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

Abstract

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.

• Authors: Paul Rutgeerts, William J Sandborn, Richard N Fedorak, Daniel Rachmilewitz, Dino Tarabar, Peter Gibson, Ole Haagen Nielsen, Gary Wild, Stefan Schreiber, Claudia Pena Rossi, Monia Zignani, Onercept Study Group
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 4 Issue 7 Pg. 888-93 (Jul 2006) ISSN: 1542-3565 [Print] United States
• PMID: 16797249 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Receptors, Tumor Necrosis Factor
• Receptors, Tumor Necrosis Factor, Type I
• Tumor Necrosis Factor Decoy Receptors
• recombinant human tumor necrosis factor-binding protein-1

Topics

• Adult
• Crohn Disease (drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Receptors, Tumor Necrosis Factor (administration & dosage)
• Receptors, Tumor Necrosis Factor, Type I
• Severity of Illness Index
• Treatment Outcome
• Tumor Necrosis Factor Decoy Receptors