Baricitinib 4 mg delivers rapid, significant hair growth in adolescents with severe alopecia areata

Q. Why is it important to study baricitinib in adolescents with alopecia areata?
First of all, we know that alopecia areata is quite frequent and about 40 percent of alopecia areata will start before the age of 20. So it’s really important and it’s affecting a lot of people. And also, it’s well demonstrated that severe alopecia areata leads to a loss in the quality of life with impaired self-esteem, stress, anxiety, depression, and it’s even more important in infants and in adolescence. So it’s clearly important to have treatments.

We have only one treatment that is FDA and EMA approved. It’s ritlecitinib that is approved after the age of 12. But there is still a high unmet need. So we need new treatments for this population.

Q. Can you give us a brief overview of the BRAVE-AA-PEDS study design and key endpoints?
In fact, this is a phase III study, including infants by starting age of 6 and adolescents, so between the age of 12 and 18. It’s a prospective randomized trial and, during the last AAD meeting, we presented the results from the adolescent populations.

So, there was a comparison between placebo, baricitinib 2mg and baricitinib 4mg. It was well balanced between the three groups. And what is quite important to note is that there were 257 adolescents included, which is by far the largest population ever included in a trial for alopecia areata. It was only severe and very severe alopecia areata, meaning at least 50 percent of the scalp with hair loss. And as usual, the primary endpoint was the SALT 20 or below at week 36.

Q. What were the main characteristics of the patient population?
In fact, that’s very important because when we looked at the population, first, most of the population were White, about 60 percent of the population, then followed by about 27–29 percent of Asians and about 5–9 percent of Black or African-American.

Most of the inclusions were done in the United States, Canada, and Europe, but there were also patients included in Japan and the rest of the world. But what is quite interesting is to note that about two-thirds of the patients were very severe—so with alopecia areata totalis and universalis, which is a very, very severe population. So it’s important to keep this in mind in terms of results, that it was a very severe population that was included in this study.

Q. What did the results show about efficacy at weeks 12 and 36 for both doses vs. placebo?
The main result for looking at SALT ≤20: 42% of the population treated with baricitinib 4mg achieved a sub 20 or below at week 36. It was more than 27% in baricitinib 2mg and less than 5% in placebo, which is highly significant.

The results were already significant at week 12, showing a very rapid response in many patients. And if we are looking at SALT of ≤10, it was 36% with baricitinib 4mg, more than 21% with baricitinib 2mg, and about 2% in the placebo group again at week 36.

Q. How did baricitinib perform in terms of safety and tolerability?
In fact, there were absolutely no new safety signals that were noted.

We knew already quite a lot about the safety of baricitinib because it’s already approved for infants and adolescents for atopic dermatitis in many countries. But here—and it’s very important in this population—there was no new safety signal. Only one serious infection that was a non-complicated appendicitis, which resolved in five days. So, very reassuring data in this trial.

Q. What are the next steps in exploring its potential for younger patients?
What will be important is to look at late endpoints because the results are good, but they are not reaching yet the plateau. So we are very excited to see how we can improve and how much we can improve those populations.

And of course—and that’s very important because so far, there is no approved treatment—we want to see the ongoing trial with infants aged between 6–12 because it’s well demonstrated that the impact is very high, and we need even more treatment for these populations.

Q. If approved, how could baricitinib fit into current treatment approaches for childhood alopecia areata?
That would be very welcome because, as I mentioned, we have—and we are happy to have—already ritlecitinib, which is providing very good results and good safety.

It’s always difficult to compare between the two trials, but the results here seem even better. And we know that, unfortunately, not all the patients are responding to ritlecitinib. So having new treatment options for patients with alopecia areata is very welcome. I think that will help a lot of adolescents suffering from severe alopecia areata.