Crohn’s disease is an inflammatory bowel disease caused by the immune system attacking cells throughout the digestive tract, leading to inflammation and damage. This chronic condition can have severe impacts on quality of life and may even require surgical intervention. There are multiple treatment approaches and types of therapies that can be used to reduce symptoms and promote a state of remission. Results from a recent clinical trial, the PROFILE study, investigating the impact of new treatment courses have shown promising results in improving symptoms for individuals recently diagnosed with Crohn’s disease.
Traditionally, Crohn’s disease has been treated using a step-up therapy where people are initially treated with aminosalicylates to reduce inflammation. People then “step-up” to stronger treatments like steroids and then immunomodulators and biologics when prior treatments are no longer successful at reducing inflammation and symptoms continue to become more severe. The PROFILE study worked on trialing a new type of treatment method called the top-down therapy where individuals are immediately started on immunomodulators, such as infliximab, regardless of the symptoms they have and the severity of their condition. Infliximab is a highly effective therapy that blocks the key signaling molecule, tumor necrosis factor-alpha, that creates inflammation.
Researchers enrolled 386 participants who were newly diagnosed with Crohn’s disease in the study. Each participant underwent biomarker profiling, where a 17-gene-based blood-biomarker was used to classify them as IBDhi, where they have a higher risk of needing more treatments, or IDBlo, where they had a lower risk of needing further treatments. Participants were then randomly assigned to receive either the top-down therapy or the traditional step-up therapy and were then followed for 48 weeks.
A new clinical trial investigating different treatment courses for Crohn’s disease has shown promising results supporting starting treatment with more intense options than what has been traditionally done.
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Results showed that 79% of participants receiving the top-down therapy remained in steroid and surgery-free remission for 48 weeks compared to 15% of participants receiving the traditional step-up therapy. 67% of participants receiving the top-down therapy had no ulceration viewed by endoscopic examination at the end of 48 weeks compared to 44% of participants receiving the traditional step-up therapy. Participants receiving the top-down therapy also reported higher quality of life scores, lower hospitalization rates, and lower frequency of steroid use as well. The researchers further noted that classification as IDBlo or IBDhi had no difference in the response to either treatment method that was used and thus might not be a useful tool in trying to predict disease severity.
These results can have many clinical implications in the management and treatment of Crohn’s disease as there is more evidence showing the effectiveness of the top-down approach. With chronic conditions, doctors need to prioritize promoting long-term health outcomes and minimize the flaring of symptoms, which increases the risk of permanent damage that could require surgical intervention. Studies such as these continue to showcase the importance of researching and developing new therapy combinations or treatment courses to try and improve patient outcomes and reduce the burden of medications they have to take.
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