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Randomized Controlled Trial
. 2025 Feb 6;74(3):387-396.
doi: 10.1136/gutjnl-2024-333385.

Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU

Javier P Gisbert  1   2 , María G Donday  3   2 , Sabino Riestra  4 , Alfredo J Lucendo  2   5 , José-Manuel Benítez  6 , Mercè Navarro-Llavat  7 , Jesús Barrio  8 , Víctor J Morales-Alvarado  9 , Montserrat Rivero  10 , David Busquets  11 , Eduardo Leo Carnerero  12 , Olga Merino  13 , Óscar Nantes Castillejo  14 , Pablo Navarro  15 , Manuel Van Domselaar  16 , Ana Gutiérrez  2   17 , Inmaculada Alonso-Abreu  18 , Rafael Mejuto  19 , Luis Fernández-Salazar  20 , Marisa Iborra  21 , María Dolores Martín-Arranz  22 , Juan Ramón Pineda  23 , Manuela Josefa Sampedro  24 , Katja Serra Nilsson  25 , Abdel Bouhmidi  26 , Lissette Batista  27 , Carmen Muñoz Villafranca  28 , Iago Rodríguez-Lago  29 , Daniel Ceballos  30 , Iván Guerra  31 , Miriam Mañosa  2   32 , Ignacio Marín Jiménez  33 , Emilio Torrella  34 , Maribel Vera Mendoza  35 , María José Casanova  3   2 , Ruth de Francisco  4 , Laura Arias-González  2   5 , Sandra Marín Pedrosa  6 , Orlando García-Bosch  7 , Francisco Javier García-Alonso  8   31 , Pedro Delgado-Guillena  9 , María José García  10 , Leyanira Torrealba  11 , Andrea Núñez-Ortiz  12 , Miren Vicuña Arregui  14 , Marta Maia Bosca-Watts  15 , Isabel Blázquez  16 , Diana Acosta  3   2 , Ana Garre  3   2 , Montse Baldán  3   2 , Concepción Martínez  36 , Manuel Barreiro-de Acosta  19 , Eugeni Domènech  2   32 , Maria Esteve  2   27 , Valle García-Sánchez  6 , Pilar Nos  21 , Julián Panés  2   37 , María Chaparro  1   2 ; EXIT Study group of GETECCU
Collaborators, Affiliations
Randomized Controlled Trial

Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU

Javier P Gisbert et al. Gut. .

Erratum in

Abstract

Background and objectives: Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it.

Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse.

Design: Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn's disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn's disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse.

Results: One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA).

Conclusion: Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment.

Trial registration number: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836.

Keywords: INFLAMMATORY BOWEL DISEASE; INFLIXIMAB; ULCERATIVE COLITIS.

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Conflict of interest statement

Competing interests: MBdA has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, GALAPAGOS, Pfizer, Sandoz, Biogen, Fresenius, Lilly, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte and Vifor Pharma. MCh has served as speaker, consultant or research or education funding from MSD, Abbvie, Hospira, Pfizer, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Biogen, Gilead and Lilly. ED has served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Biogen, Celltrion, Galapagos, Gilead, GoodGut, Imidomics, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots. JPG has served as speaker, consultant, and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma.Marisa Iborra reports grants and personal fees from MSD, Janssen, Abbvie, Takeda, Kern and Chiesi, during the conduct of the study.Eduardo Leo has received grants or honoraria for scientific activities, presentations or as a scientific advisor for MSD, Pfizer, Abbvie, Takeda, Janssen, Tillotts Pharma, Shire Pharmaceuticals, Ferring, Dr. Falk Pharma, Adacyte and Otsuka Pharmaceutical. PNM reports grants and personal fees from MSD, grants from Otsuka, AbbVie; personal fees from Takeda, Kern, Biogen, Ferring. JP received financial support for research from AbbVie and Pfizer; consultancy fees/honorarium from AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celsius, Celltrion, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Morphic, Pandion, Pfizer, Progenity, Prometheus, Protagonist, Revolo, Robarts, Sanofi, Takeda, Theravance and Wasserman; reports payment for lectures including service on speaker bureau from Abbott, Ferring, Janssen, Pfizer and Takeda; and reports payment for development of educational presentations from Abbott, Janssen, Pfizer Roche and Takeda. MR has served as a speaker or advisory member from TaKeda, Janssen, Galapagos, Ferring and Pfizer. MV has received educational funding from Janssen, Kern Pharma and Takeda. Rest of authors have nothing to declare.

Figures

Figure 1
Figure 1. Flowchart of patients included in the study. ITT, intention-to-treat; PP, per-protocol.
Figure 2
Figure 2. Proportion of patients in clinical remission at the end of follow-up.
Figure 3
Figure 3. Relapse at the end of follow-up.
Figure 4
Figure 4. Survival curve of clinical remission during follow-up (12 months).
See this image and copyright information in PMC

References

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