Clinical Efficacy | EOHILIA™ (budesonide oral suspension)

Demonstrated histologic remission and reduction in frequency and severity of dysphagia after 12 weeks*^1,2

*As measured by DSQ.

STUDY 1: STUDY DESIGN

Study 1 was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy and safety profile of EOHILIA in 318 patients (11-56 years of age) with EoE over a period of 12 weeks.¹

Efficacy endpoints

Histological remission: proportion of subjects achieving histological remission defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels¹
DSQ Scores: absolute change from baseline in subject-reported DSQ combined score¹

Key Inclusion Criteria^1,3,4

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

Key Exclusion Criteria⁴

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

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

Patient demographics

STUDY 1: EFFICACY ENDPOINTS

HISTOLOGIC REMISSION

achieved in the majority of patients on EOHILIA vs placebo after 12 weeks¹

Proportion of patients achieving histological remission (peak esophageal intraepithelial eosinophil count ≤6 eos/hpf)

The mean (SD) peak eosinophil counts at baseline were 74.5 (39.2) and 76.6 (45.0) in the EOHILIA and placebo groups, respectively.⁴

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 1: Greater change in DSQ combined score chart

The 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

CI=confidence interval; eos/hpf=eosinophils per high-power field; SD=standard deviation.

^†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.¹

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

View the DSQ

PATIENTS REPORTED DYSPHAGIA RELIEF IN STUDY 1 AND STUDY 2

During the last 2 weeks of the 12-week treatment periods in Study 1 and Study 2, a greater proportion of subjects randomized to EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared to placebo, as measured by the subject-reported DSQ.¹

STUDY 2: STUDY DESIGN

Study 2 was a multicenter, double-blind, placebo-controlled study that evaluated the efficacy and safety profile of 92 patients (11-42 years of age) with EoE over a period of 12 weeks.^1,5,6

Efficacy endpoints

Histological remission: proportion of subjects achieving histological remission defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels¹
DSQ Scores: absolute change from baseline in subject-reported DSQ combined score¹

Key Inclusion Criteria^1,5

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

Key Exclusion Criteria^1,5

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

Patient demographics

Study 2: Efficacy Endpoints

HISTOLOGIC REMISSION

achieved in more patients on EOHILIA vs placebo after 12 weeks¹

Proportion of patients achieving histological remission (peak esophageal intraepithelial eosinophil count ≤6 eos/hpf)

The mean (SD) peak eosinophil counts at baseline were 157.8 (96.1) and 133.0 (81.6) in the EOHILIA and placebo groups, respectively.⁵

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 2: Greater change in DSQ combined score chart

The 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

^§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.¹

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

View the DSQ

ADDITIONAL STUDY

After completing Study 1, 48 subjects from the EOHILIA 2 mg treatment arm entered a double-blind, randomized withdrawal extension study. These subjects received EOHILIA 2 mg twice daily or placebo for up to an additional 36 weeks. Treatment with EOHILIA did not demonstrate a statistically significant difference compared to subjects re-randomized to placebo for prespecified efficacy endpoints based on eosinophil count and/or clinical symptoms measured by the DSQ at week 36.¹

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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

Systemic effects such as hypercorticism and adrenal axis suppression may occur. Monitor patients for signs and symptoms and consider reducing the dosage of EOHILIA. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child-Pugh Class B).

Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended.

Immunosuppression and Increased Risk of Infection

Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen. Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation of EOHILIA if the patient develops an infection.

Tuberculosis reactivation may occur. Closely monitor patients with latent tuberculosis or tuberculin reactivity while receiving EOHILIA.
Varicella Zoster and Measles can be serious or fatal in non-immune patients taking corticosteroids. Avoid exposure. If a patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.
Hepatitis B Virus Reactivation can occur. Prior to starting EOHILIA for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.
Amebiasis: It is recommended that latent or active amebiasis be ruled out before starting EOHILIA in patients who have spent time in the tropics or have unexplained diarrhea.
Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides (threadworm) 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. If oropharyngeal or esophageal candidiasis develops, treat with appropriate antifungal therapy and consider discontinuing EOHILIA.

Erosive Esophagitis

Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline esophagogastroduodenoscopy (EGD), and most were receiving concomitant therapy with a proton pump inhibitor (PPI). Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation as appropriate.

Effect on Growth

Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Monitor patients who are transferred from corticosteroids with high systemic effects to corticosteroids with lower systemic availability, such as EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema) previously controlled by the systemic drug.

Other Corticosteroid Effects

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

Kaposi’s Sarcoma

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Budesonide is a substrate for CYP3A4. Avoid concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice), which can increase systemic budesonide concentrations.

USE IN SPECIFIC POPULATIONS

Pregnancy: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism and managed accordingly.
Lactation: Lactation studies have not been conducted with EOHILIA. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EOHILIA and any potential adverse effects on the breastfed infant from EOHILIA, or from the underlying maternal condition.
Hepatic Impairment: Not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), monitor for signs and/or symptoms of hypercorticism.

Indication and Limitations of Use

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

EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer 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

Tuberculosis reactivation may occur. Closely monitor patients with latent tuberculosis or tuberculin reactivity while receiving EOHILIA.
Varicella Zoster and Measles can be serious or fatal in non-immune patients taking corticosteroids. Avoid exposure. If a patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.
Hepatitis B Virus Reactivation can occur. Prior to starting EOHILIA for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.
Amebiasis: It is recommended that latent or active amebiasis be ruled out before starting EOHILIA in patients who have spent time in the tropics or have unexplained diarrhea.
Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides (threadworm) 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. If oropharyngeal or esophageal candidiasis develops, treat with appropriate antifungal therapy and consider discontinuing EOHILIA.

Erosive Esophagitis

Effect on Growth

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Other Corticosteroid Effects

Kaposi’s Sarcoma

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Pregnancy: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism and managed accordingly.
Lactation: Lactation studies have not been conducted with EOHILIA. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EOHILIA and any potential adverse effects on the breastfed infant from EOHILIA, or from the underlying maternal condition.
Hepatic Impairment: Not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), monitor for signs and/or symptoms of hypercorticism.

Indication and Limitations of Use

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

EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.

Please click here for full Prescribing Information.

References:

EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals, Inc.
Hudgens S, Evans C, Phillips E, et al. J Patient Rep Outcomes. 2017;1(1):3.
Hirano I, Collins MH, Katzka DA, et al. Clin Gastroenterol Hepatol. 2022;20(3):525-534.e10.
ClinicalTrials.gov identifier NCT02605837. November 16, 2015. Updated June 8, 2021. Accessed January 31, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT02605837.
Dellon ES, Katzka DA, Collins MH, et al. Gastroenterology. 2017;152(4):776-786.e5.
Dellon ES, Collins MH, Katzka DA, et al. Clin Gastroenterol Hepatol. 2021;19(4):699-706.e4.
Data on file, Takeda Pharmaceuticals, Inc.

The Dysphagia Symptom Questionnaire (DSQ) (v4.0) and score for each response^2,a

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
	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

Adapted with permission from Hudgens S, Evans C, Phillips E, et al. J Patient Rep Outcomes. 2017;1(1):3.

^aThe scoring algorithm was constructed from responses to questions 2 and 3, to ensure that the final DSQ score was driven by the frequency and severity of dysphagia.

^bResponse to question 1 were unscored.

^cResponse to question 4 were not included as part of the psychometric analysis; question 4 is a standalone item on the DSQ.

This questionnaire is provided for informational purposes only in order to show the questions that were asked as part of the DSQ evaluation in the EOHILIA clinical trials. This is not a diagnostic tool.

Key Demographics + Concomitant Treatments (N=92)^1,5,7
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 (≥1 PPI)	≥65% (n=64) on concomitant PPIs
Dysphagia symptoms at baseline, mean DSQ score (SD)	EOHILIA group: 30.7 (SD 16.0) Placebo group: 29.0 (SD 13.5)
Peak eosinophil count at baseline, mean (SD)	EOHILIA group: 157.8 eos/hpf (SD 96.1) Placebo group: 133.0 eos/hpf (SD 81.6)

Key Demographics + Concomitant Treatments (N=318)^1,3
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 (≥1 PPI)	≥80% (n=268) on concomitant PPIs
Dysphagia symptoms at baseline, mean DSQ score (SD)	EOHILIA group: 30.3 (SD 13.9) Placebo group: 30.4 (SD 13.1)
Peak eosinophil count at baseline, mean (SD)	EOHILIA group: 74.5 eos/hpf (SD 39.2) Placebo group: 76.6 eos/hpf (SD 45.0)
Previous esophageal dilation	EOHILIA group: 43% (n=91) Placebo group: 43% (n=45)

PROVEN TO REDUCE

ESOPHAGEAL INFLAMMATION

Demonstrated histologic remission and reduction in frequency and severity of dysphagia after 12 weeks*1,2

STUDY 1: STUDY DESIGN

STUDY 1: EFFICACY ENDPOINTS

HISTOLOGIC REMISSION

GREATER CHANGE IN DSQ COMBINED SCORE

PATIENTS REPORTED DYSPHAGIA RELIEF IN STUDY 1 AND STUDY 2

STUDY 2: STUDY DESIGN

Study 2: Efficacy Endpoints

HISTOLOGIC REMISSION

GREATER CHANGE IN DSQ COMBINED SCORE

DIVE DEEPER INTO DATA

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Study 2 patient demographics and characteristics

Key Demographics + Concomitant Treatments (N=92)1,5,7

Study 1 patient demographics and characteristics

Key Demographics + Concomitant Treatments (N=318)1,3

The Dysphagia Symptom Questionnaire (DSQ) (v4.0) and score for each response2,a

Question

Patient Response Options

Score

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Demonstrated histologic remission and reduction in frequency and severity of dysphagia after 12 weeks*^1,2

Key Demographics + Concomitant Treatments (N=92)^1,5,7

Key Demographics + Concomitant Treatments (N=318)^1,3

The Dysphagia Symptom Questionnaire (DSQ) (v4.0) and score for each response^2,a