How fast does Dupixent work?

Dupixent (generic name: dupilumab) can start to work in 2 to 4 weeks to relieve symptoms associated with inflammatory conditions like eczema, asthma, and sinus swelling due to nasal polyps. Initial improvements in chronic obstructive pulmonary disease (COPD) and prurigo nodularis (a skin condition) were seen at 12 weeks, and at 24 weeks for eosinophilic esophagitis.

In trials, Dupixent has also been shown to be effective over the long-term for the treatment of these conditions when compared to a placebo (inactive) treatment.

Dupixent is classified as an interleukin-4 (IL-4) receptor alpha antagonist and works by reducing inflammation that can lead to symptoms.

Eczema (atopic dermatitis)

In atopic dermatitis, red, scaly, itchy and crusted bumps develop on the skin. Scratching leads to redness, skin breakage, clear fluids, and finally a thickening of the skin. For eczema in adults and adolescents, Dupixent 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.

Trials

Multiple 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 a 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.

• More 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).
• More teens (37%) had significant itch relief compared to 5% of those not taking Dupixent. Itching relief started as soon as 4 weeks in some teens.

Moderate-to-severe hand and / or foot involvement

In the Phase 3 LIBERTY-AD-HAFT placebo-controlled trial, the safety and efficacy of Dupixent was evaluated in 133 adult and adolescent (aged 12 to 17 years) patients with atopic dermatitis (eczema) with moderate-to-severe hand and / or foot involvement who had an inadequate response or intolerance to topical corticosteroids.

At 16 weeks, patients treated with Dupixent experienced the following:

• 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo, the primary endpoint (a score of 0 or 1 on the Investigator Global Assessment Scale).
• 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo, the key secondary endpoint.

Children 6 to 11 years

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 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 in 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

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. In 6 to 11 year olds, those taking Dupixent improved their lung function by 5.3 percentage points compared to 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.

Dupixent is not used for the relief of acute bronchospasm or status asthmaticus (breathing problems that come on quickly).

Chronic rhinosinusitis with nasal polyps

Adults

Adults patients with uncontrolled chronic rhinosinusitis with nasal polyps had an improved ability to smell in as little as 2 weeks. In addition, 83% fewer patients required nasal polyp surgery in 24-week and 52-week clinical trials.

Patients also had a reduction in nasal congestion by as much as 50%, and 75% of patients saw a reduction in steroid use.

Adolescents

In adolescents patients aged 12 to 17 years with uncontrolled chronic rhinosinusitis with nasal polyps, Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery at 24 weeks compared to placebo.

Approval for this use in adolescents is supported by evidence from 2 positive, Phase 3 pivotal studies (SINUS-24 and SINUS-52) in adults, as well as pharmacokinetic data from asthma and safety studies in adolescent patients aged 12 years and older.

Common side effects for patients with chronic rhinosinusitis with nasal polyposis include: 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)

Patients 12 years of age and older with eosinophilic esophagitis (EoE) received Dupixent 300 mg injection weekly or a placebo (inactive substance). A reduction in disease symptoms and trouble swallowing was seen in 24 weeks.

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).

A reduction in eosinophils that led to inflammation was also achieved. 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. 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.

In patients aged 1 to 11 years old weighing at least 15 kg (33 lb), improvement was seen at 16 weeks.

• 66% of children who received higher dose Dupixent at tiered dosing regimens based on weight (n=32) achieved histological disease remission (≤6 eosinophils/high power field) at 16 weeks compared to 3% for the placebo group (n=29).
• Histological remission was sustained at week 52 in 53% of children treated with Dupixent or switched to Dupixent from placebo.

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).

Related questions

• What are the most common skin conditions? (with photos)
• Why do Dupixent injections hurt so much?
• Why does Dupixent cause eye problems?

Prurigo nodularis

Prurigo nodularis is a skin condition that consists of hard and extremely itchy nodules that can worsen and spread. In studies, adults with prurigo nodularis had clinically and significantly reduced itching at 12 and 24 weeks, and reduced skin lesions (clear or almost clear skin) at 24 weeks.

Dupixent was evaluated in two Phase 3 studies in adults with prurigo nodularis. At 12 or 24 weeks, a clinically and statistically meaningful reduction in itch was demonstrated in the Dupixent 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.

Chronic Obstructive Pulmonary Disase (COPD)

In studies, Dupixent showed a significant reduction in the yearly rate of moderate or severe COPD exacerbations ("flare-ups") compared to placebo when added to the patient's other maintenance therapy, during the 52-week treatment period.

Dupixent also improved lung function. Forced expiratory volume in 1 second (FEV1) is a measurement used in patients with respiratory diseases to predict the response to bronchodilator treatment and is part of the diagnosis of COPD and asthma.

• In adults with COPD in Phase 3 studies, improvements in post-FEV1 (after a bronchodilator treatment) was seen at week 12 compared to placebo, and sustained at 52 weeks, when added to the patient's standard COPD medicines. These changes were seen as early as 2 weeks.
• Significant improvements were also seen in the change from baseline in pre-bronchodilator FEV1 (before a bronchodilator treatment) at Weeks 12 and 52 in subjects treated with Dupixent compared to placebo across both trials.

What is Dupixent approved to treat?

Dupixent is approved by the FDA to treat:

• Adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (eczema) whose disease is not adequately controlled with topical prescription therapies (used on the skin) or when those therapies are not advisable. Can be used with or without topical corticosteroids
• Adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
• Adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). EoE can led to Inflammation and trouble swallowing
• Adults with prurigo nodularis, a skin condition that consists of hard and extremely itchy nodules that can worsen and spread.
• Adults with chronic obstructive pulmonary disease (COPD). Used as an add-on maintenance treatment in patients with inadequately controlled COPD and an eosinophilic phenotype.
• Adolescent patients aged 12 to 17 years and adults with chronic rhinosinusitis (long-term sinus inflammation) with nasal polyps (non-cancerous growths on the sinuses), as an add-on maintenance treatment.

Dupixent is not used for the relief of acute bronchospasm or status asthmaticus (breathing problems that come on quickly). You should have a rescue inhaler (for example: albuterol) for sudden breathing problems. If you need a rescue inhaler, speak to your doctor right away.

Use Dupixent exactly as prescribed by your doctor.

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.

Bottom Line

Atopic dermatitis (eczema): 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 and lead to a clear or almost clear skin improvement in 16 weeks.

Asthma: 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.

Chronic rhinosinusitis with nasal polyps: 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. In adolescents patients aged 12 to 17 years, Dupixent significantly improved nasal congestion, polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery at 24 weeks compared to placebo.

Eosinophilic esophagitis: For patients with eosinophilic esophagitis, improvements in swallowing, inflammation or other symptoms were seen in studies at 16 weeks (for children 1 to 11 years of age) or 24 weeks (for adults and adolescents).

Prurigo nodularis: 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.

COPD: Over one year, Dupixent showed a significant reduction in COPD exacerbations ("flare-ups") compared to placebo when added to the patient's other maintenance therapies. Improvements in lung function (post-bronchodilator FEV1) was also seen when added to other COPD medicines.

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 and questions with your doctor or other health care provider.