FOR U.S. HEALTHCARE PROFESSIONALS
A 12-week treatment for eosinophilic esophagitis (EoE) in patients 11 years of age and older. EOHILIA has not been shown to be safe and effective for longer than 12 weeks.1
EOHILIA is now available to prescribe to your patients 11 years and older with eosinophilic esophagitis (EoE).1
Specifically designed for EoE
EOHILIA is the first and only FDA-approved oral 12-week treatment for EoE.
Discover more in the official press release.
What is EOHILIA?
EOHILIA is an oral corticosteroid specifically engineered for EoE, proven to help reduce esophageal inflammation and improve symptoms of dysphagia (as measured by the Dysphagia Symptom Questionnaire) in patients 11 years and older after 12 weeks of taking EOHILIA.1
How EOHILIA works
EOHILIA is an oral budesonide suspension with a viscosity that can change—upon shaking, it gets more fluid for swallowing and then regains viscosity.1,2
Inflammation is a core component in the pathogenesis of EoE. Although the precise mechanism of corticosteroid actions on inflammation is not known, budesonide has a wide range of inhibitory activities against multiple cell types involved in inflammation.1
Why EOHILIA?
In the first phase 3 clinical trial ever to evaluate a pharmacological therapy for EoE, the majority of those who took EOHILIA 2 mg twice daily for 12 weeks achieved histological remission—defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels.1,3 Patients taking EOHILIA also achieved a greater absolute change from baseline in the DSQ combined score after 12 weeks of treatment vs those on placebo.1
In Study 1, a total of 318 subjects (277 adults and 41 pediatric subjects) were randomized and received at least one dose of EOHILIA or placebo.1
HISTOLOGIC REMISSION
achieved in the majority of patients on EOHILIA after 12 weeks1
Proportion of patients achieving histological remission (peak esophageal intraepithelial eosinophil count ≤6 eos/hpf)
GREATER CHANGE IN DSQ COMBINED SCORE
with EOHILIA vs placebo after 12 weeks1
Absolute change from baseline in DSQ combined score (0-84†), LS mean (SE)
STUDY DESIGN
Study 1 was a multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week study of 318 patients (277 adults and 41 pediatric subjects) 11-56 years of age with EoE. It evaluated the efficacy endpoints of histologic remission (defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels) and the absolute change from baseline in subject-reported DSQ combined score after 12 weeks of treatment with EOHILIA 2 mg twice daily.1
The mean standard deviation peak eosinophil counts at baseline were 74.5 (39.2) and 76.6 (45.0) in the EOHILIA and placebo groups, respectively.3
The mean standard deviation DSQ combined scores at baseline were 30.3 (13.9) and 30.4 (13.1) in the EOHILIA and placebo groups, respectively.1
For histological remission, the difference in percentages and 95% Newcombe confidence intervals are estimated using Mantel Haenszel weights, adjusting for age group and diet restriction. For absolute change in DSQ score, the LS mean changes, standard errors, and differences are estimated using an ANCOVA model with treatment group, age group, diet restriction, and baseline measurement as covariates.
Total biweekly DSQ scores range from 0 to 84; higher scores indicate greater frequency and severity of dysphagia. 1
SAFETY RESULTS
| Adverse reactions | EOHILIA 2 mg twice daily n=213 | Placebo n=105 |
| Respiratory tract infection includes acute sinusitis, sinusitis, nasopharyngitis, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection, rhinitis. | 13% | 11% |
| Gastrointestinal mucosal candidiasis includes esophageal candidiasis, oropharyngeal candidiasis, oral candidiasis. | 8% | 2% |
| Headache includes migraine. | 5% | 2% |
| Gastroenteritis | 3% | 1% |
| Sore throat includes throat irritation, oropharyngeal pain. | 3% | 2% |
| Adrenal suppression includes adrenal suppression, adrenal insufficiency. | 2% | 0% |
| Erosive esophagitis includes esophagitis only where erosions were present at the esophagogastroduodenoscopy conducted after 12 weeks of treatment. | 2% | 0% |
Connect your commercially insured patients with the EOHILIA Patient Support and Copay Program.
For additional information about EOHILIA, please see the EOHILIA Prescribing Information.
b.i.d.=twice daily; CI=confidence interval; DSQ=Dysphagia Symptom Questionnaire; eos/hpf=eosinophils per high-power field; LS=least squares; SE=standard errors.