Dupixent (dupilumab) for COPD

Last updated Nov. 18, 2024, by Andrea Lobo, PhD
Fact-checked by Marta Figueiredo, PhD

What is Dupixent for COPD?

Dupixent (dupilumab) is an injectable therapy approved for adults with poorly controlled chronic obstructive pulmonary disease (COPD) and high counts in the bloodstream of a type of immune cell called eosinophil.

Administered via under-the-skin, or subcutaneous, injections, Dupixent is used as an add-on COPD maintenance treatment to improve lung function, ease symptoms, and prevent exacerbations, or periods when symptoms suddenly worsen.

Dupixent, developed by Sanofi and Regeneron Pharmaceuticals, is also approved for several other diseases marked by high eosinophil counts. This includes asthma, some skin conditions, and certain types of nasal inflammation.

Therapy snapshot

How does Dupixent work?

COPD is a chronic, progressive lung disease, characterized by progressive airway inflammation and narrowing, that leads to symptoms such as shortness of breath, coughing, wheezing, and excessive mucus production. Symptoms are commonly evident after significant lung damage has occurred, and usually worsen with time.

Standard COPD treatment involves inhaled corticosteroids, which reduce inflammation, and inhaled bronchodilators, used to relax and widen the airways. However, many patients still experience frequent exacerbations or flare-ups despite such treatment.

Additionally, a significant proportion of COPD patients have elevated eosinophil levels in their blood and/or lungs, where they are significantly associated with a higher risk of severe exacerbations and greater disease severity.

Dupixent is a biological therapy, or one made from living organisms. It’s designed to target type 2 inflammation — a type of inflammation marked by elevated eosinophils in the blood and thought to contribute to COPD-related lung inflammation.

The antibody-based treatment specifically blocks the interleukin-4 receptor alpha, which is involved in the signaling of both interleukin-4 and interleukin-13, two inflammatory molecules believed to drive type 2 inflammation. By dampening those immune responses, Dupixent is expected to ease lung inflammation, facilitate breathing, and reduce the number of COPD exacerbations.

Who can take Dupixent?

Dupixent was approved by the U.S. Food and Drug Administration (FDA) in September 2024 as an add-on maintenance treatment for adults with poorly controlled COPD and raised blood eosinophils.

The therapy also is approved in the European Union for the same indication. Both decisions made Dupixent the first biologic to be approved by regulators for COPD.

Those prescribed the treatment in the U.S. may be eligible to enroll in Dupixent My Way. This patient support program is designed to improve access to the therapy by providing reimbursement and financial support, as well as other information.

Who should not take Dupixent?

According to its prescribing information, Dupixent should not be used by anyone with a known allergy to the medication or any of its ingredients.

How is Dupixent administered in COPD?

For people with COPD, Dupixent is given via subcutaneous injections, at a recommended dose of 300 mg, once every other week.

It is available as a single-dose prefilled syringe or prefilled pen containing 300 mg of the therapy’s active ingredient in 2 mL of liquid that is clear to slightly opalescent in sheen and colorless to pale yellow in color. Both the prefilled syringe and pen can be administered by patients and caregivers after appropriate training by a healthcare provider.

The injections may be done on the front of the thighs or in the abdominal area (stomach) — but not within 2 inches, or about 5 cm, of the belly button. The back of the upper arm can be used as an injection site if the medication is administered by a caregiver or a healthcare professional. Each injection should be given at a different site than the previously used one.

Before administration, the prefilled syringe or pen should be removed from the refrigerator and allowed to warm at room temperature for about 45 minutes. If needed, Dupixent can be stored at room temperature for up to 14 days.

The injection site — which should not be bruised, tender, damaged, or scarred — should first be disinfected. The prefilled syringe’s needle should be inserted at a 45-degree angle into a pinched skin site, and the plunger should be slowly pushed all the way down to make sure all the medicine is injected. The prefilled pen should be placed at a 90-degree angle against the skin and pressed down for up to 15 seconds after the start of the injection.

If a planned dose of Dupixent is missed, a new dose should be given as quickly as possible. If the therapy is administered within seven days of the missed dose, the next injection can be given according to the original schedule. But if there’s a longer delay, the next dose should be given every other week counting from the actual date of the delayed injection.

Dupixent in clinical trials

Dupixent’s approvals for COPD were mainly based on data from two Sanofi-sponsored, similarly-designed Phase 3 clinical trials: BOREAS (NCT03930732) and NOTUS (NCT04456673).

BOREAS and NOTUS

The two global trials enrolled a total of 1,874 current or former smokers with COPD and moderate to severe airflow limitation, as well as high eosinophils counts. A total of 939 were enrolled in BOREAS, while 935 were involved in NOTUS. Both trials enrolled patients with a minimum age of 40. Participants in NOTUS could be as old as 85, while those in BOREAS could have a maximum age of 80.

Eligible patients had at least two moderate exacerbations or one severe exacerbation in the previous year despite their use of standard inhaled therapy with corticosteroids and bronchodilators.

Moderate exacerbations were classified as those requiring treatment with whole-body corticosteroids and/or antibiotics. Severe flare-ups, meanwhile, were exacerbations resulting in hospitalization or observation for more than one day in an emergency department or urgent care facility.

The participants in both were randomly assigned to receive a subcutaneous injection of either Dupixent (300 mg) or a placebo, once every two weeks for 52 weeks, or one year, in addition to their background maintenance therapy.

In both trials, the main goal was to assess the effect of treatment on the annualized rate of moderate or severe COPD exacerbations.

The results showed that both studies met this goal, with the therapy resulting in a significantly lower annualized rate of exacerbations relative to the placebo: by 30% in BOREAS and by 34% in NOTUS. For patients, this resulted in a significantly lower risk of moderate to severe exacerbations with Dupixent, by 20% in BOREAS and 29% in NOTUS.

Moreover, the treatment led to significant improvements in lung function after three months, as assessed with the forced expiratory volume in one second (FEV1), which measures how much air someone can forcibly exhale in one second.

Specifically, after three months, the mean FEV1 before treatment with a bronchodilator increased by 83 mL in BOREAS and by 82 mL in NOTUS with Dupixent relative to the placebo. Further, the mean FEV1 after the use of the bronchodilator increased, with Dupixent, by 74 mL in BOREAS and 68 mL in NOTUS. These effects were sustained for up to one year, meaning that both studies met key secondary goals.

Compared with the placebo, Dupixent was also associated with greater improvements in health-related quality of life, measured using the St. George’s Respiratory Questionnaire, and a greater proportion of patients achieving clinically meaningful improvements after one year. The therapy also led to greater reductions in respiratory symptom severity, as assessed with the Evaluating Respiratory Symptoms in COPD. Still, these differences reached statistical significance only in the BOREAS trial.

Common side effects of Dupixent

The most common side effects of Dupixent in COPD patients include:

• viral infection
• headache
• common cold symptoms
• back pain
• diarrhea
• joint pain
• urinary tract infection
• injection site reaction
• inflammation inside the nose
• high eosinophil counts
• toothache
• inflammation of the stomach’s lining.

Allergic reactions

Dupixent may cause allergic reactions, which can be severe. Symptoms may include swelling of the face, mouth, and/or tongue; breathing problems; dizziness; lightheadedness; fainting; fever; general ill feeling; skin rash; and nausea or vomiting.

If a clinically significant allergic reaction occurs, appropriate treatment should be started and Dupixent should be permanently discontinued.

Eye problems

Inflammation in certain parts of the eye — particularly the conjunctiva and the cornea — has been reported in patients treated with Dupixent. Conjunctiva is the thin, clear membrane that covers the whites of the eyes, while the cornea is the clear dome-shaped covering at the front of the eye.

Patients should tell their healthcare provider if they develop new or worsening eye symptoms, including eye pain and changes in vision. Such symptoms may eventually require assessment with eye exams.

Acute COPD symptoms or exacerbations

Dupixent should not be used to manage acute symptoms or acute exacerbations of COPD. If COPD remains uncontrolled, or if it worsens after starting on Dupixent, patients should seek medical advice.

Considerations for reducing glucocorticoids

Patients on Dupixent should not abruptly stop corticosteroids, as this can lead to withdrawal symptoms and/or reveal health conditions that were being controlled by corticosteroids. As such, if the corticosteroid dosage needs to be reduced, this should be done gradually under the supervision of a physician.

Treatment for co-occurring asthma

COPD patients with co-occurring asthma should not adjust or discontinue their asthma treatments without discussing it with their healthcare providers. Asthma may occur in people with COPD.

Joint pain

Treatment with Dupixent can cause joint pain that may affect movement and, in some cases, require hospitalization. These events may occur days to months after starting the therapy. Symptoms may resolve while still on Dupixent or only after treatment discontinuation.

If patients develop new or worsening joint symptoms while on Dupixent, they should discuss this with healthcare providers, who may decide to stop the treatment.

Parasitic infections

People treated with Dupixent may be at a higher risk of parasitic infections due to the therapy’s suppressing effects on eosinophils, which may be involved in the fight against some helminths, or parasitic worms.

Patients with known parasitic worm infections were excluded from Dupixent trials, so it is unknown whether the therapy impairs the immune response of these individuals to such infections.

Those with preexisting helminth infections should receive appropriate treatment for the parasite before starting on Dupixent. If patients develop a parasitic worm infection while on Dupixent and do not respond to appropriate treatment, Dupixent should be withheld until the parasitic infection resolves.

Vaccination

As Dupixent may affect the immune system, patients should complete all age-appropriate vaccinations, according to current vaccination guidelines, before starting treatment with the medication. Also, vaccines based on live organisms should be avoided while on Dupixent.

Use in pregnancy and breastfeeding

Pregnancy outcomes in people exposed to Dupixent during pregnancy are being assessed in a registry that’s currently focused on patients with asthma or a skin condition called atopic dermatitis — two conditions for which the therapy also is approved.

Available data to date from case reports and case series have not identified a Dupixent-related risk of miscarriage, birth defects, or adverse maternal or fetal outcomes. However, because the antibody class to which Dupixent belongs is known to cross the placenta, the medication may pass from the mother to the developing fetus.

Data from animal studies suggest that the treatment may not be associated with adverse fetal outcomes when administered during pregnancy at doses much higher than those used in patients.

Whether Dupixent can be found in human breast milk or if it affects nursing infants or breastmilk production also remains unclear. However, the antibody class to which Dupixent belongs has been detected in human milk.

Patients are advised to discuss with their healthcare team the potential benefits and risks of Dupixent use by those who are pregnant or breastfeeding.

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