Evidence map›Paper›PMID 39794921›Full record

Trial reportGut2025

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

Javier P Gisbert, María G Donday, Sabino Riestra, Alfredo J Lucendo, José-Manuel Benítez, Mercè Navarro-Llavat, Jesús Barrio, Víctor J Morales-Alvarado, Montserrat Rivero, David Busquets and 49 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02994836 (Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02994836 phase4completednot on this map

Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation

TypeinterventionalSponsorFundación de Investigación Biomédica - Hospital Universitario de La PrincesaRan2017 to 2022Enrolled139ConditionsCrohn's Disease, Inflammatory Bowel Disease, Ulcerative ColitisArmsAnti-TNF: Infliximab (Infusion), Anti-TNF discontinuation: Physiological saline solution, Anti-TNF:Adalimumab (Subcutaneus)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

59 authors.

Javier P GisbertGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain mariachs2005@gmail.com javier.p.gisbert@gmail.com.ORCID http://orcid.org/0000-0003-2090-3445
María G DondayGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Sabino RiestraGastroenterology Department, Hospital Universitario Central de Asturias, e Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
Alfredo J LucendoCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
José-Manuel BenítezGastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain.
Mercè Navarro-LlavatGastroenterology Department, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.
Jesús BarrioGastroenterology Department, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain.
Víctor J Morales-AlvaradoGastroenterology Department, Hospital General de Granollers, Granollers, Spain.
Montserrat RiveroGastroenterology Department, Hospital Universitario Marqués de Valdecilla e IDIVAL, Santander, Spain.
David BusquetsGastroenterology Department, Hospital Dr. Josep Trueta, IDIBGI, Girona, Spain.
Eduardo Leo CarnereroGastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Olga MerinoGastroenterology Department, Hospital Universitario Cruces, Barakaldo, Spain.
Óscar Nantes CastillejoGastroenterology Department, Hospital Universitario de Navarra, Pamplona, Spain.ORCID http://orcid.org/0000-0002-3587-1039
Pablo NavarroGastroenterology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Manuel Van DomselaarGastroenterology Department, Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Torrejón de Ardoz, Spain.ORCID http://orcid.org/0000-0002-9950-2216
Ana GutiérrezCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Inmaculada Alonso-AbreuGastroenterology Department, Hospital Universitario de Canarias (H.U.C), Santa Cruz de Tenerife, Spain.
Rafael MejutoGastroenterology Department, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
Luis Fernández-SalazarGastroenterology Department, Hospital Clínico Universitario de Valladolid, Gerencia Regional de Salud de Castilla y León (SACYL). Universidad de Valladolid, Valladolid, Spain.
Marisa IborraGastroenterology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain.
María Dolores Martín-ArranzGastroenterology Department, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Instituto de Investigación Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
Juan Ramón PinedaGastroenterology Department, Xerencia Xestión Integrada de Vigo, SERGAS, Research Group In Digestive Diseases, Galicia Sur Health Research Institute, SERGAS-UVIGO, Vigo, Spain.
Manuela Josefa SampedroGastroenterology Department, Hospital de Mataró, Mataró, Spain.
Katja Serra NilssonGastroenterology Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.
Abdel BouhmidiGastroenterology Department, Hospital Santa Bárbara, Puertollano, Spain.
Lissette BatistaGastroenterology Department, Hospital Universitari Mutua Terrassa, Terrassa, Spain.
Carmen Muñoz VillafrancaGastroenterology Department, Hospital Universitario de Basurto, Bilbao, Spain.
Iago Rodríguez-LagoGastroenterology Department, Hospital Universitario de Galdakao, Instituto de Investigación Sanitaria Biobizkaia, Galdakao, Spain.ORCID http://orcid.org/0000-0003-1133-4578
Daniel CeballosGastroenterology Department, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.
Iván GuerraGastroenterology Department, Hospital Universitario de Fuenlabrada, Fuenlabrada, Spain.ORCID http://orcid.org/0000-0002-5175-2515
Miriam MañosaCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Ignacio Marín JiménezGastroenterology Department, Hospital Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Facultad de Medicina, Universidad Complutense, Madrid, Spain.
Emilio TorrellaGastroenterology Department, Hospital General Universitario J.M. Morales Meseguer, Murcia, Spain.
Maribel Vera MendozaGastroenterology Department, Hospital Universitario Puerta de Hierro, Majadahonda, Spain.
María José CasanovaGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Ruth de FranciscoGastroenterology Department, Hospital Universitario Central de Asturias, e Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
Laura Arias-GonzálezCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Sandra Marín PedrosaGastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain.
Orlando García-BoschGastroenterology Department, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.
Francisco Javier García-AlonsoGastroenterology Department, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain.
Pedro Delgado-GuillenaGastroenterology Department, Hospital General de Granollers, Granollers, Spain.ORCID http://orcid.org/0000-0002-5798-5491
María José GarcíaGastroenterology Department, Hospital Universitario Marqués de Valdecilla e IDIVAL, Santander, Spain.ORCID http://orcid.org/0000-0002-6517-7005
Leyanira TorrealbaGastroenterology Department, Hospital Dr. Josep Trueta, IDIBGI, Girona, Spain.
Andrea Núñez-OrtizGastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Miren Vicuña ArreguiGastroenterology Department, Hospital Universitario de Navarra, Pamplona, Spain.
Marta Maia Bosca-WattsGastroenterology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Isabel BlázquezGastroenterology Department, Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Torrejón de Ardoz, Spain.
Diana AcostaGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain.ORCID http://orcid.org/0000-0001-8347-6642
Ana GarreGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Montse BaldánGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain.ORCID http://orcid.org/0000-0003-0848-8154
Concepción MartínezDepartment of Pharmacy, Hospital Universitario de La Princesa, Madrid, Madrid, Spain.
Manuel Barreiro-de AcostaGastroenterology Department, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.ORCID http://orcid.org/0000-0001-5915-1477
Eugeni DomènechCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.ORCID http://orcid.org/0000-0002-2315-7196
Maria EsteveCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Valle García-SánchezGastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain.
Pilar NosGastroenterology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain.
Julián PanésCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
María ChaparroGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain mariachs2005@gmail.com javier.p.gisbert@gmail.com.ORCID http://orcid.org/0000-0002-9275-4242
EXIT Study group of GETECCU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesPrimary 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

objectivesto 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.

designProspective, 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.

resultsOne-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).

conclusionAnti-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.

Indexed as

Colitis, UlcerativeCrohn DiseaseGastrointestinal AgentsTumor Necrosis Factor-alphaWithholding TreatmentAdultFemaleHumansInfliximabLeukocyte L1 Antigen ComplexMaleMiddle AgedProspective StudiesQuality of LifeRecurrenceRemission InductionGastrointestinal AgentsInfliximabLeukocyte L1 Antigen ComplexTumor Necrosis Factor-alphaINFLAMMATORY BOWEL DISEASEINFLIXIMABULCERATIVE COLITIS

Identifiers

PMID39794921
PMCPMC11874338

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.