Study Designs | EOHILIA™ (budesonide oral suspension)

Histological remission and dysphasia symptom response with EOHILIA were studied in two 12-week clinical studies that included 410 patients¹

Study 1: Phase 3 study evaluated the efficacy and safety profile of EOHILIA vs placebo in 318 patients with EoE, 11 to 56 years old; treatment randomization: 2:1 for EOHILIA 2 mg b.i.d. or placebo.^1,2

Study 2: Phase 2 study evaluated the efficacy and safety profile of EOHILIA vs placebo in 92 patients with EoE, 11 to 42 years old; treatment randomization: 1:1 for EOHILIA 2 mg b.i.d. or placebo.^1,3

Efficacy Endpoints

Histological remission: proportion of subjects achieving histological remission defined as a peak eosinophil count of ≤6 eos/hpf across all available esophageal levels¹
DSQ scores: absolute change from baseline in subject-reported DSQ combined score.¹ The DSQ was a questionnaire developed and validated to specifically measure dysphagia associated with EoE⁴

Key Inclusion Criteria^1-3,5

Esophageal inflammation, defined as peak eosinophil
count ≥15 eos/hpf from at least 2 levels of the esophagus
≥4 days of dysphagia over a 2-week period prior to
randomization, as measured by the DSQ
Non-responsiveness to 6 to 8 weeks of high-dose PPI
therapy

Key Exclusion Criteria^1-3,5

Use of swallowed topical corticosteroids for EoE or
systemic corticosteroids for any condition ≤4 weeks
before screening
Pure liquid or six-food elimination diet (SFED)*
Use of CYP3A4 inhibitors
Presence of a high-grade esophageal stricture

*In Study 1, subjects were excluded if they were on a full-liquid or six-food elimination diet. In Study 2, subjects were instructed to maintain a stable diet throughout the study.¹

b.i.d.=twice daily; DSQ=Dysphagia Symptom Questionnaire; eos/hpf=eosinophils per high-power field; PPI=proton pump inhibitor.

Patient demographics

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Efficacy + Safety

Clinical Efficacy

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.
Dellon ES, Katzka DA, Collins MH, et al. Gastroenterology. 2017;152(4):776-786.e5.
Hudgens S, Evans C, Phillips E, et al. J Patient Rep Outcomes. 2017;1(1):3.
ClinicalTrials.gov identifier NCT02605837. November 16, 2015. Updated June 8, 2021. Accessed September 6, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT02605837.
Data on file, Takeda Pharmaceuticals, Inc.

Studied in a wide range of patients with EoE^1-3,6

Although there were some differences at baseline between Study 1 and Study 2, patient demographics and characteristics were generally similar.

	Study 1 (N=318) Phase 3 study	Study 2 (N=92) Phase 2 study
Months since EoE diagnosis, mean (SD)	45.9 (52.38)	37.41 (38.36)
Mean age	34 years (range: 11 to 56 years)	22 years (range: 11 to 42 years)
Sex	60% male (n=191), 40% female (n=127)	68% male (n=63), 32% female (n=29)
Race + Ethnicity	White: 95% (n=301)	White: 95% (n=87)
Concomitant PPIs	>80%	>65%
Dysphagia symptoms at baseline, mean (SD) DSQ score	EOHILIA group: 30.3* (13.9) Placebo group: 30.4 (13.1)	EOHILIA group: 30.7 (16.0) Placebo group: 29.0 (13.5)
Peak eosinophil count at baseline, mean (SD)	EOHILIA group: 74.5 (39.2) eos/hpf Placebo group†: 76.6 (45.0) eos/hpf	EOHILIA group: 158.9 (96.7) eos/hpf Placebo group: 133 (81.6) eos/hpf
Previous esophageal dilation	EOHILIA group: 43% (n=91) Placebo group: 43% (n=45)	Not applicable
Mean (SD) total EREFS at baseline	EOHILIA group: 7.6 (3.6) Placebo group: 8.2 (3.3)	EOHILIA group: 7.8 (3.57) Placebo group: 7.0 (3.31)

Study 1 (N=318) Phase 3 study
Months since EoE diagnosis, mean (SD)	45.9 (52.38)
Mean age	34 years (range: 11 to 56 years)
Sex	60% male (n=191), 40% female (n=127)
Race + Ethnicity	White: 95% (n=301)
Concomitant PPIs	>80%
Dysphagia symptoms at baseline, mean (SD) DSQ score	EOHILIA group: 30.3* (13.9) Placebo group: 30.4 (13.1)
Peak eosinophil count at baseline, mean (SD)	EOHILIA group: 74.5 (39.2) eos/hpf Placebo group†: 76.6 (45.0) eos/hpf
Previous esophageal dilation	EOHILIA group: 43% (n=91) Placebo group: 43% (n=45)
Mean (SD) total EREFS at baseline	EOHILIA group: 7.6 (3.6) Placebo group: 8.2 (3.3)

Study 1: EOHILIA, n=213; placebo, n=105. Study 2: EOHILIA, n=50; placebo, n=42.

*EOHILIA, n=211.

†Placebo, n=104.

Concomitant use of stable doses of inhaled or intranasal steroids (for conditions other than EoE), PPIs,
H₂-receptor antagonists, antacids, antihistamines or anti-leukotrienes, and maintenance immunotherapy was allowed.¹

Concomitant use of stable doses of inhaled or intranasal steroids (for conditions other than EoE), PPIs, H₂-receptor antagonists, antacids, antihistamines or anti-leukotrienes, and maintenance immunotherapy was allowed.¹

eos/hpf=eosinophils per high-power field; EREFS=endoscopic reference score; SD=standard deviation.

Study 2 (N=92) Phase 2 study
Months since EoE diagnosis, mean (SD)	37.41 (38.36)
Mean age	22 years (range: 11 to 42 years)
Sex	68% male (n=63), 32% female (n=29)
Race + Ethnicity	White: 95% (n=87)
Concomitant PPIs	>65%
Dysphagia symptoms at baseline, mean (SD) DSQ score	EOHILIA group: 30.7 (16.0) Placebo group: 29.0 (13.5)
Peak eosinophil count at baseline, mean (SD)	EOHILIA group: 158.9 (96.7) eos/hpf Placebo group: 133 (81.6) eos/hpf
Previous esophageal dilation	Not applicable
Mean (SD) total EREFS at baseline	EOHILIA group: 7.8 (3.57) Placebo group: 7.0 (3.31)

Study 1: EOHILIA, n=213; placebo, n=105. Study 2: EOHILIA, n=50; placebo, n=42.

*EOHILIA, n=211.

†Placebo, n=104.

Concomitant use of stable doses of inhaled or intranasal steroids (for conditions other than EoE), PPIs, H₂-receptor antagonists, antacids, antihistamines or anti-leukotrienes, and maintenance immunotherapy was allowed.¹

eos/hpf=eosinophils per high-power field; EREFS=endoscopic reference score; SD=standard deviation.

EVALUATED IN ONE OF THE LARGEST CLINICAL PROGRAMS OF EoE IN THE U.S.¹

Histological remission and dysphasia symptom response with EOHILIA were studied in two 12-week clinical studies that included 410 patients¹

DIVE DEEPER INTO DATA

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

Studied in a wide range of patients with EoE^1-3,6

See you later

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EVALUATED IN ONE OF THE LARGEST CLINICAL PROGRAMS OF EoE IN THE U.S.1

Histological remission and dysphasia symptom response with EOHILIA were studied in two 12-week clinical studies that included 410 patients1

DIVE DEEPER INTO DATA

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Studied in a wide range of patients with EoE1-3,6

See you later

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

EVALUATED IN ONE OF THE LARGEST CLINICAL PROGRAMS OF EoE IN THE U.S.¹

Histological remission and dysphasia symptom response with EOHILIA were studied in two 12-week clinical studies that included 410 patients¹

Studied in a wide range of patients with EoE^1-3,6