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DUPIXENT is the first and only FDA-approved eosinophilic esophagitis (EoE) treatment for adult and pediatric patients aged 12 years and older, weighing at least 40 kg. DUPIXENT is a biologic that inhibits IL-4 and IL-13 signaling, two of the key drivers of type 2 inflammation contributing to EoE. DUPIXENT is not an immunosuppressant. The mechanism of dupilumab action has not been definitively established.^1,2

ABOUT DUPIXENT

DUPIXENT has a unique mechanism of action in eosinophilic esophagitis (EoE). It is the first and only dual inhibitor of IL-4 and IL-13 signaling, inhibiting two of the key drivers of type 2 inflammation contributing to EoE. The mechanism of dupilumab action has not been definitively established.^1,2

VIEW THE UNIQUE mechanism
OF ACTION

DUPIXENT is not a steroid. DUPIXENT is a biologic that inhibits IL-4 and IL-13 signaling, two of the key drivers of type 2 inflammation contributing to eosinophilic esophagitis. The mechanism of dupilumab action has not been definitively established.^1,2

EXPLORE THE mechanism
OF ACTION

In addition to eosinophilic esophagitis (EoE), DUPIXENT is also indicated in 4 additional conditions driven in part by type 2 inflammation: uncontrolled moderate-to-severe atopic dermatitis (6+ months of age), uncontrolled moderate-to-severe eosinophilic or OCS-dependent asthma (6+ years of age), inadequately controlled chronic rhinosinusitis with nasal polyposis (18+ years of age), and prurigo nodularis (18+ years of age).¹

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Yes, the efficacy and safety of DUPIXENT was evaluated for up to 52 weeks in a multipart, phase 3 clinical trial. Part A and Part B each consisted of a 24-week double-blind treatment period. Subjects who completed Part A or Part B were then eligible to enroll in a 28-week extended active treatment period (Part A-C or Part B-C, respectively)—totaling 52 weeks of treatment.^1,3,4

A total of 188 subjects enrolled in the extended active treatment period (77 in Part A-C and 111 in Part B-C). Management of the disease was evaluated through clinical, histologic, and endoscopic endpoints.^1,3,4

VIEW THE RESULTS

Reductions in DSQ total score were first observed at Week 4 with treatment with DUPIXENT 300 mg QW (post-hoc analysis; results are descriptive).³

• Part A: 28% reduction (-9 points) from baseline with DUPIXENT (n=42) vs 11% reduction (-4 points) with placebo (n=39)
• Part B: 31% reduction (-12 points) from baseline with DUPIXENT (n=80) vs 16% reduction (-6 points) with placebo (n=79)

DUPIXENT significantly reduced DSQ total scores compared to placebo at Week 24 (coprimary endpoint).^1,3

• Part A: 69% reduction (-21.9 points) from baseline with DUPIXENT (n=42) vs 32% reduction (-9.6 points) with placebo (n=39) (P<0.001)
• Part B: 64% reduction (-23.8 points) from baseline with DUPIXENT (n=80) vs 41% reduction (-13.9 points) with placebo (n=79) (P<0.0001)

DSQ total score reductions were observed for up to 52 weeks with continued weekly DUPIXENT treatment (secondary endpoint).³

• Part A-C: 76% reduction (-23.4 points) from baseline after 52 weeks of treatment with DUPIXENT (n=29) and 66% reduction (-21.7 points) from baseline after switching to DUPIXENT from placebo at Week 24 (n=23)
• Part B-C: 81% reduction (-30.3 points) from baseline after 52 weeks of treatment with DUPIXENT (n=54) and 78% reduction (-27.3 points) from baseline after switching to DUPIXENT from placebo at Week 24 (n=24)

Extended active treatment period, results are descriptive at Week 52. Definitive conclusions cannot be made due to limitations associated with extended active treatment design, including lack of comparator arm and decreasing sample size.³

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

VIEW THE CLINICAL RESULTS

DUPIXENT demonstrated greater histologic improvements compared to placebo at Week 24.^1,3

Histologic improvements were observed at Week 52 with continued weekly DUPIXENT treatment.^1,3

Extended active treatment period, results are descriptive at Week 52. Definitive conclusions cannot be made due to limitations associated with extended active treatment design, including lack of comparator arm and decreasing sample size.³

^aCoprimary endpoint at Week 24;
secondary endpoint at Week 52.^1,3

^bSecondary endpoint at Weeks 24 and 52.
In Part B, this endpoint was ordered after the point at which hierarchical testing procedure failed; results are descriptive.³

To be eligible to participate in the study, all participants must have had uncontrolled EoE as defined by ≥15 intraepithelial EOS/HPF despite an 8-week course of a high-dose PPI and a Dysphagia Symptom Questionnaire (DSQ) score of ≥10.^1,4

Histologic improvements were defined as the proportion of participants who achieved peak esophageal intraepithelial eosinophil counts of <15 EOS/HPF (histologic response) or ≤6 EOS/HPF (histologic remission).¹

VIEW THE HISTOLOGIC RESULTS

Visible changes in the esophagus were observed at Week 24.^3,a

• Part A: 49% reduction (-3.2 points) from baseline with DUPIXENT (n=42) vs 5% reduction (-0.3 points) with placebo (n=39)
• Part B: 66% reduction (-4.5 points) from baseline with DUPIXENT (n=80) vs 8% reduction (-0.6 points) with placebo (n=79)

EREFS total score was reduced at Week 52 with continued weekly DUPIXENT treatment.^3,a

• Part A-C: 63% reduction (-4.1 points) from baseline after 52 weeks of treatment with DUPIXENT (n=35) and 65% reduction (-3.9 points) from baseline after switching to DUPIXENT from placebo at Week 24 (n=30)
• Part B-C: 77% reduction (-5.3 points) from baseline after 52 weeks of treatment with DUPIXENT (n=63) and 76% reduction (-6.1 points) from baseline after switching to DUPIXENT from placebo at Week 24 (n=37)

Extended active treatment period, results are descriptive at Week 52. Definitive conclusions cannot be made due to limitations associated with extended active treatment design, including lack of comparator arm and decreasing sample size.³

^aSecondary endpoint at Weeks 24 and 52. Results are descriptive; thresholds for clinically meaningful changes in EREFS scores have not been established. Additionally, in Part B this endpoint was ordered after the point at which hierarchical testing procedure failed.³

EREFS is an endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. Each feature is graded on its severity and is assigned an associated value. The EREFS total score (range: 0 to 18) is the composite value of the proximal and distal esophageal regions with each region scored from 0 to 9.^4-8

A higher score indicates greater disease severity. However, thresholds for clinically meaningful changes in EREFS scores have not been established.^1,3

VIEW THE ENDOSCOPIC RESULTS

EREFS is an endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. Each feature is graded on its severity and is assigned an associated value. The EREFS total score (range: 0 to 18) is the composite value of the proximal and distal esophageal regions with each region scored from 0 to 9.^4-8

A higher score indicates greater disease severity. However, thresholds for clinically meaningful changes in EREFS scores have not been established.^1,3

VIEW THE ENDOSCOPIC RESULTS

DUPIXENT was studied in a multipart, phase 3 clinical trial. All enrolled subjects (81 in Part A and 159 in Part Ba) were required to have uncontrolled EoE—as defined by ≥15 intraepithelial eosinophils per high-power field (EOS/HPF) despite an 8-week course of a high-dose proton pump inhibitor (PPI) and a Dysphagia Symptom Questionnaire (DSQ) score of ≥10.^1,3,4

Demographics and baseline characteristics were similar in Parts A and B. At baseline, 43% of subjects in Part A and 37% of subjects in Part B had a history of prior esophageal dilations. The mean age in years was 32 years (range 13 to 62 years) in Part A and 28 years (range 12 to 66 years) in Part B. The majority of subjects were male (60% in Part A and 68% in Part B) and White (96% in Part A and 90% in Part B). The mean baseline DSQ score (SD) was 33.6 (12.4) in Part A and 37.2 (10.7) in Part B.¹

Unless used as rescue medications, systemic and/or swallowed topical corticosteroids were prohibited during the treatment period. Patients using PPI during screening were to continue throughout the treatment period.³

^aDUPIXENT 300 mg Q2W was studied in Part B (n=81) and Part B-C (n=116). Patients from placebo arm in Part B were randomized to receive either DUPIXENT 300 mg Q2W (n=37) or DUPIXENT 300 mg QW (n=37) in Part B-C of the study. DUPIXENT 300 mg Q2W is not approved for the treatment of EoE.^1,3

VIEW THE FULL STUDY DESIGN

In Parts A and B (n=122; 24-week safety pool), the most common adverse reactions (incidence ≥2%) were injection site reactions,^a upper respiratory tract infections,^b arthralgia, and herpes viral infections.^1,c

^a Injection site reactions include, but are not limited to, injection site swelling, pain, and bruising.^1
b Upper respiratory tract infections are composed of several terms including, but not limited to, COVID-19, sinusitis, and upper respiratory tract infection.^1
c Herpes viral infections are composed of oral herpes and herpes simplex.¹

Part A-C—Week 52: The most frequently reported TEAEs (in ≥5% of participants overall) were: injection site reaction (15.6%), injection site erythema (11.7%), injection site pain (6.5%), headache (6.5%), nasopharyngitis (5.2%), acne (5.2%), and insomnia (5.2%).³

Part B-C—Week 52: The most frequently reported TEAEs (in ≥5% of participants overall) were: injection site reaction (13.7%), injection site pain (8.4%), injection site erythema (6.6%), and COVID-19 (7.9%).³

EXPLORE THE DUPIXENT
SAFETY PROFILE

The safety profile of DUPIXENT in 72 pediatric subjects 12 to 17 years of age, weighing at least 40 kg, and adults in Parts A and B was similar.¹

EXPLORE THE DUPIXENT
SAFETY PROFILE

There is no requirement for initial lab testing or ongoing lab monitoring with DUPIXENT according to the Prescribing Information.¹

SEE PRESCRIBING
INFORMATION

DUPIXENT is a medicine that is administered by subcutaneous injection. You may decide whether patients self-administer DUPIXENT at home, or you can administer in office.¹

Administer the subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection. Be sure to rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.¹

DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the 300 mg pre-filled syringe or 300 mg pre-filled pen. For pediatric patients 12 to 17 years of age, it is recommended that DUPIXENT be administered under the supervision of an adult. There is no loading dose for eosinophilic esophagitis (EoE) patients.¹

Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use.¹

LEARN MORE ABOUT DOSING
AND ADMINISTRATION

The pre-filled syringe and the pre-filled pen each come with their own set of specific instructions and guidelines for administration. After choosing your preferred method of treatment, it is important to provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use to ensure each step is followed correctly. In pediatric patients 12 to 17 years of age, it is recommended that DUPIXENT be administered under the supervision of an adult.¹

Advise patients to follow sharps disposal recommendations after administering DUPIXENT. Patients and/or caregivers should read the Instructions for Use prior to injecting.¹

Download the full Instructions for Use below.

DUPIXENT should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If necessary, DUPIXENT may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. DUPIXENT should not be stored above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose DUPIXENT to heat or direct sunlight. Do not freeze or shake.¹

• For the 300 mg/2 mL pre-filled pen or syringe, allow 45 minutes for DUPIXENT to reach room temperature

SEE INFORMATION ON PREPARATION FOR USE, STORAGE, AND HANDLING OF DUPIXENT

If a dose is missed, instruct the patient to administer the dose as soon as possible, and start a new weekly schedule from the date of the last administered dose.¹

LEARN MORE ABOUT DOSING
FOR DUPIXENT

DUPIXENT is not an immunosuppressant. DUPIXENT is a biologic that inhibits IL-4 and IL-13 signaling, two of the key drivers of type 2 inflammation contributing to eosinophilic esophagitis (EoE). The mechanism of dupilumab action has not been definitively established.¹

DISCOVER HOW DUPIXENT
WORKS

DUPIXENT does not have a boxed warning. In Parts A and B (n=122; 24-week safety pool), the most common adverse reactions (incidence ≥2%) were injection site reactions,^a upper respiratory tract infections,^b arthralgia, and herpes viral infections.^1,c

^a Injection site reactions include, but are not limited to, injection site swelling, pain, and bruising.^1
b Upper respiratory tract infections are composed of several terms including, but not limited to, COVID-19, sinusitis, and upper respiratory tract infection.^1
c Herpes viral infections are composed of oral herpes and herpes simplex.¹

The safety profile of DUPIXENT in 72 pediatric subjects 12 to 17 years of age, weighing at least 40 kg, and adults in Parts A and B was similar.¹

Note: Select Important Safety Information: Warnings and Precautions–Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

EXPLORE THE DUPIXENT SAFETY PROFILE

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the safety or effectiveness of these vaccines. Limited data are available regarding coadministration of DUPIXENT with non-live vaccines.¹

LEARN MORE ABOUT DOSING
AND ADMINISTRATION

DUPIXENT does NOT have any known drug-to-drug interactions. DUPIXENT is NOT metabolized through the liver or excreted through the kidneys.¹

In Parts A and B (n=122; 24-week safety pool), the most common adverse reactions (incidence ≥2%) were injection site reactions,^a upper respiratory tract infections,^b arthralgia, and herpes viral infections.^1,c

^a Injection site reactions include, but are not limited to, injection site swelling, pain, and bruising.^1
b Upper respiratory tract infections are composed of several terms including, but not limited to, COVID-19, sinusitis, and upper respiratory tract infection.^1
c Herpes viral infections are composed of oral herpes and herpes simplex.¹

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

EXPLORE THE DUPIXENT
SAFETY PROFILE

No. Tuberculosis testing is not required with DUPIXENT according to the Prescribing Information.¹

SEE PRESCRIBING
INFORMATION

DUPIXENT MyWay is a patient support program that can help enable access to DUPIXENT and offers financial assistance for eligible patients, one-on-one nursing support, and more.

To contact DUPIXENT MyWay, please call 1-844-DUPIXENT (1-844-387-4936). DUPIXENT MyWay coordinators are available Monday-Friday 8 am to 9 pm ET. The fax number is 1-844-387-9370.

When filling out the DUPIXENT MyWay Enrollment Form, both you and your patient will be required to supply information, such as the patient’s insurance, diagnosis, and prescription. You can email or print the enrollment forms below.

LEARN MORE ABOUT THE SUPPORT OFFERED BY DUPIXENT MyWay

You can visit DUPIXENT MyWay coverage support and resources webpage to find out about the prior authorization request and appeal process, if necessary.

In addition, CoverMyMeds support is available for DUPIXENT. It provides additional enrollment and prior authorization process-related support for DUPIXENT. Live support is available at 866-452-5017 or covermymeds.com.

NAVIGATING PRIOR AUTHORIZATIONS AND APPEALS FOR DUPIXENT

If you have a current process for prescribing biologics delivered through a specialty pharmacy, you can utilize that process to get DUPIXENT approved for your patients.

LEARN MORE ABOUT DUPIXENT MyWay

Yes. DUPIXENT MyWay is committed to helping all eligible patients throughout the treatment process. At any time in the process, you or your patient can contact DUPIXENT MyWay for any needed support, such as help covering the cost of DUPIXENT or supplemental injection training. The DUPIXENT MyWay Nurse Educator will communicate directly with your patient and address any questions they may have about DUPIXENT, including the insurance process. While the insurance benefits for DUPIXENT are being confirmed, your patient will receive a Welcome Call from their DUPIXENT MyWay Nurse Educator.

LEARN MORE ABOUT
DUPIXENT MyWay

The amount your patients pay for DUPIXENT will largely depend on whether they have insurance, the type of insurance they have, whether their insurance provider considers the medication to be preferred or not preferred, and whether they’ve met their deductible.

GET PRICING INFORMATION YOU CAN SHARE WITH YOUR PATIENTS