Gut
Cure8 research brief
Why This Matters
Perianal fistulas are a serious complication of Crohn’s disease with limited high-quality trial evidence. This randomized trial suggests ustekinumab may increase the chance of combined clinical and MRI remission at 12 weeks compared with placebo.
Who Should Pay Attention
Adults with Crohn’s disease and active draining perianal fistulas; gastroenterologists and surgeons treating perianal Crohn’s disease; researchers of biologic therapies.
Study Snapshot
Story typeResearch paper
Evidence typeResearch paper
Source depthJournal abstract
What To Know
This was a double-blind multicentre trial (NCT04496063) that randomized 32 patients to ustekinumab or placebo following standardised surgical care. The primary endpoint combined absence of drainage from external fistula openings and absence of abscesses >2 cm on central MRI at week 12.
At week 12 combined remission was reported in 62% on ustekinumab versus 25% on placebo. Placebo non-responders could switch to ustekinumab after week 12 and some patients entered open-label intensification.
Keep In Mind
Small randomized trial (32 patients) with short-term primary endpoint at 12 weeks; many participants had prior anti-TNF failure and there was an open-label switch for placebo non-responders after week 12. This summary is grounded in the article abstract.
Source Details
Review the original publication for the complete reporting, methods, and context.
Research paper
Evidence type derived from source or registry metadata.
PublicationGut
PublisherBMJ
AuthorsPauline Wils, Stéphane Nancey, Elodie Messmer +13 more
Study typeJournal Article
Indexed viaCrossref
Source typeResearch paper
PublishedJul 24, 2026, 12:00 AM
Content availableJournal abstract
Funding disclosed by the source: Johnson and Johnson, award CNTO1275CRD4031
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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