Experts in dermatology discuss ideal candidates for dupilumab.
Raj Chovatiya, MD, PhD: For those that might be concerned about the heavy degree of overlap between patients that maybe have atopic dermatitis and prurigo nodularis [PN], the trial went to great lengths to do the best that it could to really sort those people out that you might be treating with moderate to severe atopic dermatitis. So, that was part of the key exclusion criteria for the trial itself. And really, even in terms of the atopic subgroup, no more than 10% of the participants were allowed to have active mild atopic dermatitis. And so, individuals that had even moderate to severe disease in the last 6 months, in particular, were also excluded. So really, for the small chunk of people that perhaps had mild eczema and the baseline, but also had moderate to severe forms of prurigo nodularis, that’s what you were capturing, and a really smaller chunk of that.
And, even when you subset out the data from the trial, and some of those post-hoc analyses, you can see similar responses whether they were those people with atopic history or no atopic history. And this ties very nicely back to the point that both of you made earlier which is really trying to understand this as a disease state, and not just an associated feature or finding that comes along with other disease states. I really like the high-level impressions you gave the data, but maybe we can take it into the clinic a bit and give a little more practical advice. If I’m somebody that maybe doesn’t see that much prurigo nodularis, or maybe I’ve made that diagnosis, in what patient might this be a good choice? When would I think about introducing this as therapy? Sarina, I’ll start with you this time.
Sarina B. Elmariah, MD, PhD: Everybody will learn where they’re comfortable trying to launch different medications for the treatment of prurigo nodularis. I would say that, particularly in light of the favorable safety profile, and these data from the PRIME and PRIME2 trials and now that it is the only FDA [Federal Drug Administration]-approved medication for PN, I would take anyone who would meet the criteria to me of having a true impact on their quality of life, having moderate to severe PN, I would think of this as even first line for them. You may have a patient who has already been successfully managed, for example, on a combination of methotrexate and pregabalin, or gabapentin, and we would talk about what are the benefits and risks of transitioning over, or if somebody was just insufficiently controlled on their existing regimen, this might be another option for them. And I think that’s the importance of having medications now at our fingertips that are approved for this, and hopefully, that list will also grow. But I think this would be the first line for many moderate patients.
Raj Chovatiya, MD, PhD: Shawn, how about you?
Shawn Kwatra, MD: I would say that dupilumab is definitely a great safety profile and a great place to start now for many of our patients. I think that there are going to be a number of new therapies in the future as well that are going to be added to this landscape. But being the only FDA-approved therapy currently, I don’t think there’s a reason not to start with it. And what was interesting is the FDA did not say that folks had to have failed topical therapies. I believe that’s highlighting the fact that this is truly a systemic disease, and what I want is for the degree of time between making a diagnosis and getting on appropriate systemic therapy to be shortened. And I think that we need to diminish that time and dupilumab has a great safety profile as an excellent agent. I do think there’s going to be a role for nemolizumab, and I think there’s going to be a role for certain JAK inhibitors and other agents as well, but at the current time, I’d absolutely go with dupilumab.
Raj Chovatiya, MD, PhD: I love that you made that point about the indication because I was itching to get that in. And I think that really speaks to the fact that we will criticize some of the decisions that the FDA chooses to make, particularly when it comes to dermatologic therapy. This is one of those cases where they truly understood the need. And, much as you pointed out before, realize that this is a systemic condition that people need treatment for. And we really do not need to waste time jumping through hoops or making weird cautions and guidelines for something that very clearly has convincing data in the context of safety.
Transcript edited for clarity