Adults newly diagnosed with Crohn’s disease who received a combination of two medicines straight after diagnosis needed far fewer operations and hospital admissions over the following five years than those given standard step-by-step treatment, according to long-term results from a UK trial. The findings, reported in The Lancet, could influence how doctors approach treatment as soon as Crohn’s disease is diagnosed.
Background
Crohn’s disease is a long-term condition that causes inflammation in the digestive system, leading to symptoms such as abdominal pain, diarrhoea and fatigue. Doctors have traditionally used a “step-up” approach, starting with milder treatments such as steroids and only moving to stronger medicines if symptoms do not improve. An alternative approach, known as “top-down” treatment, involves starting stronger medicines earlier. This trial compared the two strategies directly.
What the researchers found
The trial, known as PROFILE, involved 386 adults with newly diagnosed Crohn’s disease treated across 40 UK hospitals. Half were given a biologic medicine called infliximab together with an immune-calming medicine known as an immunomodulator, right from diagnosis. The other half received standard step-up care, where treatment was intensified gradually if needed. Both approaches were followed closely for the first year, after which patients returned to routine care from their local teams.
Researchers then tracked outcomes for up to five years. Those who started on the combination treatment early were far less likely to need surgery related to Crohn’s disease. Only six patients in this group required an operation, compared with 26 patients in the step-up group. People who had step-up treatment also tended to need surgery sooner and were more likely to be admitted to hospital, and sooner, than those who started on the stronger combination early.
Importantly, the researchers reported no meaningful difference in side effects between the two approaches, suggesting that starting stronger treatment early did not come with an obvious additional safety concern in this trial.
Why this matters
Doctors have sometimes been cautious about starting stronger combination treatments immediately after diagnosis, partly because of concerns about infection risk associated with more intensive immune-related therapy. These findings suggest that, for people with newly diagnosed Crohn’s disease, starting effective treatment early may help reduce the chances of the disease progressing to the point where surgery or hospital admission is needed, regardless of how severe the condition first appeared. The researchers noted that this approach may be straightforward to introduce into routine care, since it does not require specialised setup beyond access to the relevant medicines.
What to keep in mind
This was a single trial, and while the five-year follow-up is a notable strength, individual results can vary and not everyone responds to treatment in the same way. Decisions about starting or changing Crohn’s disease treatment should always be made with a specialist gastroenterology team, taking into account each person’s individual circumstances. Further research may help clarify which patients benefit most from this approach and how it fits alongside other treatment options.
Reference
Noor NM, Sousa P, Paul S, et al. Early treatment with rapid step-up versus top-down infliximab and immunomodulator therapy in newly diagnosed patients with Crohn’s disease (PROFILE): a multicentre, open-label, randomised controlled trial. Lancet Gastroenterology & Hepatology. 2024;9(5):415-427. doi:10.1016/S2468-1253(24)00034-7.
This article is a journalistic summary for informational purposes only. It does not constitute clinical advice or a recommendation to alter treatment decisions.