期刊
GASTROENTEROLOGY
卷 142, 期 1, 页码 63-U201出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2011.09.034
关键词
Inflammatory Bowel Disease; IBD; Clinical TrialStopping Therapy Factors That Contribute to Relapse
资金
- Schering-Plough
- Abbott Laboratories
- MSD
- Ferring Pharmaceuticals
- Shire, Millennium Pharmaceuticals
- UCB
- AstraZeneca
- Falk
- Menarini
- Chiesi, and Nycomed
- Norgine
- Roche
- LFB
- Janssen-Cilag
- ActogeniX
- Albireo Pharma
- Amgen
- Bayer AG
- Biogen Idec
- Boehringer Ingelheim GmbH
- Bristol-Myers Squibb
- Cellerix
- Centocor
- ChemoCentryx
- Cosmo Technologies
- Danone Research
- Elan Pharmaceuticals
- Genentech
- Giuliani SpA
- Given Imaging
- GlaxoSmithKline
- Hutchison MediPharma
- Merck Sharp Dohme Corp
- Takeda
- Neovacs
- Ocera Therapeutics
- Pfizer
- Shire Pharmaceuticals
- Prometheus Laboratories
- Sanofi-Aventis
- Synta Pharmaceuticals Corp
- Teva
- Therakos
- UCB Pharma
- Wyeth
- Merck
- Sharp Dohme Corp
- Otsuka America Pharmaceutical
- Tillotts Pharma
- [NCT00571337]
BACKGROUND & AIMS: It is important to determine whether infliximab therapy can be safely interrupted in patients with Crohn's disease who have undergone a period of prolonged remission. We assessed the risk of relapse after infliximab therapy was discontinued in patients on combined maintenance therapy with antimetabolites and identified factors associated with relapse. METHODS: We performed a prospective study of 115 patients with Crohn's disease who were treated for at least 1 year with scheduled infliximab and an antimetabolite and had been in corticosteroid-free remission for at least 6 months. Infliximab was stopped, and patients were followed up for at least 1 year. We associated demographic, clinical, and biologic factors with time to relapse using a Cox model. RESULTS: After a median follow-up period of 28 months, 52 of the 115 patients experienced a relapse; the 1-year relapse rate was 43.9% +/- 5.0%. Based on multivariable analysis, risk factors for relapse included male sex, the absence of surgical resection, leukocyte counts >6.0 x 10(9)/L, and levels of hemoglobin <= 145 g/L, C-reactive protein >= 5.0 mg/L, and fecal calprotectin >= 300 mu g/g. Patients with no more than 2 of these risk factors (approximately 29% of the study population) had a 15% risk of relapse within 1 year. Re-treatment with infliximab was effective and well tolerated in 88% of patients who experienced a relapse. CONCLUSIONS: Approximately 50% of patients with Crohn's disease who were treated for at least 1 year with infliximab and an antimetabolite agent experienced a relapse within 1 year after discontinuation of infliximab. However, patients with a low risk of relapse can be identified using a combination of clinical and biologic markers.
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