Indications of safe, tolerable benefit with ruxolitinib cream for atopic dermatitis—as highlighted in a series of new data presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience this weekend—could spell its eventual marketing approval by the US Food and Drug Administration (FDA), if sought out.
What the topical JAK 1/2 inhibitor may mean for real-world patients is an opportunity for more reasoanable disease management—but the parameters of the novel therapy’s use will have to be first refined by clinicians.
In the second segment of an interview with HCPLive during AAD VMX, Lawrence Eichenfield, MD, of the Rady Children’s Hospital and UC San Diego School of Medicine, discussed the evolution of therapeutic use from the “core clinical studies” procedure, to actual clinical practice strategies. As he noted, ruxolitinib cream may become altered by prescribing clinicians from a daily, 8-week regimen, to something a more infrequent maintenance therapy once that regimen is complete.
“That’s off-label to discuss that, but that’s what we’re trying to do in real life: What’s the least amount we could use to keep the disease under control?” he explained. “There’s always work after we get the drug in our hands, in figuring out how we might use it and how we might use it with other agents. That’s part of the fun, but also the challenge.”
On the matter of possible FDA application and marketing approval, Eichenfield said ruxolitinib cream may need to clear safety and tolerability questions raised by previous non-steroid topical treatments decades ago—as well as safety concerns associated with oral JAK inhibitors. Additionally, the matter of skin permeation risk with the topical therapy beyond the assessed 8 weeks needs to be answered in ongoing research.
Nonetheless, Eichenfield expressed reasonable hope for the thus-far promising agent.
“We’re hoping that the data we’ve seen so far reflects the sense of topical ruxolitinib, which is that it appears to be incredibly well tolerated, the safety data looks good, and the efficacy looks good—and it’ll be differential, therefore, to oral medications,” he said.
Eichenfield also touched on the matter of using successes observed with ruxolitinib cream and its emerging topical JAK inhibitor drug class to re-engage chronic skin disease patients previously let down by past medications.
“I do think there’s a placement for this in atopic dermatitis, and I think topical ruxolitinib—as you discussed with vitiligo and other disease states—as an anti-inflammatory could also be very useful,” he said.