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Video

Dr Surya Bhatt on Dupilumab's Promise in Reducing COPD Exacerbations, Enhancing Quality of Life

Surya Bhatt, MD, MSPH, of the University of Alabama at Birmingham, explained the phase 3 BOREAS and NOTUS trials demonstrated comparable safety profiles for dupilumab in treating patients with chronic obstructive pulmonary disease (COPD).

Surya Bhatt, MD, MSPH, medical director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham, explained that the phase 3 BOREAS and NOTUS trials showed comparable safety profiles for dupilumab, with nonspecific treatment-emergent adverse events.1,2

Therefore, if FDA-approved, he noted that dupilumab could significantly reduce chronic obstructive pulmonary disease (COPD) exacerbations and improve lung function and quality of life for patients. Bhatt discussed these topics further at the American Thoracic Society 2024 International Conference, where he presented the phase 3 NOTUS trial results.

Transcript

How do the dupilumab safety and efficacy results from the phase 3 BOREAS trial and the phase 3 NOTUS trial compare?

The safety profile was very comparable between the BOREAS and the NOTUS trials. In both of them, about two-thirds of them had treatment-emergent adverse events, which were rather nonspecific.

So, both of the trials were conducted predominantly during the time of COVID. So, some of the adverse events were related to COVID-19 infections, and some of them had COPD exacerbations, which are not unanticipated events.

Other potential adverse events were nonspecific and included nasopharyngitis, headaches, and so on. They were very balanced between the treatment and the placebo group. Essentially, there was no major safety signal with dupilumab, and this is consistent with the known safety profile of dupilumab, which is already in clinical use for other indications.

If FDA approved, how do you think dupilumab will impact the overall management of COPD? How will it affect the quality of life of patients with COPD?


There's a huge unmet need for additional treatments and people already going through exacerbations. With the specific endotype of type 2 inflammation, almost 50% of these patients, even after being on maximal inhaled triple therapy, continue to have exacerbations.

So, these patients will be an immediate target for this biologic once it's approved. I think we will see a significant reduction, potentially reflecting the clinical trial efficacy results of almost a 30% reduction in exacerbation frequency.

Very importantly, the drug also resulted in a very rapid and sustained improvement in lung function and quality of life, and we potentially see that in clinical practice, as well.

References

1. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. New England Journal of Medicine. 2023;389(3). doi:10.1056/nejmoa2303951

2. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. New England Journal of Medicine. Published online May 20, 2024. doi:10.1056/nejmoa2401304

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