Stella Lee, MD: CRSwNP Patients, Before Dupilumab

A new pooled analysis of data from the pivotal phase 3 SINUS-24 and SINUS-52 trials showed that dupilumab significantly improved upper and lower airway outcomes in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and comorbid asthma versus placebo.

The data from the pair of double-blind studies, presented at the American Thoracic Society (ATS) 2019 International Meeting in Dallas, TX, show a new promise of improved symptoms previously unknown to patients with a severe form of CRSwNP.

In an interview with MD Magazine®, study author Stella Lee, MD, director of Sino-Nasal Disorders & Allergy at the University of Pittsburgh, explained the brief history of CRSwNP care, and what the investigative biologic could provide to patients.

MD Mag: What does the CRSwNP patient population look like, and why is it critical they receive optimal therapy?

Lee: So patients who have chronic rhinosinusitis, especially with nasal polyps, they have very impaired quality of life. It's a common condition worldwide, and we really don't understand what causes it. It's a bit of a mystery still—there's a lot of host and genetic factors in play, and perhaps it's a type 2 inflammatory disease.

These patients suffer greatly from loss of smell, they can't breathe, they can't taste. Their nose has taken over their lives—imagine if you had a cold that never went away, compounded by times 100. These patients suffer a lot from these symptoms, but unfortunately there are no treatments available for these patients.

Previous treatment has emphasized upper-airway or lower-airway pressure care. What led to dupilumab's assessment in CRSwNP?

Well, the story begins at the University of Pittsburgh. My colleague Sally Wenzel, who is one of my amazing colleagues in pulmonary medicine, was doing this trial with dupilumab in asthma. And she did see a trend that perhaps these patients who have asthma had approved SNOT-22 scores.

Fortunately, we were able to be involved in the phase 2 trial. I was skeptical at first, because I had patients who had significant disease, who hadn't been able to smell, taste, or breathe in over a decade. And after the first week, patients were telling me, "I can smell again, I can breathe again." I really was in disbelief.

That was really exciting for us to be a part of the phase 2 trials. And we were one of the few US sites, actually. And that has now transitioned to the phase 3 US trials, and we know the results are quite similar to the phase 2, which is also reassuring it wasn't just in that small population of patients.

I was really in disbelief, when patients with the most severe blockage in their sinuses—you know, when you meet a patient who has not been able to smell or breathe for a decade, you wonder, "Is surgery even going to help them? I don't think even oral steroids are going to help them."

It's been incredibly promising for me to see that, and exciting for our patients.