Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse: A Multinational Retrospective Cohort Study

Gionata Fiorino*, Pablo Navarro Cortes, Pierre Ellul, Carla Felice, Pantelis Karatzas, Marco Silva, Peter L. Lakatos, Fabrizio Bossa, Bella Ungar, Shaji Sebastian, Federica Furfaro, Konstantinos Karmiris, Konstantinos H. Katsanos, Martina Muscat, Dimitrios K. Christodoulou, Giovanni Maconi, Uri Kopylov, Fernando Magro, Gerassimos J. Mantzaris, Alessandro ArmuzziMarta Maia Boscà-Watts, Shomron Ben-Horin, Stefanos Bonovas, Silvio Danese

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

39 Scopus citations


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 re-initiation. 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 (log-rank 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 re-initiation is effective and safe.

Original languageEnglish
Pages (from-to)1426-1432.e1
JournalClinical Gastroenterology and Hepatology
Issue number10
StatePublished - 1 Oct 2016


FundersFunder number
Horizon 2020 Framework Programme633168


    • Anti-TNF Agent
    • Discontinuation
    • IBD
    • Management
    • Surgery


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