Abstract
Background & Aims: Crohn's disease (CD) patients included in the Tailored Treatment With Infliximab for Active Crohn's Disease (TAILORIX) trial started infliximab in combination with an immunosuppressant for 1 year. The aim of the present study was to determine the long-term disease course beyond the study period. Methods: We compared the outcomes of patients who did or did not reach the primary end point of the TAILORIX trial, defined as sustained corticosteroid-free clinical remission from weeks 22 through 54, with no ulcers on ileocolonoscopy at week 54. The primary outcome of this follow-up study was the progression-free survival of CD defined by anal or major abdominal surgery, CD-related hospitalization, or the need for a new systemic CD treatment. Results: The 95 patients (median disease duration, 4.5 mo; interquartile range, 1.0–56.6 mo) analyzed, including 45 (47%) who achieved the primary end point, were followed up for a median duration of 64.2 months (interquartile range, 57.6–69.9 mo) after the end of the study period. There was no significant difference in CD progression-free survival at 1, 3, and 5 years between patients who achieved the TAILORIX primary end point and patients who did not (P =.64). No difference was observed between both groups for each component of CD progression: anal surgery, major abdominal surgery, CD-related hospitalization, or the need for a new systemic CD treatment. Conclusions: Achieving a sustained clinical remission off steroids with complete endoscopic remission in this cohort of 95 patients with early CD was not associated with less disease progression. Prospective trials to define the therapeutic goals that change the natural history of CD and prevent complications are needed.
| Original language | English |
|---|---|
| Pages (from-to) | 2074-2082 |
| Number of pages | 9 |
| Journal | Clinical Gastroenterology and Hepatology |
| Volume | 20 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Sept 2022 |
Bibliographical note
Funding Information:The authors thank their colleague Benjamin Pariente for his important involvement in the present study; he acted in all steps, from the study design to data interpretation and draft of the manuscript. David Laharie (Conceptualization: Lead; Data curation: Lead; Formal analysis: Lead; Investigation: Lead; Methodology: Lead; Supervision: Lead; Validation: Lead; Writing – original draft: Lead; Writing – review & editing: Lead), Geert D'Haens (Data curation: Supporting; Writing – review & editing: Supporting), Maria Nachury (Data curation: Supporting; Writing – review & editing: Supporting), Guy Lambrecht (Data curation: Supporting; Writing – review & editing: Supporting), Peter Bossuyt (Data curation: Supporting; Writing – review & editing: Supporting), Yoram Bouhnik (Data curation: Supporting; Writing – review & editing: Supporting), Edouard Louis (Data curation: Supporting; Writing – review & editing: Supporting), Christien Janneke van der Woude (Data curation: Supporting; Writing – review & editing: Supporting), Anthony Buisson (Data curation: Supporting; Writing – review & editing: Supporting), Philippe Van Hootegem (Data curation: Supporting; Writing – review & editing: Supporting), Matthieu Allez (Data curation: Supporting; Writing – review & editing: Supporting), Jérôme Filippi (Data curation: Supporting; Writing – review & editing: Supporting), Hedia Brixi (Data curation: Supporting; Writing – review & editing: Supporting), Cyrielle Gilletta (Data curation: Supporting; Writing – review & editing: Supporting), Laurence Picon (Data curation: Supporting; Writing – review & editing: Supporting), Filip Baert (Conceptualization: Supporting; Data curation: Supporting; Writing – review & editing: Supporting), Séverine Vermeire (Conceptualization: Supporting; Data curation: Supporting; Writing – review & editing: Supporting), Nicolas Duveau (Data curation: Supporting; Methodology: Lead; Validation: Lead; Writing – original draft: Supporting; Writing – review & editing: Supporting), Laurent Peyrin-Biroulet (Conceptualization: Supporting; Data curation: Supporting; Writing – original draft: Supporting; Writing – review & editing: Supporting) Conflicts of interest These authors disclose the following: David Laharie received counseling, advisory board, transport, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC Pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots; Geert D'Haens received consultancy fees from AbbVie, Ablynx, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Echo Pharmaceuticals, Eli Lilly, Engene, Ferring, Dr Falk Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Millenium/Takeda, Medtronics, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Pfizer/Hospira, Photopill, Prodigest, Prometheus Laboratories/Nestle, Progenity, Protagonist, RedHill, Robarts Clinical Trials, Samsung Bioepis, Sandoz, Seres/Nestle, Setpoint, Shire, Takeda, Teva, Tigenix, Tillotts, Topivert, Versant, and Vifor; Maria Nachury received consulting fees or lecture fees from AbbVie, MSD, Amgen, Adacyte, Arena, Biogen, CTMA, Ferring, Janssen, Mayoli-Spindler, Pfizer, and Takeda; Peter Bossuyt received financial support for research from AbbVie, Mundipharma, Pfizer, Janssen, Amgen, and Mylan, lecture fees from AbbVie, Takeda, Pfizer, and Janssen, advisory board fees from AbbVie, Arena Pharmaceuticals, BMS, Takeda, Hospira, Janssen, MSD, Mundipharma, Roche, Pfizer, Sandoz, PSI-CRO, and Pentax; Edouard Louis received research grants from Takeda, Pfizer, and Janssen, educational grants from AbbVie, Takeda, and Janssen, speaker fees from AbbVie, Ferring, MSD, Falk, Takeda, Janssen, Pfizer, and Celgene, served on the advisory boards of AbbVie, Ferring, MSD, Takeda, Celgene, Janssen, Gilead-Galapagos, Arena, Pfizer, and Eli Lilly, and consulted for AbbVie; Christien Janneke van der Woude received financial support for research from Pfizer, Janssen, and Falk, lecture fees from AbbVie, and advisory board fees from Mundipharma, Celltrion, and Galapagos; Anthony Buisson received speaker fees from AbbVie, Ferring, Janssen, and Takeda; Philippe Van Hootegem served as an advisory board member for Takeda and Janssen, and received speaker fees from AbbVie, Ferring, Janssen, and Takeda; Cyrielle Gilletta has served both on the boards or received fees from AbbVie, Gilead, Janssen, Pfizer, and Takeda; Séverine Vermeire received research support from MSD, AbbVie, Pfizer, Takeda, and Janssen, consulted for AbbVie, MSD, Prometheus Laboratories, Tillotts Pharma, Eli Lilly, Pfizer, Takeda, Janssen, Celgene, Ferring Pharmaceuticals, Arena, Galagapos, Gilead, Hospira, MundiPharma, Progenity, Second Genome, and Biogen, and served on the speakers bureau for AbbVie, Pfizer, Takeda, Janssen, Ferring Pharmaceuticals, Galagapos, GSK, Genentech/Roche, Gilead, Hospira, and Tillotts Pharma; Laurent Peyrin-Biroulet has received personal fees from AbbVie, Janssen, Genentech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Boerhinger Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance, received grants from AbbVie, MSD, and Takeda, and has stock options in CTMA. The remaining authors disclose no conflicts. Funding The Tailored Treatment With Infliximab for Active Crohn's Disease trial was supported financially by Merck Sharp Dome and Janssen, which also provided the infliximab study drug during the study period. No funding was provided for the present follow-up study.
Funding Information:
Funding The Tailored Treatment With Infliximab for Active Crohn's Disease trial was supported financially by Merck Sharp Dome and Janssen, which also provided the infliximab study drug during the study period. No funding was provided for the present follow-up study.
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