Closing the Gap Between Trials and Real-World Care

Panel discussions and abstract presentations at the European Respiratory Society (ERS) 2026 International Congress focused on biologic treatments, personalized medicine, and predictive biomarkers in asthma and chronic obstructive pulmonary disease (COPD).

Francesca Puggioni, MD, is an adjunct professor of respiratory diseases at Humanitas University and vice director of the Personalized Medicine Asthma and Allergy Clinic at Humanitas in Milan, Italy, and a speaker at the ERS Congress, where she discussed new clinical data on dupilumab in COPD and asthma.

In an interview with The American Journal of Managed Care^® (AJMC^®), Puggioni spoke about how these biologic findings translate into everyday practice.

This transcript was lightly edited for clarity.

AJMC: Exacerbation rates in real-world cohorts often look different from trial populations. In your own patients, does reducing exacerbations translate as cleanly into better quality of life as the trial data suggest, or do other factors end up mattering just as much day to day?

Puggioni: We have to work a lot on this. What we don't have to do is look at exacerbation as just symptoms. The problem with exacerbation is that when there is only one exacerbation, one hospitalization per year, and when we are in repeated exacerbations, it is too late. Remodeling is on; inflammation is over. That means that between one exacerbation and the other, there is a subclinical inflammation that is very severe, which is acting on the remodeling in the disease in the lung.

This means that we should look at exacerbations as a very strong warning signal, and there should be a pivotal shift in our therapeutic approach as soon as we know that we have an exacerbation. And we should also consider that we don't know the exact number of exacerbations of the patient, because usually they take oral corticosteroids by themselves through auto-prescription or antibiotics through auto-prescription, so maybe we are aware of only 1 or 2 exacerbations, while over the years maybe they had 2, 3, or more courses of therapies without the direct control of the general practicioners or the specialist.

AJMC: Biomarker-driven eligibility (eosinophils, FeNO) is central to how dupilumab and similar biologics get prescribed and reimbursed. Do you think current biomarker thresholds for access are well-calibrated, or are they excluding patients who'd still benefit?

Puggioni: Well, biomarkers are a huge context in which there is a lot of debate between specialists. Of course, we need noninvasive biomarkers that are easy to perform everywhere, not only in research centers. FeNO, eosinophils, and IgE are tests that the majority of hospitals and doctors can perform, and the majority of patients can afford. Of course, we need more detailed biomarkers. But let me say, I wouldn't search for a single biomarker, but a combined score of biomarkers that gives us a better idea of the complexity of the disease, the degree of the disease, and the endotypes of the disease.

In this case, we need the help of other specialists, like, for example, ear, nose, and throat doctors, who are used to performing biopsies on polyps, or dermatologists or gastroenterologists for eosinophilic esophagitis. But I think that we should develop algorithms that are a little bit sophisticated, not in the biomarkers by themselves, but in the relationship between them. The research in this case has a long way to go.

AJMC: Both the COPD and asthma data this year point toward earlier intervention—treating before structural damage or before failing first-line options. Practically speaking, in the Italian/European system, what's the biggest barrier to actually shifting biologic use earlier in the disease course?

Puggioni: Of course, we have regulations that assess whether we can use biologics both in COPD and in severe asthma, in particular situations when the maximum of the total possible inhaled therapy is prescribed and where there are exacerbations with specific characteristics. But I think the most important barrier to accessing this is not regulatory but the education of the patient to understand that this is not normal: their quality of life is not normal, not being able to breathe, not being able to walk properly, not practicing sports, and having exacerbations and continuous cough and dyspnea. This is a big task, a huge task we are doing with the patients' association. Then, of course, there is the referral from the GPs to the specialist, and I think it's a big problem all around the world, not only in Italy or in Europe.

Too few doctors and too many patients, so this is another barrier. But I think that registries in this sense could be more useful—for example, for severe asthma patients, we have the Severe Asthma Network Italy, and there is a website where patients can find a center that is close to their town, and so they know where to go, to the doctor or doctors who are working at the center of excellence, and this can help them achieve the right therapy. Also, the patients' association receives emails from patients who are a little bit confused about what to do—they write to us—and in this network, we are all available to visit the patient to assess the level of the disease.

References

1. Couillard S, Chatt S, Rabe K, Martinez F, Bruselle G, Al-Ahmad M. Exploring new clinical data for dupilumab and itepekimab in COPD and asthma. Respir AMJ. 2026;4(1):42-53. doi:10.33590/respiramj/A3973834