Key takeaways:
- A “top-down” infliximab/immunomodulator therapy reduced long-term risk for abdominal surgery vs. a “step-up” approach in newly diagnosed Crohn’s.
- It also lowered risk for disease progression and hospitalization.
CHICAGO — Early treatment with infliximab and an immunomodulator was associated with more than five times reduced risk for abdominal surgery at 5 years among patients with newly diagnosed Crohn’s disease, according to a presenter.
Follow-up PROFILE trial data presented at Digestive Disease Week showed that early control of inflammation during a 48-week treatment period also lowered long-term risk for disease progression and hospitalization.
Nurulamin “Nuru” Noor, MD, speaks at Digestive Disease Week. Image: Robert Stott.
“Historically, there has been a reluctance among some clinicians to use a ‘top-down’ approach due to potential concerns about overtreatment,” Nurulamin “Nuru” Noor, MD, clinical lecturer in gastroenterology at University of Cambridge, said at the presentation. “Over 5 years follow-up, we found no difference in safety outcomes between the two groups, either for serious infections or malignancies.
“Patients receiving ‘top-down’ infliximab from diagnosis had a more than five times lower risk of Crohn’s disease-related abdominal surgery.”
Prior data from the randomized, controlled PROFILE trial showed improved clinical outcomes at 48 weeks for patients who received the “top-down” therapy approach with infliximab and an immunomodulator compared with an accelerated “step-up” strategy, or conventional treatment.
Noor and colleagues followed 386 participants for a median 5 years after the 48-week visit to evaluate whether early treatment can impact long-term outcomes of Crohn’s disease. They reviewed medical records for abdominal surgeries, hospital admissions and disease progression.
Follow-up data were available for 358 patients (93%), of whom 182 received top-down therapy and 176 received step-up therapy.
Analysis showed 28 Crohn’s-related abdominal surgeries were required among patients who received step-up therapy compared with six surgeries among those who received top-down therapy (adjusted HR = 5.23: 95% CI, 1.99-13.76). Time to surgery also was earlier in the step-up group.
Patients who received top-down therapy were about 2.5 times less likely to experience disease progression and two times less likely to be hospitalized.
“Our data suggest that the course of Crohn’s disease can be modified with therapy and this should be considered the standard of care,” Noor said.
Sources/Disclosures
Source:
Noor N, et al. Profile trial 5-year disease modification outcomes. Presented at: Digestive Disease Week; May 2-5, 2026; Chicago.
Disclosures:
Noor reports educational or travel grants and/or speaker fees from AbbVie, Bristol Myers Squibb, Celltrion, Falk, Ferring, Johnson & Johnson, Eli Lilly and Co., Medfyle, Pfizer, Pharmacosmos, Spyre, Takeda and Tillotts Pharma. Please see the study for all other authors’ relevant financial disclosures.
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