Earlier this year, at the JP Morgan Healthcare conference, Regeneron CEO Leonard Schleifer referred to Dupixent (dupilumab), the fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, as “a pipeline in a single product.”
Eugenio De Corso. Image from adventprogram.com
The drug, co-developed by Sanofi and Regeneron, is following a similar course to AbbVie’s Humira (adalimumab), a fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody, in terms of its growing roster of indications. Dupixent is now approved as a treatment for eczema (atopic dermatitis), asthma, chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic spontaneous urticaria.
The drug generated $14.15 billion in sales between Regeneron and Sanofi in 2024, representing a 22% year-over-year jump.
Dupixent showed superiority over Xolair for chronic rhinosinusitis subtype in a phase 4 study
Yet the “pipeline in a product” strategy involves more than solely racking up new approvals. The next step is to show superiority within its approved indications over competitors, thus solidifying its value to physicians and patients. Here, Dupixent is doing just that. Most recently, the phase 4 EVEREST study results showed that Dupixent demonstrated superiority over Xolair (omalizumab) in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) in patients with coexisting asthma.
For CRSwNP outcomes, Dupixent significantly reduced nasal polyp size and improved the ability to identify different smells compared to omalizumab at 24 weeks, with rapid improvements seen as early as four weeks. Dupixent also showed greater improvements on asthma outcomes compared to omalizumab, including lung function and asthma control, demonstrating its efficacy in treating both upper and lower respiratory diseases.
To learn more about the significance of Dupixent targeting both CRSwNP and asthma in a single trial, we spoke with Eugenio De Corso, an ENT specialist, and a physician at Gemelli Hospital and an adjunct professor of Otorhinolaryngology at the Catholic University of the Sacred Heart, who is also the lead investigator of the EVEREST study. In the following interview, De Corso described how the recent clinical trial can help physicians compare Dupixent versus Xolair in proving the treatment of upper and lower airway diseases, while also sharing why the EVEREST data sheds light on how two biologic medicines that have been on the market for a long time compare.
What is the significance of targeting both CRSwNP and asthma in a single trial, and how does Dupixent’s mechanism of action support this dual benefit?
CRSwNP and asthma are comorbid diseases, with the majority of patients living with CRSwNP also having asthma. Dupixent blocks IL-4 and IL-13, key drivers of the type 2 inflammation that is known to be a central driver of both of these respiratory diseases.
In your opinion, does this data suggest a shift in treatment guidelines for patients with coexisting upper and lower airway disease?
Biologics are approved for use in patients who are uncontrolled on other treatments like steroids and inhalers, and are not restricted to patients who have coexisting disease. Given this trial compared Dupixent to Xolair versus earlier lines of treatment, results from this study wouldn’t impact when these treatments are approved or recommended for use. Instead, these data can provide information to physicians about how two biologics compare on improving key signs and symptoms of upper and lower airway diseases to help guide treatment decision making for patients with uncontrolled disease.
How might these findings influence how physicians approach treating patients who have both CRSwNP and asthma?
These findings provide important insights into how two biologic medicines that have been on the market for a long time compare to each other in patients who suffer from a higher disease burden because of their coexisting diseases. Dupixent outperformed Xolair in all CRSwNP and asthma endpoints, including reducing nasal polyp size, sense of smell and lung function, signs and symptoms of these diseases that can substantially impact patients’ day-to-day lives, and they showed generally similar safety profiles.
Are there ongoing or planned studies to evaluate Dupixent in other type 2 inflammatory conditions or pediatric or other populations with CRSwNP and asthma?
Dupixent is already approved to treat seven diseases with underlying type 2 inflammation, which span dermatological, respiratory and gastrointestinal diseases. In patients with asthma, Dupixent is already approved for certain children as young as 6 years of age and as young as 12 years of age with CRSwNP. Dupixent is still in clinical development for other diseases where type 2 inflammation is thought to play an important role, including bullous pemphigoid, chronic pruritis of unknown origin and lichen simplex chronicus.
Filed Under: Biologics, clinical trials, Immunology, Pulmonology
