Dupixent (generic name Dupilumab) has showed great promise in a recently published study in the New England Journal of Medicine. In a previous post, we have discussed extensively Dupilumab. Click on the link below to read further about Dupixent (dupilumab).
For background, atopic dermatitis or eczema, is a chronic, relapsing inflammatory skin disease that is characterized by upregulation of type 2 immune responses, an impaired skin barrier and increased Staphylococcus aureus colonization. In patients with moderate to severe eczema, skin lesions can encompass a large surface area and is frequently accompanied by intense itching, sleep deprivation, anxiety or depression and a poor quality of life. Topical therapies have limited efficacy in severe patients. There is an unmet need for a safe and long term medication for eczema patients.
Dupixent (dupilumab) is a fully human monoclonal antibody that binds specifically to the the shared alpha chain subunit of interleukin 4 and 13 receptors, thereby inhibiting signaling of IL-4 and IL-13, which are inflammatory cytokines that are important for allergic diseases such as atopic dermatitis and asthma. Here are two phase 3 trials of Dupixent (dupilumab) in adults with moderate to severe atopic dermatitis who were inadequately controlled by topical treatment.
Patients enrolled in the study were randomly assigned to receive Dupixent (dupilumab) or placebo every other week for 16 weeks. Patients receiving the medication, received a 600-mg loading dose of dupilumab on day 1 and 300 mg every other week.
A total of 1,1315 patients were enrolled in both studies. The most common adverse event or side effect were exacerbations of eczema, injection-site reactions and nasopharyngitis. The rates of conjunctivitis with an unspecified cause was higher in the Dupixent (dupilumab) group than in placebo.
Dupixent (dupilumab) resulted in better results than placebo over 16 weeks of treatment across multiple outcome measures that reflected objective signs of atopic dermatitis, subjective symptoms (e.g. itching), important aspects of mental health (i.e. anxiety and depression) and quality of life.
In conclusion, dupilumab or Dupixent was superior than placebo in moderate to severe atopic dermatitis in patients inadequately treated with topical medications. Both regimens of Dupixent (weekly and every other week) ameliorated the sign and symptoms of atopic dermatitis, causing clinically meaningful reductions in anxiety, depression and improving health related quality of life. The results of this trial, extend the findings on Dupixent (dupilimab) from earlier trials.
Update January 11, 2017
Dupilumab (Dupixent) was on course for a release date in March 2017, but there may be a hang up now. The Sanofi plant which will manufacture the medication has been cited by the FDA with a form 483.
The FDA did not have any problems with the safety or effectiveness of the drug, but they wanted some plant issues resolved. Stay tuned for more updates about the expected launch date of Dupixent (Dupilumab).
Regeneron is still coming out with very positive data for Dupilumab from the CHRONOS studies, http://investor.regeneron.com/releasedetail.cfm?releaseid=1014618. Now it is just waiting for the launch of Dupixent. There are no further updates from the FDA regarding form 483, the previous expected time when it should have been available is at the end of March 2017. As we approach that date, hopefully we will have more information when Dupixent will be available to patients.
Dupixent Wins FDA Approval (update March 28th, 2017)
Sanofi and Regeneron have announced today that Dupixent (dupilumab) has won FDA approval for the treatment of moderate to severe atopic dermatitis in patients who have failed topical treatments. Dupilumab will have a wholesale cost of $37,000. It will come as a pre-filled syringe that can be administered at home every other week after an initial loading dose. The loading dose will be given as 2 injections at a physicians office (600 mg total) and the following doses can be self-administered at home. It will be 300mg/2ml vial that will be injected every 2 weeks and it will need to be refrigerated. Because of the high cost, Sanofi and Regeneron have announced a patient assistance program, Dupixent MyWay to help offset the costs in patients who can not afford the medication. Dupixent should be available sometime this week. Dupilumab will be the first biological medication available to patients with moderate to severe eczema. Side effects that patients and providers have to be concerned about are, allergic reactions and eye problems. Although the most common side effects are, injection site reactions, eye and eyelid inflammation, and redness and swelling and cold sore in the mouth. Currently there is no risk of anaphylaxis from Dupixent injections unlike other biological medications such as Xolair.
Dupilumab is also being currently studied for the treatment of asthma. But the agency cautioned that patients being treated with the medication who have eczema and asthma, should not adjust their asthma medications as it is still under investigation for the treatment of asthma.