TOPLINE:
Patients with eosinophilic oesophagitis (EoE) unresponsive to off-label swallowed topical corticosteroids (STCs) demonstrated a positive response to an oesophageal-targeted budesonide formulation. Younger age (< 30 years), longer treatment duration, and low treatment adherence were factors associated with off-label STC treatment failure.
METHODOLOGY:
- Researchers analysed data of 340 patients with EoE (median age at the last visit, 43 years; 76% men; median disease duration, 14 years) who were enrolled in the Swiss Eosinophilic Esophagitis Cohort Study (SEECS) from 2016 to 2023.
- Patients were divided into three groups: Those with prior histologic non-response to off-label STCs (n = 89), those with histologic response to off-label STCs (n = 54), and off-label STC-naive patients (n = 197).
- Symptom-based Eosinophilic Esophagitis Activity Index (EEsAI) Patient-Reported Outcome, EoE-specific quality of life in adults, Endoscopic Reference Score (EREFS) for endoscopic activity, and peak eosinophil counts per high-power field (hpf) for histologic activity were used to assess symptoms.
- Predictors of non-response to off-label STCs were evaluated along with outcomes following a switch to treatment with budesonide orodispersible tablets (BOT).
TAKEAWAY:
- Factors associated with histologic non-response to off-label STCs included a longer treatment duration (adjusted odds ratio [aOR], 1.37; P = .002), age less than 30 years (aOR, 6.57; P = .004), and adherence below 80% (aOR, 6.30; P = .03).
- In patients who previously did not respond to off-label STCs, the maximum peak eosinophil counts decreased from a median of 70 per hpf to nine per hpf after switching from off-label STCs to BOT.
- No significant difference in histologic remission rates with BOT was observed between prior off-label STC responders and non-responders (77.3% vs 62.1%; P = .095).
- Although no statistical difference in combined remission rates (defined as EREFS ≤ 2, EEsAI ≤ 20, and eosinophil counts less than 15 per hpf) was observed between prior off-label STC responders and non-responders, a positive trend favouring prior off-label STC responders was observed (61.4% vs 42.4%; P = .052).
IN PRACTICE:
"Our results might help in the process of developing treatment strategies for refractory disease and shedding light into the therapeutic pyramid that arises in the era of biologics," the authors wrote.
SOURCE:
This study was led by Fritz R. Murray, Department of Gastroenterology & Hepatology, Stadtspital Zürich, Zürich, Switzerland. It was published online on March 31, 2025, in The American Journal of Gastroenterology.
LIMITATIONS:
The small cohort of off-label STC non-responders limited the generalisability of the findings. The median follow-up period of 2 years was short, and the follow-up for off-label STC non-responders was not sufficient for assessing the long-term efficacy of BOT. Additionally, the absence of a control group hindered the ability to rule out natural disease course effects.
DISCLOSURES:
The SEECS was supported by grants from the Swiss National Science Foundation, the Swiss EoE Foundation, BMS, Dr Falk Pharma, and Sanofi-Genzyme. Some authors reported receiving consulting fees from various pharmaceutical companies. One author reported receiving consulting and/or speaker fees and/or research grants and another reported receiving a travel grant from various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
