Imagine the profound impact of a skin condition that erodes not just pigmentation but also a person's sense of self-worth and everyday confidence. For those battling vitiligo, this is a daily struggle that can lead to social withdrawal and emotional turmoil. But here's a glimmer of hope: AbbVie has just shared encouraging preliminary outcomes from their Phase 3 trials on upadacitinib, known by the brand name RINVOQ®, as a potential game-changer for adults and teenagers dealing with this autoimmune disorder. And this is the part most people miss—these results aren't just about skin; they're about reclaiming lives.
In a pair of identical Phase 3 studies, upadacitinib (RINVOQ®) hit the mark on its two main goals: a 50% improvement in the Total Vitiligo Area Scoring Index (T-VASI) from the starting point and a 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI) after 48 weeks. To put that in simpler terms, T-VASI measures how much of the body's skin has lost its color, like a map showing areas of depigmentation. F-VASI zooms in on the face, where changes are often most noticeable and can hit hardest emotionally. Both trials also succeeded in meeting important secondary targets¹, setting the stage for what could be a systemic approach to treatment.
These trials focused on non-segmental vitiligo (NSV), the most widespread type affecting over 90% of people with the condition. NSV creates symmetrical white patches on both sides of the body, often appearing in visible spots like the face, hands, feet, and groin²⁻⁴. As Kori Wallace, M.D., Ph.D., AbbVie's vice president and global head of immunology clinical development, explains: 'Vitiligo isn't merely a cosmetic issue—it's a long-term autoimmune disorder that can shake someone's self-image, identity, and routine.' She adds that there are currently no systemic medications approved specifically for repigmentation in vitiligo. 'These Phase 3 findings mark a major step forward in our dedication to aiding patients and broadening our immunology offerings with cutting-edge therapies.'
Delving deeper, T-VASI evaluates the overall extent of pigment loss across the entire body, while F-VASI concentrates on facial areas, which are particularly significant for psychological well-being in NSV patients. In both studies, about 70% of participants started with a T-VASI score over 10, indicating substantial involvement. Upadacitinib achieved its co-primary endpoints: T-VASI 50 (at least 50% reduction in T-VASI from baseline) and F-VASI 75 (at least 75% reduction in F-VASI from baseline) at week 48, outperforming the placebo group. Statistically meaningful differences also emerged for upadacitinib over placebo in secondary endpoints, such as F-VASI 50 at week 48¹.
Here's a snapshot of the key effectiveness data:
Phase 3 Effectiveness Findings¹
| Metric | Study 1 - Upadacitinib 15 mg (N=206), % | Study 1 - Placebo (N=102), % | Study 2 - Upadacitinib 15 mg (N=205), % | Study 2 - Placebo (N=101), % |
|--------|---------------------------------------|-----------------------------|---------------------------------------|-----------------------------|
| Co-Primary Endpoints | | | | |
| T-VASI 50 at week 48 | 19.4 | 5.9 | 21.5 | 5.9 |
| F-VASI 75 at week 48 | 25.2 | 5.9 | 23.4 | 6.9 |
| Secondary Endpoints | | | | |
| F-VASI 50 at week 48 | 48.1 | 12.7 | 43.4 | 12.9 |
Thierry Passeron, M.D., Ph.D., professor and chair in the Department of Dermatology at Université Côte d'Azur, shares his perspective: 'Many individuals with vitiligo face a path filled with doubt, irritation, and limited options for whole-body treatment.' He notes that these promising outcomes hint at the possibility of addressing the root inflammation, potentially providing a comprehensive solution that delivers tangible, visible improvements.
Safety-wise, upadacitinib's profile in these studies aligned with what's seen in its approved uses, with no unexpected concerns popping up. In the 48-week treatment periods across both trials, the most common side effects were upper respiratory tract infections, acne, and nasopharyngitis. Serious adverse events occurred in 3.9% of the upadacitinib group and 4% of the placebo group in Study 1, and 2% versus 1% in Study 2. No confirmed major cardiovascular events (MACE) or venous thromboembolism (VTE) were reported. Three cancer cases emerged: one in each placebo group and one in the upadacitinib arm in Study 1 (a genital neoplasm). No fatalities occurred in the upadacitinib groups, while one death was noted in the placebo arm of Study 2¹. Remember, upadacitinib isn't approved for NSV yet, and its safety and effectiveness haven't been reviewed by regulatory bodies.
Let's take a moment to understand vitiligo better for those new to the topic. It's a persistent autoimmune condition where the body attacks its own pigment-producing cells (melanocytes), leading to white patches that can show up anywhere, anytime. It's the leading depigmenting disorder globally, impacting 0.5% to 2.3% of the world's population. NSV dominates, making up about 84% of cases, and typically features asymmetrical patches on both body sides. Common sites include the face, feet, hands, and groin, and the condition often brings mental health challenges, like increased rates of depression and anxiety, due to its visible nature and emotional toll.
The Viti-Up trials (identified as M19-044) combined two identical Phase 3 studies under one protocol, each with separate randomization, sites, and data handling. They assessed upadacitinib's benefits, safety, and tolerability in adults and adolescents aged 12+ with NSV who qualified for systemic treatment. In the initial 48-week period (Period A), participants were assigned 2:1 to either upadacitinib 15 mg daily or placebo. Those finishing could enter Period B, a 112-week open-label extension with everyone on upadacitinib 15 mg daily, spanning 160 weeks total. Altogether, 614 NSV patients were enrolled across 90 sites worldwide. For more details, check clinicaltrials.gov (NCT06118411).
The co-primary goals centered on reaching T-VASI 50 (a 50% or greater drop in T-VASI from baseline at week 48) and F-VASI 75 (a 75% or greater drop in F-VASI at week 48) with upadacitinib versus placebo for NSV patients. Secondary aims included F-VASI 50 (50% reduction in F-VASI at week 48) and F-VASI 75 at week 24, focusing on the speed and extent of facial repigmentation—an area critical for visibility and psychological impact. Study 1 even incorporated 3D digital imaging for a subset to evaluate facial repigmentation more precisely.
Developed by AbbVie's researchers, RINVOQ® is a JAK inhibitor explored for various inflammatory immune conditions. In lab tests on human cells, it powerfully blocks cytokine-driven STAT phosphorylation via JAK1 and JAK1/JAK3 pathways more effectively than JAK2/JAK2. However, how this ties to real-world safety and effectiveness remains under investigation. Upadacitinib is currently in Phase 3 trials for conditions like alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.
RINVOQ® (upadacitinib) U.S. Approved Uses and Critical Safety Details⁵
RINVOQ is prescribed for:
- Adults with moderate to severe rheumatoid arthritis (RA) after trying and not responding to one or more TNF blockers.
- Adults with active psoriatic arthritis (PsA) who haven't seen success with TNF blockers.
- Adults with active ankylosing spondylitis (AS) where TNF blockers failed.
- Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) showing signs of inflammation, if TNF blockers weren't effective.
- Adults with giant cell arteritis (GCA).
- Adults with moderate to severe ulcerative colitis (UC) after other treatments, including TNF blockers or systemic options.
- Adults with moderate to severe Crohn's disease (CD) following unsuccessful TNF blocker or systemic therapies.
Its safety and efficacy in children aren't established for AS, nr-axSpA, UC, or CD.
- Adults and children 12+ with moderate to severe eczema (atopic dermatitis [AD]) that resisted prior treatments, excluding biologics or other injections when not advised.
Effectiveness in kids under 12 with AD is unknown.
It's unclear if RINVOQ LQ works in children with AD.
RINVOQ/RINVOQ LQ treats:
- Children 2+ with active polyarticular juvenile idiopathic arthritis (pJIA) after TNF blockers didn't work.
- Children 2 to under 18 with active psoriatic arthritis (PsA) if TNF blockers failed.
Safety for kids under 2 with pJIA or PsA remains unconfirmed.
Essential Safety Warnings for RINVOQ/RINVOQ LQ (upadacitinib)
What's the key info to remember? RINVOQ can trigger severe issues, so let's break it down clearly.
RINVOQ might lead to serious infections, weakening your defenses against bugs like TB, bacteria, fungi, or viruses. Some have died from these. Get tested for TB before starting, and watch for symptoms. Don't begin if infected unless advised. Call your doctor if an infection arises—you might pause treatment. Shingles risk increases too.
For those 50+ with heart risk factors, there's a higher chance of death.
It could raise cancer risks, including lymphoma and skin cancers. Smokers are more vulnerable to lymphoma and lung cancer. Get skin checks and protect from sun.
People 50+ with heart risk factors face increased major CV events like heart attacks, strokes, or death—worse for smokers.
Blood clots in legs, lungs, or arteries are possible and can be fatal, especially in those 50+ with heart risks.
Allergic reactions might occur, with symptoms like hives, breathing trouble, dizziness, or swelling—seek emergency help immediately.
Tears in the stomach or intestines can happen, often with NSAIDs or steroids. Get help for stomach pain, fever, chills, nausea, or vomiting.
Lab tests may show changes; your doctor will monitor and might pause treatment.
Avoid if allergic to upadacitinib or ingredients. Consult the Medication Guide for the full list.
Before starting, inform your doctor about infections, TB exposure, smoking, heart history, cancer, hepatitis, shingles, blood clots, diverticulitis, or intestinal ulcers. Mention liver issues, low blood counts, diabetes, lung disease, HIV, or weak immunity. If you've been to high-risk fungal areas (like certain U.S. regions), note that. Discuss vaccines—avoid live ones. For pregnancy, use contraception during and 4 weeks after; report pregnancies. Don't breastfeed during or for 6 days post-treatment.
Tell your doctor about all medications, including supplements, to avoid interactions, especially with antifungals, antibacterials, rifampicin, phenytoin, or immunosuppressants.
Steer clear of grapefruit products to reduce side effect risks.
After starting, report infections promptly. Seek urgent care for heart attack signs (chest discomfort, pressure, shortness of breath, sweating, nausea, weakness, slurred speech) or blood clot symptoms (swelling, leg pain, sudden chest/back pain, breathing issues). Alert for persistent fever, stomach pain, or bowel changes.
Common side effects: upper respiratory infections, shingles, herpes simplex, bronchitis, nausea, cough, fever, acne, headache, foot/hand swelling, high creatine phosphokinase, allergies, folliculitis, abdominal pain, weight gain, flu, fatigue, low white blood cells (neutropenia, etc.), muscle pain, flu-like symptoms, rash, high cholesterol, elevated liver enzymes, pneumonia, low red blood cells, gastroenteritis.
Retinal detachment has occurred in AD patients—call your doctor for vision changes.
Some may see tablet residue in stool; notify your provider.
These aren't all possible effects.
Dosage: RINVOQ once daily, with or without food; don't crush. RINVOQ LQ twice daily as oral solution. Follow your doctor's instructions exactly.
*Unless specified, 'RINVOQ' includes both forms.
This covers the essentials, but chat with your doctor for more. Report side effects to the FDA at medwatch or 1-800-FDA-1088.
If costs are a barrier, AbbVie offers support—visit AbbVie.com/PatientAccessSupport.
For full details, see the Prescribing Information and Medication Guide.
Global prescribing varies; check local labels.
About AbbVie
AbbVie's goal is to innovate medicines and solutions tackling today's severe health problems while preparing for future challenges. We focus on impactful areas like immunology, oncology, neuroscience, eye care, and aesthetics through our Allergan portfolio. Learn more at abbvie.com. Follow us on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
Forward-Looking Statements
Certain remarks here may qualify as forward-looking under the 1995 Private Securities Litigation Reform Act. Terms like 'believe,' 'expect,' 'anticipate,' and future verbs signal these. AbbVie warns that actual outcomes could vary due to risks such as intellectual property disputes, competition, R&D hurdles, legal issues, regulatory shifts, global economic factors (e.g., downturns, conflicts, trade tensions), and operational uncertainties. See AbbVie's 2024 Form 10-K, updates in 10-Qs, and filings for more on these risks. We don't commit to updating these statements unless law requires.
References:
- AbbVie. Data on file ABVRRTI82042
- Ezzedine K, et al. Lancet. 2015;386(9988):74–84
- Mazzei Weiss ME. Cutis. 2020;105(4):189–90
- Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13
- RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025
But here's where it gets controversial: while these results paint an optimistic picture, some experts question whether early access to unapproved drugs like upadacitinib could sidestep rigorous regulatory checks, potentially exposing patients to unknown long-term risks. Others argue it's unethical to delay promising treatments in diseases with few options. What do you think—is the potential for faster repigmentation worth the unknowns, or should we prioritize proven safety first? Could this signal a shift in how we approach autoimmune skin conditions, or might it overpromise on quality of life improvements? Share your views and debate in the comments—let's hear your take!
