Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial

TY - JOUR

T1 - Onercept for moderate-to-severe Crohn's disease

T2 - a randomized, double-blind, placebo-controlled trial

AU - Rutgeerts, Paul

AU - Sandborn, William J

AU - Fedorak, Richard N

AU - Rachmilewitz, Daniel

AU - Tarabar, Dino

AU - Gibson, Peter

AU - Haagen Nielsen, Ole

AU - Wild, Gary

AU - Schreiber, Stefan

AU - Pena Rossi, Claudia

AU - Zignani, Monia

AU - Onercept Study Group

PY - 2006/7

Y1 - 2006/7

N2 - BACKGROUND AND AIMS: Onercept is a recombinant, soluble human p55 receptor to tumor necrosis factor-alpha.METHODS: A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of onercept induction therapy in patients with Crohn's disease (CD). Patients (n = 207) with moderate-to-severe acute or chronic active CD were randomized to receive subcutaneous onercept (10, 25, 35, or 50 mg) or placebo 3 times weekly for 8 weeks. Primary analysis was induction of remission (defined as a CD activity index score < or = 150) at week 8.RESULTS: A total of 104 patients had acute active CD. Remission rates at week 8 were 23.5% for placebo (n = 17), and 34.8%, 20.0%, 26.1%, and 28.6% for onercept 10 mg (n = 23), 25 mg (n = 20), 35 mg (n = 23), and 50 mg (n = 21), respectively (P = .98). A total of 103 patients had chronic active CD. Remission rates at week 8 were 23.8% for placebo (n = 21), and 23.8%, 9.1%, 35.3%, and 13.6% for onercept 10 mg (n = 21), 25 mg (n = 22), 35 mg (n = 17), and 50 mg (n = 22), respectively (P = .66). There were no differences between treatment groups in the incidence of adverse events. However, mild-to-moderate injection-site reactions occurred in up to 12% of onercept-treated patients.CONCLUSIONS: Onercept was well tolerated but was not effective at the doses studied in patients with active CD.

AB - BACKGROUND AND AIMS: Onercept is a recombinant, soluble human p55 receptor to tumor necrosis factor-alpha.METHODS: A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of onercept induction therapy in patients with Crohn's disease (CD). Patients (n = 207) with moderate-to-severe acute or chronic active CD were randomized to receive subcutaneous onercept (10, 25, 35, or 50 mg) or placebo 3 times weekly for 8 weeks. Primary analysis was induction of remission (defined as a CD activity index score < or = 150) at week 8.RESULTS: A total of 104 patients had acute active CD. Remission rates at week 8 were 23.5% for placebo (n = 17), and 34.8%, 20.0%, 26.1%, and 28.6% for onercept 10 mg (n = 23), 25 mg (n = 20), 35 mg (n = 23), and 50 mg (n = 21), respectively (P = .98). A total of 103 patients had chronic active CD. Remission rates at week 8 were 23.8% for placebo (n = 21), and 23.8%, 9.1%, 35.3%, and 13.6% for onercept 10 mg (n = 21), 25 mg (n = 22), 35 mg (n = 17), and 50 mg (n = 22), respectively (P = .66). There were no differences between treatment groups in the incidence of adverse events. However, mild-to-moderate injection-site reactions occurred in up to 12% of onercept-treated patients.CONCLUSIONS: Onercept was well tolerated but was not effective at the doses studied in patients with active CD.

KW - Adult

KW - Crohn Disease

KW - Dose-Response Relationship, Drug

KW - Double-Blind Method

KW - Drug Administration Schedule

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Injections, Subcutaneous

KW - Male

KW - Middle Aged

KW - Receptors, Tumor Necrosis Factor

KW - Receptors, Tumor Necrosis Factor, Type I

KW - Severity of Illness Index

KW - Treatment Outcome

KW - Tumor Necrosis Factor Decoy Receptors

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.cgh.2006.04.022

DO - 10.1016/j.cgh.2006.04.022

M3 - Journal article

C2 - 16797249

SN - 1542-3565

VL - 4

SP - 888

EP - 893

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 7

ER -