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 -
