Safety and efficacy of Profermin® to induce remission in ulcerative colitis.

ABSTRACT:

Aim

To test the efficacy and safety of Profermin(®) in inducing remission in patients with active ulcerative colitis (UC).

Methods

The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated open-label with Profermin(®) twice daily for 24 wk. Daily SCCAI was reported observer blinded via the Internet.

Results

In an intention to treat (ITT) analysis, the mean reduction in SCCAI score was 56.5%. Of the 39 patients, 24 (62%) reached the primary endpoint, which was proportion of patients with ≥ 50% reduction in SCCAI. Our secondary endpoint, the proportion of patients in remission defined as SCCAI ≤ 2.5, was in ITT analysis reached in 18 of the 39 patients (46%). In a repe

SUBMITTER: Krag A 

PROVIDER: S-EPMC3332290 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature