Dr. Amit G. Pandya discusses study results for recently approved ruxolitinib cream for vitiligo and what researchers are reporting on investigational oral JAK inhibitors for vitiligo on the face and body.
Amit G. Pandya, MD, Director, Pigmentary Disorders Clinic, Palo Alto Foundation Medical Group, Sunnyvale, California; and Adjunct Professor of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas
“This is the most exciting time of my career when it comes to treatment of vitiligo. We haven’t had FDA-approved treatments for vitiligo up until last year, and there are many new products that are in the development stage,” said Amit G. Pandya, MD, who presented “Vitiligo Medical Treatment Advances” at the Pigmentary Disorders Exchange meeting in Chicago.
The Approved Topical
Last year, the FDA approved 1.5% ruxolitinib cream (Opzelura, Incyte) for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
“The phase 2 study showed that 50% of patients achieved 75% re-pigmentation on their face, called a facial Vitiligo Area Scoring Index 75, or F-VASI75. One out of three got 90% of the color back on their face, which is exciting.”1
Patients in the phase 2 study received the topical cream, got the same sun exposure they would get during their normal daytime activities, and did not receive phototherapy, said Dr. Pandya.
“Half the patients, after one year of use, got half their color back over their total body, also called a T-VASI50, which was encouraging because this was again without any phototherapy.”
Responses in the phase 2 study were better on the face, trunk, and proximal extremities than on the hands and feet. But a significant number of those studied did get a response on the hands and feet, as well, said Dr. Pandya.
The safety profile for ruxolitinib cream was excellent, he said.
“Less than 10% of patients got any acne, pruritis, or dermatitis.”
Dr. Pandya said he was among the authors of a follow-up study that showed adding phototherapy to ruxolitinib cream further improved results.2
“The phase 3 study, which led to the FDA’s approval, showed very similar results to the phase 2 study. Half of patients got 75% of the color back on their faces and 50% of patients got half the color back over their total body surface area.”3
“Again, acne, as well as pruritis, occurred in less than 10% and were the only significant side effects different from placebo,” he said.
In The Pipeline
Dtudies on medications for vitiligo that are in the pipeline, said Dr. Pandya, including one he participated in with oral ritlecitinib, a Janus kinase 3 (JAK3) inhibitor.
“In this study patients had to have active vitiligo, which is a higher bar to achieve compared to people with stable vitiligo like the previously discussed studies. This study showed a 66% reduction of vitiligo on the face after one year of treatment. About 37% of patients achieved F-VASI75 after one year. A lower percentage got 50% re-pigmentation over the total body [T-VASI50].”4
Side effects were similar to placebo indicating that ritlecitinib was well tolerated, said Dr. Pandya.
“The final study I talked about was the povorcitinib study whose results I presented recently at the Spring AAD meeting. This is a different medication than the others in that it inhibits JAK1, which may cause fewer side effects than other JAK inhibitors.”
Researchers looked at the effect of povorcitinib in improving vitiligo on the face and whole body, he said.
“I was only able to show the 36-week results, as they were hot off the press. We don’t have the 52-week results yet, but the 36-week results showed similar changes to the ritlecitinib study, with one-third of the patients getting 75% of the color back on their face after 36 weeks (F-VASI75).”
Safety was excellent, with side effects similar to placebo, said Dr. Pandya.
“Acne, the only significant side effect compared to placebo, was seen in less than 10% of patients.”
“Overall, these are some exciting announcements about JAK inhibitors for vitiligo. There will be a lot more to come in the future,” he said.
References:
- Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(10244):110-120. doi:10.1016/S0140-6736(20)30609-7.
- Pandya AG, Harris JE, Lebwohl M, et al. Addition of Narrow-Band UVB Phototherapy to Ruxolitinib Cream in Patients With Vitiligo. J Invest Dermatol. 2022;142(12):3352-3355.e4. doi:10.1016/j.jid.2022.05.1093.
- Rosmarin D, Passeron T, Pandya AG, et al. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022;387(16):1445-1455. doi:10.1056/NEJMoa2118828.
- Ezzedine K, Peeva E, Yamaguchi Y, et al. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial [published correction appears in J Am Acad Dermatol. 2023 Apr 6; J Am Acad Dermatol. 2023;88(2):395-403. doi:10.1016/j.jaad.2022.11.005.
Disclosures: Dr. Pandya is an investigator for Incyte; a consultant for Abbvie, Arcutis, Avita, Immune Tolerance Network, Incyte, Pfizer, Thalocan, Trifecta, Twi, Villaris, Vimela, and Vyne; and he has stock options in Tara Medical and Zerigo Health.