First Biologic Medicine - Dupixent - Approved for COPD
Background
About one-half of patients with COPD have flare-ups (called exacerbations) despite being on triple therapy. Triple therapy means two inhaled bronchodilators and an inhaled corticosteroid. About 300,000 people in the US live with inadequately controlled COPD and also have an elevated blood count of eosinophils (a type of white blood cell). Those with elevated eosinophils are associated with about 30% increase in flare-ups and an increased risk of COPD-related hospitalizations within a year.
FDA Approval
On September 27, 2024, the U.S. Food and Drug Administration approved dupilumab (brand name: Dupixent) as add-on maintenance treatment of patients with COPD who are inadequately controlled and have elevated eosinophils.
How Does Dupilumab Work?
The medication works by interfering with inflammation (redness and swelling) in the airways:
Inhibition of Interleukin-4 signaling
Inhibition of Interleukin-13 signaling
The results of two phase III studies (called BOREAS and NOTUS) were published in the New England Journal of Medicine. Compared to placebo treatment, there were 30% and 34% reductions in the rate of moderate and severe flare-ups over one year (see Figure below). In addition, those receiving dupilumab had greater increases in breathing test results (FEV1) at 12 weeks that was sustained at 52 weeks (see Figure below).
Figure A (Top) shows reduced moderate and severe flare-ups with dupilumab compared with placebo. Figure B (Bottom) shows increase in FEV1 starting at 2 weeks and continuing for 52 weeks.
Is Dupilumab safe?
Safety results were consistent with the known safety profile as dupilumab is also used to treat certain types of asthma, atopic dermatitis, and eosinophilic esophagitis. The most common side effects compared wih placebo were a viral infection, headache, nasopharyngitis, back pain, diarrhea, joint pains, urinary tract infections, and soreness at the injection site.
Subcutaneous injection in arm
How Is Dupilumab Administered?
Dupilumab is an injectable medicine that is administered by subcutaneous injection (under the skin). It can be given in a doctor’s office or patients can self-administer dupilumab at home.
For COPD, the dose is 300 mg every two weeks.
My Comments
Dupilumab has been a “game changer” for some individuals with persistent asthma and elevated blood eosinopils. Recently, dupilumab became the first biologic medicine approved by the FDA to treat patients with COPD who are indequately controlled on triple therapy and have high eosinophils in the blood. If you are experiencing frequent flare-ups, ask your health care professional and/or pulmonologist whether dupilumab is an option for you.