A large clinical trial led by researchers at the University of Cambridge has found that giving the immunotherapy drug infliximab immediately after a Crohn’s disease diagnosis — rather than waiting for conventional treatments to fail — puts nearly four in five patients into sustained remission and cuts the need for emergency surgery by a factor of 10.
At a glance
- Crohn’s disease remission: 79% of patients who received early infliximab showed sustained steroid- and surgery-free remission at one year, compared to just 15% in the conventional treatment group.
- Top-down therapy: The strategy involves giving the drug immediately after diagnosis, regardless of symptom severity — a direct reversal of the current standard of care, which delays advanced therapy until simpler treatments fail.
- Endoscopic remission: Two-thirds of early-treatment patients had no visible ulcers on camera examination at the end of the trial, far exceeding the 20–30% rate most previous trials have considered highly successful.
Why the timing of treatment matters so much
Crohn’s disease is a chronic inflammatory bowel condition that causes painful flare-ups and, over time, progressive structural damage to the gut. Current standard care relies on steroids for acute episodes, reserving more powerful drugs for later stages. But the problem with waiting is that the damage compounds.
“As soon as a patient is diagnosed with Crohn’s disease, the clock is ticking — and has likely been ticking for some time — in terms of damage happening to the bowel,” said Nuru Noor, the study’s lead author.
Under the current approach, between 17% and 25% of Crohn’s patients still require surgical removal of part of the bowel within five years of diagnosis. The Cambridge trial, published in The Lancet: Gastroenterology & Hepatology, set out to test whether moving the most effective tools to the front of treatment could change that picture.
How the trial worked
The researchers enrolled 386 patients aged 16 to 80 who had been diagnosed with active Crohn’s disease within the previous six months. All participants completed an eight-week course of oral steroids. They were then split into two groups and followed for a year.
The “top-down” group received infliximab combined with an immune-modulating drug, starting immediately. The “accelerated step-up” group received conventional therapy, with treatments escalated only as flare-ups occurred.
Infliximab is a monoclonal antibody that works by blocking tumor necrosis factor alpha (TNF-alpha), a protein the body produces during acute inflammation. It is delivered intravenously or by injection under the skin. Concerns about its cost and a slightly elevated infection risk have historically kept it as a last resort — but this trial challenged both assumptions.
The results challenged decades of received wisdom
The gap between the two groups was stark. In the top-down group, 79% of patients achieved sustained remission without steroids or surgery. In the step-up group, that figure was 15%.
Ten patients in the conventional treatment group needed urgent abdominal surgery. One patient in the early-treatment group did.
Critically, the researchers found no meaningful difference in serious infection rates between the groups — the safety concern that had kept infliximab off the table for early use. “We now know we can prevent the majority of adverse outcomes, including the need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable,” said Miles Parkes, the study’s corresponding author.
Patients in the top-down group also reported higher quality of life scores and fewer hospitalizations during the year-long follow-up.
Affordability is catching up with the evidence
One of the long-standing barriers to wider infliximab use has been cost. That barrier is eroding. The drug is now available as a cheaper biosimilar — a near-identical generic version — in both the U.K. and the U.S. In Australia, treatment is subsidized through the Pharmaceutical Benefits Scheme. The Cambridge team is currently analyzing whether the economic benefits of avoiding surgery and hospitalization outweigh the cost of early treatment.
For patients and clinicians, the research reframes what “early” even means. “Historically, treatment with an advanced therapy like infliximab within two years of diagnosis has been considered ‘early,'” Noor said. “But our findings redefine what should be considered early treatment.”
What still needs answering
The trial focused specifically on infliximab. Other anti-TNF drugs, including adalimumab, work by a similar mechanism and are available at significantly lower cost, but whether they produce the same clinical outcomes in a top-down strategy remains unclear. More research is needed before they can be recommended as equivalents.
Guidelines will also need to catch up. Changing treatment protocols at a system level — updating training, reimbursement structures, and referral pathways — takes time even when the clinical evidence is strong. Some patients will continue to receive delayed treatment while that transition happens.
Still, the implications of this trial are hard to overstate. The Crohn’s & Colitis Foundation estimates that Crohn’s disease affects roughly three million people in the U.S. alone. If even a fraction of newly diagnosed patients gain access to early infliximab treatment, the reduction in surgeries, hospitalizations, and long-term bowel damage could be enormous.
The University of Cambridge study, conducted alongside collaborators at multiple U.K. centers and published in early 2025 C.E., now stands as one of the strongest arguments yet for rethinking how medicine responds to Crohn’s disease from the very first day of diagnosis. The Lancet: Gastroenterology & Hepatology peer review adds further weight to a finding that could reshape clinical practice around the world.
Read more
For more on this story, see: New Atlas
For more from Good News for Humankind, see:
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- The Good News for Humankind archive on global health
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