Risankizumab vs Ustekinumab for Crohn's Disease

(SEQUENCE Trial)

This trial tests the effectiveness of two treatments, risankizumab and ustekinumab, for individuals with moderate to severe Crohn's disease, a condition causing inflammation in the digestive tract. Researchers continue to study risankizumab, while ustekinumab has already received approval for use. Participants will be divided into groups to receive either risankizumab or ustekinumab and will undergo regular check-ups to monitor changes in their condition. This trial suits individuals who have had Crohn's disease for at least three months and have not found success with other treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants access to potentially groundbreaking treatments.

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have received certain biologic agents before the trial, so it's best to discuss your current medications with the trial team.

Research has shown that risankizumab is generally safe for people with Crohn's disease. In one study, patients who used risankizumab for a year experienced good results with manageable side effects. Another study in real-world settings found that many patients with difficult-to-treat Crohn's disease responded well to risankizumab, with no major safety issues identified.

Ustekinumab, already approved for treating moderate to severe Crohn's disease, has undergone thorough safety testing. Most people tolerate it well, and serious side effects are rare.

Researchers are excited about risankizumab for Crohn's disease because it targets a specific protein called IL-23, which plays a crucial role in the inflammation process. Unlike current treatments like infliximab and adalimumab that often target TNF-alpha, risankizumab offers a different approach by focusing on this distinct pathway. Additionally, the dosing schedule is flexible, starting with intravenous doses followed by subcutaneous injections, which might offer convenience and sustained relief for patients.

This trial will compare Risankizumab and Ustekinumab for treating Crohn's disease. Studies have shown that Risankizumab, which participants in this trial may receive, effectively treats Crohn's disease. In real-world settings, about 58% of patients improved without needing steroids, and around 59% experienced significant symptom relief after three months of treatment. Ustekinumab, another treatment option in this trial, is already approved for Crohn's and works well for moderate to severe cases. Both treatments have shown promising results in reducing Crohn's symptoms, with Risankizumab demonstrating strong early success.¹³⁵⁶⁷