Dupilumab for asthma has been accepted for FDA review as an add-on maintenance treatment in adults and adolescents (12 and up) with moderate to severe persistent asthma. Dupilumab (brand name is Dupixent) is currently approved for patients with moderate to severe eczema, it was approved March 2017.
Dupilumab is a monoclonal antibody that works by inhibiting the signaling of IL-4 and IL-13 which contribute to allergic inflammation in the body. There have been pivotal clinical asthma trials from the LIBERTY ASTHMA clinical development program that support its use in reducing asthma attacks and improving lung function.
The dosage for atopic dermatitis is 300 mg every other week after a loading dose of 600 mg. The studies of dupilumab for asthma looked at loading dosages of 400 mg and 600 mg followed by maintenance doses of 200 mg or 300 mg. It still remains to be seen what the dose will be when its approved.
The IL-4 and IL-13 pathway is being seen as an important pathway for allergic inflammation, besides its current approval for atopic dermatitis, Dupixent is also being studied for nasal polyps.
There has been a recent influx of biologic therapy to treat moderate to severe asthma patients. Xolair (omalizumab) was approved over 10 years ago, but most recently Nucala, Cinqair and Fasenra have been approved, with more to come soon.
We have discussed future potential treatments too.
The monthly cost of Dupixent for eczema is approximately $3,000/month, although insurance companies have been covering it if certain criteria are met.
Please check back with us on Dupilumab’s approval, there is a target action date of October 20, 2018. If you suffer from moderate to severe persistent asthma that is not well controlled, speak to your asthma and allergy doctor to see which treatment is best for you.
Once Dupixent for asthma is approved, it may be hard to choose which add on medication is best for patients uncontrolled with moderate to severe persistent asthma. Xolair (0malizumab) which was the first biologic medication approved, works best for allergic asthma. Those patients with high IgE counts and perennial allergic triggers, such as dust mites, mold, cat or dog dander. The other biologic medications (Nucala, Cinqair, Fasenra) and soon to be released Dupixent, work best for eosinophilic asthma. Among that class of medications it may be harder to choose, as each have their pros and cons. Nucala was the first one to be released and allergists are most likely more familiar with it. Cinqair’s dosing can be modified according to patient’s IgE count but it is currently only available as intravenous. Fasenra’s mechanism of action is more “upstream” and it can be given every other month. We will find out more about dupilumab for asthma once its fully approved. There was a recent study comparing two of them, see below for details.
Update October 3rd, 2018
A recent study published in the New England Journal of Medicine, looked at 2 independent phase 3 randomized controlled trials to test Dupilumab’s efficacy in treating uncontrolled and glucocorticoid-dependent asthma.. Patients either received 200 or 300 mg of dupilumab every 2 weeks or placebo, irrespective of asthma biomarkers. Both doses of dupilumab decreased the annual severe asthma exacerbation rate nearly 50%. Additionally, both doses increased FEV1. Dupilumab worked best for patients with eosinophil counts greater than 300. In terms of decreasing oral glucocorticoid-treated asthma, dupilumab decreased the dose by 70% compared to 40% for placebo. Collectively, these results show that dupilumab for asthma decreases exacerbations and increases lung function in patients with asthma, with a more pronounced effect in patients with increased blood eosinophil counts.
Update Oct. 22, 2018
The FDA approves Dupixent for add-on maintenance therapy in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral steroid dependent asthma. The drugmaker is also co-developing Dupixent for other conditions as well, including pediatric asthma, chronic sinus infection with nasal polyps and adolescent eczema. The list price for Dupixent is $37,000 per year for asthma.