Rinvoq and Opzelura for Vitiligo: What the JAK Inhibitors Can and Cannot Do

For most of the last century the answer to "is there a drug for vitiligo?" was no. That changed in 2022–2023, when the first medicine developed specifically for repigmentation, Opzelura (ruxolitinib cream), was approved in the USA and the European Union. In 2026 the second is arriving: Rinvoq (upadacitinib), a once-daily tablet, received a positive opinion from the European Medicines Agency's CHMP on 29 June 2026 for non-segmental vitiligo in adults and adolescents, and is under review by the FDA.

Both belong to the same drug class – Janus kinase (JAK) inhibitors – and both have been tested in large, well-run trials. This article explains how they work, what the trials actually showed, who they are for, what they cost, what the risks are and how they fit with the treatments people already use. It is written for patients, not for prescribers; the decision to start either drug belongs to you and your dermatologist.

Why JAK inhibitors work in vitiligo

Vitiligo is an autoimmune disease. Cytotoxic T-cells in the skin attack melanocytes, the cells that make pigment. They are recruited and kept active by a signalling molecule called interferon-gamma, which acts through the JAK–STAT pathway inside skin cells. The chemokines that this pathway produces (CXCL9 and CXCL10) are the "homing signal" that brings more T-cells into the patch.

JAK inhibitors block that pathway. Without the interferon signal the T-cells stop being recruited, the attack on melanocytes fades, and melanocyte stem cells from the hair follicles can migrate back into the patch – the same repigmentation process that narrowband UVB stimulates, but triggered from inside the cell instead of by light.

There are four JAK enzymes (JAK1, JAK2, JAK3, TYK2). Ruxolitinib blocks JAK1 and JAK2; upadacitinib is selective for JAK1. Interferon-gamma signals mainly through JAK1 and JAK2, which is why both drugs help.

Opzelura (ruxolitinib cream 1.5 %)

What it is. A topical cream containing 15 mg/g ruxolitinib, made by Incyte. Applied as a thin layer twice a day to the depigmented areas, up to 10 % of the body surface area.

Who it is approved for. In the EU (approved April 2023) and USA (July 2022): non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. In England, NICE recommended it in March 2026 for non-segmental vitiligo from age 12 as a second-line option, after topical corticosteroids or calcineurin inhibitors have failed or are unsuitable.

What the trials showed. The two phase 3 trials, TRuE-V1 and TRuE-V2, enrolled 674 patients. The main endpoint was F-VASI75 – at least a 75 % improvement in the facial vitiligo score:

Two things stand out. Repigmentation kept increasing beyond week 24 – the 52-week numbers are much better than the 24-week numbers – and the face responded far better than the hands and feet, as with every other vitiligo treatment. In the long-term extension, most patients who reached F-VASI75 and kept applying the cream kept their result; those who stopped gradually lost some of it over a year.

Side effects. Application-site acne (about 6 %), itching, redness and nasopharyngitis were the most common. Blood levels of ruxolitinib from the cream are low, but the US label carries the class warning that applies to all JAK inhibitors (see below), and the EU label advises against use with other immunosuppressants and in patients with serious infections.

Cost and reimbursement. List prices in Europe are roughly 900–1 000 € per 100 g tube (Germany: about 960 €, PZN 18313923). Reimbursement varies: covered by statutory insurance in Germany for the licensed indication, recommended by NICE in England under conditions, not reimbursed or not yet available in several smaller EU markets. A 100 g tube lasts 1–3 months depending on the area treated.

Rinvoq (upadacitinib 15 mg tablets)

What it is. A once-daily oral JAK1 inhibitor by AbbVie, already approved for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease and other conditions. The 15 mg dose is the one studied and recommended for vitiligo.

Who it is for. The CHMP opinion covers non-segmental vitiligo in adults and adolescents from 12 years who are candidates for systemic therapy – in practice, people with active, more extensive vitiligo where creams alone are not enough. The European Commission decision usually follows a positive opinion within about two months; the FDA decision is expected later in 2026.

What the trials showed. The phase 3 programme, Viti-Up 1 and Viti-Up 2, randomised 614 adults and adolescents at 134 sites in 18 countries 2:1 to upadacitinib 15 mg or placebo. The primary endpoint was T-VASI50 – at least 50 % improvement over the whole body – at week 48; F-VASI75 was the key secondary endpoint. Results were published in The Lancet in 2026:

The response curves were still rising at week 48 and continued to rise in the open-label extension, with no sign of plateau – which mirrors the phase 2 study, where repigmentation at week 52 was clearly better than at week 24. In plain terms: about one in five patients gets a large whole-body improvement within a year, about one in four gets a large facial improvement, and results keep building with continued treatment.

Side effects. In Viti-Up the most common were upper respiratory tract infections, acne, nasopharyngitis and headache. Herpes zoster (shingles) occurred in 1.5–2 % of treated patients. No new safety signals were seen compared with the other approved indications – but the known JAK class risks apply.

Cost. Rinvoq 15 mg is already on the market: about 1 280 € for 30 tablets in Germany (PZN 15620317), similar elsewhere in the EU – roughly 15 000 € a year at list price. Whether health insurers will pay for it in vitiligo depends on the national assessment that follows EU approval (in Germany the AMNOG/G-BA process); until then it is available for vitiligo only off-label or through studies.

The JAK class warning – what it means for you

In 2021–2022 the FDA and EMA added warnings to all systemic JAK inhibitors after a large safety study of tofacitinib in rheumatoid arthritis patients over 50 with cardiovascular risk factors found higher rates of serious infections, major cardiovascular events, blood clots, cancer and death than with TNF blockers. The EMA now advises that systemic JAK inhibitors should be used in people over 65, smokers or ex-smokers, and those with cardiovascular or cancer risk factors only if no suitable alternative exists.

For a typical vitiligo patient – young, otherwise healthy, non-smoker – the absolute risk from a JAK1-selective drug at 15 mg is considered low, and Viti-Up did not show these events at a higher rate than placebo. But vitiligo is not life-threatening, so the risk–benefit calculation is different from rheumatoid arthritis. Expect your dermatologist to check blood counts, liver enzymes, cholesterol, hepatitis B/C and tuberculosis before starting, and to repeat blood tests during treatment. Live vaccines (including the shingles vaccine) should be given before, not during, treatment.

For the cream, systemic exposure is much lower and no such events have been attributed to it in trials; the warning is inherited from the class.

Opzelura vs Rinvoq at a glance

What both drugs do not change

Light is still the engine. Every vitiligo guideline – and the investigators of both drug programmes – treat JAK inhibitors as a way to switch off the immune attack, and narrowband UVB as the way to stimulate melanocytes to come back. A phase 2 study combining ruxolitinib cream with NB-UVB showed better repigmentation than the cream alone, and combination trials with upadacitinib are under way. If you have access to phototherapy, whether in a clinic or with a home 311 nm lamp, it makes sense to continue it alongside a JAK inhibitor, with your dermatologist adjusting the dose.

Results take a year. In both programmes the 48–52-week results were roughly double the 24-week results. Anyone who expects a visible change in eight weeks will be disappointed; anyone who stays consistent for a year is likely to see one.

Hands and feet remain hard. The facial scores in every table above are far better than the total-body scores. Areas with few hair follicles – fingertips, wrists, ankles, lips – repigment slowly with any treatment.

Maintenance is needed. Stopping treatment after repigmentation leads to gradual relapse in a proportion of patients. Plans for tapering, maintenance creams and sun protection should be made before you stop, not after.

The basics still apply. Sun protection on patches, control of associated thyroid disease and vitamin deficiencies, stress management and consistent skin care are part of every protocol, with or without a JAK inhibitor.

Frequently asked questions

Can I get Rinvoq for vitiligo now?
In the EU, formal approval is expected in the months after the June 2026 CHMP opinion; reimbursement decisions follow country by country. Until then a dermatologist can prescribe it only off-label, usually at your own cost. In the USA the FDA decision is pending.

Is Opzelura available in my country?
It is licensed across the EU, UK and USA, but stocked and reimbursed unevenly. Ask a dermatologist or hospital pharmacy; in some countries it must be ordered from abroad.

Can children use them?
Both are approved (or recommended) from age 12. Below 12, tacrolimus cream and narrowband UVB remain the standard.

Can I use Opzelura and Rinvoq together?
No – this has not been studied and combining two JAK inhibitors adds risk without evidence of benefit.

Do they work for segmental vitiligo?
The trials enrolled non-segmental vitiligo only. Segmental vitiligo has a different, less immune-driven course and usually responds best to phototherapy and, when stable, surgery.

What about the other JAK inhibitors – ritlecitinib, povorcitinib, baricitinib?
Ritlecitinib (Litfulo) and povorcitinib have completed or are completing phase 3 trials in vitiligo; baricitinib combined with NB-UVB showed strong results in a French phase 2 trial. Expect more approvals in 2027–2028.

Sources

• AbbVie press release, 29 June 2026: positive CHMP opinion for upadacitinib in non-segmental vitiligo.
• Efficacy and safety of upadacitinib in adults and adolescents for treatment of non-segmental vitiligo (Viti-Up): results of two phase 3 randomised controlled studies. The Lancet, 2026; DOI 10.1016/S0140-6736(26)00896-2.
• Rosmarin D et al. Two phase 3, randomized, controlled trials of ruxolitinib cream for vitiligo (TRuE-V1, TRuE-V2). New England Journal of Medicine 2022; 387: 1445–1455.
• European Medicines Agency: Opzelura EPAR (2023); Rinvoq EPAR and CHMP meeting highlights (June 2026).
• NICE technology appraisal (March 2026): Ruxolitinib cream for treating non-segmental vitiligo in people 12 years and over.
• EMA, PRAC recommendations on the use of JAK inhibitors in chronic inflammatory disorders (2022).

This article is for information only and does not replace advice from your dermatologist. VitiligoShop does not sell prescription medicines; we sell the UVB lamps and skin-care products that dermatologists combine with them – our treatment plan explains how.