Catherine Reenaers1, Jean-Yves Mary2, Maria Nachury3, Yoram Bouhnik4, David Laharie5, Matthieu Allez6, Mathurin Fumery7, Aurélien Amiot8, Guillaume Savoye9, Romain Altwegg10, Martine Devos11, Georgia Malamut12, Arnaud Bourreille13, Bernard Flourie14, Philippe Marteau15, Lucine Vuitton16, Benoît Coffin17, Stéphanie Viennot18, Jérôme Lambert2, Jean-Frédéric Colombel19, Edouard Louis20. 1. Gastroenterology Department, Centre Hospitalier Universitaire de Liège, Liège, Belgium. Electronic address: catherine.reenaers@chu.ulg.ac.be. 2. INSERM U717, Biostatistics and Clinical Epidemiology, Université Paris Diderot-Paris 7, Paris, France. 3. Centre Hospitalier Régional Universitaire de Lille, Université Lille Nord de France, Lille, France. 4. Hôpital Beaujon, Université Paris Diderot-Paris 7, Paris, France. 5. Hôpital Haut-Lévêque, INSERM U853, Université Bordeaux 2, Bordeaux, France. 6. Hôpital Saint-Louis, Université Paris Diderot-Paris 7, Paris, France. 7. Centre Hospitalier Universitaire d'Amiens, Hôpital Nord, Amiens, France. 8. Hôpital Henri Mondor, Paris Est-Créteil Val de Marne University, Creteil, France. 9. Hôpital Charles Nicolle, Université de Rouen, Rouen, France. 10. Hôpital Saint-Eloi, University Hospital of Montpellier, Montpellier, France. 11. Faculty of Medicine and Health Science, University of Ghent, Ghent, Belgium. 12. Hôpital Européen Georges Pompidou Assistance Publique-Hôpitaux Paris, Université Paris Descartes-Sorbonne Paris Centre, Paris, France. 13. Centre Hospitalier Universitaire de Nantes, Hôtel-Dieu, Nantes, France. 14. Centre Hospitalo-Universitaire Lyon-Sud, Hospices Civils de Lyon, Pierre Bénite, France. 15. Hôpital Lariboisière, Assistance Publique-Hôpitaux Paris, University Denis Diderot, Paris, France. 16. Hôpital Universitaire de Besançon, Besançon, France. 17. Hopital Louis Mourier, Université Paris Diderot-Paris 7, Paris, France. 18. Hôpital Universitaire de Caen, Caen, France. 19. Icahn School of Medicine at Mount Sinai, Feinstein Inflammatory Bowel Disease Clinical Center, New York, New York. 20. Gastroenterology Department, Centre Hospitalier Universitaire de Liège, Liège, Belgium.
Abstract
BACKGROUND & AIMS: Little is known about long-term outcomes of patients with Crohn's disease (CD) after infliximab withdrawal. We aimed to describe the long-term outcomes of patients with CD in clinical remission after infliximab treatment was withdrawn. METHODS: We performed a retrospective analysis of data from the 115 patients included in the infliximab discontinuation in patients with CD in stable remission on combined therapy with antimetabolites (STORI) study, performed at 20 centers in France and Belgium from March 2006 through December 2009. The STORI cohort was a prospective analysis of risk and factors associated with relapse following withdrawal of maintenance therapy with infliximab, maintained on antimetabolites, while in clinical remission. We collected data from the end of the study until the last available follow-up examination on patient surgeries, new complex perianal lesions (indicating major complications), and need for and outcomes of restarting therapy with infliximab or another biologic agent. The de-escalation strategy was considered to have failed when a major complication or infliximab restart failure occurred. RESULTS: Of the 115 patients initially included, data from 102 patients (from 19 of the 20 study centers) were included in the final analysis. The median follow-up time was 7 years. Twenty-one percent of the patients did not restart treatment with infliximab or another biologic agent and did not have a major complication 7 years after infliximab withdrawal (95% CI, 13.1-30.3). Among patients who restarted infliximab, treatment failed for 30.1% 6 years after restarting (95% CI, 18.5-42.5). Overall, at 7 years after stopping infliximab therapy, major complications occurred in 18.5% of patients (95% CI, 10.2-26.8) whereas 70.2% of patients had no failure of the de-escalation strategy (95% CI, 60.2-80.1). Factors independently associated with major complications were upper-gastrointestinal location of disease, white blood cell count ≥ 5.0 × 109/L, and hemoglobin level ≤12.5 g/dL at the time of infliximab withdrawal. Patients with at least 2 of these factors had a more than 40% risk of major complication in the 7 years following infliximab withdrawal. CONCLUSIONS: In a long-term follow-up of the STORI cohort (7 years) one fifth of the patients did not restart infliximab or another biologic agent and did not develop major complications. Seventy percent of patients had no failure of the de-escalation strategy (no major complication and no failure of infliximab restart).
BACKGROUND & AIMS: Little is known about long-term outcomes of patients with Crohn's disease (CD) after infliximab withdrawal. We aimed to describe the long-term outcomes of patients with CD in clinical remission after infliximab treatment was withdrawn. METHODS: We performed a retrospective analysis of data from the 115 patients included in the infliximab discontinuation in patients with CD in stable remission on combined therapy with antimetabolites (STORI) study, performed at 20 centers in France and Belgium from March 2006 through December 2009. The STORI cohort was a prospective analysis of risk and factors associated with relapse following withdrawal of maintenance therapy with infliximab, maintained on antimetabolites, while in clinical remission. We collected data from the end of the study until the last available follow-up examination on patient surgeries, new complex perianal lesions (indicating major complications), and need for and outcomes of restarting therapy with infliximab or another biologic agent. The de-escalation strategy was considered to have failed when a major complication or infliximab restart failure occurred. RESULTS: Of the 115 patients initially included, data from 102 patients (from 19 of the 20 study centers) were included in the final analysis. The median follow-up time was 7 years. Twenty-one percent of the patients did not restart treatment with infliximab or another biologic agent and did not have a major complication 7 years after infliximab withdrawal (95% CI, 13.1-30.3). Among patients who restarted infliximab, treatment failed for 30.1% 6 years after restarting (95% CI, 18.5-42.5). Overall, at 7 years after stopping infliximab therapy, major complications occurred in 18.5% of patients (95% CI, 10.2-26.8) whereas 70.2% of patients had no failure of the de-escalation strategy (95% CI, 60.2-80.1). Factors independently associated with major complications were upper-gastrointestinal location of disease, white blood cell count ≥ 5.0 × 109/L, and hemoglobin level ≤12.5 g/dL at the time of infliximab withdrawal. Patients with at least 2 of these factors had a more than 40% risk of major complication in the 7 years following infliximab withdrawal. CONCLUSIONS: In a long-term follow-up of the STORI cohort (7 years) one fifth of the patients did not restart infliximab or another biologic agent and did not develop major complications. Seventy percent of patients had no failure of the de-escalation strategy (no major complication and no failure of infliximab restart).
Authors: Michał Łodyga; Piotr Eder; Magdalena Gawron-Kiszka; Agnieszka Dobrowolska; Maciej Gonciarz; Marek Hartleb; Maria Kłopocka; Ewa Małecka-Wojciesko; Piotr Radwan; Jarosław Reguła; Edyta Zagórowicz; Grażyna Rydzewska Journal: Prz Gastroenterol Date: 2021-11-19
Authors: Siddharth Singh; Deborah Proctor; Frank I Scott; Yngve Falck-Ytter; Joseph D Feuerstein Journal: Gastroenterology Date: 2021-06 Impact factor: 33.883
Authors: Thomas Langford; Zehra Arkir; Anastasia Chalkidou; Kate Goddard; Lamprini Kaftantzi; Mark Samaan; Peter Irving Journal: JMIR Res Protoc Date: 2018-10-19