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Dermbits

How clinically relevant are the boxed warnings that are in the package insert with topical ruxolitinib cream?

Atopic Dermatitis

When box warnings appear in the label, we certainly have to recognize that that is something that could come up in the conversation. But remember that they also appear with some of the other nonsteroidal agents that we have for atopic dermatitis, like pimacrolomus cream and tuchrolamus ointment. In the case of topical ruxalitinib, the box warnings are essentially preventative. They're conditions like serious infections, potential for malignancy, cardiac events, thrombosis, thromboembolic events that were seen with oral Janus kinase inhibitors and not seen in the studies with topical ruxalitinib, except for a couple of cases of thrombosis that we don't know are necessarily related. So we have to recognize that we're there. We have to address risk factors in general. Certainly patients that are smoking or on oral contraceptives have a greater risk of thromboembolic events unrelated to the topical ruxalitinib. But in fact, the risk of these serious effects happening with topical ruxalitinib are essentially negligible if you're using it less than 20% body surface area only in the areas where the examiner's dermatitis is present. And in the studies that was about 10% of the patients.

How clinically relevant are the boxed warnings that are in the package insert with topical ruxolitinib cream?

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