An expert dermatologist provides insight on unmet needs in clinical trial endpoint measurements that would improve the management of atopic dermatitis.
Andrew Blauvelt, MD, MBA: In recent years, we’ve had a number of clinical trials for moderate to severe atopic dermatitis [AD], so we’re getting very comfortable with these trials. We’re getting comfortable not only performing them but also looking at the data from these trials. From the beginning, we’ve had the FDA telling pharmaceutical companies and dermatologists that the primary end points of these trials need to include the IGA [Investigator’s Global Assessment] 0/1 score. That’s the percentage of patients who have clear skin or almost-clear skin. We’re also seeing EASI [Eczema Area and Severity Index] 75 being incorporated as a primary end point in a number of trials. That’s the percentage of patients who are 75% or more improved on the EASI score.
To me, they don’t tell the whole story. There are a number of issues with looking at just at IGA 0/1 and or just EASI 75. Those are scoring the signs of atopic dermatitis and don’t address the symptoms or quality of life at all. We know that itch is a dominant symptom in patients with atopic dermatitis, much more in atopic dermatitis than in psoriasis. Pruritus dominates patients’ lives. It’s a horrible thing for them with their AD, so I’ve been advocating for an itch measurement or an itch score to be incorporated in the primary end point, or at least as a coprimary end point.
The other thing that’s big in atopic dermatitis is quality of life. For example, we know that quality of life is worse in patients with moderate to severe AD compared with those with moderate to severe psoriasis. If you take those 2 diseases, the quality of life is even worse in moderate to severe AD compared with psoriasis. The triumvirate is to have a primary end point that incorporates 3 measurements: a signs score such as IGA 0/1 or EASI, an itch score like NRS [numeric rating scale] drop of 4 points, and then a quality-of-life score such as DLQI [Dermatology Life Quality Index] 0/1, which means no impact on quality of life. I’d love to have a composite score for assessing these drugs. We need to look at how well they’re doing in all 3 domains. Short of that, we’re getting that data, but we’re not having them as primary end point, so we can’t do subanalyses post hoc to look at this particular way to measure success for our drugs.
Transcript Edited for Clarity