Healing intestinal ulcers, absence of symptoms and reduction in the number of hospitalizations related to Crohn’s disease, all thanks to monitoring and therapeutic intensification based on biomarkers of inflammation. This is the result of an international study published in the magazine Lancet.

Researchers in the 74 centers around the world (Europe, the United States, Japan, South Africa and Israel) have shown that the timely intensification of therapy with biological anti-TNF drugs (inhibitors of tumor necrosis factors, a cytokine that regulates cells of the immune system), based on clinical symptoms associated with biomarkers in patients with newly diagnosed Crohn’s disease, leads to better clinical and endoscopic results than treatment based solely on symptoms.

As Professor Silvio Danese, one of the authors of the study, responsible for the Centre for Inflammatory Chronic Intestinal Diseases of Humanitas, coordinator of Humanitas Immunology Center and professor at Humanitas University, explains: “This work revolutionizes Crohn’s disease treatment strategy by demonstrating that symptoms alone are not a sufficient parameter on which to change the therapy’s long-term remission maintenance of patients, while close monitoring and therapeutic intensification based on biomarkers of inflammation can lead to better endoscopic remission (healing of intestinal ulcers), clinical control (absence of symptoms) and reduce the number of hospital admissions related to the disease.


The study

The randomized, controlled, open-ended, phase III multicenter trial was conducted in 22 countries and involved adult patients (18-75 years old) with early Crohn’s disease who were never exposed to any immunosuppressive or biological therapy.

“Intestinal inflammation biomarkers, such as fecal calprotectin and C reactive protein, are used in monitoring patients with Crohn’s disease, but there is still no certainty that their use in monitoring disease activity and modifying therapy based on these will improve long-term outcomes in patients. We have tried to compare endoscopic and clinical results in patients with moderate or severe Crohn’s disease who have been managed with a strict monitoring algorithm, using clinical symptoms and biomarkers, with those in patients managed with a clinical management algorithm (clinical symptoms only),” explained prof. Danese.


Crohn’s disease

Crohn’s disease is a chronic, progressive and disabling disease that causes inflammation of the gastrointestinal tract and may promote the development of contractions, fistulae or abscesses that require surgery in about half of the patients within ten years of diagnosis.

Clinical disease management with the sequential use of corticosteroids, immunomodulators, tumor necrosis factor inhibitors (TNFs) and other biological agents may not be sufficient to adequately control underlying inflammation and may delay the onset of a more effective strategy (such as using biologics in patients with onset disease and adverse prognostic factors). This approach could also expose patients to an increased risk of infection and morbidity due to prolonged corticosteroid intake.

It should also be noted that the severity of symptoms is not necessarily indicative of the condition of the intestine visible at the endoscopic level and may not be a reliable criterion for modulating treatment in order to control inflammation and avoid permanent damage of the intestine.