Pilot studies have suggested that interferon alpha (IFN-alpha) is effective in the treatment of active ulcerative colitis.
In this study, physicians from Europe evaluated the safety of pegylated interferon alpha (PegIFN), and investigated its role in induction of remission in patients with active ulcerative colitis.
|Higher dose was associated with a significant decrease in C reactive protein.|
The team randomized 60 patients to receive either placebo, PegIFN 0.5 µg/kg, or PegIFN 1.0 µg/kg once weekly during a 12-week period.
They included patients receiving 5-aminosalicylates, steroids, and/or azathioprine in stable dosages.
There were no serious adverse events in the placebo patients. However, the physicians observed adverse events in 16% of the PegIFN 0.5 µg/kg group, and in 14% of the PegIFN 1.0 µg/kg group.
The team determined that clinical remission rates at week 12 were 35% in the placebo group, 47% in the PegIFN 0.5 µg/kg group, and 33% in the PegIFN 1.0 µg/kg group.
Early withdrawal from the study occurred in 55% of placebo patients, 17% of patients in the PegIFN 0.5 µg/kg group, and 48% of patients in the PegIFN 1.0 µg/kg group.
The team found that the higher PegIFN dose was associated with a significant decrease in levels of C reactive protein.
Dr Tilg's team concluded, "PegIFN is safe but not effective, at the dosages used, in patients with ulcerative colitis".