Upadacitinib for Eosinophilic Esophagitis

(ATUNE Trial)

This trial tests whether upadacitinib, a Janus kinase inhibitor, combined with topical corticosteroids, can better manage Eosinophilic Esophagitis (EoE), a condition causing symptoms like trouble swallowing and heartburn. Participants will take either upadacitinib or a placebo daily for 12 weeks, followed by upadacitinib for another 12 weeks. Ideal participants have experienced ongoing EoE symptoms despite using topical corticosteroids for at least eight weeks. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

You will need to continue taking your current topical corticosteroids and any other EoE treatments, like proton pump inhibitors or diet elimination, throughout the study. However, you cannot use systemic corticosteroids, dupilumab, estrogen, or certain other medications close to the start of the trial.

Research has shown that upadacitinib is well-tolerated by patients with conditions similar to eosinophilic esophagitis (EoE). Specifically, studies found that 91% of patients with severe and difficult-to-treat EoE experienced symptom improvement with upadacitinib, indicating that many patients found the treatment both manageable and effective.

However, collecting long-term safety information remains crucial, especially for younger patients. So far, no major safety issues have been consistently reported, but side effects can occur with any medication. While most participants in previous studies have seen improvements, individual experiences can differ.

Unlike the standard treatments for eosinophilic esophagitis, which typically include corticosteroids or dietary modifications, upadacitinib offers a different approach by targeting Janus kinase (JAK) enzymes. This mechanism can potentially reduce inflammation more effectively by precisely blocking the pathways that lead to the overproduction of eosinophils, which are a type of white blood cell involved in this condition. Researchers are excited because this targeted action could provide relief with fewer side effects compared to existing therapies, offering a new hope for patients who struggle with current treatment limitations.

Research has shown that upadacitinib can help treat eosinophilic esophagitis (EoE). In one study, patients with severe EoE who took upadacitinib experienced symptom relief, with 91% reporting improvements. Another case showed a patient with both symptom and esophagus inflammation improvement. Lab studies suggest that upadacitinib targets key areas of inflammation in EoE. These findings indicate that upadacitinib may help reduce EoE symptoms for many patients. Participants in this trial will either receive upadacitinib 30mg for the entire 24-week treatment period or start with a placebo for 12 weeks, followed by upadacitinib 30mg for the remaining 12 weeks.¹²³⁵⁶