Key Points

• For eczema in adults and adolescents, Dupixent (generic name: dupilumab) can start to work as quickly as 2 to 4 weeks to relieve itching and in 16 weeks for a clear or almost clear skin improvement.
• In children 6 to 11 years old using Dupixent or placebo plus a topical corticosteroid for severe eczema, studies at 16 weeks show that 4.5 times more children using Dupixent had reduced itching. In addition, twice as many children on Dupixent saw clear or almost clear skin improvements.
• In children aged 6 months to 5 years with moderate-to-severe eczema treated with Dupixent and topical corticosteroids, children achieved clearer skin and significantly reduced itch at 16 weeks compared to use of topical corticosteroids alone.
• Children 6 years of age and older with moderate-to-severe asthma started to see an improvement in lung function in 2 weeks in clinical studies, which is sustained through 52 weeks. Improvement was statistically significant at week 12. In 6 to 11 year olds, those taking Dupixent improved their lung function by 5.32 percentage points compared to placebo.
• Adults patients with uncontrolled chronic rhinosinusitis with nasal polyps had an improved ability to smell in as little as 2 weeks. In addition, over 80% fewer patients required nasal polyp surgery in 24-week and 52-week clinical trials.
• In patients 12 years and older with eosinophilic esophagitis (EoE), a reduction in disease symptoms and trouble swallowing was seen in 24 weeks. A reduction in eosinophils that lead to inflammation was also achieved.
• Adults with prurigo nodularis, a skin condition that consists of hard and extremely itchy nodules that can worsen and spread, had clinically and significantly reduced itching at 12 and 24 weeks, and reduced skin lesions (clear or almost clear skin) at 24 weeks.

Dupixent (dupilumab) is approved for use in adults and children at least 6 months of age for treatment of moderate-to-severe eczema (atopic dermatitis) when other topical therapies (used on the skin) are not effective. For eczema, Dupixent can be used with or without topical corticosteroids.

Dupixent is also used as an add-on maintenance treatment in patients 6 years of age and older with moderate-to-severe asthma with high levels of white blood cells known as eosinophils or with oral corticosteroid-dependent asthma. Dupixent is not used to treat an asthma attack. Use a rescue inhaler such as albuterol to treat sudden breathing problems.

Dupixent is approved as an add-on maintenance treatment for adults with nasal polyps (growths on the sinuses) accompanied by chronic rhinosinusitis (sinus and nasal cavity swelling).

In May 2022, Dupixent was approved to treat eosinophilic esophagitis (EoE) in patients aged 12 years and older, weighing at least 40 kg (88 lbs).

In Sept. 2022, Dupixent was cleared as the first FDA-approved treatment for prurigo nodularis in adults.

Does Dupixent contain steroids?

Dupixent is a steroid-free, injectable biologic drug and an interleukin-4 (IL-4) receptor alpha antagonist from Regeneron. This is an advantage as steroids (oral and topical), often used to lower swelling and inflammation, can cause serious side effects with longer-term use.

Dupixent is administered as an injection under the skin (subcutaneous injection). It was first approved in March 2017.

The manufacturer reports that it takes 16 weeks of treatment with Dupixent to reach steady state levels. Steady state is the time point at which the concentration of the drug in the body stays consistent. In other words, steady state is when the rate of the drug going into your body is equal to the rate of drug elimination. Your doctor may prescribe topical corticosteroids or other treatments if needed while Dupixent takes effect.

Eczema Studies with Dupixent

Eczema (atopic dermatitis) studies were conducted for 16 weeks in children, teens and adults with moderate or severe eczema (atopic dermatitis). These studies looked at skin improvement and reduction in itching.

Adults

In clinical trials in over 2,100 adults with uncontrolled moderate-to-severe eczema (atopic dermatitis), clearer skin was seen in 16 weeks of treatment with Dupixent.

• Clear or almost clear skin was reported in 37% of patients taking Dupixent compared to 9% of those not using the drug, a four-fold increase. Nearly half of adult patients (48%) saw a 75% skin improvement, and some saw a 90% improvement, compared to those not using Dupixent (13%).
• Itch reduction with Dupixent occurred rapidly, as early as 2 weeks, and was sustained. Close to 4 times more adults also had a significant reduction in itching when using Dupixent compared to those not using the drug.
• Also, in a 52-week study, 13% of patients receiving Dupixent who did not respond at week 16 were reported to have responded by week 52. Itch reduction has been shown to last through one year, as well.

Teens

For teens 12 to 17 years of age with moderate-to-severe eczema not adequately controlled with topical prescription treatments, significant results were seen 16 weeks after starting treatment.

• Roughly twelve times as many teens saw clearer skin (24% vs. 2%) when compared to teens not receiving Dupixent.
• Nearly half of teen patients (42%) saw a 75% skin improvement, with some seeing a 90% improvement (23%), compared to those not using Dupixent (8% and 2% improvement, respectively).
• Seven times more teens (37%) had significant itch relief compared to 5% of those not taking Dupixent. Itching releif started as soon as 4 weeks in some teens.

Children

In children 6 to 11 years old using Dupixent plus a topical corticosteroid (TCS) for severe eczema, who received either the 200 mg or 300 mg dose, over twice as many children saw clear or almost clear skin at 16 weeks when compared to those using a topical corticosteroid only.

• 30% taking 300 mg dose, every 4 weeks vs 13% on TCS only
• 39% taking 200 mg dose, every 2 weeks vs 10% on TCS only.

Itching was reduced in about 4.5 times as many children using Dupixent when compared to the group only using topical corticosteroids at 16 weeks.

• 54% taking 300 mg dose, every 4 weeks vs 12% on TCS only
• 61% taking 200 mg dose, every 2 weeks vs 13% on TCS only

In Phase III studies children 6 months to 5 years of age, participants received Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids or topical corticosteroids alone (placebo group). The primary endpoint was the proportion of subjects with an IGA of 0 (clear) or 1 (almost clear) at Week 16.

• The primary endpoint was met in this Phase III study: at 16 weeks 28% of children receiving Dupixent achieved clear or almost-clear skin compared to 4% with placebo.
• The safety profile of Dupixent in this age group was similar to the safety profile in patients 6 years and older with atopic dermatitis.

Side effects (≥1%) in atopic dermatitis studies include: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eyes, cold sores in the mouth or on the lips, and eosinophilia (high blood count of a certain white blood cells).

Asthma Studies with Dupixent

In asthma, for patients 12 years and older, an improvement in lung function was seen in about 2 weeks, was significant at week 12 and was sustained through 52 weeks.

Also, severe breathing exacerbations were reduced by up to 81%. About 86% of people reduced or eliminated their oral steroid dose.

In a Phase 3 study in 408 children 6 to 11 years of age with uncontrolled moderate-to-severe asthma, Dupixent was shown to reduce asthma attacks by 65% and lower the use of a steroid burst by 66% when compared to a placebo.

Common side effects in asthma patients include: injection site reactions, pain in the throat, high count of a certain white blood cell, and parasitic (helminth) infections

For asthma patients, it’s important to remember that Dupixent is used as a long-term maintenance treatment. It is not used for the relief of acute asthma symptoms or worsening disease. Use your fast-acting inhaler, such as albuterol, for relief of sudden symptoms.

Chronic rhinosinusitis / nasal polyp studies with Dupixent

For adults patients with uncontrolled chronic rhinosinusitis with nasal polyposis, 83% fewer patients required nasal polyp surgery. Results in studies were assessed at 24 and 52 weeks.

Patients also had an improved ability to smell in as little as 2 weeks, a reduction in nasal congestion by as much as 50%, and 75% of patients saw a reduction in steroid use.

Common side effects for patients with chronic rhinosinusitis with nasal polyposis includes: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia).

Eosinophilic esophagitis (EoE) studies with Dupixent

Patients 12 years of age and older received Dupixent 300 mg injection weekly or a placebo (inactive substance). In these patients at 24 weeks, a 69% and 64% reduction in disease symptoms (trouble swallowing) from baseline was seen compared to 32% and 41% for placebo (based on the Dysphagia Symptom Questionnaire).

Histological disease remission (based on eosinophil count) was achieved in 60% and 59% of patients in the active group compared to 5% and 6% of patients receiving placebo. Eosinophils are a type of white blood cell. A reduction in eosinophils may lead to a reduction in inflammation (swelling) in the esophagus, and improve symptoms.

Common side effects in studies for eosinophilic esophagitis included: injection site reactions, upper respiratory tract infections, cold sores in the mouth or on the lips, and joint pain (arthralgia).

Prurigo nodularis (PN) in adults

Dupixent was evaluated in two Phase 3 studies in adults with prurigo nodularis, a skin condition that consists of unsightly, hard and extremely itchy nodules that can worsen and spread. At 12 or 24 weeks, a clinically and statistically meaningful reduction in itch was demonstrated in the Dupixent patients groups (ranging from 37% to 60%) compared to placebo (16% to 22%).

In addition, Dupixent significantly reduced skin lesions (defined as clear or almost clear skin) in 24 weeks compared to a placebo. More than twice as many patients in the Dupixent groups achieved clear or almost clear skin at 24 weeks (48% and 45%), compared to 18% and 16% for placebo.

More than triple the number of Dupixent patients experienced both a clinically meaningful reduction in itch AND clear or almost clear skin (39% and 32%), compared to 9% of placebo patients (both groups) at 24 weeks.

In the studies looking at prurigo nodularis, the most common side effects (in at least 2% of patients) were nasopharyngitis (the common cold), conjunctivitis (eye and eyelid inflammation and itching), herpes virus infection, dizziness, myalgia (muscle pain), and diarrhea.

Bottom Line

• In adults and children, Dupixent (generic name: dupilumab) can start to work as quickly as 2 to 4 weeks to relieve itching due to eczema lead to a clear or almost clear skin improvement in 16 weeks.
• Asthma improvements in patients 12 years and older may begin as quickly as week 2 after starting treatment, and will continue to improve through 12 weeks and up to one year.
• For adults patients with uncontrolled chronic rhinosinusitis with nasal polyps, patients may begin to see an improved ability to smell in as little as 2 weeks.
• For patients with eosinophilic esophagitis (EoE), improvements in swallowing and inflammation was seen in studies in 24 weeks.
• In adults with prurigo nodularis, clinically and significantly reduced itching was seen at 12 and 24 weeks, and reduced skin lesions (clear or almost clear skin) at 24 weeks.

This is not all the information you need to know about Dupixent for safe and effective use. Results among patients are variable and your results may be different. Review the full Dupixent information here, and discuss this information with your doctor or other health care provider.