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, P. 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

Research output: Contribution to journalArticle

16 Citations (Scopus)

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 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
Volume14
Issue number10
DOIs
Publication statusPublished - Oct 1 2016

Fingerprint

Ulcerative Colitis
Cohort Studies
Retrospective Studies
Recurrence
Colectomy
Incidence
Hospitalization
Confidence Intervals
Therapeutics
Infliximab
Israel
Tertiary Healthcare
Inflammatory Bowel Diseases
Medical Records
Referral and Consultation
Control Groups

Keywords

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

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse : A Multinational Retrospective Cohort Study. / Fiorino, Gionata; Cortes, Pablo Navarro; Ellul, Pierre; Felice, Carla; Karatzas, Pantelis; Silva, Marco; Lakatos, P.; Bossa, Fabrizio; Ungar, Bella; Sebastian, Shaji; Furfaro, Federica; Karmiris, Konstantinos; Katsanos, Konstantinos H.; Muscat, Martina; Christodoulou, Dimitrios K.; Maconi, Giovanni; Kopylov, Uri; Magro, Fernando; Mantzaris, Gerassimos J.; Armuzzi, Alessandro; Boscà-Watts, Marta Maia; Ben-Horin, Shomron; Bonovas, Stefanos; Danese, Silvio.

In: Clinical Gastroenterology and Hepatology, Vol. 14, No. 10, 01.10.2016, p. 1426-1432.e1.

Research output: Contribution to journalArticle

Fiorino, G, Cortes, PN, Ellul, P, Felice, C, Karatzas, P, Silva, M, Lakatos, P, Bossa, F, Ungar, B, Sebastian, S, Furfaro, F, Karmiris, K, Katsanos, KH, Muscat, M, Christodoulou, DK, Maconi, G, Kopylov, U, Magro, F, Mantzaris, GJ, Armuzzi, A, Boscà-Watts, MM, Ben-Horin, S, Bonovas, S & Danese, S 2016, 'Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse: A Multinational Retrospective Cohort Study', Clinical Gastroenterology and Hepatology, vol. 14, no. 10, pp. 1426-1432.e1. https://doi.org/10.1016/j.cgh.2016.05.044
Fiorino, Gionata ; Cortes, Pablo Navarro ; Ellul, Pierre ; Felice, Carla ; Karatzas, Pantelis ; Silva, Marco ; Lakatos, P. ; Bossa, Fabrizio ; Ungar, Bella ; Sebastian, Shaji ; Furfaro, Federica ; Karmiris, Konstantinos ; Katsanos, Konstantinos H. ; Muscat, Martina ; Christodoulou, Dimitrios K. ; Maconi, Giovanni ; Kopylov, Uri ; Magro, Fernando ; Mantzaris, Gerassimos J. ; Armuzzi, Alessandro ; Boscà-Watts, Marta Maia ; Ben-Horin, Shomron ; Bonovas, Stefanos ; Danese, Silvio. / Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse : A Multinational Retrospective Cohort Study. In: Clinical Gastroenterology and Hepatology. 2016 ; Vol. 14, No. 10. pp. 1426-1432.e1.
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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 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.",
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TY - JOUR

T1 - Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse

T2 - A Multinational Retrospective Cohort Study

AU - Fiorino, Gionata

AU - Cortes, Pablo Navarro

AU - Ellul, Pierre

AU - Felice, Carla

AU - Karatzas, Pantelis

AU - Silva, Marco

AU - Lakatos, P.

AU - Bossa, Fabrizio

AU - Ungar, Bella

AU - Sebastian, Shaji

AU - Furfaro, Federica

AU - Karmiris, Konstantinos

AU - Katsanos, Konstantinos H.

AU - Muscat, Martina

AU - Christodoulou, Dimitrios K.

AU - Maconi, Giovanni

AU - Kopylov, Uri

AU - Magro, Fernando

AU - Mantzaris, Gerassimos J.

AU - Armuzzi, Alessandro

AU - Boscà-Watts, Marta Maia

AU - Ben-Horin, Shomron

AU - Bonovas, Stefanos

AU - Danese, Silvio

PY - 2016/10/1

Y1 - 2016/10/1

N2 - 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.

AB - 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.

KW - Anti-TNF Agent

KW - Discontinuation

KW - IBD

KW - Management

KW - Surgery

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