Safety and efficacy of Profermin~to induce remission in ulcerative colitis

摘要

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 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 was generally well tolerated.CONCLUSION:Profermin is safe and may be effective in inducing remission of active UC.