• Posted February 26, 2024

Treating Crohn's Sooner, More Aggressively Greatly Improves Outcomes: Study

In a finding that suggests sooner is better than later, a new trial shows that giving advanced treatment early to Crohn's patients can dramatically improve their gut health.

About 80% of those who got therapy with an immune-suppressing drug called infliximab shortly after their Crohn's diagnosis experienced an improvement in their symptoms and inflammatory markers related to the disease, researchers report.

By comparison, only 15% of patients who received conventional therapy had similar results.

“We've shown that by treating earlier, we can achieve better outcomes for patients than have previously been reported,” said lead researcher Dr. Nuru Noor, from the University of Cambridge in the U.K.

“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, so there's a need to start on an advanced therapy such as infliximab as soon as possible,” Noor added in a Cambridge news release.

The clinical trial involved 386 patients with newly diagnosed Crohn's disease being treated in 40 hospitals across the U.K.

Crohn's disease involves inflammation of the intestines, possibly due to an autoimmune reaction. Symptoms include diarrhea, cramping, abdominal pain and fatigue, and Crohn's causes enough intestinal damage that as many as one in 10 patients will require urgent abdominal surgery to treat their condition within the first year of diagnosis, researchers said.

Patients were assigned at random to undergo one of two treatment strategies using infliximab, which works by blocking a protein found in the immune system. It is administered through IV drip or injection.

One strategy followed the usual pattern of slowly tapering up the dosage of the drug, and only starting the drug if their disease was progressing and not responding to other simpler treatments.

The second group received “top-down” therapy, where they were given infliximab as soon as possible following diagnosis, regardless of the severity of their symptoms.

Two-thirds (67%) of patients in the top-down group had no intestinal ulcers in their follow-up endoscopy test at the end of the trial. That sort of remission is very important, researchers said, because it's consistently associated with decreased risk of later complications in Crohn's disease.

Up to now, clinical trials have been considered highly successful if they got just 20% to 30% of patients into remission, the researchers noted.

The top-down patients also had a tenfold lower need for urgent abdominal surgery within the first year of treatment, about 0.5% compared with around 5% of those receiving conventional therapy.

The researchers also found no difference in the risk of serious infection from infliximab, which is now available in a cheaper generic form.

The new study was published Feb. 22 in The Lancet Gastroenterology and Hepatology journal.

“Up until now, the view has been, ‘Why would you use a more expensive treatment strategy and potentially over-treat people if there's a chance they might do fine anyway?' said researcher Miles Parkes, director of the NIHR Cambridge Biomedical Research Center.

“We now know we can prevent the majority of adverse outcomes, including need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable,” Parkes added. “If you take a holistic view of safety, including the need for hospitalizations and urgent surgery, then the safest thing from a patient point of view is to offer ‘top-down' therapy straight after diagnosis rather than having to wait and use ‘step-up' treatment.”

More information

The National Institutes of Health have more about Crohn's disease.

SOURCE: University of Cambridge, news release, Feb. 22, 2024