Vitiligo

Korea's first new drug for vitiligo, how effective is Rinvoq?

Rinvoq (upadacitinib) is a once-daily oral JAK inhibitor that was approved in Korea in October 2026 for the treatment of non-segmental vitiligo in patients aged 12 years and older. In clinical trials, nearly half (43–48%) of patients who took it for 48 weeks achieved a 50% or greater reduction in facial vitiligo area, and about one in four (23–25%) achieved a 75% or greater reduction. These results are from Rinvoq alone; a small study combining it with phototherapy showed even greater improvement.

What is Rinvoq and how does it work for vitiligo?

Rinvoq is a medication that selectively blocks JAK, a key molecule in the immune signals that cause vitiligo. It is taken orally once a day.

Vitiligo is an autoimmune disease in which T cells, a type of immune cell, attack melanocytes. T cells that accumulate in the skin release interferon-gamma, an immune signaling substance. When nearby skin cells receive the interferon-gamma signal, they release various inflammatory substances via JAK inside the cells, and these substances attract more T cells to the skin. The increased T cells attack melanocytes while releasing interferon-gamma again, and this cycle repeats, causing vitiligo to spread. By inhibiting JAK, Rinvoq blocks this signaling, preventing further T cell accumulation and weakening the attack.

This medication is not entirely new. It has been used for several years for conditions such as atopic dermatitis and rheumatoid arthritis. In October 2026, approval was expanded to include non-segmental vitiligo in adults and adolescents aged 12 years and older (15 mg once daily). Rinvoq is the first drug approved for vitiligo treatment in Korea.

Previously, oral medications used for vitiligo were steroids or immunosuppressants. These were mainly used to suppress the spread of lesions, while repigmentation was induced with ointments and phototherapy (light therapy). Rinvoq is the first oral medication confirmed in phase 3 clinical trials to also restore lost skin color.

Compared to the topical JAK inhibitor OPZELURA cream (not approved in Korea), the differences are as follows.

CategoryOPZELURA creamRinvoq
TypeTopical cream, twice dailyOral tablet, 15 mg once daily
Area of actionOnly on the applied areaWhole body
Usable areaUp to 10% of body surface areaNo area limit
Main side effects monitoredAcne, itching at the application siteSystemic side effects such as infection, changes in blood tests

How much does Rinvoq actually improve vitiligo?

In phase 3 clinical trials, 43–48% of patients aged 12 years and older with non-segmental vitiligo who took Rinvoq for 48 weeks achieved a 50% or greater improvement in facial vitiligo score, and 23–25% achieved a 75% or greater improvement. In the placebo group, these rates were 13% and 6–7%, respectively.

The evidence comes from two phase 3 clinical trials (Viti-Up-1 and Viti-Up-2) published in the international journal The Lancet in August 2026. A total of 614 patients aged 12 years and older with non-segmental vitiligo participated across 138 centers in 18 countries. They took either Rinvoq 15 mg or a placebo once daily for 48 weeks, without any ointment or phototherapy—only Rinvoq. The participants had had vitiligo for an average of nearly 16 years. Considering that older vitiligo tends to be more resistant to repigmentation, this was a challenging condition.

48-week results (range across the two trials)

Evaluation ItemRinvoq 15 mgPlacebo
50% or greater improvement on face (F-VASI50)43~48%13%
75% or greater improvement on face (F-VASI75)23~25%6~7%
90% or greater improvement on face (F-VASI90)12~16%2~3%
50% or greater improvement on whole body (T-VASI50)19~21%6%

F-VASI is a score for facial vitiligo area, and T-VASI is for the whole body. For example, F-VASI75 means that facial vitiligo has decreased by 75% or more compared to before treatment.

You may feel that Rinvoq's F-VASI75 of 23–25% is lower than expected. In overseas data, about half of patients using OPZELURA cream reached F-VASI75 at 52 weeks. However, the two trials involved different patient populations. The OPZELURA trial included patients with vitiligo covering less than 10% of the body, while the Rinvoq trial included patients with more extensive vitiligo. It is difficult to compare the numbers directly.

The body responds more slowly than the face. At 48 weeks, only 5% of patients achieved a 75% or greater improvement in whole-body score (T-VASI75), which was not significantly different from the placebo group (2–3%). Repigmentation on the body requires a longer treatment period or combination with phototherapy.


Does Rinvoq work better the longer you take it? Does it also prevent spreading?

Rinvoq's facial improvement continued to increase without plateauing through 48 weeks. Among patients with active spreading vitiligo, the proportion who did not show an increase in lesion area at weeks 8 and 12 was 76% in the Rinvoq group and 60–61% in the placebo group.

Facial scores began to differ from the placebo group starting at week 8 of treatment. Averaged across the two trials, the facial score decreased by about 35% at 24 weeks and about 50% at 48 weeks. The improvement curve continued without flattening even at 48 weeks.

What about after 48 weeks? Results at 76 weeks were presented at the European Academy of Dermatology and Venereology (EADV 2026) in Vienna, Austria. The proportion of patients achieving 75% improvement on the face and 50% improvement on the whole body continued to increase through 76 weeks. I also participated as a co-author in the presentation covering these 76-week results and the results of combination with phototherapy.

It also has the effect of preventing spread. About 60% of participants had active vitiligo, where new spots appeared or existing spots enlarged. Among these, the proportion whose vitiligo did not spread at 8 and 12 weeks was 76% in the Rinvoq group and 60–61% in the placebo group. For those worried about vitiligo spreading, this result is as welcome as repigmentation.

Duration of treatmentMean change in facial score (Rinvoq group)
8 weeksDifference from placebo begins
24 weeksApproximately 35% reduction
48 weeksApproximately 50% reduction, continuous improvement without plateau
76 weeksProportion reaching improvement continues to increase (conference presentation)

Vitiligo treatment naturally takes time. You may not notice a big difference when you look in the mirror after about three months of taking it. We recommend observing for at least 6 months to 1 year before judging.


Is it better to combine Rinvoq with phototherapy?

Adding whole-body phototherapy to Rinvoq tended to improve both the face and body more than taking Rinvoq alone. This is still from a small study.

A separate trial was conducted within the Viti-Up study. 84 adults who had not achieved 90% or more whole-body improvement by 48 weeks were divided into two groups. One group continued Rinvoq alone; the other added whole-body phototherapy (narrowband UVB) twice a week. After about 28 weeks, both the face and body improved more in the group that received phototherapy together.

Although confirmation through larger studies is needed, this result is highly suggestive. Rinvoq suppresses the immune response that destroys melanocytes, while UV light stimulates the proliferation and migration of melanocyte stem cells remaining in hair follicles. Because the two treatments act at different stages, their effects may be additive when used together.

Treatment speed varied by body area. According to a site-specific analysis presented at the same conference, the head and neck improved the most, and the feet improved the slowest. Fingertips and feet have fewer hairs, and therefore fewer hair follicles containing melanocyte stem cells. This is why they respond slowly to any treatment.

While taking Rinvoq, combining it with phototherapy such as excimer laser can lead to faster and more effective repigmentation. This is especially true for slow-responding areas like the hands and feet.


What are the side effects and precautions of Rinvoq?

In the 48-week clinical trial, common side effects of Rinvoq were upper respiratory tract infection, acne, nasopharyngitis, and headache, and no serious safety issues were observed compared to placebo. As a class, JAK inhibitors have general precautions, so pre-treatment tests and regular monitoring are essential.

Item48-week clinical trial results
Common adverse reactionsUpper respiratory tract infection, acne, nasopharyngitis, headache (Rinvoq group 8–18%, placebo group 3–14%)
AcneAll mild to moderate; discontinuation due to acne in 1 patient
Herpes zoster1–2%, no disseminated cases
Blood test changesNeutropenia, anemia, transient liver enzyme elevation in some patients. No serious cases.
Discontinuation due to side effectsRinvoq group 2–3%, placebo group 4–5%
Major adverse cardiovascular events, thrombosis, active tuberculosis, lymphoma, non-melanoma skin cancerNot reported
Other cancersRinvoq group: 1 patient (detected on day 46 of treatment, judged to have low association with the drug); placebo group: 2 patients

No new safety issues were identified in the conference presentation that followed patients up to 76 weeks.

'Not reported' and 'no risk' are different statements. For the JAK inhibitor class, in other diseases such as rheumatoid arthritis, warnings exist for serious infections, cardiovascular events, thrombosis, and cancer in older patients or those with cardiovascular risk factors. If you are 65 or older, a current smoker, or have a history of cardiovascular disease, thrombosis, or cancer, the benefits and risks of taking the drug must be carefully weighed before deciding on treatment.

Several tests are needed before starting treatment: tuberculosis (including latent TB), hepatitis B and C, blood cell counts, liver function, and cholesterol. Regular blood tests are also performed while taking the medication. It cannot be taken during pregnancy, and contraception is required during treatment and for 4 weeks after the last dose. If you are breastfeeding, have upcoming vaccinations, or are taking other medications, please inform your doctor during the consultation.


Which vitiligo patients is Rinvoq suitable for?

Rinvoq is a treatment considered for non-segmental vitiligo that is extensive or rapidly spreading, or when topical treatments and phototherapy alone are insufficient. It is not the first-line treatment for all vitiligo patients.

For example, if you have a single coin-sized spot on your arm that has remained unchanged for years, systemic medication is generally not necessary. Topical ointment and excimer laser are usually sufficient. If you have recently noticed new spots appearing on your neck, arms, or knees, Rinvoq may be considered.

When Rinvoq is consideredWhen other treatments come first
Extensive vitiligo that is difficult to manage with topical treatmentsStable vitiligo limited to a small area
Active vitiligo with recent new spots or enlargementSegmental vitiligo (not included in this clinical trial)
Insufficient response to topical treatments and phototherapyLesions with many white hairs (leukotrichia): consider surgical treatment
Non-segmental vitiligo in patients aged 12 years and olderUnder 12 years of age, pregnant or planning pregnancy

There are still unknowns. Data on the possibility of relapse after stopping the drug are not yet available. Most clinical trial participants were White, with about 10–20% being Asian. Experience in Korean patients is still being accumulated.

As of October 2026, there is no health insurance coverage for vitiligo, so the cost burden cannot be ignored. Decisions about whether to take it, duration, cost, and testing schedule can be made together in the consultation room.

It is welcome news to share the first new drug for vitiligo. However, this drug alone does not solve all cases of vitiligo. We consider how much it is spreading, where and how extensive it is, and your age and health status, and combine medication, phototherapy, and surgery if needed to create a treatment plan.


References

Jung Min Bae

Dermatologist · Gangnam Branch

With sincere care and continuous research, I will be a reliable companion for vitiligo patients.