Real-World ERS 2026 Data Show Dupilumab's Edge in Severe Asthma

Biologics innovation, technology, and data supporting these therapies are rapidly growing in the respiratory disease landscape—a key speaking point across the European Respiratory Society (ERS) 2026 International Congress in Barcelona, Spain.

Dupilumab (Dupixent; Regeneron) is one of many biologics highlighted at ERS, but a more pressing issue, as these therapies continue expanding, is patient access. But regulatory access is based on real-world and clinical trial data, among other factors, Francesca Puggioni, MD, a pulmonary allergology specialist at Humanitas Research Hospital in Milan, Italy, and speaker at ERS, said in an interview with The American Journal of Managed Care®.

“We have differences, for example, in the timing of prescription and administration because we are developing biologics, for example, that can be administered just twice per year,” she said. “And this is innovative because there is a change in the life of the patient and could be taken into consideration if the results are good, also by regulation.”

Respiratory diseases and conditions, like chronic obstructive pulmonary disease (COPD) and asthma, require large real-world data sets, best assessed through international registries, Puggioni said. For example, the EU-ADVANTAGE study presented at ERS assessed the risk of severe asthma exacerbation and oral corticosteroid (OCS) prescription across 4 biologics: dupilumab, omalizumab (Xolair; Genentech), benralizumab (Fasrena; AstraZeneca), and mepolizumab (Nucala; GSK).¹

The study found that dupilumab was associated with a lower risk of severe asthma exacerbations and significantly reduced OCS prescriptions in over 2700 patients with SA.¹

“That means that also in real life, where the patient is not the perfect patient of the registration trial with no comorbidities, perfect compliance, and perfect control,” Puggioni said. “We had to learn more about the therapy, and we are using it now.”

But patient access must come first, she concluded, noting that although regulatory bodies have “a big responsibility,” the data must first support safety and efficacy.

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References

1. Canonica GW, Virchow JC, Bourdin A, et al. Real-world comparative effectiveness of biologic therapies in severe asthma: EU-ADVANTAGE. ERJ Open Res. 2025;11(4):01217-2024. doi:10.1183/23120541.01217-2024