). The efficacy of SOD as an antiinflammatory drug in Crohn's disease needs to be confirmed by controlled trials.