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Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse: A Multinational Retrospective Cohort Study
- Source :
- Clinical Gastroenterology and Hepatology, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, instname
- Publication Year :
- 2016
- Publisher :
- Elsevier BV, 2016.
-
Abstract
- BACKGROUND & AIMS: Infliximab is a safe and effective therapy for ulcerative colitis (UC). We conducted a multicenter retrospective cohort study that included 7 European countries and Israel to examine whether infliximab discontinuation can be considered for patients who achieve sustained remission. METHODS: We performed a retrospective cohort study, collecting medical records from 13 tertiary care referral inflammatory bowel disease centers of all patients with UC treated with infliximab (n = 193). We compared the disease course of patients with at least 12 months of clinical remission who discontinued infliximab (n = 111) with that of patients who continued scheduled treatment (controls, n = 82). We examined the incidence rates of relapse, hospitalization and colectomy, the comparative effectiveness of different therapeutic strategies after discontinuation, and assessed the rates of response, remission, and adverse effects after infliximab reinitiation. Statistical analyses used time-to-event methods. RESULTS: In the entire cohort, 67 patients (34.7%) relapsed during the follow-up period. The incidence rate of relapse was significantly higher after discontinuation (23.3 per 100 person-years) compared with the control group (7.2 per 100 person-years) in univariable analysis (logrank P < .001 hazard ratio, 3.41 95% confidence interval, 1.88-6.20) and multivariable analysis (hazard ratio, 3.70 95% confidence interval, 2.02-6.77). Rates of hospitalization and colectomy did not differ between groups. Thiopurines appeared to be the best treatment option after infliximab discontinuation (incidence of relapse: 15.0 per 100 person-years for thiopurines, 27.4 per 100 person-years for thiopurines plus aminosalicylates, and 31.2 per 100 person-years for aminosalicylates alone log-rank P = .032). Response was regained in 77.1% of patients and remission in 51.4% of patients who re-initiated infliximab. However, 17.1% had infusion reactions and 17.1% reported other adverse events. CONCLUSIONS: In a multinational retrospective cohort study of patients with UC in sustained clinical remission, we associated discontinuation of infliximab with an increased risk of relapse. Treatment reinitiation is effective and safe.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Settore MED/12 - GASTROENTEROLOGIA
IBD
Anti-TNF Agent
Discontinuation
Risk Assessment
Inflammatory bowel disease
Young Adult
03 medical and health sciences
0302 clinical medicine
Gastrointestinal Agents
Recurrence
Internal medicine
Humans
Medicine
Israel
Adverse effect
ulcerative colitis
Aged
Retrospective Studies
Aged, 80 and over
Gastrointestinal agent
Hepatology
business.industry
Gastroenterology
Retrospective cohort study
Middle Aged
medicine.disease
Ulcerative colitis
Infliximab
Management
Surgery
Europe
Withholding Treatment
030220 oncology & carcinogenesis
Cohort
Colitis, Ulcerative
Female
030211 gastroenterology & hepatology
business
medicine.drug
Subjects
Details
- ISSN :
- 15423565
- Volume :
- 14
- Database :
- OpenAIRE
- Journal :
- Clinical Gastroenterology and Hepatology
- Accession number :
- edsair.doi.dedup.....125a1677b1a48e5eb83d58352aace5c0