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TRuE-AD1 and TRuE AD2 Trial: Baseline Characteristics

Video

Thought leaders provide an overview of the basline characteristics of the TRuE-AD1 and TRuE AD2 phase 3 trial.

James Q. Del Rosso, DO: The mean age in the study was in the lower 30s, from 31 to 34 years. About 4 of 10 were men, which means that 6 of 10 were women. As far as their race designation, the majority were White. About 1 of 4 were Black. There was an inclusion of the Asian population, but 1 of the limitations is that it was relatively low. A significant number of patients were looked at in the study. The median duration disease going into this was about 15 or 16 years. These were individuals who had had atopic dermatitis for some time.

Let’s look at the body surface area. You’re envisioning a patient who’s going into the trial and how much of their body surface area is affected by eczematous dermatitis. It was between 9% and 10%, which means the amount involved is the individual’s palmar surface of their hand. Including the palmar surface of the fingers and the palm, it’s 1%. About 9% to 10% of their hand sizes affect the different parts of their body. The scalp was excluded in that particular assessment.

The EASI [Eczema Area and Severity Index] score looks at different parts of the body and corrects for the extent of eczematous dermatitis and the intensity based on specific criteria. You’re looking at each individual, correcting for the amount of body surface area, and coming up with a score. That’s the major tool that’s used. Other tools, such as SCORAD [scoring of atopic dermatitis], are sometimes used. It’s a significant feature. They use a numeric rating scale for that.

With the baseline Investigator Global Assessment, the first thing you do when you go into the room is look at the subject and grade them, looking at all the areas involved. You’re looking at their entire skin surface. About 3 of 4 were moderate, and the rest were rated mild. Mild is a 2, and moderate is a 3.

What is the Worst Itch Numeric Rating Scale? For the week between screening and going into the baseline, the subjects are given a diary. They rate each day on an 11-point scale: 0 means they had no itching at all, and 10 is the worst possible itch that they could experience. Then they pick a number in between. At the end of that week, those numbers are added up, and you come in with the mean or the average score. They had to report at least 4 of 7 days. If it was less than that, their data were not included. This gives you an assessment of how severe their itching is. It’s about a 5, which is fairly significant itching. That’s the mean score, so some could obviously be higher and some could be less, but everyone had itching going into the study. We’re looking at patients who had a 2 or greater. Over 8 of 10 had that, and two-thirds had a baseline itch score of 4 or greater. These patients had fairly significant itching.

One thing that’s important to assess is facial involvement, which is very common in atopic dermatitis. Having eczematous dermatitis—red, itchy, scaly skin—on your face is obviously not something individuals like, so they scratch it. Facial involvement is significant. With some topical medications, we have concerns, and there are limitations on the face. About 4 of 10 patients in the study had facial involvement, and they could use the vehicle cream or the ruxolitinib [Opzelura] cream. They didn’t know which 1 they were using. They could use it on the face, including the eyelids. It was important to look at the evaluation on the face because we have some limitations with other medications.

Raj Chovatiya, MD, PhD: Was there anything about the baseline patient characteristics that surprised you, that made you feel this is reflective of your practice?

Lisa Swanson, MD: It was very reflective of my practice: patients with mild to moderate atopic dermatitis, patients who had suffered from it for a while, patients with itch related to their atopic dermatitis. I felt it was very representative of the patients I see.

Raj Chovatiya, MD, PhD: In terms of the hard numbers, around 10% was the number I quoted in my clinical experience. That’s what you saw on average in patients across treatment groups. By and large, most patients here had moderate disease, with a smaller chunk having a mild disease. Finally, individuals had atopic dermatitis for a long time. You weren’t dealing with the population that was just diagnosed. There’s a long existence of the disease.

There was a lot of itch as well. Oftentimes, when we use this scale of 0 to 10, we subset things out: 1 to 3, 4 to 6, and 7 to 10 for mild, moderate, and severe. Most of our patients were fall in the middle of that scale, meaning they definitely had pretty bad itch on a daily basis.

TRANSCRIPT EDITED FOR CLARITY

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