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Rutgeerts, P. et al.

Rutgeerts, Sandborn, Fedorak, Rachmilewitz, Tarabar, Gibson, Haagen Nielsen, Wild, Schreiber, Pena Rossi, Zignani,

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

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.[1]

References

Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial. Rutgeerts, P., Sandborn, W.J., Fedorak, R.N., Rachmilewitz, D., Tarabar, D., Gibson, P., Haagen Nielsen, O., Wild, G., Schreiber, S., Pena Rossi, C., Zignani, M. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. (2006) [Pubmed]

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