Clinical Efficacy

STUDY 1, PHASE 3 STUDY

Demonstrated improvement vs placebo in esophageal inflammation and dysphagia relief^1,2

Histological Remission (≤6 eos/hpf)

Greater proportion of patients achieved histological remission with EOHILIA vs placebo after 12 weeks¹

Mean (SD) peak eosinophil counts at baseline were 74.5 (39.2) eos/hpf and 76.6 (45.0) eos/hpf in the EOHILIA and placebo groups, respectively.²

DSQ Combined Score

Greater reduction with EOHILIA vs placebo in absolute change from baseline in DSQ combined score (0-84†), LS mean (SE) after 12 weeks¹

Mean (SD) DSQ combined scores at baseline were 30.3 (13.9) and 30.4 (13.1) in the EOHILIA vs 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.¹

^†Total biweekly DSQ scores range from 0 to 84; higher scores indicate greater frequency and severity of dysphagia.¹

^‡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.¹

CI=confidence interval; LS=least squares; SE=standard errors.

STUDY 2, PHASE 2 STUDY

Demonstrated improvement vs placebo in esophageal Inflammation and dysphagia relief^1,4

Histological Remission (≤6 eos/hpf)

Greater proportion of patients achieved histological

remission with EOHILIA vs placebo after 12 weeks¹

Mean (SD) peak eosinophil counts at baseline were 158.9 (96.7) eos/hpf and 133.0 (81.6) eos/hpf in the EOHILIA and placebo groups, respectively.⁵

DSQ Combined Score

Greater reduction with EOHILIA vs placebo in absolute change from baseline in DSQ combined score (0-84†), LS mean (SE) after 12 weeks¹

Mean (SD) DSQ combined scores at baseline were 30.7 (16.0) and 29.0 (13.5) in the EOHILIA vs placebo groups, respectively.¹

ADDITIONAL STUDY

After completing Study 1, 48 subjects from the EOHILIA 2 mg treatment arm entered a double-blind, randomized withdrawal extension study and received EOHILIA 2 mg twice daily or placebo for up to an additional 36 weeks.¹

There was no statistically significant difference between the EOHILIA group and those re-randomized to the placebo group for prespecified efficacy endpoints based on eosinophil count and/or clinical symptoms measured by the DSQ at week 36.¹

STUDY 1 AND STUDY 2 SECONDARY ENDPOINTS

Proportion of histological responders with a peak eosinophil count of ≤15 eos/hpf or ≤1 eos/hpf at week 12^2,5

Study 1

In Study 2, the proportion of histological responders post treatment in the EOHILIA group (n=48) vs the placebo group (n=38) who had a peak eosinophil count ≤15 eos/hpf was 48% vs 8%, respectively, and the proportion with ≤1 eos/hpf was 31% vs 0%, respectively.⁵

Data Limitations: The prespecified secondary endpoints shown above were not powered to determine treatment effect and appropriate multiplicity adjustments were not applied. The results need cautious interpretation and could represent chance findings.

STUDY 1 AND STUDY 2 SECONDARY ENDPOINTS

LS mean (SEM) change in total EREFS from baseline

to week 12^2,5

Study 1

Baseline mean (SD) EREFS was 7.6 (3.6) in the EOHILIA group and 8.2 (3.3) in the placebo group.²

Study 2

Baseline mean (SD) EREFS was 7.8 (3.57) in the EOHILIA group and 7.0 (3.31) in the placebo group.⁵

SEM=standard error of the mean.

Data Limitations: The prespecified secondary endpoint shown above was not powered to determine treatment effect and appropriate multiplicity adjustments were not applied. The results need cautious interpretation and could represent chance findings. Thresholds for clinically meaningful changes in EREFS have not been established.

DIVE DEEPER INTO DATA

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Study Designs

Safety Profile

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products.

WARNINGS AND PRECAUTIONS

Hypercorticism and Adrenal Axis Suppression

Monitor patients for signs and symptoms and consider reducing the EOHILIA dosage. Use is not recommended in severe hepatic impairment (Child-Pugh Class C). Monitor for hypercorticism in moderate hepatic impairment (Child-Pugh Class B). Where patients are subject to stress situations (e.g., trauma, surgery, infection) supplementation with a systemic corticosteroid is recommended.

Immunosuppression and Increased Risk of Infection

Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation if infection develops.

Tuberculosis and Hepatitis B Virus (HBV) reactivation may occur. Closely monitor EOHILIA patients. Screen for HBV.
Varicella Zoster (VZ) and Measles can be serious or fatal. Avoid exposure. If a patient is exposed to varicella, consider prophylaxis with VZ immune globulin (IG); if varicella develops, consider antiviral treatment. If a patient is exposed to measles, consider prophylaxis with IG.
Rule out amebiasis before starting EOHILIA in patients who were in the tropics or have unexplained diarrhea.
Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides infection, cerebral malaria, and active ocular herpes simplex.
Localized Infections: In clinical trials, some patients developed Candida albicans infections in the mouth, throat, and esophagus. Instruct patients: do not eat or drink for 30 minutes after taking EOHILIA; after 30 minutes rinse mouth with water and spit without swallowing. Treat candidiasis infections with appropriate antifungal therapy and consider discontinuing EOHILIA.

Erosive Esophagitis

Patients who experienced erosive esophagitis in clinical trials did not have erosions at baseline and most were receiving a proton pump inhibitor. Advise patients or caregivers to report new onset or worsening of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation.

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Adrenocortical function monitoring may be required in patients who are transferred from high systemic effects corticosteroids to EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop.

Taper slowly from high systemic effects corticosteroids. Replacing systemic corticosteroids with EOHILIA may unmask previously controlled allergies (e.g., rhinitis and eczema).

Other Corticosteroid Effects

Monitor patients with or family history of: hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts or with other conditions where corticosteroids may have unwanted effects.

Additional Established Class Effects of Corticosteroids not seen in EOHILIA 12-week clinical trials. The maximum recommended duration of treatment with EOHILIA is 12 weeks:

Effect on Growth: Use of corticosteroids may cause a reduction of growth velocity. Monitor the growth of pediatric patients on EOHILIA.
Kaposi’s Sarcoma: Reported to occur with corticosteroids, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) are: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%).

DRUG INTERACTIONS

Avoid concomitant use with CYP3A4 inhibitors (including grapefruit juice), which can increase systemic budesonide concentrations.

USE IN SPECIFIC POPULATIONS

Pregnancy: Hypoadrenalism may occur in infants whose mothers received corticosteroids during pregnancy. Carefully observe infants for hypoadrenalism and manage accordingly.
Lactation: Lactation studies have not been conducted. Consider the benefits of breastfeeding, the mother’s need for EOHILIA, and any potential adverse effects on the infant from EOHILIA, or from the underlying maternal condition.
Hepatic Impairment: Not recommended in severe hepatic impairment (Child-Pugh Class C). Monitor for hypercorticism in moderate hepatic impairment (Child-Pugh Class B).

Indication and Limitations of Use

EOHILIA (budesonide oral suspension) is indicated for 12 weeks of treatment in patients 11 years and older with eosinophilic esophagitis (EoE).

EOHILIA has not been shown to be safe and effective for more than 12 weeks.

Please click here for full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products.

WARNINGS AND PRECAUTIONS

Hypercorticism and Adrenal Axis Suppression

Immunosuppression and Increased Risk of Infection

Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation if infection develops.

Tuberculosis and Hepatitis B Virus (HBV) reactivation may occur. Closely monitor EOHILIA patients. Screen for HBV.
Varicella Zoster (VZ) and Measles can be serious or fatal. Avoid exposure. If a patient is exposed to varicella, consider prophylaxis with VZ immune globulin (IG); if varicella develops, consider antiviral treatment. If a patient is exposed to measles, consider prophylaxis with IG.
Rule out amebiasis before starting EOHILIA in patients who were in the tropics or have unexplained diarrhea.
Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides infection, cerebral malaria, and active ocular herpes simplex.
Localized Infections: In clinical trials, some patients developed Candida albicans infections in the mouth, throat, and esophagus. Instruct patients: do not eat or drink for 30 minutes after taking EOHILIA; after 30 minutes rinse mouth with water and spit without swallowing. Treat candidiasis infections with appropriate antifungal therapy and consider discontinuing EOHILIA.

Erosive Esophagitis

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Taper slowly from high systemic effects corticosteroids. Replacing systemic corticosteroids with EOHILIA may unmask previously controlled allergies (e.g., rhinitis and eczema).

Other Corticosteroid Effects

Additional Established Class Effects of Corticosteroids not seen in EOHILIA 12-week clinical trials. The maximum recommended duration of treatment with EOHILIA is 12 weeks:

Effect on Growth: Use of corticosteroids may cause a reduction of growth velocity. Monitor the growth of pediatric patients on EOHILIA.
Kaposi’s Sarcoma: Reported to occur with corticosteroids, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.

ADVERSE REACTIONS

DRUG INTERACTIONS

Avoid concomitant use with CYP3A4 inhibitors (including grapefruit juice), which can increase systemic budesonide concentrations.

USE IN SPECIFIC POPULATIONS

Pregnancy: Hypoadrenalism may occur in infants whose mothers received corticosteroids during pregnancy. Carefully observe infants for hypoadrenalism and manage accordingly.
Lactation: Lactation studies have not been conducted. Consider the benefits of breastfeeding, the mother’s need for EOHILIA, and any potential adverse effects on the infant from EOHILIA, or from the underlying maternal condition.
Hepatic Impairment: Not recommended in severe hepatic impairment (Child-Pugh Class C). Monitor for hypercorticism in moderate hepatic impairment (Child-Pugh Class B).

Indication and Limitations of Use

EOHILIA (budesonide oral suspension) is indicated for 12 weeks of treatment in patients 11 years and older with eosinophilic esophagitis (EoE).

EOHILIA has not been shown to be safe and effective for more than 12 weeks.

Please click here for full Prescribing Information.

References:

EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals, Inc.
Hirano I, Collins MH, Katzka DA, et al. Clin Gastroenterol Hepatol. 2022;20(3):525-534.e10.
Hudgens S, Evans C, Phillips E, et al. J Patient Rep Outcomes. 2017;1(1):3.
Dellon ES, Katzka DA, Collins MH, et al. Gastroenterology. 2017;152(4):776-786.e5.
Data on file, Takeda Pharmaceuticals, Inc.
Hirano I, Furuta GT. Gastroenterology. 2020;158(4):840-851.
Lucendo AJ, Molina-Infante J, Arias A, et al. United European Gastroenterol J. 2017;5(3):335-358.
Dellon ES, Liacouras CA, Molina-Infante J, et al. Gastroenterology. 2018;155(4):1022-1033.e10.
National Library of Medicine. National Institutes of Health. Memon RJ, Savliwala MN. Eosinophilic gastroenteritis. ©2024, StatPearls Publishing LLC. Figure contributed by Michael Bonert. Last updated: June 26, 2023. Accessed May 28, 2024. https://www.ncbi.nlm.nih.gov/books/NBK547729/.
Hirano I, Moy N, Heckman MG, et al. Gut. 2013;62(4):489-495.
Vračarić V, Savić Ž, Živojinov M, et al. Vojnosanit Pregl. 2017;74(1):64-68.

Question
1.Since you woke up this morning, did you eat solid food?^b
Patient Response	Score
No
Yes
2.Since you woke up this morning, has food gone down slowly or been stuck in your throat?
Patient Response	Score
No	0
Yes	2
3.For the most difficult time you had swallowing food today (during the past 24 hours), did you have to do anything to make the food go down or to get relief?
Patient Response	Score
No, it got better or cleared up on its own	0
Yes, I had to drink liquid to get relief	1
Yes, I had to cough and/or gag to get relief	2
Yes, I had to vomit to get relief	3
Yes, I had to seek medical attention to get relief	4
4.The following question concerns the amount of pain you have experienced when swallowing food. What was the worst pain you had while swallowing food over the past 24 hours?^c
Patient Response	Score
None, I had no pain	0
Mild	1
Moderate	2
Severe	3
Very Severe	4

Question	Patient Response Options	Score
1.Since you woke up this morning, did you eat solid food?^b	No
1.Since you woke up this morning, did you eat solid food?^b	Yes
2.Since you woke up this morning, has food gone down slowly or been stuck in your throat?	No	0
	Yes	2
3.For the most difficult time you had swallowing food today (during the past 24 hours), did you have to do anything to make the food go down or to get relief?	No, it got better or cleared up on its own	0
	Yes, I had to drink liquid to get relief	1
	Yes, I had to cough and/or gag to get relief	2
	Yes, I had to vomit to get relief	3
	Yes, I had to seek medical attention to get relief	4
4.The following question concerns the amount of pain you have experienced when swallowing food. What was the worst pain you had while swallowing food over the past 24 hours?^c	None, I had no pain	0
	Mild	1
	Moderate	2
	Severe	3
	Very Severe	4

STUDY 1, PHASE 3 STUDY

Demonstrated improvement vs placebo in esophageal inflammation and dysphagia relief^1,2

STUDY 2, PHASE 2 STUDY

Demonstrated improvement vs placebo in esophageal Inflammation and dysphagia relief^1,4

STUDY 1 AND STUDY 2 SECONDARY ENDPOINTS

Proportion of histological responders with a peak eosinophil count of ≤15 eos/hpf or ≤1 eos/hpf at week 12^2,5

STUDY 1 AND STUDY 2 SECONDARY ENDPOINTS

LS mean (SEM) change in total EREFS from baseline

to week 12^2,5

DIVE DEEPER INTO DATA

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

Histological response is used to assess EoE treatment response⁶

Eosinophilic inflammation in the esophageal mucosa is the hallmark observation from which EoE derives its name.⁷

EoE Endoscopic Reference Score (EREFS)^10,11

The Dysphagia Symptom Questionnaire (DSQ) was developed specifically to measure dysphagia associated with EoE³

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CLINICAL EFFICACY

STUDY 1, PHASE 3 STUDY

Demonstrated improvement vs placebo in esophageal inflammation and dysphagia relief1,2

STUDY 2, PHASE 2 STUDY

Demonstrated improvement vs placebo in esophageal Inflammation and dysphagia relief1,4

STUDY 1 AND STUDY 2 SECONDARY ENDPOINTS

Proportion of histological responders with a peak eosinophil count of ≤15 eos/hpf or ≤1 eos/hpf at week 122,5

STUDY 1 AND STUDY 2 SECONDARY ENDPOINTS

LS mean (SEM) change in total EREFS from baseline

to week 122,5

DIVE DEEPER INTO DATA

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Histological response is used to assess EoE treatment response6

Eosinophilic inflammation in the esophageal mucosa is the hallmark observation from which EoE derives its name.7

EoE Endoscopic Reference Score (EREFS)10,11

The Dysphagia Symptom Questionnaire (DSQ) was developed specifically to measure dysphagia associated with EoE3

See you later

You are about to leave this website and enter a website operated by an independent third party

Demonstrated improvement vs placebo in esophageal inflammation and dysphagia relief^1,2

Demonstrated improvement vs placebo in esophageal Inflammation and dysphagia relief^1,4

Proportion of histological responders with a peak eosinophil count of ≤15 eos/hpf or ≤1 eos/hpf at week 12^2,5

to week 12^2,5

Histological response is used to assess EoE treatment response⁶

Eosinophilic inflammation in the esophageal mucosa is the hallmark observation from which EoE derives its name.⁷

EoE Endoscopic Reference Score (EREFS)^10,11

The Dysphagia Symptom Questionnaire (DSQ) was developed specifically to measure dysphagia associated with EoE³