New Budesonide Formulation Provides a Safe, Convenient Option for Treating Eosinophilic Esophagitis

Adults with eosinophilic esophagitis (EoE) who switched to budesonide orodispersible tablets from swallowed topical corticosteroids (STCs) maintained remission and reported improved quality of life and higher treatment satisfaction, according to data presented during Digestive Disease Week (DDW) 2024.

STCs have been used off-label as a first-line therapy for EoE. The recent approval of a new formulation of budesonide, in the form of an orodispersible tablet (BOT), as induction therapy for adults with EoE has provided physicians with a new tool designed specifically for esophageal targeting. Clinical research has previously shown that long-term treatment with BOT (0.5 mg or 1.0 mg twice daily) was highly superior to placebo in maintaining clinical and histologic remission in adults with EoE, with both dosages equally effective and well tolerated (Straumann A et al. Gastroenterology 2020; 159(5):1672-1685.e5). A recent study conducted in Milan, Italy showed that patients with EoE not only maintained remission, but were content to switch to BOT and found this formulation easy to manage.

The study, presented by Gaia Pellegatta, MD, a gastroenterologist at the IRCCS Humanitas Research Hospital, in Milan, Italy, was designed to evaluate the efficacy and safety of BOT, as well as patient satisfaction after the switch from off-label STCs to BOT. Thirty-one patients treated at the center, who did not respond to proton pump inhibitors and initially received off-label STCs, switched to BOT as treatment for EoE. Of those, 90% underwent endoscopic and histologic evaluation during treatment with STCs and again 12 to 16 weeks after switching to BOT. The researchers used questionnaires to assess the severity of symptoms, quality of life, and satisfaction with treatment, including taste and perception of safety, before and after the switch.

The results showed that 90% of the patients who still had active disease during treatment with STCs, diagnosed by the presence of at least 15 eosinophils per high power field, achieved deep remission after switching to BOT. Moreover, a significant majority of patients who were in histological remission on STCs (94%) maintained or achieved deep remission with BOT. The investigators noted that, overall, there was a significant increase in the number of patients who were in deep remission after the therapeutic switch (92% vs 57%), with no major adverse events reported.

Patients who switched to BOT also experienced a significant improvement in the severity of symptoms and in quality of life. Overall satisfaction with BOT as a therapy for EoE and the perceived convenience of using this formulation were significantly higher compared to those reported for previous treatments.

A separate analysis presented at the DDW 2024 meeting showed that patients who received BOT as maintenance therapy over 48 weeks following initial BOT induction therapy did not experience adverse events related to bone metabolism, nor did they exhibit symptoms associated with adrenal insufficiency. “This positive safety profile is notable considering the durability of the therapeutic effect of both BOT regimens (0.5 mg BID and 1.0 mg BID) used in the BUL-2/EER trial, with 73.5% and 75% of participants, respectively, still in clinic-histologic remission at week 48 after initiation of treatment versus 4.4% of the placebo group, further supporting the utility of BOT as maintenance treatment in adults with EoE,” said Alfredo J. Lucendo, MD, PhD, a gastroenterologist at Hospital General de Tomelloso, Spain, who presented the results.

While the debate about indications for maintenance therapy after EoE remission continues, future studies may clarify whether the long-term use of orodispersible budesonide should be reserved for patients with severe disease or should be reinitiated after relapse.