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Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months.
- Source :
-
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2010 Jul; Vol. 8 (7), pp. 600-9. Date of Electronic Publication: 2010 Feb 01. - Publication Year :
- 2010
-
Abstract
- Background & Aims: The safety and efficacy of maintenance therapy with the anti-tumor necrosis factor certolizumab pegol has not been reported beyond 6 months. We assessed the long-term efficacy, safety, and immunogenicity of continuous versus interrupted maintenance therapy with subcutaneous certolizumab pegol in patients with Crohn's disease.<br />Methods: Patients who responded to induction therapy at week 6 of the PEGylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy (PRECiSE) 2 trial were assigned randomly to groups given certolizumab pegol (continuous) or placebo (drug-interruption) during weeks 6 to 26. Patients who completed PRECiSE 2 were eligible to enter PRECiSE 3, an ongoing, prospective, open-label extension trial in which patients have received certolizumab pegol (400 mg) every 4 weeks for 54 weeks to date, and were not offered the option to increase their dose. Disease activity was measured by the Harvey-Bradshaw Index.<br />Results: Harvey-Bradshaw Index responses at week 26 for the continuous and drug-interruption groups were 56.3% and 37.6%, respectively; corresponding remission rates were 47.9% and 32.4%, respectively. Of patients responding at week 26, response rates at week 80 after the start of PRECiSE 2 in the continuous and drug-interruption groups were 66.1% and 63.3%, respectively; among patients in remission at week 26, week 80 remission rates were 62.1% and 63.2%, respectively. More patients in the drug-interruption group developed antibodies against certolizumab pegol (and had lower plasma concentrations of certolizumab pegol) than the continuously treated group.<br />Conclusions: Certolizumab pegol effectively maintains remission of Crohn's disease for up to 18 months. Continuous therapy is more effective than interrupted therapy.<br /> (Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adolescent
Adult
Antibodies, Monoclonal, Humanized
Certolizumab Pegol
Chronic Disease drug therapy
Female
Humans
Male
Middle Aged
Placebos administration & dosage
Prospective Studies
Severity of Illness Index
Treatment Outcome
Young Adult
Crohn Disease drug therapy
Immunoglobulin Fab Fragments administration & dosage
Immunoglobulin Fab Fragments adverse effects
Immunologic Factors administration & dosage
Immunologic Factors adverse effects
Polyethylene Glycols administration & dosage
Polyethylene Glycols adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1542-7714
- Volume :
- 8
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
- Publication Type :
- Academic Journal
- Accession number :
- 20117244
- Full Text :
- https://doi.org/10.1016/j.cgh.2010.01.014