Introduction
Eosinophilic oesophagitis (EoE) is a chronic, progressive type 2 inflammatory disease. Proton-pump inhibitors (PPIs), swallowed topical corticosteroids (STCs), and elimination diets have been used as standard treatments for EoE patients. However, the real-world evidence (RWE) highlighting disease burden in Europe are limited.
Aims & Methods
To assess disease burden and treatment patterns among adolescent and adult patients with EoE in real-world practice.
Medical records were retrospectively reviewed for patients (aged ≥12 years) who were newly diagnosed with EoE between 1 January 2009 and 31 December 2019 (index) in Germany, France, Spain, and the United Kingdom. Patients with a peak eosinophil (eos) count (PEC) of ≥15 eos/hpf within 90 days of the index date and ≥1 follow-up endoscopy within 24 months of the index date were included. Demographics, clinical features, treatment patterns, and health outcomes were assessed from the 12-month pre-index period to the last medical record entry or death. Disease progression was assessed via physician-defined (based on symptoms, endoscopy findings, histology, need for dilation, and food impaction) and proxy-reported outcomes (dilation performed, strictures, dysphagia, evidence of food impaction, treatment initiation in treatment-naïve patients and switching/augmentation).
Results
Overall, 385 patients were included, with 70.1%–78.1% being male; the mean age was 27.8 to 33.9 years. At EoE diagnosis, the PEC was 35.3–46.1 eos/hpf, the endoscopic appearance of the oesophagus was abnormal in 73.7%–85.6% of patients, and dysphagia was present in 59.8%–82.8% of patients. Most of the patients across all 4 countries were treated with PPIs (61.5%–91.8%), STCs (56.7%–82.3%) and elimination diets (41.4%–55.2%) after EoE diagnosis. Of the patients with available data, abnormal histology (≥15 eos/hpf) was reported in 44.8%–72.0% of patients during the first 5 years after EoE diagnosis. The abnormal endoscopic appearance of the oesophagus was observed in 34.6%–83.3% of patients after approximately 2 years of EoE diagnosis and dysphagia was present in 10.2%–25.0% of patients after 4 years of EoE diagnosis across all 4 countries. While physician-defined disease progression occurred in 6.1%–16.1% of patients, 19.4%–35.1% of patients experienced proxy-reported outcomes of potential disease progression (including oesophageal dilation performed in 10.8%–21.7% of patients) after EoE diagnosis. An overview of patient and clinical characteristics at EoE diagnosis and treatment patterns and disease progression (physician-defined and proxy-reported) after EoE diagnosis across Germany, France, Spain, and the United Kingdom is provided in the Table.
Patient and clinical characteristics at eosinophilic oesophagitis diagnosis
| Germany
(N=96)
| France
(N=99)
| Spain
(N=97)
| United Kingdom
(N=93)
|
Male, n (%) / Age, years, mean (standard deviation)
| 78.1 / 32.0 (14.9)
| 72.7 / 27.8 (13.4)
| 70.1 / 32.2 (14.1)
| 72.0 / 33.9 (13.5)
|
Peak eosinophil count/ high-power field, mean (standard deviation)
| 35.3 (29.1)
| 39.5 (46.3)
| 46.1 (41.7)
| 43.3 (56.7)
|
Treatment patterns and disease progression (physician-defined and proxy-reported) after eosinophilic oesophagitis diagnosis
|
Proton-pump inhibitors, n (%)
| 59 (61.5)
| 87 (87.9)
| 89 (91.8)
| 62 (66.7)
|
Swallowed topical corticosteroids (e.g., fluticasone budesonide), n (%) / Systemic (oral) corticosteroids, n (%)
| 79 (82.3) / 24 (25.0)
| 76 (76.8) / 7 (7.1)
| 55 (56.7) / 8 (8.3)
| 55 (59.1) / 4 (4.3)
|
Dietary modifications or eliminations, n (%)
| 53 (55.2)
| 41 (41.4)
| 46 (47.4)
| 41 (44.1)
|
Physician-defined disease progression, n (%)
| 12 (12.5)
| 6 (6.1)
| 7 (7.2)
| 15 (16.1)
|
Proxy-reported disease progression, n (%) / dilation performed, n (%)
| 26 (27.1) / 20 (20.8)
| 31 (31.3) / 16 (16.2)
| 34 (35.1) / 21 (21.7)
| 18 (19.4) / 10 (10.8) |
Overall disease progression (Physician-defined OR Proxy-reported), n (%)
| 33 (34.4)
| 34 (34.3)
| 36 (37.1)
| 30 (32.3)
|
Conclusion
Adolescent and adult patients with EoE chronically experienced substantial disease burden. A subset demonstrated disease progression, perhaps underrecognised despite treatment with PPIs, STCs, and elimination diets. Hence, successful EoE management may include proactive disease monitoring, treating underlying pathophysiology and prescribing maintenance therapies to achieve long-term clinical remission.
References
Disclosure
Ulrike von Arnim: Consulting and/or speaker fees from Dr. Falk Pharma, Sanofi, Astra Zeneca, EsoCap, Abbvie, Janssen, Takeda, Pfizer, Bristol Myers Squibb.
Frank Zerbib: Consulting and/or speaker fees from Sanofi, Dr Falk pharma, Bristol Myers Squibb, Bioprojet, AstraZeneca.
Tiffany Pela, Juby A. Jacob-Nara, Gaelle Le-Bagousse-Bego, Sarette T. Tilton: Employees of Sanofi; may hold stocks and/or stock options in the company.
Bram P. Raphael, Amr Radwan, Ryan B. Thomas: Employees of Regeneron Pharmaceuticals, Inc.; may hold stocks and/or stock options in the company.
Rohan C. Parikh, Fareedat Bello: Employees of RTI Health Solutions, which received research funding from Sanofi to design and execute this study.
Funding: This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
Acknowledgement: Medical writing support was provided by Akshata Rao and Ali Nasir Siddiqui, PhD, of Sanofi.