Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
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.
Rutgeerts
Paul
P
University Hospital Gasthuisberg, Leuven, Belgium. Paul.Rutgeerts@uz.kuleuven.ac.be
Sandborn
William J
WJ
Fedorak
Richard N
RN
Rachmilewitz
Daniel
D
Tarabar
Dino
D
Gibson
Peter
P
Haagen Nielsen
Ole
O
Wild
Gary
G
Schreiber
Stefan
S
Pena Rossi
Claudia
C
Zignani
Monia
M
D000328:Adult; D003424:Crohn Disease / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D047888:Receptors, Tumor Necrosis Factor, Type I; D012720:Severity of Illness Index; D016896:Treatment Outcome; D053319:Tumor Necrosis Factor Decoy Receptors
D018124:Receptors, Tumor Necrosis Factor; D047888:Receptors, Tumor Necrosis Factor, Type I; D053319:Tumor Necrosis Factor Decoy Receptors; C069521:recombinant human tumor necrosis factor-binding protein-1