Dr Elaine Siegfried on Safety Considerations for JAK Inhibitors in Pediatric Atopic Dermatitis

There are insufficient data on the long-term safety of Janus kinase (JAK) inhibitors for the treatment of atopic dermatitis, with blackbox warnings indicating risks such as thrombosis and all-cause mortality, said Elaine Siegfried, MD, professor of pediatrics and dermatology, Saint Louis University Health Sciences Center.

Transcript

Can you speak on the general safety considerations of JAK inhibitor use for pediatric patients with atopic dermatitis?

Well, of course, JAK inhibitors were just recently approved. We all know about the class labeling blackbox warnings that include things like thrombosis and all-cause mortality. What we don't have is great data, that is, long term data that distinguishes between the pan-JAK inhibitors or the selective JAK inhibitors. We just do not have enough data to talk about long-term safety.

In the clinical trials, all we have is 4 weeks in adolescents—we have longer in adults, but we also have blackbox warnings. In my mind, there'd be a little bit better lab abnormality following, so if thrombosis is a real risk in children, especially, I would be worried about just a microangiopathic process that would lead to the thrombosis. We don't even understand that very well.

If we had better lab parameters that monitor that, something like, for example, D-dimers, to look to see what was happening with that over time, we'd probably have a little bit more comfort level with that. But so far, we have limited long-term data. I think JAK inhibitors have been proven to be incredibly effective for short-term relief, and that may be the niche for those drugs, but we can't really say much about long-term safety.