Centocor compares ulcerative colitis remission to employment, disability compensation

By Elaine Rigoli

Tampa, Fla., May 24 - Centocor said results from a new analysis of the ACT trials (active ulcerative colitis trials 1 & 2) showed that, among patients not employed at baseline in the studies, significantly more patients in clinical remission at weeks 30 and 54 were employed, compared to those not in clinical remission.

In addition, of 10 patients receiving disability compensation at the start of the trial, 80% of those in remission after one year were no longer receiving disability compensation, the company said in a news release.

Results from the ACT trials showed that significantly more patients treated with Remicade experienced clinical remission compared to patients given a placebo infusion, the release said.

Remicade was recently approved by the Food and Drug Administration for the treatment of moderately to severely active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy.

"It is important to examine the potentially significant impact of UC on patients' employment and the overall cost and burden of their disease," said William Sandborn, a professor of medicine at Mayo College of Medicine and lead study investigator, in a news release.

"Clinical remission is a critical therapeutic goal for UC patients, both in terms of overall health as well as their ability to maintain productive lives."

The analysis of the ACT 1 and ACT 2 clinical data revealed that, at baseline, 35% of the 727 patients in the studies were not employed and 7.0% were receiving disability compensation.

Among patients not employed at baseline, a significantly greater percentage of those in clinical remission at week 30 and week 54 were employed, compared to patients not in clinical remission [week 30 (ACT 1 and 2): 20.6% vs. 8.3%; week 54 (ACT 1): 30.4% vs. 8.8%

In addition, of patients receiving disability compensation at the start of the trials, greater percentages of those in clinical remission at weeks 30 and 54 were no longer receiving disability compensation compared to those not in clinical remission [week 30 (ACT 1 and 2): 58.8% vs. 20.0%; week 54 (ACT 1): 80.0% vs. 16.7%.

Centocor is a Johnson & Johnson subsidiary.

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