Name: What was the primary measure of efficacy in the 2 randomized double-blind clinical trials conducted on baricitinib?
Uploaded: 2023-10-01T00:00:00.000Z
Description: What was the primary measure of efficacy in the 2 randomized double-blind clinical trials conducted on baricitinib?

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Lilly Olumiant AA October 2023

What was the primary measure of efficacy in the 2 randomized double-blind clinical trials conducted on baricitinib?

Alopecia

You on the phase three trials, which are double bind, randomized, placebo controlled trials in adults with severe alopecia areata that were evaluated with oral varicitinib. They evaluated two different doses of varicitinib, two milligrams or four milligrams that were utilized in the trials versus the placebo. And to enter into the study, there had to be at least 50% scalp hair loss. It's what's called a salt score, the severity of alopecia score. And essentially that number, if you say 50%, equates to 50% involvement of hair loss on the scalp so you can visualize it. So at week 36, which is when the primary endpoints were evaluated for the study in phase three, in both the trials, they had to get to at least 20% or less hair loss from where they started. Now, in the study, the average salt score was 85%. So picture someone with 85% scalp hair loss. And over 36 weeks, which is nine months, they would have to get to less than or at 20% hair loss from an average of 85, even though the entry level was 50% hair loss. So that shows you if you can visualize that difference. Some of them got to complete growth regrowth, but they had to get to at least 20% or less, starting at an average of 85%.

What was the primary measure of efficacy in the 2 randomized double-blind clinical trials conducted on baricitinib?

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