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In this segment of his interview, Chovatiya speaks about how new consensus definitions on atopic dermatitis disease activity could impact clinical trials.
In his recent interview discussing a new consensus framework published in JAMA, Raj Chovatiya, MD, PhD, of Rosalind Franklin University Chicago Medical School, spoke in greater depth on the value of integrating both clinician-reported signs and patient-reported symptoms when looking at disease control in those living with atopic dermatitis.1,2
Chovatiya described the framework’s development as having been driven by recognition of atopic dermatitis as not defined solely by visible inflammation, but also by the experiences of patients, particularly symptoms such as pruritus, or itch, which often contribute substantially to disease burden and quality-of-life impairment.
According to Chovatiya, the initiative intentionally avoided creating definitions focused exclusively on either objective clinical findings or subjective symptom reports. The following Q&A interview summary highlights his responses to inquiries in the second half of his interview with HCPLive:
HCPLive: I know the framework separates clinician reported signs and patient reported symptoms. So how important is that distinction when assessing true disease control?
Chovatiya: You know, you really can't have one without the other in this disease state that is so much driven by not only what you see, but what the patient experiences. And this is something that we kind of knew coming into the exercise, that we did not want to try to come up with definitions that really looked at just a symptom or just a sign. So our goal was truly to combine both, and that's the reason why you'll see in these different categories. We're looking at a couple of different ways that you could report the overall lesional burden, but it was an important component of this too, given that it's the predominant symptom that our patients experience with this disease state. So you really can't have them dissociated. They really need to be thought of around the same time.
HCPLive: In your view, how could these consensus definitions potentially impact clinical research, particularly in terms of comparing efficacy across drugs or supporting regulatory decisions?
Chovatiya: You kind of answered that question a little bit in that question itself, given the fact that I think this is absolutely vital for thinking about how we might position new therapies that are coming to market, how we might query the true potential of a therapy to maybe even have remission for our patients. Then, we really need to think about how we design our endpoints around studies, and this is going to probably impact the entire regulatory pathway in terms of what type of claim we might make for a treatment with a patient. I think if we can sort of communicate this language and implement some of these signs and symptoms cut offs into the way we design studies, we'll be able to really communicate the potential of a drug and its possible effect a lot simpler.
HCPLive: Do you see the framework moving the field closer to a treat-to-target approach in atopic dermatitis, and what challenges might remain in implementing that strategy globally?
Chovatiya: We've seen a lot of different bites of this apple over a few years, there's been a couple of different rounds of treat to target strategies. There's been sort of the ahead recommendations, really trying to combine pros and clinician reported outcomes. We're seeing some of these definitions here for this low disease, very low disease, and on drug and off drug, control and remission that's incorporating both signs and symptoms. I think that maybe the biggest takeaway here is that we are beginning to see that there is a push for getting individuals to think about not only clinician assessments, but patient report.
I think that's vital. And I think also this idea that, you know, day to day practice sometimes it's really hard to have such strict numbers and multiple scores. It's just not the way practice in the US, at least is done. I think keeping a couple of general, vague cut offs in line for how we talk about how our patients are doing is really the most important point to take out of this. So rather than moving to get a new framework, I think it probably at least allows us to communicate patient status and also therapeutic success a little more straightforwardly.
Chovatiya previously reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.
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