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In the VOYAGE trial, dupilumab (Dupixent) significantly reduced asthma exacerbations and improved lung function and asthma control in children (ages 6 to 11 years) with uncontrolled, moderate-to-severe asthma, with an acceptable safety profile. A post hoc analysis presented at the recent American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, evaluated the association between lung function improvements and asthma control in this population.

In this last of four exclusive episodes, 番茄社区 brought together three expert leaders in the field -- moderator Michael Wechsler, MD, of National Jewish Health in Denver, is joined by Flavia Hoyte, MD, also of National Jewish Health, and Leonard Bacharier, MD, of Vanderbilt University Medical Center in Nashville, Tennessee -- for a virtual roundtable discussion on the .

Click here to watch other episodes in this roundtable series.

Following is a transcript of their remarks:

Wechsler: So welcome back to another AAAAI roundtable sponsored by 番茄社区. I'm Professor Michael Wechsler, and I'm joined today by my colleagues Dr. Len Bacharier, professor of pediatrics at Vanderbilt University, and Dr. Flavia Hoyte, who's a professor of medicine in the allergy division at National Jewish Health in Denver, Colorado.

Again, the AAAAI took place in Washington, D.C., in February of 2024. There were a lot of exciting topics that came out. We've already discussed in other roundtable sessions about studies looking at some of the biologics, looking at EGPA [eosinophilic granulomatosis with polyangiitis], looking at food allergies.

Now, in this session we're going to talk a little bit about pediatric asthma, and again, at the AAAAI this year there were some post hoc analyses of the VOYAGE study, which looked at dupilumab's efficacy in the pediatric population. Len, you were intimately involved in the study, the VOYAGE study, so maybe you could talk a little bit about the VOYAGE study overall and some of the post hoc analyses that were done at the AAAAI.

Bacharier: Sure, thanks, Mike. So the VOYAGE study was the pivotal clinical trial of dupilumab versus placebo in children 6 to 11 years of age with type 2 asthma, which was uncontrolled despite moderate- to high-dose inhaled corticosteroid background therapy. Randomized controlled trials a year in duration clearly demonstrated that the addition of dupilumab over placebo led to substantial reductions in the risk of severe exacerbations, led to substantial improvements in lung function, improvements in asthma control, reductions in type 2 biomarkers, and had a very favorable safety profile.

This study was followed up by the study, which confirmed all of those outcomes for an additional year and reaffirmed the safety profile as well.

What we presented at the AAAAI meeting was a post hoc analysis where we wanted to try to relate the degree of lung function improvement that occurred during the study and how that related to patients' improvement of asthma control, because there's been back and forth about whether asthma control ACQ [Asthma Control Questionnaire] scores and FEV1 [forced expiratory volume in 1 second] are really interrelated, or whether they manifest different aspects of disease activity.

So what we did is we pooled all the patients in this study, irrespective of the treatment arm they were assigned to, and we divided them up into three groups based on the amount of FEV1 percent predicted change they had over the 1-year trial. So there was the group that changed the least, the group that changed in the middle, and the group that changed their FEV1 in the greatest fashion.

And what we found is that the group that you landed in, in terms of your FEV1 improvement related to the likelihood and magnitude to which your asthma control scores improved, such that a higher improvement in FEV1 was associated with a much greater likelihood that you would achieve well-controlled asthma and a better Asthma Control Questionnaire score.

So I think what we've seen here is that -- and that was again irrespective of treatment arm -- so if your lung function improved in placebo, this relationship held true as well. So I think what we're seeing is another motivator to try to maximize lung function in children, because not only does it reduce their rate of lung function decline, which is a very common pattern in childhood asthma, but also knowing that you've improved your lung function should suggest that you'll also improve other aspects of asthma management such as asthma control. And I think this is yet another motivator for therapies to maximize lung function.

Wechsler: Flavia, again, these data are exciting, or reaffirming our impression that dupilumab is an effective therapy in the pediatric population. What are your thoughts on this study and on the efficacy of dupilumab overall in the pediatric population specifically?

Hoyte: Yeah, I mean, I do agree that this is a very interesting study, and I think the impact goes well beyond childhood. So lately we've been talking more and more about clinical remission in asthma, and we talk about trying to optimize lung function and stabilize it at that optimized lung function. And sometimes the ship has sailed when you're talking about older patients, and that damage happens early on. And so I think trying to really maximize lung function early and minimize that loss from day one, I think is very important.

So this is really impactful. Like you said, Len, another reason to aim for that preserved lung function, and it's interesting to see that correlation. I would be interested to see what this study would look like in the adult data from the dupilumab studies.

Wechsler: Yeah, great. Another exciting study from the American Academy of Allergy, Asthma & Immunology from Washington, D.C., this February, again, highlighting the importance of treating both adult and pediatric patients. This study in pediatrics, the importance of treating patients with biologic therapies like dupilumab that can really have a benefit over the short term and over the long term, and really have a significant impact in terms of reducing morbidity over the long term as well.

So, thanks a lot for joining us today, and thank you to Len and Flavia for reporting about these important studies at the AAAAI. We'll see you next time.

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