Increased response and remission rates in short-duration Crohn's disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data.

Abstract

OBJECTIVES:

We sought to analyze the efficacy (response and remission) and safety data from the PRECiSE 2 trial of certolizumab pegol according to duration of Crohn's disease since diagnosis at baseline.

METHODS:

Responders to induction treatment with certolizumab pegol at week 6 in PRECiSE 2 (n=425) were randomized to receive certolizumab pegol 400 mg (n=215) or placebo (n=210) until week 26. Logistic regression analysis identified factors linked to Crohn's disease history (short duration, no prior infliximab use, no corticosteroids, no operations) as prognostics of outcome. Efficacy (response, remission) and safety data were reanalyzed according to duration of Crohn's disease since diagnosis at baseline.

RESULTS:

The proportions of patients in response at study end were inversely related to duration of Crohn's disease. Maintenance of response with certolizumab pegol was achieved in 89.5% of patients with a diagnosis <1 year (P<0.01 vs. placebo), compared with 57.3% of patients with a diagnosis > or = 5 years (P<0.001 vs. placebo). Corresponding remission rates were 68.4% (P<0.05 vs. placebo) and 44.3% (P<0.001 vs. placebo), respectively. Response and remission rates did not differ significantly by disease duration in placebo subgroups. Incidences of adverse events were unaffected by duration of disease at baseline.

CONCLUSIONS:

These data suggest that patients treated with certolizumab pegol 400 mg earlier rather than later, with a confirmed Crohn's disease diagnosis, may achieve better treatment outcomes.

• Authors: Stefan Schreiber, Jean-Frédéric Colombel, Ralph Bloomfield, Susanna Nikolaus, Jürgen Schölmerich, Julian Panés, William J Sandborn, PRECiSE 2 Study Investigators
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 105 Issue 7 Pg. 1574-82 (Jul 2010) ISSN: 1572-0241 [Electronic] United States
• PMID: 20234346 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Immunoglobulin Fab Fragments
• Immunologic Factors
• Placebos
• Polyethylene Glycols
• Certolizumab Pegol

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized
• Certolizumab Pegol
• Crohn Disease (drug therapy, pathology)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Immunoglobulin Fab Fragments (administration & dosage, therapeutic use)
• Immunologic Factors (administration & dosage, therapeutic use)
• Injections, Subcutaneous
• Logistic Models
• Male
• Middle Aged
• Placebos
• Polyethylene Glycols (administration & dosage, therapeutic use)
• Prognosis
• Remission Induction
• Treatment Outcome