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

TY - JOUR

T1 - Safety and efficacy of Profermin® to induce remission in ulcerative colitis

AU - Krag, Aleksander

AU - Israelsen, Hans

AU - von Ryberg, Bjørn

AU - Andersen, Klaus

AU - Bendtsen, Flemming

PY - 2012

Y1 - 2012

N2 - 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.

AB - 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.

U2 - 10.3748/wjg.v18.i15.1773

DO - 10.3748/wjg.v18.i15.1773

M3 - Journal article

C2 - 22553401

SN - 1009-3079

VL - 18

SP - 1773

EP - 1780

JO - World Chinese Journal of Digestology

JF - World Chinese Journal of Digestology

IS - 15

ER -