John Harris, MD, PhD: Year 1 of Ruxolitinib Cream for Vitiligo

In what’s been arguably the most productive year of treatment development for vitiligo, experts find themselves brimming with fresh patient feedback and prospective new drug options.

In an interview with HCPLive prior to the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this weekend, John Harris, MD, PhD, director of the Vitiligo Clinic and Research Center and chair of dermatology at UMass Chan Medical School, highlighted the contents of the annual meeting’s three-hour vitiligo symposium—which include evolving discussions around phototherapy, surgery, medical therapies and emerging treatments for different pathogeneses.

Especially after the US Food and Drug Administration (FDA) approved ruxolitinib cream (Opzelura) as the first treatment indicated for vitiligo last year, the session topics are beginning to resemble a carousel: ruxolitinib moves from “emerging treatments” to “medical therapies,” new agents move to “emerging treatments,” and the process starts over.

“It’s kind of fun because now we’re transitioning,” Harris said. “I used to talk about ruxolitinib as an emerging therapy—but now it’s going to move to the medical treatment section because it’s approved. Just watching that…that really highlights all the excitement around this.”

Regarding emerging therapies, Harris and company had plenty to review: Pfizer’s candidate JAK inhbitior ritlecitinib, upcoming oral JAK inhibitor options, as well as developing pediatric and open-label extension trials for later-stage agents. What’s more, he reviewed his own involvement with the development of auremolimab—an agent acquired by ruxolitinib cream’s Incyte last October that is nearing clinical trial initiation for vitiligo.

“In the background…of course we’re constantly doing new research and finding new mechanisms of disease which we hope leads to new therapies as well,” Harris said. “There’s no end to the excitement.”

But 2022 belonged to the historic approval of vitiligo cream, as Harris and colleagues find themselves “knee-deep in prior authorizations and trying to get (this drug) out to patients.” The advantages between the first-in-class drug versus the previous vitiligo treatment standard has been night and day.

“Previously, the conventional therapy was to alternate Class I topical steroids with topical tacrolimus,” Harris said. The steroids gave you a little better efficacy but you had to get a break from there or you could get side effects from chronic use. Ruxolitinib appears…to be the most potent and effective topical we have, better than a class 1 topical steroid. And the benefit is that there are none of the side effects that topical steroids have: deadening of the skin, color changes, permanent alterations.”

Regarding real-world safety outcomes, Harris highlighted acne—prevalent in approximately 1 in 10 patients receiving ruxolitinib cream for vitiligo, he noted—as the primary concern. Many more patients have discussed the drug’s Black Box Warning, which notes risk of chronic heart disease and even “sudden death” associated with treatment.

“People read that and are understandably confused and concerned, and no one has seen any of those side effects with topical ruxolitinib,” Harris said. “Oral ruxolitinib can give you those things, in rare populations.”

As is standard with most first-in-class options, an extended dialogue between patients and physicians around ruxolitinib cream is to be expected. After years of waiting for this opportunity to truly treat the disease, Harris encourages every single chance to talk it over.

“(The Black Box Warning) is a ‘better safe than sorry’ approach, but it does result in very long conversations with patients,” Harris said. “As a dermatologist, my job isn’t to convince someone to take this cream, but I really do want them to understand enough to make a good decision.”