Safety and efficacy of Profermin(R) to induce remission in ulcerative colitis

Aleksander Krag, Hans Israelsen, Bjørn von Ryberg, Klaus Kaae Andersen, Flemming Bendtsen

    Research output: Contribution to journalJournal articleResearchpeer-review

    Abstract

    AIM: To test the efficacy and safety of Profermin(R) 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(R) 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 repeated-measure regression analysis, the estimated mean reduction in score was 5.0 points (95% CI: 4.1-5.9, P < 0.001) and the estimated mean time taken to obtain half the reduction in score was 28 d (95% CI: 26-30). There were no serious adverse events (AEs) or withdrawals due to AEs. Profermin(R) was generally well tolerated.

    CONCLUSION: Profermin(R) is safe and may be effective in inducing remission of active UC.
    Original languageEnglish
    JournalWorld Journal of Gastroenterology
    Volume18
    Issue number15
    Pages (from-to)1773-1780
    ISSN1007-9327
    DOIs
    Publication statusPublished - 2012

    Keywords

    • Ulcerative colitis
    • Diet
    • Probiotic
    • Profermin
    • Inflammatory bowel disease
    • Dietary management
    • Medical foods

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