Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial
In brief
Stopping anti-TNF causes flares in 52% of ulcerative colitis patients
In a randomized trial of 172 patients in deep remission, two-year endoscopic remission fell from 96% with continued anti-TNF to 80% after withdrawal, and flares rose from 12% to 52%. Retreatment succeeded in three-quarters of flare cases, but no predictors of relapse were identified, questioning routine discontinuation.
- Journal
- Journal of Crohn's & colitis (Q1)
- Published
- 5 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Ingrid Prytz Berset, Frode Lerang, Bjørn Moum, Jørgen Jahnsen, Tore Grimstad, Vendel Kristensen, et al.
- PMID
- 42557857
- DOI
- 10.1093/ecco-jcc/jjag110
Why clinicians should know about it
- Picked for Gastroenterology (top studies of the week, 9 August 2026): Anti‑TNF withdrawal vs maintenance in ulcerative colitis RCT
Abstract
BACKGROUND AND AIMS: Anti-tumour necrosis factor (anti-TNF) treatment is effective in ulcerative colitis (UC). Optimal treatment duration is uncertain. This trial studies outcome after anti-TNF withdrawal compared to maintenance treatment in UC. METHODS: In this prospective, multicentre, randomized, controlled, open-label non-inferiority study, patients in deep clinical, biochemical and endoscopic remission were randomized 1:1 to anti-TNF withdrawal or maintenance treatment. Primary endpoint was endoscopically confirmed remission (Mayo Endoscopic Score 0 or 1) after two years, including UC flares treated with anti-TNF, or non-biologic agents. Secondary endpoints were clinical remission, UC flare rate and treatment response. We needed 170 participants to show non-inferiority with a 15% margin. RESULTS: Between June 2017 and December 2021, 172 UC patients from 19 Norwegian hospitals were randomized; 86 in each group. The per-protocol population was 163 patients. Nine patients were excluded due to consent withdrawal or protocol violation. Eighty percent (66/82) of anti-TNF withdrawal and 96% (78/81) of maintenance patients were in endoscopic remission after 2 years. UC flares occurred in 52% (45/86) of withdrawal and 12% (10/86) of maintenance patients. Anti-TNF retreatment was successful in 74% (20/27). CONCLUSION: Two years after anti-TNF withdrawal in UC patients in deep remission, endoscopically confirmed remission rate was significantly lower compared to maintenance treatment. Non-inferiority could not be proven. UC flare rate after anti-TNF withdrawal was high, but most were successfully treated. The majority did not receive AZA. Importantly, 48% of anti-TNF withdrawal patients remained in steroid-free remission. No significant predictors for UC activity after anti-TNF withdrawal were identified. TRIAL REGISTRATION: ClinicalTrials.gov (registration number NCT03011268), and EudraCT (registration number 2016-001409-18).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.