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Expert Interview

Slingshot members are talking to an expert! The topic is:

A look at Dupixent's recent FDA approval for its new indication of EoE and the Phase 3 study(NCT03633617)

Ticker(s): REGN

Who's the expert?

Institution: Scripps Clinic

  • Medical director of the Ambulatory Surgical Center at Scripps Clinic & an Associate Professor of Medicine at the Uniformed Services University of Health Sciences,
  • Treats 200-300 patients with EoE and has used Dupixent a handful of times off label
  • Clinical interests are in esophageal and gut motility disorders, while his research focuses on esophageal conditions, particularly eosinophilic esophagitis and gastroesophageal reflux disease and the complex interaction between the two conditions. 

Interview Questions

Intro - Background info and details about clinical practice
How many patients with EoE do you treat?

Added By: user1ae2bf5f

Prior to Dupixent's approval for this indication, how do you manage patients with this disease?  What other drugs are used in what sequence, and what is the unmet need as you see it?

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If you have used Dupixent off label for EoE, how has that experience gone?  Did patients benefit?  
Was this only in patients with comorbidities where the drug was already approved?

Added By: user1ae2bf5f

In the clinical trial, benefit was shown with weekly dosing.  Although for other indications the approved dose commonly used is every other week dosing.  
Were your off label patients being treated with weekly or every other week dosing?  Was this a factor in the amount of benefit they experienced?
What dosing regimen do you anticipate using now that it is approved and given that it seems weekly would be needed for this disease?   Will patients comply with a weekly dosing regimen?

Added By: user1ae2bf5f

What was your view of the Phase 3 trial results in general, and is this something you have been excited about for your patients? 

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In the Phase 3 trials, in Part A they showed 60% vs. 5% and in Part B, 59% vs. 6% achieving ≤ 6 eos/hpf on peak esophageal intraepithelial eosinophil count
They also showed 22 pts improvement vs. 10 on placebo on the DSQ score In part B 24 vs. 14What were your takeaways from these results? Are these the most important endpoints in this disease and are these clinically meaningful changes?    

Added By: user1ae2bf5f

Since no other drugs are approved for this indication, there was no requirement to compare Dupixent to a standard of care in the clinical program. How do you think those Dupixent results compare with steroids or other unapproved drugs that are used for this condition?   

Added By: user1ae2bf5f

They also showed 39% reduction in abnormal endoscopic findings compared to 0.6% for placebo on the EoE Endoscopic Reference Score (EoE-EREFS), where patients experienced a 3.2 point reduction with Dupixent compared to a 0.3 point reduction for placebo (p<0.0001).  On Patient Global Impression of change Survey, 40% vs. 7.7% reported "very much better" on dysphagia.  Out of all the endpoints in the trials, what stands out to you the most from these results, and what is the most important aspect to patients?

Added By: user1ae2bf5f

In the past, companies tried to develop IL-5 inhibitors in this setting (like Nucala and Cinqair), but they failed to show a benefit over placebo in Phase 3 trials.  Is this something where the IL-5 pathway for whatever reason is just not sufficient to treat this disease, but blocking IL-4 and IL-13 can?  

Added By: user1ae2bf5f

How comfortable are you with the safety profile of Dupixent in this indication?  What are the risks you are most concerned about, if any?

Does the longer term data from other indications with this drug give you some reassurance about its longterm safety profile with chronic use?

Added By: user1ae2bf5f

As you think about patients with EoE where you tried Dupixent in the past, vs. which EoE patients you will give the drug going forward post-approval, how do you see that evolving? In terms of patient type/severity/profile etc.

What percentage of your EoE patients do you anticipate putting on Dupixent, in the next 6 months, 1 year, and years into the future?  What will be the factors that the trend of your usage will depend on?

Added By: user1ae2bf5f

Will Dupixent be the new standard of care for EoE? Are there certain patients you wouldn't want to put on this drug?

Added By: user1ae2bf5f

What is your level of excitement about Dupixent for EoE? On a scale of 1-10 what number would you choose and why?

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Are there any other drugs in development for EoE that you are excited about?

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