Iltefat Hamzavi, MD: New Phase 2b Findings on Upadacitinib for Non-Segmental Vitiligo

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Hamzavi discusses new late-breaking data from AAD 2024, including major takeaways and safety profile after 52 weeks.

In a new interview with HCPLive, Iltefat Hamzavi, MD, discussed new phase 2b findings on once-daily upadacitinib monotherapy in adults with extensive non-segmental vitiligo (NSV). The findings suggested that the drug led to clinically meaningful re-pigmentation of patients’ extensive vitiligo.

Hamzavi works as senior staff physician for Henry Ford Health System's department of dermatology and has served as the founding co-chair of the Global Vitiligo Foundation. His team’s late-breaking data were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

“So the study was a phase 2b study for 52 weeks, and it had adult patients 18 - 66,” Hamzavi explained. “The primary endpoint was the facial (F)-VASI and the total (T)-VASI. The study was broken up into 2 periods. About 185 patients received once-daily, 20 milligrams packets in. Some patients received 11 milligrams, some received 6, and then there's a placebo group.”

Hamzavi explained the dose-ranging component to the study, explaining that treatments were continued for about 28 weeks. By that point, study participants who received placebo were able to switch over to either active drug, at 11 or 22 milligrams.

His team found that skin re-pigmentation, assessed using F-VASI and T-VASI, was observed in all of those treated with upadacitinib from week 0–24, which met their study’s primary endpoint. This persisted through to week 52.

“So the biggest takeaways were that efficacy of facial VASI75, which is 75% repigmentation of the face, was achieved in about 63% at the highest level,” Hamzavi said. “And that was the 11 milligram dosing. The 22 milligram dosing had 38% and 6 milligram dosing had 37%. The placebo was around 29%, 51%, and 26%, respectively, for those 3 different doses, so for the 6, 11, 22 comparison.

Hamzavi noted that the placebo response of around 29%, and then the optimal dose of around 11 milligrams being 63%, suggested that the active drug was more effective. He added that there seemed to be a dose response curve, but explained that it plateaus out, concluding that 11 is better than 6 milligrams.

“The repigmentation across the body was also significantly different between placebo and the active comparator,” Hamzavi said. “And again, the same thing happened with the total body VASI. At the highest dose, there wasn't that much difference. So it seems…that 11 milligrams might be the sweet spot for the use of this particular medication. It's exciting that we're seeing an active response, but like all the other studies that we're seeing with vitiligo, it takes time to see the results.”

Later, Hamzavi was asked about the drug’s safety profile.

“So dermatologists know the safety profile of JAK inhibitors,” he explained. “The big question is, are there any new safety signals that we're not going to anticipate? And there are no new safety signals within this group. So it is something we, the company and the other investigators, will be tracking but so far no new safety signals that we're not surprised to see.”

To learn more from Hamzavi’s team’s data, view the full interview segment posted above.

The quotes contained in this summary were edited for clarity.