Treatment of active Crohn's disease with onercept (recombinant human soluble p55 tumour necrosis factor receptor): results of a randomized, open-label, pilot study.

Abstract

BACKGROUND:

Monoclonal antibodies to the pro-inflammatory cytokine tumour necrosis factor-alpha have shown efficacy in treating Crohn's disease, but can be immunogenic. Soluble tumour necrosis factor-binding proteins are being studied as potential alternative anti-tumour necrosis factor agents in Crohn's disease.

AIM:

To investigate the safety and efficacy of onercept, a recombinant form of the natural human soluble p55 tumour necrosis factor receptor, in the treatment of patients with active Crohn's disease.

METHODS:

In a pilot study, 12 patients with active Crohn's disease were randomized to receive onercept at either 11.7 or 50 mg three times weekly for 2 weeks. Patients were followed up for 6 months after the end of treatment.

RESULTS:

The Crohn's disease activity index decreased rapidly during treatment in both groups. Seven responses (Crohn's disease activity index decrease of 100 points) were observed over the first 6 weeks of the study, including five remissions (Crohn's disease activity index decrease of 150 points). Improvement was sustained for 2-4 months after stopping treatment. Treatment was well tolerated. No patients developed antibodies to onercept.

CONCLUSIONS:

Neutralizing the activity of tumour necrosis factor-alpha with its soluble p55 receptor may be valuable in the treatment of patients with Crohn's disease. Larger placebo-controlled trials are indicated.

• Authors: P Rutgeerts, L Lemmens, G Van Assche, M Noman, I Borghini-Fuhrer, R Goedkoop
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 17 Issue 2 Pg. 185-92 (Jan 2003) ISSN: 0269-2813 [Print] England
• PMID: 12534402 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Carrier Proteins
• Gastrointestinal Agents
• Receptors, Tumor Necrosis Factor
• Receptors, Tumor Necrosis Factor, Type I
• Tumor Necrosis Factor Decoy Receptors
• recombinant human tumor necrosis factor-binding protein-1

Topics

• Administration, Cutaneous
• Adult
• Aged
• Anti-Inflammatory Agents (administration & dosage, adverse effects, pharmacokinetics)
• Carrier Proteins (administration & dosage, adverse effects, pharmacokinetics)
• Crohn Disease (drug therapy)
• Female
• Gastrointestinal Agents (administration & dosage, adverse effects, pharmacokinetics)
• Humans
• Male
• Middle Aged
• Pilot Projects
• Receptors, Tumor Necrosis Factor
• Receptors, Tumor Necrosis Factor, Type I
• Treatment Outcome
• Tumor Necrosis Factor Decoy Receptors