How fast does Dupixent work?
Key Points
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.
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.
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.
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.
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.
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
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.
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