Cure8 research brief
This trial directly informs a common clinical question: whether patients in deep remission can safely stop anti‑TNF therapy. Results show higher relapse risk after withdrawal, but many patients can be successfully retreated and some remain in remission without ongoing biologic therapy.
Adults with ulcerative colitis in deep remission, patients considering stopping anti‑TNF biologics, gastroenterologists and IBD clinicians, and researchers studying treatment de‑escalation strategies.
This randomized, multicentre open‑label non‑inferiority trial (BIOSTOP) compared stopping anti‑TNF therapy versus continuing maintenance treatment in ulcerative colitis patients who were in deep clinical, biochemical, and endoscopic remission.
After two years, endoscopic remission was lower in the withdrawal group (80%) than the maintenance group (96%), and flares were more frequent after withdrawal (52% vs 12%). Anti‑TNF retreatment worked for most who flared, and about 48% of those who stopped anti‑TNF remained in steroid‑free remission at two years.
Key details: 172 patients were randomized across 19 Norwegian hospitals; primary outcome was endoscopic remission (Mayo endoscopic score 0–1) at two years. The study did not demonstrate non‑inferiority of withdrawal with a 15% margin. No clear predictors of relapse after stopping therapy were identified in the trial.
What this means for patients: Stopping anti‑TNF in carefully selected UC patients in deep remission was associated with a higher risk of relapse over two years, though many relapses were responsive to restarting therapy and nearly half of those who stopped remained in remission.
Decisions about stopping should weigh relapse risk, patient priorities, and plans for monitoring and retreatment.
This is a randomized controlled non‑inferiority trial with two‑year follow‑up reported in Journal of Crohn’s & Colitis. It enrolled patients in deep clinical, biochemical and endoscopic remission; group sizes met the prespecified sample size. The article provides abstract‑level structured results; full paper reading is recommended for detailed subgroup and protocol information.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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