FREQUENTLY ASKED QUESTIONS

DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: DUPIXENT is not indicated for treatment of other forms of urticaria.¹

DUPIXENT has demonstrated results in two 24-week, randomized, double-blind, placebo-controlled, multicenter, parallel-group studies. A total of 284 adults and adolescents (12-17 years) with CSU who remained symptomatic despite H1 antihistamine treatment were randomized in CUPID-A and CUPID-C to DUPIXENT or placebo. All participants were anti-IgE treatment naive and remained on a stable H1 antihistamine dose. All DUPIXENT-treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose, and adolescents 30 to <60 kg received 200 mg Q2W after a 400 mg loading dose. At baseline, mean ISS7 (on a scale of 0 to 21) for CUPID-A was 16.0 and for CUPID-C was 15.1; mean HSS7 (on a scale of 0 to 21) for CUPID-A was 15.4 and for CUPID-C was 13.1; mean UAS7 (on a scale of 0 to 42) for CUPID-A was 31.4 and for CUPID-C was 28.2.^1,2

CUPID-B enrolled 108 adult and pediatric patients 12 years of age and older with CSU who were inadequate responders (N=104) to H1 antihistamines and anti-IgE treatments or intolerant (N=4) to anti-IgE therapy.¹

The efficacy of DUPIXENT was based only on CUPID-A and CUPID-C; CUPID-B did not meet the primary endpoint.¹

Select inclusion criteria^1,2:

• Anti-IgE treatment naive
• Diagnosis of CSU >6 months prior to screening
• Presence of itch and hives for >6 consecutive weeks inadequately controlled by H1 antihistamines
• Used a study-defined H1 antihistamine for CSU treatment and were on a stable H1 antihistamine dose for at least 3 consecutive days prior to the screening visit
• ISS7 ≥8 and UAS7 ≥16

Select exclusion criteria²:

• Weight less than 30 kg in adults and adolescents
• Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
• Patients with active atopic dermatitis or with the presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes
• Severe concomitant illness(es) that would adversely affect the patient’s participation in the study
• Known or suspected immunodeficiency, including history of invasive opportunistic infections
• History of systemic hypersensitivity or anaphylaxis to any biologic therapy

CUPID-A and CUPID-C assessed the efficacy of DUPIXENT on itch relief and hive reduction.

The severity of itch is measured by a patient-reported itch severity score (ISS, ranging from 0 = none to 3 = intense). The ISS7 score is the sum of daily ISS scores measured by a patient at the same time each day over 7 days, with an overall scale of 0 to 21²:

• 0 (none)
• 1 (mild itch)
• 2 (moderate itch)
• 3 (intense itch)

The severity of hives is measured by a patient-reported hive severity score (HSS, ranging from 0 = none to 3 = more than 50 hives). The HSS7 score is the sum of daily HSS scores measured by a patient at the same time each day over 7 days, with an overall scale of 0 to 21²:

• 0 (none)
• 1 (<20 hives)
• 2 (20 to 50 hives)
• 3 (>50 hives)

Urticaria activity score (UAS) is a composite patient-reported outcome measure, which is the sum of the daily itch severity score (ISS, ranging from 0 = none to 3 = intense) and daily hive severity score (HSS, ranging from 0 = none to 3 = more than 50 hives). UAS7 is the sum of the preceding 7 days’ itch and hives scores, for a total UAS7 range of 0 to 42. Urticaria disease activity is classified in 5 severity categories²:

• Urticaria-free or complete resolution (UAS7 = 0)
• Well-controlled urticaria (UAS7 = 1 to 6)
• Mild urticaria activity (UAS7 = 7 to 15)
• Moderate urticaria activity (UAS7 = 16 to 27)
• Severe urticaria activity (UAS7 = 28 to 42)

Reduction from baseline in ISS7 at Week 24 was the primary endpoint in two randomized, double-blind, placebo-controlled, multicenter, parallel-group studies (CUPID-A and CUPID-C).^1,2

• CUPID-A: 64% with DUPIXENT vs 35% with placebo (10.44-point LSM reduction from baseline vs 6.02-point, respectively [P=0.0003])
• CUPID-C: 48% with DUPIXENT vs 33% with placebo (8.50-point LSM reduction from baseline vs 6.13-point, respectively [P=0.0270])

The most common adverse reactions (incidence ≥2%) in patients with CSU were injection site reactions.¹

Injection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, injection site swelling.

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT.¹

DUPIXENT is not an immunosuppressant and avoids broad immunosuppression. It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. DUPIXENT is a human monoclonal antibody that inhibits the signaling of IL-4 and IL-13, two of the type 2 cytokines that contribute to type 2 inflammation in CSU.¹

In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥2%) in patients with CSU were injection site reactions.¹

Injection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, injection site swelling.

DUPIXENT can be self-administered by patients and/or caregivers at home with training on proper administration prior to use.¹

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

DUPIXENT does not have a boxed warning. In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥2%) in patients with CSU were injection site reactions.¹

Injection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, injection site swelling.

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.¹

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

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

In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥2%) in patients with CSU were injection site reactions.¹

Injection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, injection site swelling.

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

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

DUPIXENT is not a steroid. DUPIXENT is a human monoclonal antibody that inhibits the signaling of IL-4 and IL-13, two type 2 cytokines that contribute to the type 2 inflammation in CSU. The mechanism of dupilumab action has not been definitively established.¹

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.

A great place to start is with DUPIXENT MyWay®, a patient support program that provides guidance with the insurance approval process as well as patient-centric education.

The DUPIXENT MyWay Interim Access Program assists eligible, commercially insured patients who previously started DUPIXENT and are experiencing a specific, short-term lapse in therapy. It temporarily provides eligible patients DUPIXENT at no cost, subject to program terms and conditions. You or your patients can contact DUPIXENT MyWay at 1-844-DUPIXEN(T) (1-844-387-4936) to learn more.

You can use this guide to find out about the prior authorization request and appeal process for your patients appropriate for DUPIXENT.