EOHILIA was proven effective for reducing difficulty swallowing and reducing inflammation in the esophagus
In one 12-week clinical study of 318 patients 11 years and older with EoE, 213 patients were treated with EOHILIA (2 mg twice daily), while 105 were given placebo.
In this clinical study, EOHILIA was proven to:
Reduce difficulty swallowing
10.2-point reduction
for patients taking EOHILIA in their overall DSQ score from when they started the study, while patients on placebo had a 6.5-point difference.*
Reduce inflammation in the esophagus
53% of patients
taking EOHILIA had a decrease in the number of eosinophils in the esophagus compared to 1% of patients on placebo.†
In a smaller, 12-week clinical study
of 92 patients, 50 patients were treated with EOHILIA (2 mg twice daily), while 42 were given placebo. The results were: EOHILIA patients had a 14.5-point reduction in the DSQ from when they started the study compared to 5.9 for placebo patients,* and 38% of EOHILIA patients had a reduction in eosinophils in the esophagus compared to 2.4% on placebo.†
Talk to your doctor to learn more about EOHILIA clinical study results.
*Patients experiencing less difficulty swallowing: Improvement in trouble swallowing with EOHILIA was calculated using the Dysphagia Symptom Questionnaire (DSQ) biweekly score, a point-based self-assessment that patients took daily to track how frequently they experienced dysphagia symptoms and the severity of those symptoms while taking EOHILIA treatment. Scores ranged from 0 to 84, with higher scores indicating greater frequency and severity of dysphagia. At the start of one study, the average biweekly DSQ score of patients taking EOHILIA (n=213) was 30.3 and 30.4 for patients on placebo (n=105). At the start of the second study, the average biweekly DSQ score of patients taking EOHILIA (n=50) was 30.7 and 29.0 for patients on placebo (n=42).
†Patients with a reduction in eosinophils: Eosinophils are white blood cells that can contribute to inflammation. In one study, 113 of 213 patients (53%) taking EOHILIA had a reduction in number of eosinophils vs 1 of 105 patients (1%) taking placebo after 12 weeks. In the second study, 19 of 50 patients (38%) taking EOHILIA had a reduction in number of eosinophils vs 1 of 42 patients (2.4%) taking placebo after 12 weeks. Reduction was calculated by counting the number of eosinophils in the esophagus under a microscope before and after treatment. Successful treatment response was defined as a reduction to 6 or fewer eosinophils per high-power field. The high-power field is the area of a slide visible under the high-magnification system of a microscope.
An established safety profile
- The safety of EOHILIA was established in a 12-week clinical study of 318 adult and adolescent patients 11 years of age and older with EoE. Safety results were similar in a second, smaller study of 92 patients.
In a 12-week clinical study, the most common side effects included:
Side effects | EOHILIA patients (n=213) | Placebo patients (n=105) |
---|---|---|
Respiratory tract infection | 13% | 11% |
Fungal infections of the mouth, throat, and esophagus (thrush) | 8% | 2% |
Headache | 5% | 2% |
Infection of the stomach and intestine (gastroenteritis) | 3% | 1% |
Sore throat | 3% | 2% |
Adrenal suppression | 2% | 0% |
Acid-related damage to the lining of the esophagus (erosive esophagitis) | 2% | 0% |
EOHILIA may cause serious side effects, including hypercorticism (effects of having too much corticosteroid medicine in your blood), adrenal suppression (a condition in which the adrenal glands do not make enough steroid hormones), immunosuppression (decreased ability of your body to fight infections) and increased risk of infection, erosive esophagitis (acid-related damage to the esophagus lining), effect on growth, worsening of allergies, and Kaposi’s sarcoma.
- Be sure to talk to your or your child’s doctor about any side effects that are bothersome or do not go away.
- Make sure to ask your doctor about potential side effects. It’s an important part of the conversation, and it’s important for you to understand both the benefits and the risks of treatment.
- For additional information, please see the Important Safety Information, Prescribing Information, and Patient Information.