AAD 2022: Incyte's latest Opzelura data show med's benefit grows over time in vitiligo

As Incyte awaits the FDA’s decision on a second dermatology use for eczema newcomer Opzelura, the company is rolling out fresh 52-week data showing the benefits of its topical JAK inhibitor increase over time. 

At the one-year mark, teens and adults with nonsegmental vitiligo who received Opzelura throughout Incyte’s late-stage TRuE-V study saw “clinically meaningful facial and total body repigmentation.” Specifically, greater proportions of patients hit facial and body endpoints on a measure of depigmentation severity called the Vitiligo Area Scoring Index, Incyte said Saturday at the American Academy of Dermatology’s 2022 annual meeting in Boston. 

Vitiligo is a condition in which part of a patient's skin loses its pigmentation. 

Among patients who applied 1.5% ruxolitinib cream—the generic name for Opzelura—twice daily for the entire study period, roughly 50% saw at least 75% improvement on a scoring index for facial vitiligo compared with roughly 30% improvement from baseline originally seen at Week 24. 

By Week 52, 75% of that same group of patients hit at least 50% improvement in facial repigmentation while about 30% achieved at least 90% improvement.

A greater proportion of patients at the one-year mark saw at least 50% improvement on the total body Vitiligo Area Scoring Index, and more than one-third of patients achieved a Vitiligo Noticeability Scale response, Incyte said. 

Opzelura’s safety—especially relevant given recent side effect concerns on the JAK inhibitor class at large—tracked with previous data on the med, Incyte said.

The yearlong results “add to the robust data showing ruxolitinib cream has the potential to be a meaningful treatment option for those with vitiligo," Jim Lee, M.D., Ph.D., Incyte's group vice president of inflammation and autoimmunity, said in a statement. 

Opzelura was originally up for an FDA ruling in vitiligo in April, but the med hit a snag several weeks back when the FDA delayed its decision by three months, pushing its action date out to July 18. 

The delay cropped up after the FDA requested additional data from Opzelura’s phase 3 program, with Incyte’s submission ultimately constituting a “major amendment” in the regulator’s eyes, Incyte said in March. 

The move doesn’t seem to spell any “major concern given Opzelura is continuing its launch in atopic dermatitis (AD), and all [chemistry, manufacturing and controls] issues should have been addressed during the AD review,” SVB Leerink analysts wrote in a note to clients earlier this month. 

Given that the regulator simply stalled its decision instead of handing down a complete response letter, the delay is likely “temporary and more procedural in nature versus substantive,” the analysts said.

Meanwhile, the company’s 52-week data help paint a fuller picture of Opzelura’s benefit in vitiligo, Incyte’s Lee said in an interview with Fierce Pharma. The results build on a positive, six-month readout debuted in October. That said, the company “knew going ahead into our clinical studies that 24 weeks was not going to be sufficient.”

That’s because it takes time to see Opzelura’s effect in vitiligo, the executive explained. 

“From our phase 2 data, we knew that longer durations would give us a better idea of how well the drug worked in this disease, in these patients,” Lee said. 

It’s important to recognize that vitiligo is an autoimmune disease, with many patients also suffering from other autoimmune diseases, he noted. 

Patients whose disease affects their face and other cosmetically sensitive areas like the neck and hands “suffer the most” from stigma, Lee said. “[W]hen they go out, they get stared at, and no one likes that.”

“[Y]ou’ll see in the literature that the majority of patients feel that they have the stigma, and many of those patients do develop psychological problems and thus have a severe impact on their quality of life,” he added. 

Current treatment options for vitiligo patients are slim. Opzelura, meanwhile, could snatch the crown as the first therapy FDA-approved for repigmentation in people suffering from the autoimmune disease. 

Given the sparsity of the current therapeutic landscape, education efforts for doctors and patients would be essential to Opzelura’s vitiligo launch, Lee explained. 

“I think there are a lot of patients out there who have been told that there’s nothing for their disease and have essentially stopped seeing their doctors and stopped seeking care for their vitiligo,” he said. The company will need to inform patients of the new treatment option and encourage doctors to bring back patients whose options were previously limited.

The FDA is set to make a decision on Opzelura in vitiligo by July 18.